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Through the Lens of Patient Partners: Challenges in Accrual of Older Adults to NCI Clinical Trials

Through the Lens of Patient Partners: Challenges in Accrual of Older Adults to NCI Clinical Trials Abstract The workshop “Engaging Older Adults in Cancer Clinical Trials Conducted in the NCI Clinical Trials Network: Challenges and Opportunities” included a Patient Stakeholder Workgroup that explored the needs and concerns of older adults with cancer regarding clinical trials. To accomplish this, the workgroup conducted patient focus groups in which participants were interviewed, recorded conversations were analyzed and coded, and salient themes were identified. The focus groups identified general barriers to accrual such as complex consent forms, general communication, restrictive eligibility, nonreferrals, patient costs, cultural insensitivity, limited accessibility in community settings, and transportation issues. They also identified the influence of knowledgeable information presenters, improved care, family or caregiver support, and the desire to help others as drivers or reasons to participate in clinical trials. The workshop concluded that multi-level interventions could be used to increase the accrual of older adults to National Cancer Institute clinical trials as well as others. Cancer is an important disease in the United States threatening the health and quality of life of adults aged 65 years and older. The median age of cancer diagnosis is 66 years, with more than 50% of cancer cases occurring in persons older than 65 years (1). The number of adults older than 65 years has been growing dramatically and is predicted to make up approximately 24% of the total population by 2060 (2). With the increasing population of older adults, the number of those needing cancer treatment in the future will substantially increase. Potentially beneficial cancer treatments are validated in clinical trials. For this reason, clinical trials aimed at decreasing the morbidity and mortality of cancer need to include proportionally representative numbers of older adults so the results encompass them. A retrospective study of more than 41 000 patients from 55 National Cancer Institute (NCI) clinical trials found that only 29% of patients were 65 years and older (3). Another study that investigated the external validity of the evidence base for the treatment of non-small cell lung cancer found that 2 major guidelines developed for the management of non-small cell lung cancer based their recommendations largely on studies that did not include patients older than 80 years. However, this is largely a disease in older adults (4). Calls to action to improve the accrual of older adults in trials have been made to generate the evidence needed for safe and effective treatments for this population (5-8). There are many barriers to the enrollment of older adults in clinical trials. Sedrak and colleagues (9) conducted a systematic review to evaluate published clinical trial barriers. They identified 4 major categories of barriers related to the trial system, providers, patients, and caregivers. Examples of the specific obstacles include restrictive eligibility criteria, providers not suggesting trials, and patient and caregiver perceptions of investigational therapies. Other known barriers include lack of awareness or knowledge of clinical trials, time and transportation burden, the unclear cost to participants, inability to pay out-of-pocket costs, misconceptions or mistrust about research, lengthy consent forms that may be difficult to read and understand, fear of not receiving adequate treatment if randomly assigned to the control group, lack of cultural sensitivity, and inherent bias in the health-care systems (9–15). The NCI Community Oncology Research Program (NCORP) is a national network that brings cancer clinical trials (CCTs) to community clinical settings and touches more than 1000 practices across the United States. The NCORP network is the primary source of accrual to NCI cancer control symptom management trials and health-related quality-of-life trials embedded into National Clinical Trials Network treatment trials (16). When recruiting and enrolling participants in NCI trials, NCORP uses a screening tool to learn why patients choose not to participate in clinical trials. St. Germain and McCaskill‐Stevens (17) reported on an analysis of more than 16 000 patient entries with a median patient age of 60 years. They found a lower percentage (17%) of patients aged 70 years and older who were screened and enrolled compared with 23% who were screened but not enrolled. The top reasons patients stated for not wanting to participate was wanting a different treatment than the trial offered or not wanting to participate in a clinical trial (17). The US Food and Drug Administration (FDA) has identified multiple interventions to enhance clinical trial enrollment, including removing restrictive eligibility criteria to allow older patients with controlled comorbidities on multiple concomitant medications to enter trials (18). Recommendations for modernizing eligibility criteria to improve access to clinical trials for older patients have been developed by the American Society of Clinical Oncology and Friends of Cancer Research (Friends). In a series of articles, American Society of Clinical Oncology and Friends provide inclusion criteria for investigators to use to stimulate broader enrollment in protocols (19,20). Liu and colleagues (21) recommend increased resources at academic institutions to engage community sites, including developing educational and behavioral interventions to promote patient enrollment, expanding trial designs that support older adult inclusion, and including community physicians in the design of trials and eligibility criteria. Soto-Perez-De-Celis and Litchman (22) go beyond inclusion criteria, suggesting that geriatric assessments should be embedded in studies, designing studies specifically for frail older adults and using endpoints in addition to survival that include quality of life, stable functional status, and cognition status, to name a few. In 2021, the Cancer MoonshotSM Network for Direct Patient Engagement Implementation Team supported a workshop entitled “Engaging Older Adults in Cancer Clinical Trials Conducted in the NCI Clinical Trials Network: Challenges and Opportunities.” The Planning Committee included a Patient Stakeholder Workgroup (the Workgroup), which consisted of patient advocates, National Clinical Trials Network and NCORP investigators, clinical trial enrollment and accrual scholars, and NCI staff who have “on the ground” experience with patients who participate in clinical trials. A key objective was to identify the needs and concerns of older adults with cancer that could be used in developing and implementing interventions to address those concerns. This article describes data collected from patient focus groups explicitly designed for the 2021 Cancer Moonshot Network for Direct Patient Engagement Implementation Team sponsored workshop. Methods Participants were recruited for focus groups from NCORP community sites and patient representatives on NCI research committees who were identified as knowledgeable regarding clinical trial participation. As described above, NCI’s NCORP research program is a national network of community sites that brings CCTs and care delivery studies to individuals in their communities. Eligibility criteria for participation included having been invited to participate in an NCI-sponsored CCT, irrespective of whether they participated; having access to technology to participate in a virtual focus group; aged 65 years or older; able to speak English; and able to give consent. The sample size was limited to no more than 9 participants in accordance with the Paperwork Reduction Act of 1995 (23). The sample size is adequate for collecting qualitative data in focus groups (24). Due to the preimposed limit on the number of participants, saturation was not expected to be met (25). The purposive selection was used to recruit individuals of any gender who had been invited to participate in a CCT across a broad spectrum of older age, educational levels, geographic, and racial and ethnic backgrounds. Outreach efforts were used to increase participant diversity, including contacting specific NCORP sites working with the populations of interest and reaching out to NCI programs working with patient advocates or advocacy organizations affiliated with racial and ethnic minority or geographically underserved communities. The project research team and the authors of this article comprised 4 PhDs, 1 DNP, 1 MS, RN, and a patient advocate. The team members who conducted the data analysis (K.B. and I.O.) were trained and experienced in qualitative research. Reporting of the study results followed guidelines for qualitative research outlined in the Standards of Reporting Qualitative Research (26). Focus Group Structure The workgroup developed an interview guide for the focus groups based on the literature, clinical and research experience, and 3 research questions. The research questions were 1) How do consent forms and the consenting process contribute to older adult cancer patients’ decision making about participating in a CCT? 2) What are the drivers for and/or additional barriers to older adult patients participating in CCTs? and 3) How can providers encourage older adult patients with cancer to participate in clinical trials? The interview guide consisted of 5 questions, each with 1 to 5 additional probes, to facilitate discussion (the interview guide can be found in the Supplementary Material, available online). The questions covered the participants’ experience of being invited to participate in a clinical trial, aspects of their decision-making process, the consent process, appropriateness of the information provided about clinical trials, and what health-care providers could do differently to increase the recruitment of older adults with cancer. Participants were asked to join in 1 of 2 virtual 90-minute focus group sessions. Both focus groups were conducted using Cisco WebEx video conferencing (27). Participants provided written consent via email; an experienced facilitator led the focus groups, and both focus groups were audio-recorded. The audio files were transcribed verbatim by Rev, a secure audio-to-text company (https://www.rev.com). Data Analysis Content analysis was used to identify patterns and themes from the data (28). Two authors (K.B. and I.O.) conducted the data analysis individually for both focus groups. K.B. developed the initial codebook based on the wording of the questions, followed by both authors developing codes based on the data. They met to review codes, discuss disagreements, and identify themes. Additionally, based on the literature review, the identified themes were examined and compared with the Context of Barriers Domain Framework developed by Unger et al. (29). The framework proposes that barriers to participation in CCTs fall into 1 of 4 levels: structural, clinical, physician, and patient. Dedoose v. 7.0.23 was used for data management, coding, and excerpting (30). Results Participant Characteristics Eight patients diagnosed and treated for cancer participated in the focus groups: 5 in the first and 3 in the second. Table 1 presents focus group participant characteristics. The mean age of participants was 75 years (SD = 4.7; range = 67–81 years). The participants were primarily women (n = 7, 87.5%); 75% (n = 6) were college educated and 62.5% (n = 5) were White. All had participated in a clinical trial. The most common cancers were breast (n = 4, 50%) and lung (n = 2, 25%), and 25% (n = 2) were currently receiving treatment. Participants resided in the Northeast (n = 1), mid-Atlantic (n = 1), Southeast (n = 1), Midwest (n = 1), Southwest (n = 3), and Pacific (n = 1) regions of the United States. Most (n = 5) participants were offered a clinical trial during their first treatment (62.5%), whereas others were offered trials at recurrence (n = 1, 12.5%) or before the first treatment (n = 1, 12.5%). Information on the phase of the trial(s) they were in was not collected. To assess participants’ perception of their overall health, participants were asked to indicate in a background questionnaire their overall quality of health (multiple-choice response options included excellent, good, fair, and poor). Seventy-five percent of participants reported they were in excellent or good health. Table 1. Demographics of focus group participants (n = 8) Characteristic . No. (%) . Female 7 (87.5) Education   High school graduate 2 (25)   Advanced degree 6 (75) Race and ethnicity   Asian 1 (12.5)   Black and African American 1 (12.5)   Hispanic 1 (12.5)   White 5 (62.5) Primary cancer diagnosis   Breast 4 (50)   NSCLC 2 (25)   Ovarian 1 (12.5)   Amyloidosis 1 (12.5) Currently in treatment: yes 2 (25) Geographic region   Northeast 1 (12.5)   Mid-Atlantic 1 (12.5)   Southeast 1 (12.5)   Midwest 1 (12.5)   Southwest 3 (37.5)   Pacific 1 (12.5) When asked to participate in clinical trial   Before first treatment 1 (12.5)   During first treatment 5 (12.5)   At recurrence of treatment 1 (12.5) Overall health   Excellent 3 (37.5)   Good 3 (37.5)   Fair 2 (25.0) Characteristic . No. (%) . Female 7 (87.5) Education   High school graduate 2 (25)   Advanced degree 6 (75) Race and ethnicity   Asian 1 (12.5)   Black and African American 1 (12.5)   Hispanic 1 (12.5)   White 5 (62.5) Primary cancer diagnosis   Breast 4 (50)   NSCLC 2 (25)   Ovarian 1 (12.5)   Amyloidosis 1 (12.5) Currently in treatment: yes 2 (25) Geographic region   Northeast 1 (12.5)   Mid-Atlantic 1 (12.5)   Southeast 1 (12.5)   Midwest 1 (12.5)   Southwest 3 (37.5)   Pacific 1 (12.5) When asked to participate in clinical trial   Before first treatment 1 (12.5)   During first treatment 5 (12.5)   At recurrence of treatment 1 (12.5) Overall health   Excellent 3 (37.5)   Good 3 (37.5)   Fair 2 (25.0) Open in new tab Table 1. Demographics of focus group participants (n = 8) Characteristic . No. (%) . Female 7 (87.5) Education   High school graduate 2 (25)   Advanced degree 6 (75) Race and ethnicity   Asian 1 (12.5)   Black and African American 1 (12.5)   Hispanic 1 (12.5)   White 5 (62.5) Primary cancer diagnosis   Breast 4 (50)   NSCLC 2 (25)   Ovarian 1 (12.5)   Amyloidosis 1 (12.5) Currently in treatment: yes 2 (25) Geographic region   Northeast 1 (12.5)   Mid-Atlantic 1 (12.5)   Southeast 1 (12.5)   Midwest 1 (12.5)   Southwest 3 (37.5)   Pacific 1 (12.5) When asked to participate in clinical trial   Before first treatment 1 (12.5)   During first treatment 5 (12.5)   At recurrence of treatment 1 (12.5) Overall health   Excellent 3 (37.5)   Good 3 (37.5)   Fair 2 (25.0) Characteristic . No. (%) . Female 7 (87.5) Education   High school graduate 2 (25)   Advanced degree 6 (75) Race and ethnicity   Asian 1 (12.5)   Black and African American 1 (12.5)   Hispanic 1 (12.5)   White 5 (62.5) Primary cancer diagnosis   Breast 4 (50)   NSCLC 2 (25)   Ovarian 1 (12.5)   Amyloidosis 1 (12.5) Currently in treatment: yes 2 (25) Geographic region   Northeast 1 (12.5)   Mid-Atlantic 1 (12.5)   Southeast 1 (12.5)   Midwest 1 (12.5)   Southwest 3 (37.5)   Pacific 1 (12.5) When asked to participate in clinical trial   Before first treatment 1 (12.5)   During first treatment 5 (12.5)   At recurrence of treatment 1 (12.5) Overall health   Excellent 3 (37.5)   Good 3 (37.5)   Fair 2 (25.0) Open in new tab Codes and Themes Four themes emerged from the content analysis: structural, clinical, care team and research team, and patient. These themes fit within the Context of Barriers Domain Framework developed by Unger et al. (29) with modifications. Figure 1 presents the original framework with conceptualization, the 4 expanded levels, and their conceptualizations. Figure 1. Open in new tabDownload slide Original and modified barrier frameworks and conceptualization. Modifications to expand Context of Barriers Domain Framework developed by Unger et al. (29). Used with permission. Structural Level The structural level, as conceptualized by Unger et al. (29), addresses trials made available for a specific disease type and stage. Based on the data from the focus groups, we have extended the conceptualization to include factors related to clinical trial structure, design, and suggestions about messaging on CCT. This theme and its expansion were based on consent form–related challenges and barriers specific to older adults that focus group participants reported experiencing during the trial enrollment process (see Table 2 for Summary of Results). Table 2. Summary of findings Structural Consent form–related challenges: overly burdensome, not concise, highly technical Lack of clear messaging: eg, perceptions of age limitations Lack of access to relevant technology (computer, tablet, printer) Clinical Lack of accessibility: trials not available or not approached to participate Overly strict eligibility criteria Perceived benefit to participation: eg, better clinical care on CCTs Care team and research team Lack of care team and research team communication, knowledge of current trials Financial conflicts of interest Bias precluding consideration of older adults Building trust through respect and clear communication: taking time to explain process and what to expect, dispelling misperceptions, use of patient navigators Patient Suspicion of trials: being treated as a “guinea pig” View cancer trials as last resort Fear of not getting standard care Fear of randomly assignment to placebo Being proactive about asking to participate Understanding the value of participation Feeling supported by the care and research team Future benefit to society Getting a sense of hope Positive influence from family and friends to participate Worries regarding costs Fatalism Structural Consent form–related challenges: overly burdensome, not concise, highly technical Lack of clear messaging: eg, perceptions of age limitations Lack of access to relevant technology (computer, tablet, printer) Clinical Lack of accessibility: trials not available or not approached to participate Overly strict eligibility criteria Perceived benefit to participation: eg, better clinical care on CCTs Care team and research team Lack of care team and research team communication, knowledge of current trials Financial conflicts of interest Bias precluding consideration of older adults Building trust through respect and clear communication: taking time to explain process and what to expect, dispelling misperceptions, use of patient navigators Patient Suspicion of trials: being treated as a “guinea pig” View cancer trials as last resort Fear of not getting standard care Fear of randomly assignment to placebo Being proactive about asking to participate Understanding the value of participation Feeling supported by the care and research team Future benefit to society Getting a sense of hope Positive influence from family and friends to participate Worries regarding costs Fatalism Open in new tab Table 2. Summary of findings Structural Consent form–related challenges: overly burdensome, not concise, highly technical Lack of clear messaging: eg, perceptions of age limitations Lack of access to relevant technology (computer, tablet, printer) Clinical Lack of accessibility: trials not available or not approached to participate Overly strict eligibility criteria Perceived benefit to participation: eg, better clinical care on CCTs Care team and research team Lack of care team and research team communication, knowledge of current trials Financial conflicts of interest Bias precluding consideration of older adults Building trust through respect and clear communication: taking time to explain process and what to expect, dispelling misperceptions, use of patient navigators Patient Suspicion of trials: being treated as a “guinea pig” View cancer trials as last resort Fear of not getting standard care Fear of randomly assignment to placebo Being proactive about asking to participate Understanding the value of participation Feeling supported by the care and research team Future benefit to society Getting a sense of hope Positive influence from family and friends to participate Worries regarding costs Fatalism Structural Consent form–related challenges: overly burdensome, not concise, highly technical Lack of clear messaging: eg, perceptions of age limitations Lack of access to relevant technology (computer, tablet, printer) Clinical Lack of accessibility: trials not available or not approached to participate Overly strict eligibility criteria Perceived benefit to participation: eg, better clinical care on CCTs Care team and research team Lack of care team and research team communication, knowledge of current trials Financial conflicts of interest Bias precluding consideration of older adults Building trust through respect and clear communication: taking time to explain process and what to expect, dispelling misperceptions, use of patient navigators Patient Suspicion of trials: being treated as a “guinea pig” View cancer trials as last resort Fear of not getting standard care Fear of randomly assignment to placebo Being proactive about asking to participate Understanding the value of participation Feeling supported by the care and research team Future benefit to society Getting a sense of hope Positive influence from family and friends to participate Worries regarding costs Fatalism Open in new tab Consent Forms and Consent Process The facilitator asked, “Do you remember reading and signing a consent form and discussing the form with someone from the study? Was it paper or electronic consent?” Seven participants responded that they had paper consent. One further suggested that …if you had an electronic copy that you could look at in advance, that would be helpful. That way, you’re not trying to read it in the doctor’s office and make a quick decision on 20 pages of paper. In response to this, another participant said I find that in my age group, among my friends, many of them still don’t have a computer or a printer, or even a tablet. Several participants commented on the excessive consent length and language used: Perhaps it would be helpful if there was sort of an entry consent…an entrance to participate, and then once that is done, and the patient is comfortable, then you get to the point where you have to check all those little boxes. We have a multi-ethnic population as our base…so there is a language barrier. Barriers Specific to Older Adults The structural barrier addressed most often was the perception of age limitations for eligibility. The big thing that has to be changed is to expand the age limitations. One participant suggested a way to address the perception of age limitations is better messaging. One way to communicate to the public that older adults are welcome to join clinical trials is to have a message that says, “you are never too old for a trial.” Clinical Level For the clinical level theme, the codes addressed types of barriers and reasons to participate. The Unger et al. (29) framework identified clinical barriers as trial-related eligibility factors. The participant discussion during the focus groups supported the issue around eligibility criteria but went beyond Unger et al. (29) to highlight other clinical level barriers and positive aspects of CCT participation. General Barriers The main general barrier at the clinical level identified by the participants was a lack of accessibility. My experience has been if you’re not in a community that has a comprehensive cancer center that offers clinical trials, they’re not going to be offered to you. Even at this large regional medical center, which is a trauma center, they did not offer a clinical trial. Because I’ve done educational research, I knew enough to ask about this. Barriers Specific to Older Adults Identified barriers that are specific to older adults are related to eligibility criteria. Older people are not asked to participate as much. They are eliminated from trials because researchers believe—this is my understanding—researchers believe that there are too many confounding factors. So older people are not as welcome. I think many studies have proven that we’re just as sturdy and just as healthy to be able to partake in a clinical trial if we want to. In contrast to comments regarding barriers, 1 participant stated: I’m noticing, too, that now they’re trying to get more, I guess they call it geriatric patients, into clinical trials and trying to remove some of the hurdles. Reasons to Participate and Perceived Benefits The better care a patient on CCTs receives was both a reason to participate and a perceived benefit noted by several participants. One of the things that influenced my participating was basically getting better care in a long-term study; someone contacted me every month for like 6 years, once a month, and said, “How are you doing, you know? Do you have any problems with this?” Care Team and Research Team In the framework of Unger et al. (29), the physician level corresponds to physician-related barriers. We expanded the title of this level to “Care Team and Research Team” to be more inclusive of the range of staff who interact with a patient receiving treatment and all staff who interact with a patient about a CCT. General Barriers Comments included patients’ perceptions regarding provider communication, provider knowledge of current trials, financial considerations, and attitudes of care team members and research team members recruiting for CCTs. One participant shared what they told their care team about not being notified about CCTs. Okay, you know I’m a patient advocate. I’ve been a patient here for over 12 years. You should know to offer that [clinical trials] to me whether or not you may think it’s something I want to do. I have the right to make that decision. It’s my body and my life. Other comments noted why community oncologists do not support CCT. Money speaks very loudly and if you’re a community oncologist, to give up a patient to a clinical trial is a financial consideration. It’s sort of the elephant in the room. Another comment was on the attitudes of CCT recruiters. A friend and I went to a conference on [CT] accrual, and there was an attitude like [among recruiters], “I’m just doing my job, I just need to get this done. I get paid for everyone that I accrue.” And they [the recruiters] couldn’t have given a hoot about the person they were speaking to. Barriers Specific to Older Adults Additionally, focus group participants noted the need for clear communication and feeling valued by the care team and research team. For older people to be more accepting, it’s going to have to be their GP [general practitioner] that has to sit with them and develop communication with them. I think clinical trials have to be very clearly explained. And I don’t think the medical community is doing a good job. If you feel valued, you’re going to listen with a very different ear than if you don’t. Introduction to CCT Many comments indicated the importance of how participants are approached about CCTs by their care team and research team. Two examples are: I was approached by my doctor. She just said there are a couple of studies and wanted to know if I would be interested in participating. The way it was approached is the person was not the treating doctor. It was someone I think was experienced in talking to people about this, and they laid it out very nicely. One participant described concerns about taking away from a younger patient an opportunity to participate in a clinical trial. I was worried because I thought I’m 80 years old and I might take something away from a younger person who needed it more than I did. But they said no. I didn’t know that they [were] having trouble getting people to volunteer. Reasons to Participate and Perceived Benefits Reasons focused on the perception of better care and the availability of clinical research professionals to provide support. The patient should understand what the benefit of the participation should be. It’s not guaranteed, but there is a possibility of improved outcome. So, I think [it is] important to communicate the value of participating. Having that person that I can call and say, “You know, this is happening to me. Is this really part of this?” [It] makes a big difference. You have that contact person that is going to be there. And you’re not out there alone. Patient Level The patient level, as conceptualized by Unger et al. (29), is the decision made by the patient. This level did not change as an outcome of the data analysis. General Barriers General barriers included: There’s a suspicion about participating in any sort of clinical trials. I think [another participant] mentioned about being guinea pigs. Until you educate yourself about cancer and the cancer community, most people think that clinical trials are a last resort. So, there’s a huge misconception about that. I do not see the research community making much effort in educating the larger community that clinical trials are a first step, not your last step. Barriers Specific to Older Adults Participants also described barriers for older adults, including: I have a feeling that many older people don’t like trials because they think, what if I don’t get well or it keeps me [from getting] the normal treatment? I think that should be more explained, that we get checked out all the time, and they keep on top of it, so I don’t think it should be a problem, but maybe people think that way. One of the things that would help is transportation, given that some of the patients become further disabled because of the illness. Introduction to CCT Several participants talked about how their oncologist approached them about a trial. One example is: [My oncologist] hand wrote the schedule of how every phase would be, ’cause it started out with high dose chemo and then went down from there to additional things over those 9 months. I could look at that and see what was coming next as I continued to survive through the treatment. So, to me, that was just an amazing gift, that he was able to sit down and do that for me to help me understand because at the time… Another participant described how she approached her oncologist about getting on a trial. After the third time [diagnosis], I saw a flier in a waiting room. I asked my oncologist [about] participating in any clinical trial that I was eligible for, and I’ve been on the lookout for any possible trials that I could participate in. I’m thinking I can’t just be a passive patient. I need to advocate for myself. My oncologist was very open. So, I’m very grateful to be participating and learning and actually helping myself. Reasons to Participate and Perceived Benefits Participants identified many perceived benefits of clinical trial participation and reasons to participate. I think for me it’s more, is this gonna make a difference in my life and in my family’s life, because in our culture, family is very dear to us and we are very supportive of each other, and if this is going to possibly help them in the future or help others in the future, I think that’s very important to participate. Even though it’s a bad diagnosis, it gave me hope. [What] I thought was helpful was the fact that the doctor and oncologist, the radiation oncologist, the nurse navigator, they all came to my treatment room and met with me and didn’t make me wander from doctor to doctor to get the information I needed. And that, to me, when you’re going through a really bad diagnosis, was really helpful. Support to Enroll The ways participants felt supported in their decision making highlighted the importance of family, friends, or physician support. …my son is an Emergency Department doctor. He was in residency when I got diagnosed, so his immediate reaction was “Get to a teaching hospital, that’s where the cutting-edge treatments are.” I met a patient advocate who’s been through 5 recurrences. She’s been my inspiration. She’s a very strong advocate of clinical trials. She believes that it saved her life. I trusted my doctor. He’s very well-known in the lung cancer community. And so, I just trusted him, and I think that’s important. Worries About Participation The participants also discussed their worries about the cost of CCT participation. The maintenance chemo I was on after the stem cell transplant was $10 000 per month. I asked about the cost, what I would have to pay, and I was told it would be provided throughout the clinical trial period, which was 1 year. Why Not Participate The participants also identified potential reasons patients may not participate in a clinical trial. There is one issue of clinical trials that I would never, ever do. And I would never, ever go on a trial with a placebo. To me, there’s always something that it [new treatment] can be compared to. To me, a placebo is like a sugar pill. It’s nothing. When I reviewed the recent clinical trials, one of the things that is in the documents is a waiver, like “If this drug, the experimental drug, is approved by the FDA, then the patient might have to assume the cost.” I think there is a fatalism as you get older, which may stop you. Discussion To our knowledge, this is the first national focus group of older adult patient participants to identify and discuss barriers to clinical trial participation among their peers. Key findings from these focus groups include barriers related to the consent process and language, strict eligibility criteria such as age limitations, lack of accessibility, lack of health-care team knowledge of clinical trials, poor recruitment techniques, and distrust of clinical research (see Table 2 for summary of findings). Our findings fit well with Unger and colleagues’ (29) Framework of the Context of Barriers Domains. The original Framework had 4 levels: structural, clinical, physician, and patient. Our findings expanded the conceptual definitions in 3 of the 4 levels described below and summarized in Figure 1. Expansion in the structure level includes the use of consistent wording on consent forms and how forms are presented to patients at each site, improved infrastructure support to allow for more care teams to engage with patients in discussing trials, and explicit inclusion criteria for older adults to be included in trial design. At the clinical level, we expand considerations beyond eligibility criteria to include access to CCTs in one’s community and require that all trial implementations be the same at each trial site, notably having someone on the research team assigned to follow up with a patient throughout the trial. The final adaptation was renaming the physician level to the care team and research team level, expanding beyond the physician’s role in recruitment and retention. The context of the framework is that participation starts at diagnosis and continues throughout treatment and that the patient makes the decision based on the outcome of each of the levels sequentially. Specifically, if there are structural barriers, CCTs will never be offered to potential participants; if there are barriers at the clinical level, the option of participating in a CCT will not be presented to the patient; and if there are care team and research team barriers, the patient will not be offered the option or not offered in a way they are comfortable with and thus not have the information needed to decide to participate in a trial. Structural Level Participants identified structural barriers such as paperwork and the overall information received as overwhelming when considering a clinical trial. Further, others discussed language barriers in terms of both health literacy and spoken language. Consent language is an ongoing issue in the literature. It has often been mentioned that consent language is too technical for the layperson to comprehend (31–34). Health literacy and participants’ reading level must be considered. It is estimated that 20%-36% of all adults in the United States have limited health literacy; the percentage is higher among marginalized populations (35). The impact of health literacy in the oncology population is of particular importance because cancer care commonly requires patients to navigate a complex health-care system (36); decision making to enroll in a clinical trial only heightens the complexity. Two studies found that patients with lower health literacy levels were likely to participate in clinical trials but relied heavily on their providers for the recommendation (32–37). Potential clinical trial participants may not speak English, and translating consent forms is a complicated and expensive process. In addition to the consent form, other study-related documents are often available only in English (38). The extra time required to consent an older adult may be a barrier; Freedman et al. (7) cited the lack of personnel and resources to support older adult accrual. It is difficult for researchers to review in plain language with a patient all aspects of participants’ rights and protections. Therefore, it is important to work with a plain language expert and give the patient adequate time to review the consent and ask questions. Unfortunately, the time needed for older adults is incompatible with our current fee-for-service, relative value unit (RVU) based health-care system. RVU is a standard set by Medicare to determine the amount to pay a provider depending on time and productivity (39). Clinicians are typically limited to 15- to 20-minute appointments, which is not enough time for a thorough discussion with a patient about a potential clinical trial (7,40). The limitations on time exist across all types of cancer care settings, academic as well as community based. Per the FDA (41), a potential clinical trial participant should always have adequate time to review and ask questions before signing the consent. Clinicians and research personnel need to know that this time should be longer when working with older adults, because they may have age-related considerations such as poor eyesight or hearing loss (42). Most comprehensive cancer centers are affiliated with academic centers where a research culture is primary. Unfortunately, research is often not a priority in community settings, where most patients with cancer, including older adults, are treated (43). Community cancer centers are heavily RVU based. The time required to enroll patients into trials is not reimbursed, making community practices less likely to participate in clinical research (29). This issue was noted in the focus groups and highlighted as a recurrent structural barrier in the community clinical setting that needs to be addressed; however, the workshop did not have data to estimate if older adult enrollment was greater at academic centers. For Community Sites to be successful in clinical research, a commitment among providers and administrators to value and support clinical research and become familiar with the populations they serve is imperative. Programs need knowledgeable and reliable clinical, operational, and administrative staff experienced in meaningfully engaging with trial and potential trial participants. It is of utmost importance to have an efficient structure to sustain clinical research in the community and involve higher percentages of individuals diagnosed with cancer (44). An example of a sustainable community oncology research system is the NCORP. Its grant funding supports infrastructure for community sites to participate in NCI-sponsored research for cancer control, supportive care, health-related quality of life, cancer care delivery, treatment, and imaging trials. Infrastructure in all cancer care settings needs increased funding and resources, especially staffing. The NCI is aware of this barrier and in 2020 held the inaugural Primary Care Alliance in Research Trials Involving NCORP Sites Workshop. The workshop aimed to develop a platform for addressing barriers to CCT accrual (45). The burden should not only fall on the oncologist; other health-care providers such as primary care providers, advanced practice providers, pharmacists, nurses, social workers, navigators, and medical assistants can all play a role in promoting and recruiting patients for CCTs (46,47). Focus group participants also identified age limits as barriers to older adults’ participation in clinical trials. Interestingly, CCTs are the most age-inclusive compared with other disciplines (48). Currently, the NCI does not have an upper age limit for trial participation, but such limits may exist among other sponsors. It is interesting to note that the perception of upper age limitations in cancer trials, even when nonexistent, may play a role in discouraging participation among older adults. Clinical Level Comorbidities and other clinical conditions that may be barriers from both an eligibility and a referral standpoint were identified. The authors are aware of the barriers within eligibility criteria; for example, a lower creatinine clearance may make an older patient ineligible, or the assumed treatment toxicity level that may result in a physician not making a referral (29,40). Work is ongoing in protocol development and design to address these barriers. In addition, it has been highlighted that underrepresentation of a diverse older adult population can lead to increased toxicity and more treatment-related complications in everyday practice (49). One facilitator identified by the focus groups and seen in the literature was the improved care coordination patients feel when enrolled in a clinical trial study (50). This facilitator is supported by National Cancer Comprehensive Network guidelines. A statement at the bottom of every guideline page says that National Cancer Comprehensive Network believes the best management of a patient with cancer is in a clinical trial (42). Care Team and Research Team Level Participants frequently talked about the physician and other staff on the care team and research team as facilitators or barriers to their consideration and participation in a clinical trial. This mirrors known data that physicians have the greatest influence on whether a patient enters a clinical trial (51,52). In addition, how the clinical trial was presented was both a facilitator and a barrier. It was noted that if the research team does a good job explaining a trial, it truly helps. These findings also highlight the need for age-friendly approaches to communication. Haase and others (53) found that older adults want improved communication and clinicians to speak with them loudly and slowly. Also, a follow-up phone call and written communication in layman’s terms also assisted interactions between the care team and older adults. Clinicians and research staff need to consider this when speaking with older adults about CCT. Patient Level Misconceptions surround clinical trials, such as being a last resort or being more toxic. The fear of “being a guinea pig” and concerns about finances, placebos, and cultural insensitivity were discussed. These barriers could be addressed through better education for patients, caregivers, and the community at large. Increased understanding about what to expect and protections for participants in clinical trials in general as well as the specific clinical trial that will be presented to a patient are needed. Again, this will take time and dedication. Multiple focus group participants recognized their interest in giving back and how this could help loved ones and the greater community. Many barriers identified under the patient level were recurring themes throughout the discussions, with continued importance regarding patient, provider, and overall community education. Multi-level interventions successfully address health inequities (54,55) and could be applied to clinical trial education and older adults. These interventions should include individual patients, the communities they live and work in, and all members of health-care systems. The main limitation of this study is the lack of diversity among the focus group participants. We acknowledge that most of the participants had graduate degrees and may have had greater knowledge of opportunities to participate in clinical trials. The number of participants was also small, and whether data saturation was achieved in qualitative analysis is unknown. Having only 1 male voice also limited the perspective of the focus groups. Finally, self-selection bias reduced the opportunity for a broader picture of older adults with cancer experiences with CCT. Future Directions When considering recommendations for future directions, the authors would like to highlight the importance of time spent, tailored communication style, and clear messaging when introducing and discussing clinical trials with older adults. Focus group participants repeatedly mentioned the importance of communication and education, whether from providers, research staff, in consent language, or in overall understanding of clinical research. Time and resources should be dedicated to meaningful communication and engagement with older adult patients and their caregivers if we want to make tangible progress regarding older adult accrual to clinical trials. In addition, broadening eligibility criteria will allow for the inclusion of more individuals with comorbidities and true representation of older adults treated in everyday practice. Given their unique needs and perspectives, older adults should also have more opportunities to provide input during protocol development because they can offer a unique vantage point that providers and researchers may not have. Finally, given the concentration of patients with cancer-seeking treatment at community centers, further research on differences in trial participation of older adults in community vs academic cancer settings would help identify unique barriers and advantages within each environment that would inform future strategies to improve older adult participation in trials. In conclusion, many of the issues identified by older adults in our focus groups supported what has already been reported in the literature regarding barriers to trial participation. We did, however, identify experiences not previously reported. The data analysis of the focus groups fit within the Context of Barriers Domain Framework with a few modifications broadening the original framework concepts to include considerations for clinical trial structure, communication, interaction with patients, and trial access. The data presented here can provide a foundation for developing multi-level interventions across systems and stakeholders. Funding No author received funding for the generation of this manuscript. Notes Role of the funder: Not applicable. Disclosures: The authors declared no potential conflict of interest with respect to the research, authorship, and publication of this article. Author contributions: Research conceptualization: KB, BC, AD, CBI, AB, ECS. Data collection: ECS, AB. Data analysis: KB, IO. Manuscript writing and review: All authors. Acknowledgements: The authors thank all participants who took the time to express their views on this research project. The authors also wish to thank Ms Perquita Perry, Staff Assistant to the Associate Director of Clinical Research at the Division of Cancer Prevention/NCI, for her administrative support on this project. Data Availability The Office of Management and Budget policy on data collection from 9 people or fewer is for internal agency program evaluation only; therefore, data cannot be shared. References 1 Cancer Stat Facts: Cancer of Any Site . https://seer.cancer.gov/statfacts/html/all.html. Accessed January 15, 2022. 2 Colby SL , Ortman JM. Projections of the Size and Composition of the US Population: 2014 to 2060 . US Census Bureau, US Department of Commerce . https://www.census.gov/content/dam/Census/library/publications/2015/demo/p25-1143.pdf. Accessed January 15, 2022. 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Through the Lens of Patient Partners: Challenges in Accrual of Older Adults to NCI Clinical Trials

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Abstract

Abstract The workshop “Engaging Older Adults in Cancer Clinical Trials Conducted in the NCI Clinical Trials Network: Challenges and Opportunities” included a Patient Stakeholder Workgroup that explored the needs and concerns of older adults with cancer regarding clinical trials. To accomplish this, the workgroup conducted patient focus groups in which participants were interviewed, recorded conversations were analyzed and coded, and salient themes were identified. The focus groups identified general barriers to accrual such as complex consent forms, general communication, restrictive eligibility, nonreferrals, patient costs, cultural insensitivity, limited accessibility in community settings, and transportation issues. They also identified the influence of knowledgeable information presenters, improved care, family or caregiver support, and the desire to help others as drivers or reasons to participate in clinical trials. The workshop concluded that multi-level interventions could be used to increase the accrual of older adults to National Cancer Institute clinical trials as well as others. Cancer is an important disease in the United States threatening the health and quality of life of adults aged 65 years and older. The median age of cancer diagnosis is 66 years, with more than 50% of cancer cases occurring in persons older than 65 years (1). The number of adults older than 65 years has been growing dramatically and is predicted to make up approximately 24% of the total population by 2060 (2). With the increasing population of older adults, the number of those needing cancer treatment in the future will substantially increase. Potentially beneficial cancer treatments are validated in clinical trials. For this reason, clinical trials aimed at decreasing the morbidity and mortality of cancer need to include proportionally representative numbers of older adults so the results encompass them. A retrospective study of more than 41 000 patients from 55 National Cancer Institute (NCI) clinical trials found that only 29% of patients were 65 years and older (3). Another study that investigated the external validity of the evidence base for the treatment of non-small cell lung cancer found that 2 major guidelines developed for the management of non-small cell lung cancer based their recommendations largely on studies that did not include patients older than 80 years. However, this is largely a disease in older adults (4). Calls to action to improve the accrual of older adults in trials have been made to generate the evidence needed for safe and effective treatments for this population (5-8). There are many barriers to the enrollment of older adults in clinical trials. Sedrak and colleagues (9) conducted a systematic review to evaluate published clinical trial barriers. They identified 4 major categories of barriers related to the trial system, providers, patients, and caregivers. Examples of the specific obstacles include restrictive eligibility criteria, providers not suggesting trials, and patient and caregiver perceptions of investigational therapies. Other known barriers include lack of awareness or knowledge of clinical trials, time and transportation burden, the unclear cost to participants, inability to pay out-of-pocket costs, misconceptions or mistrust about research, lengthy consent forms that may be difficult to read and understand, fear of not receiving adequate treatment if randomly assigned to the control group, lack of cultural sensitivity, and inherent bias in the health-care systems (9–15). The NCI Community Oncology Research Program (NCORP) is a national network that brings cancer clinical trials (CCTs) to community clinical settings and touches more than 1000 practices across the United States. The NCORP network is the primary source of accrual to NCI cancer control symptom management trials and health-related quality-of-life trials embedded into National Clinical Trials Network treatment trials (16). When recruiting and enrolling participants in NCI trials, NCORP uses a screening tool to learn why patients choose not to participate in clinical trials. St. Germain and McCaskill‐Stevens (17) reported on an analysis of more than 16 000 patient entries with a median patient age of 60 years. They found a lower percentage (17%) of patients aged 70 years and older who were screened and enrolled compared with 23% who were screened but not enrolled. The top reasons patients stated for not wanting to participate was wanting a different treatment than the trial offered or not wanting to participate in a clinical trial (17). The US Food and Drug Administration (FDA) has identified multiple interventions to enhance clinical trial enrollment, including removing restrictive eligibility criteria to allow older patients with controlled comorbidities on multiple concomitant medications to enter trials (18). Recommendations for modernizing eligibility criteria to improve access to clinical trials for older patients have been developed by the American Society of Clinical Oncology and Friends of Cancer Research (Friends). In a series of articles, American Society of Clinical Oncology and Friends provide inclusion criteria for investigators to use to stimulate broader enrollment in protocols (19,20). Liu and colleagues (21) recommend increased resources at academic institutions to engage community sites, including developing educational and behavioral interventions to promote patient enrollment, expanding trial designs that support older adult inclusion, and including community physicians in the design of trials and eligibility criteria. Soto-Perez-De-Celis and Litchman (22) go beyond inclusion criteria, suggesting that geriatric assessments should be embedded in studies, designing studies specifically for frail older adults and using endpoints in addition to survival that include quality of life, stable functional status, and cognition status, to name a few. In 2021, the Cancer MoonshotSM Network for Direct Patient Engagement Implementation Team supported a workshop entitled “Engaging Older Adults in Cancer Clinical Trials Conducted in the NCI Clinical Trials Network: Challenges and Opportunities.” The Planning Committee included a Patient Stakeholder Workgroup (the Workgroup), which consisted of patient advocates, National Clinical Trials Network and NCORP investigators, clinical trial enrollment and accrual scholars, and NCI staff who have “on the ground” experience with patients who participate in clinical trials. A key objective was to identify the needs and concerns of older adults with cancer that could be used in developing and implementing interventions to address those concerns. This article describes data collected from patient focus groups explicitly designed for the 2021 Cancer Moonshot Network for Direct Patient Engagement Implementation Team sponsored workshop. Methods Participants were recruited for focus groups from NCORP community sites and patient representatives on NCI research committees who were identified as knowledgeable regarding clinical trial participation. As described above, NCI’s NCORP research program is a national network of community sites that brings CCTs and care delivery studies to individuals in their communities. Eligibility criteria for participation included having been invited to participate in an NCI-sponsored CCT, irrespective of whether they participated; having access to technology to participate in a virtual focus group; aged 65 years or older; able to speak English; and able to give consent. The sample size was limited to no more than 9 participants in accordance with the Paperwork Reduction Act of 1995 (23). The sample size is adequate for collecting qualitative data in focus groups (24). Due to the preimposed limit on the number of participants, saturation was not expected to be met (25). The purposive selection was used to recruit individuals of any gender who had been invited to participate in a CCT across a broad spectrum of older age, educational levels, geographic, and racial and ethnic backgrounds. Outreach efforts were used to increase participant diversity, including contacting specific NCORP sites working with the populations of interest and reaching out to NCI programs working with patient advocates or advocacy organizations affiliated with racial and ethnic minority or geographically underserved communities. The project research team and the authors of this article comprised 4 PhDs, 1 DNP, 1 MS, RN, and a patient advocate. The team members who conducted the data analysis (K.B. and I.O.) were trained and experienced in qualitative research. Reporting of the study results followed guidelines for qualitative research outlined in the Standards of Reporting Qualitative Research (26). Focus Group Structure The workgroup developed an interview guide for the focus groups based on the literature, clinical and research experience, and 3 research questions. The research questions were 1) How do consent forms and the consenting process contribute to older adult cancer patients’ decision making about participating in a CCT? 2) What are the drivers for and/or additional barriers to older adult patients participating in CCTs? and 3) How can providers encourage older adult patients with cancer to participate in clinical trials? The interview guide consisted of 5 questions, each with 1 to 5 additional probes, to facilitate discussion (the interview guide can be found in the Supplementary Material, available online). The questions covered the participants’ experience of being invited to participate in a clinical trial, aspects of their decision-making process, the consent process, appropriateness of the information provided about clinical trials, and what health-care providers could do differently to increase the recruitment of older adults with cancer. Participants were asked to join in 1 of 2 virtual 90-minute focus group sessions. Both focus groups were conducted using Cisco WebEx video conferencing (27). Participants provided written consent via email; an experienced facilitator led the focus groups, and both focus groups were audio-recorded. The audio files were transcribed verbatim by Rev, a secure audio-to-text company (https://www.rev.com). Data Analysis Content analysis was used to identify patterns and themes from the data (28). Two authors (K.B. and I.O.) conducted the data analysis individually for both focus groups. K.B. developed the initial codebook based on the wording of the questions, followed by both authors developing codes based on the data. They met to review codes, discuss disagreements, and identify themes. Additionally, based on the literature review, the identified themes were examined and compared with the Context of Barriers Domain Framework developed by Unger et al. (29). The framework proposes that barriers to participation in CCTs fall into 1 of 4 levels: structural, clinical, physician, and patient. Dedoose v. 7.0.23 was used for data management, coding, and excerpting (30). Results Participant Characteristics Eight patients diagnosed and treated for cancer participated in the focus groups: 5 in the first and 3 in the second. Table 1 presents focus group participant characteristics. The mean age of participants was 75 years (SD = 4.7; range = 67–81 years). The participants were primarily women (n = 7, 87.5%); 75% (n = 6) were college educated and 62.5% (n = 5) were White. All had participated in a clinical trial. The most common cancers were breast (n = 4, 50%) and lung (n = 2, 25%), and 25% (n = 2) were currently receiving treatment. Participants resided in the Northeast (n = 1), mid-Atlantic (n = 1), Southeast (n = 1), Midwest (n = 1), Southwest (n = 3), and Pacific (n = 1) regions of the United States. Most (n = 5) participants were offered a clinical trial during their first treatment (62.5%), whereas others were offered trials at recurrence (n = 1, 12.5%) or before the first treatment (n = 1, 12.5%). Information on the phase of the trial(s) they were in was not collected. To assess participants’ perception of their overall health, participants were asked to indicate in a background questionnaire their overall quality of health (multiple-choice response options included excellent, good, fair, and poor). Seventy-five percent of participants reported they were in excellent or good health. Table 1. Demographics of focus group participants (n = 8) Characteristic . No. (%) . Female 7 (87.5) Education   High school graduate 2 (25)   Advanced degree 6 (75) Race and ethnicity   Asian 1 (12.5)   Black and African American 1 (12.5)   Hispanic 1 (12.5)   White 5 (62.5) Primary cancer diagnosis   Breast 4 (50)   NSCLC 2 (25)   Ovarian 1 (12.5)   Amyloidosis 1 (12.5) Currently in treatment: yes 2 (25) Geographic region   Northeast 1 (12.5)   Mid-Atlantic 1 (12.5)   Southeast 1 (12.5)   Midwest 1 (12.5)   Southwest 3 (37.5)   Pacific 1 (12.5) When asked to participate in clinical trial   Before first treatment 1 (12.5)   During first treatment 5 (12.5)   At recurrence of treatment 1 (12.5) Overall health   Excellent 3 (37.5)   Good 3 (37.5)   Fair 2 (25.0) Characteristic . No. (%) . Female 7 (87.5) Education   High school graduate 2 (25)   Advanced degree 6 (75) Race and ethnicity   Asian 1 (12.5)   Black and African American 1 (12.5)   Hispanic 1 (12.5)   White 5 (62.5) Primary cancer diagnosis   Breast 4 (50)   NSCLC 2 (25)   Ovarian 1 (12.5)   Amyloidosis 1 (12.5) Currently in treatment: yes 2 (25) Geographic region   Northeast 1 (12.5)   Mid-Atlantic 1 (12.5)   Southeast 1 (12.5)   Midwest 1 (12.5)   Southwest 3 (37.5)   Pacific 1 (12.5) When asked to participate in clinical trial   Before first treatment 1 (12.5)   During first treatment 5 (12.5)   At recurrence of treatment 1 (12.5) Overall health   Excellent 3 (37.5)   Good 3 (37.5)   Fair 2 (25.0) Open in new tab Table 1. Demographics of focus group participants (n = 8) Characteristic . No. (%) . Female 7 (87.5) Education   High school graduate 2 (25)   Advanced degree 6 (75) Race and ethnicity   Asian 1 (12.5)   Black and African American 1 (12.5)   Hispanic 1 (12.5)   White 5 (62.5) Primary cancer diagnosis   Breast 4 (50)   NSCLC 2 (25)   Ovarian 1 (12.5)   Amyloidosis 1 (12.5) Currently in treatment: yes 2 (25) Geographic region   Northeast 1 (12.5)   Mid-Atlantic 1 (12.5)   Southeast 1 (12.5)   Midwest 1 (12.5)   Southwest 3 (37.5)   Pacific 1 (12.5) When asked to participate in clinical trial   Before first treatment 1 (12.5)   During first treatment 5 (12.5)   At recurrence of treatment 1 (12.5) Overall health   Excellent 3 (37.5)   Good 3 (37.5)   Fair 2 (25.0) Characteristic . No. (%) . Female 7 (87.5) Education   High school graduate 2 (25)   Advanced degree 6 (75) Race and ethnicity   Asian 1 (12.5)   Black and African American 1 (12.5)   Hispanic 1 (12.5)   White 5 (62.5) Primary cancer diagnosis   Breast 4 (50)   NSCLC 2 (25)   Ovarian 1 (12.5)   Amyloidosis 1 (12.5) Currently in treatment: yes 2 (25) Geographic region   Northeast 1 (12.5)   Mid-Atlantic 1 (12.5)   Southeast 1 (12.5)   Midwest 1 (12.5)   Southwest 3 (37.5)   Pacific 1 (12.5) When asked to participate in clinical trial   Before first treatment 1 (12.5)   During first treatment 5 (12.5)   At recurrence of treatment 1 (12.5) Overall health   Excellent 3 (37.5)   Good 3 (37.5)   Fair 2 (25.0) Open in new tab Codes and Themes Four themes emerged from the content analysis: structural, clinical, care team and research team, and patient. These themes fit within the Context of Barriers Domain Framework developed by Unger et al. (29) with modifications. Figure 1 presents the original framework with conceptualization, the 4 expanded levels, and their conceptualizations. Figure 1. Open in new tabDownload slide Original and modified barrier frameworks and conceptualization. Modifications to expand Context of Barriers Domain Framework developed by Unger et al. (29). Used with permission. Structural Level The structural level, as conceptualized by Unger et al. (29), addresses trials made available for a specific disease type and stage. Based on the data from the focus groups, we have extended the conceptualization to include factors related to clinical trial structure, design, and suggestions about messaging on CCT. This theme and its expansion were based on consent form–related challenges and barriers specific to older adults that focus group participants reported experiencing during the trial enrollment process (see Table 2 for Summary of Results). Table 2. Summary of findings Structural Consent form–related challenges: overly burdensome, not concise, highly technical Lack of clear messaging: eg, perceptions of age limitations Lack of access to relevant technology (computer, tablet, printer) Clinical Lack of accessibility: trials not available or not approached to participate Overly strict eligibility criteria Perceived benefit to participation: eg, better clinical care on CCTs Care team and research team Lack of care team and research team communication, knowledge of current trials Financial conflicts of interest Bias precluding consideration of older adults Building trust through respect and clear communication: taking time to explain process and what to expect, dispelling misperceptions, use of patient navigators Patient Suspicion of trials: being treated as a “guinea pig” View cancer trials as last resort Fear of not getting standard care Fear of randomly assignment to placebo Being proactive about asking to participate Understanding the value of participation Feeling supported by the care and research team Future benefit to society Getting a sense of hope Positive influence from family and friends to participate Worries regarding costs Fatalism Structural Consent form–related challenges: overly burdensome, not concise, highly technical Lack of clear messaging: eg, perceptions of age limitations Lack of access to relevant technology (computer, tablet, printer) Clinical Lack of accessibility: trials not available or not approached to participate Overly strict eligibility criteria Perceived benefit to participation: eg, better clinical care on CCTs Care team and research team Lack of care team and research team communication, knowledge of current trials Financial conflicts of interest Bias precluding consideration of older adults Building trust through respect and clear communication: taking time to explain process and what to expect, dispelling misperceptions, use of patient navigators Patient Suspicion of trials: being treated as a “guinea pig” View cancer trials as last resort Fear of not getting standard care Fear of randomly assignment to placebo Being proactive about asking to participate Understanding the value of participation Feeling supported by the care and research team Future benefit to society Getting a sense of hope Positive influence from family and friends to participate Worries regarding costs Fatalism Open in new tab Table 2. Summary of findings Structural Consent form–related challenges: overly burdensome, not concise, highly technical Lack of clear messaging: eg, perceptions of age limitations Lack of access to relevant technology (computer, tablet, printer) Clinical Lack of accessibility: trials not available or not approached to participate Overly strict eligibility criteria Perceived benefit to participation: eg, better clinical care on CCTs Care team and research team Lack of care team and research team communication, knowledge of current trials Financial conflicts of interest Bias precluding consideration of older adults Building trust through respect and clear communication: taking time to explain process and what to expect, dispelling misperceptions, use of patient navigators Patient Suspicion of trials: being treated as a “guinea pig” View cancer trials as last resort Fear of not getting standard care Fear of randomly assignment to placebo Being proactive about asking to participate Understanding the value of participation Feeling supported by the care and research team Future benefit to society Getting a sense of hope Positive influence from family and friends to participate Worries regarding costs Fatalism Structural Consent form–related challenges: overly burdensome, not concise, highly technical Lack of clear messaging: eg, perceptions of age limitations Lack of access to relevant technology (computer, tablet, printer) Clinical Lack of accessibility: trials not available or not approached to participate Overly strict eligibility criteria Perceived benefit to participation: eg, better clinical care on CCTs Care team and research team Lack of care team and research team communication, knowledge of current trials Financial conflicts of interest Bias precluding consideration of older adults Building trust through respect and clear communication: taking time to explain process and what to expect, dispelling misperceptions, use of patient navigators Patient Suspicion of trials: being treated as a “guinea pig” View cancer trials as last resort Fear of not getting standard care Fear of randomly assignment to placebo Being proactive about asking to participate Understanding the value of participation Feeling supported by the care and research team Future benefit to society Getting a sense of hope Positive influence from family and friends to participate Worries regarding costs Fatalism Open in new tab Consent Forms and Consent Process The facilitator asked, “Do you remember reading and signing a consent form and discussing the form with someone from the study? Was it paper or electronic consent?” Seven participants responded that they had paper consent. One further suggested that …if you had an electronic copy that you could look at in advance, that would be helpful. That way, you’re not trying to read it in the doctor’s office and make a quick decision on 20 pages of paper. In response to this, another participant said I find that in my age group, among my friends, many of them still don’t have a computer or a printer, or even a tablet. Several participants commented on the excessive consent length and language used: Perhaps it would be helpful if there was sort of an entry consent…an entrance to participate, and then once that is done, and the patient is comfortable, then you get to the point where you have to check all those little boxes. We have a multi-ethnic population as our base…so there is a language barrier. Barriers Specific to Older Adults The structural barrier addressed most often was the perception of age limitations for eligibility. The big thing that has to be changed is to expand the age limitations. One participant suggested a way to address the perception of age limitations is better messaging. One way to communicate to the public that older adults are welcome to join clinical trials is to have a message that says, “you are never too old for a trial.” Clinical Level For the clinical level theme, the codes addressed types of barriers and reasons to participate. The Unger et al. (29) framework identified clinical barriers as trial-related eligibility factors. The participant discussion during the focus groups supported the issue around eligibility criteria but went beyond Unger et al. (29) to highlight other clinical level barriers and positive aspects of CCT participation. General Barriers The main general barrier at the clinical level identified by the participants was a lack of accessibility. My experience has been if you’re not in a community that has a comprehensive cancer center that offers clinical trials, they’re not going to be offered to you. Even at this large regional medical center, which is a trauma center, they did not offer a clinical trial. Because I’ve done educational research, I knew enough to ask about this. Barriers Specific to Older Adults Identified barriers that are specific to older adults are related to eligibility criteria. Older people are not asked to participate as much. They are eliminated from trials because researchers believe—this is my understanding—researchers believe that there are too many confounding factors. So older people are not as welcome. I think many studies have proven that we’re just as sturdy and just as healthy to be able to partake in a clinical trial if we want to. In contrast to comments regarding barriers, 1 participant stated: I’m noticing, too, that now they’re trying to get more, I guess they call it geriatric patients, into clinical trials and trying to remove some of the hurdles. Reasons to Participate and Perceived Benefits The better care a patient on CCTs receives was both a reason to participate and a perceived benefit noted by several participants. One of the things that influenced my participating was basically getting better care in a long-term study; someone contacted me every month for like 6 years, once a month, and said, “How are you doing, you know? Do you have any problems with this?” Care Team and Research Team In the framework of Unger et al. (29), the physician level corresponds to physician-related barriers. We expanded the title of this level to “Care Team and Research Team” to be more inclusive of the range of staff who interact with a patient receiving treatment and all staff who interact with a patient about a CCT. General Barriers Comments included patients’ perceptions regarding provider communication, provider knowledge of current trials, financial considerations, and attitudes of care team members and research team members recruiting for CCTs. One participant shared what they told their care team about not being notified about CCTs. Okay, you know I’m a patient advocate. I’ve been a patient here for over 12 years. You should know to offer that [clinical trials] to me whether or not you may think it’s something I want to do. I have the right to make that decision. It’s my body and my life. Other comments noted why community oncologists do not support CCT. Money speaks very loudly and if you’re a community oncologist, to give up a patient to a clinical trial is a financial consideration. It’s sort of the elephant in the room. Another comment was on the attitudes of CCT recruiters. A friend and I went to a conference on [CT] accrual, and there was an attitude like [among recruiters], “I’m just doing my job, I just need to get this done. I get paid for everyone that I accrue.” And they [the recruiters] couldn’t have given a hoot about the person they were speaking to. Barriers Specific to Older Adults Additionally, focus group participants noted the need for clear communication and feeling valued by the care team and research team. For older people to be more accepting, it’s going to have to be their GP [general practitioner] that has to sit with them and develop communication with them. I think clinical trials have to be very clearly explained. And I don’t think the medical community is doing a good job. If you feel valued, you’re going to listen with a very different ear than if you don’t. Introduction to CCT Many comments indicated the importance of how participants are approached about CCTs by their care team and research team. Two examples are: I was approached by my doctor. She just said there are a couple of studies and wanted to know if I would be interested in participating. The way it was approached is the person was not the treating doctor. It was someone I think was experienced in talking to people about this, and they laid it out very nicely. One participant described concerns about taking away from a younger patient an opportunity to participate in a clinical trial. I was worried because I thought I’m 80 years old and I might take something away from a younger person who needed it more than I did. But they said no. I didn’t know that they [were] having trouble getting people to volunteer. Reasons to Participate and Perceived Benefits Reasons focused on the perception of better care and the availability of clinical research professionals to provide support. The patient should understand what the benefit of the participation should be. It’s not guaranteed, but there is a possibility of improved outcome. So, I think [it is] important to communicate the value of participating. Having that person that I can call and say, “You know, this is happening to me. Is this really part of this?” [It] makes a big difference. You have that contact person that is going to be there. And you’re not out there alone. Patient Level The patient level, as conceptualized by Unger et al. (29), is the decision made by the patient. This level did not change as an outcome of the data analysis. General Barriers General barriers included: There’s a suspicion about participating in any sort of clinical trials. I think [another participant] mentioned about being guinea pigs. Until you educate yourself about cancer and the cancer community, most people think that clinical trials are a last resort. So, there’s a huge misconception about that. I do not see the research community making much effort in educating the larger community that clinical trials are a first step, not your last step. Barriers Specific to Older Adults Participants also described barriers for older adults, including: I have a feeling that many older people don’t like trials because they think, what if I don’t get well or it keeps me [from getting] the normal treatment? I think that should be more explained, that we get checked out all the time, and they keep on top of it, so I don’t think it should be a problem, but maybe people think that way. One of the things that would help is transportation, given that some of the patients become further disabled because of the illness. Introduction to CCT Several participants talked about how their oncologist approached them about a trial. One example is: [My oncologist] hand wrote the schedule of how every phase would be, ’cause it started out with high dose chemo and then went down from there to additional things over those 9 months. I could look at that and see what was coming next as I continued to survive through the treatment. So, to me, that was just an amazing gift, that he was able to sit down and do that for me to help me understand because at the time… Another participant described how she approached her oncologist about getting on a trial. After the third time [diagnosis], I saw a flier in a waiting room. I asked my oncologist [about] participating in any clinical trial that I was eligible for, and I’ve been on the lookout for any possible trials that I could participate in. I’m thinking I can’t just be a passive patient. I need to advocate for myself. My oncologist was very open. So, I’m very grateful to be participating and learning and actually helping myself. Reasons to Participate and Perceived Benefits Participants identified many perceived benefits of clinical trial participation and reasons to participate. I think for me it’s more, is this gonna make a difference in my life and in my family’s life, because in our culture, family is very dear to us and we are very supportive of each other, and if this is going to possibly help them in the future or help others in the future, I think that’s very important to participate. Even though it’s a bad diagnosis, it gave me hope. [What] I thought was helpful was the fact that the doctor and oncologist, the radiation oncologist, the nurse navigator, they all came to my treatment room and met with me and didn’t make me wander from doctor to doctor to get the information I needed. And that, to me, when you’re going through a really bad diagnosis, was really helpful. Support to Enroll The ways participants felt supported in their decision making highlighted the importance of family, friends, or physician support. …my son is an Emergency Department doctor. He was in residency when I got diagnosed, so his immediate reaction was “Get to a teaching hospital, that’s where the cutting-edge treatments are.” I met a patient advocate who’s been through 5 recurrences. She’s been my inspiration. She’s a very strong advocate of clinical trials. She believes that it saved her life. I trusted my doctor. He’s very well-known in the lung cancer community. And so, I just trusted him, and I think that’s important. Worries About Participation The participants also discussed their worries about the cost of CCT participation. The maintenance chemo I was on after the stem cell transplant was $10 000 per month. I asked about the cost, what I would have to pay, and I was told it would be provided throughout the clinical trial period, which was 1 year. Why Not Participate The participants also identified potential reasons patients may not participate in a clinical trial. There is one issue of clinical trials that I would never, ever do. And I would never, ever go on a trial with a placebo. To me, there’s always something that it [new treatment] can be compared to. To me, a placebo is like a sugar pill. It’s nothing. When I reviewed the recent clinical trials, one of the things that is in the documents is a waiver, like “If this drug, the experimental drug, is approved by the FDA, then the patient might have to assume the cost.” I think there is a fatalism as you get older, which may stop you. Discussion To our knowledge, this is the first national focus group of older adult patient participants to identify and discuss barriers to clinical trial participation among their peers. Key findings from these focus groups include barriers related to the consent process and language, strict eligibility criteria such as age limitations, lack of accessibility, lack of health-care team knowledge of clinical trials, poor recruitment techniques, and distrust of clinical research (see Table 2 for summary of findings). Our findings fit well with Unger and colleagues’ (29) Framework of the Context of Barriers Domains. The original Framework had 4 levels: structural, clinical, physician, and patient. Our findings expanded the conceptual definitions in 3 of the 4 levels described below and summarized in Figure 1. Expansion in the structure level includes the use of consistent wording on consent forms and how forms are presented to patients at each site, improved infrastructure support to allow for more care teams to engage with patients in discussing trials, and explicit inclusion criteria for older adults to be included in trial design. At the clinical level, we expand considerations beyond eligibility criteria to include access to CCTs in one’s community and require that all trial implementations be the same at each trial site, notably having someone on the research team assigned to follow up with a patient throughout the trial. The final adaptation was renaming the physician level to the care team and research team level, expanding beyond the physician’s role in recruitment and retention. The context of the framework is that participation starts at diagnosis and continues throughout treatment and that the patient makes the decision based on the outcome of each of the levels sequentially. Specifically, if there are structural barriers, CCTs will never be offered to potential participants; if there are barriers at the clinical level, the option of participating in a CCT will not be presented to the patient; and if there are care team and research team barriers, the patient will not be offered the option or not offered in a way they are comfortable with and thus not have the information needed to decide to participate in a trial. Structural Level Participants identified structural barriers such as paperwork and the overall information received as overwhelming when considering a clinical trial. Further, others discussed language barriers in terms of both health literacy and spoken language. Consent language is an ongoing issue in the literature. It has often been mentioned that consent language is too technical for the layperson to comprehend (31–34). Health literacy and participants’ reading level must be considered. It is estimated that 20%-36% of all adults in the United States have limited health literacy; the percentage is higher among marginalized populations (35). The impact of health literacy in the oncology population is of particular importance because cancer care commonly requires patients to navigate a complex health-care system (36); decision making to enroll in a clinical trial only heightens the complexity. Two studies found that patients with lower health literacy levels were likely to participate in clinical trials but relied heavily on their providers for the recommendation (32–37). Potential clinical trial participants may not speak English, and translating consent forms is a complicated and expensive process. In addition to the consent form, other study-related documents are often available only in English (38). The extra time required to consent an older adult may be a barrier; Freedman et al. (7) cited the lack of personnel and resources to support older adult accrual. It is difficult for researchers to review in plain language with a patient all aspects of participants’ rights and protections. Therefore, it is important to work with a plain language expert and give the patient adequate time to review the consent and ask questions. Unfortunately, the time needed for older adults is incompatible with our current fee-for-service, relative value unit (RVU) based health-care system. RVU is a standard set by Medicare to determine the amount to pay a provider depending on time and productivity (39). Clinicians are typically limited to 15- to 20-minute appointments, which is not enough time for a thorough discussion with a patient about a potential clinical trial (7,40). The limitations on time exist across all types of cancer care settings, academic as well as community based. Per the FDA (41), a potential clinical trial participant should always have adequate time to review and ask questions before signing the consent. Clinicians and research personnel need to know that this time should be longer when working with older adults, because they may have age-related considerations such as poor eyesight or hearing loss (42). Most comprehensive cancer centers are affiliated with academic centers where a research culture is primary. Unfortunately, research is often not a priority in community settings, where most patients with cancer, including older adults, are treated (43). Community cancer centers are heavily RVU based. The time required to enroll patients into trials is not reimbursed, making community practices less likely to participate in clinical research (29). This issue was noted in the focus groups and highlighted as a recurrent structural barrier in the community clinical setting that needs to be addressed; however, the workshop did not have data to estimate if older adult enrollment was greater at academic centers. For Community Sites to be successful in clinical research, a commitment among providers and administrators to value and support clinical research and become familiar with the populations they serve is imperative. Programs need knowledgeable and reliable clinical, operational, and administrative staff experienced in meaningfully engaging with trial and potential trial participants. It is of utmost importance to have an efficient structure to sustain clinical research in the community and involve higher percentages of individuals diagnosed with cancer (44). An example of a sustainable community oncology research system is the NCORP. Its grant funding supports infrastructure for community sites to participate in NCI-sponsored research for cancer control, supportive care, health-related quality of life, cancer care delivery, treatment, and imaging trials. Infrastructure in all cancer care settings needs increased funding and resources, especially staffing. The NCI is aware of this barrier and in 2020 held the inaugural Primary Care Alliance in Research Trials Involving NCORP Sites Workshop. The workshop aimed to develop a platform for addressing barriers to CCT accrual (45). The burden should not only fall on the oncologist; other health-care providers such as primary care providers, advanced practice providers, pharmacists, nurses, social workers, navigators, and medical assistants can all play a role in promoting and recruiting patients for CCTs (46,47). Focus group participants also identified age limits as barriers to older adults’ participation in clinical trials. Interestingly, CCTs are the most age-inclusive compared with other disciplines (48). Currently, the NCI does not have an upper age limit for trial participation, but such limits may exist among other sponsors. It is interesting to note that the perception of upper age limitations in cancer trials, even when nonexistent, may play a role in discouraging participation among older adults. Clinical Level Comorbidities and other clinical conditions that may be barriers from both an eligibility and a referral standpoint were identified. The authors are aware of the barriers within eligibility criteria; for example, a lower creatinine clearance may make an older patient ineligible, or the assumed treatment toxicity level that may result in a physician not making a referral (29,40). Work is ongoing in protocol development and design to address these barriers. In addition, it has been highlighted that underrepresentation of a diverse older adult population can lead to increased toxicity and more treatment-related complications in everyday practice (49). One facilitator identified by the focus groups and seen in the literature was the improved care coordination patients feel when enrolled in a clinical trial study (50). This facilitator is supported by National Cancer Comprehensive Network guidelines. A statement at the bottom of every guideline page says that National Cancer Comprehensive Network believes the best management of a patient with cancer is in a clinical trial (42). Care Team and Research Team Level Participants frequently talked about the physician and other staff on the care team and research team as facilitators or barriers to their consideration and participation in a clinical trial. This mirrors known data that physicians have the greatest influence on whether a patient enters a clinical trial (51,52). In addition, how the clinical trial was presented was both a facilitator and a barrier. It was noted that if the research team does a good job explaining a trial, it truly helps. These findings also highlight the need for age-friendly approaches to communication. Haase and others (53) found that older adults want improved communication and clinicians to speak with them loudly and slowly. Also, a follow-up phone call and written communication in layman’s terms also assisted interactions between the care team and older adults. Clinicians and research staff need to consider this when speaking with older adults about CCT. Patient Level Misconceptions surround clinical trials, such as being a last resort or being more toxic. The fear of “being a guinea pig” and concerns about finances, placebos, and cultural insensitivity were discussed. These barriers could be addressed through better education for patients, caregivers, and the community at large. Increased understanding about what to expect and protections for participants in clinical trials in general as well as the specific clinical trial that will be presented to a patient are needed. Again, this will take time and dedication. Multiple focus group participants recognized their interest in giving back and how this could help loved ones and the greater community. Many barriers identified under the patient level were recurring themes throughout the discussions, with continued importance regarding patient, provider, and overall community education. Multi-level interventions successfully address health inequities (54,55) and could be applied to clinical trial education and older adults. These interventions should include individual patients, the communities they live and work in, and all members of health-care systems. The main limitation of this study is the lack of diversity among the focus group participants. We acknowledge that most of the participants had graduate degrees and may have had greater knowledge of opportunities to participate in clinical trials. The number of participants was also small, and whether data saturation was achieved in qualitative analysis is unknown. Having only 1 male voice also limited the perspective of the focus groups. Finally, self-selection bias reduced the opportunity for a broader picture of older adults with cancer experiences with CCT. Future Directions When considering recommendations for future directions, the authors would like to highlight the importance of time spent, tailored communication style, and clear messaging when introducing and discussing clinical trials with older adults. Focus group participants repeatedly mentioned the importance of communication and education, whether from providers, research staff, in consent language, or in overall understanding of clinical research. Time and resources should be dedicated to meaningful communication and engagement with older adult patients and their caregivers if we want to make tangible progress regarding older adult accrual to clinical trials. In addition, broadening eligibility criteria will allow for the inclusion of more individuals with comorbidities and true representation of older adults treated in everyday practice. Given their unique needs and perspectives, older adults should also have more opportunities to provide input during protocol development because they can offer a unique vantage point that providers and researchers may not have. Finally, given the concentration of patients with cancer-seeking treatment at community centers, further research on differences in trial participation of older adults in community vs academic cancer settings would help identify unique barriers and advantages within each environment that would inform future strategies to improve older adult participation in trials. In conclusion, many of the issues identified by older adults in our focus groups supported what has already been reported in the literature regarding barriers to trial participation. We did, however, identify experiences not previously reported. The data analysis of the focus groups fit within the Context of Barriers Domain Framework with a few modifications broadening the original framework concepts to include considerations for clinical trial structure, communication, interaction with patients, and trial access. The data presented here can provide a foundation for developing multi-level interventions across systems and stakeholders. Funding No author received funding for the generation of this manuscript. Notes Role of the funder: Not applicable. Disclosures: The authors declared no potential conflict of interest with respect to the research, authorship, and publication of this article. Author contributions: Research conceptualization: KB, BC, AD, CBI, AB, ECS. Data collection: ECS, AB. Data analysis: KB, IO. Manuscript writing and review: All authors. Acknowledgements: The authors thank all participants who took the time to express their views on this research project. The authors also wish to thank Ms Perquita Perry, Staff Assistant to the Associate Director of Clinical Research at the Division of Cancer Prevention/NCI, for her administrative support on this project. Data Availability The Office of Management and Budget policy on data collection from 9 people or fewer is for internal agency program evaluation only; therefore, data cannot be shared. References 1 Cancer Stat Facts: Cancer of Any Site . https://seer.cancer.gov/statfacts/html/all.html. Accessed January 15, 2022. 2 Colby SL , Ortman JM. Projections of the Size and Composition of the US Population: 2014 to 2060 . US Census Bureau, US Department of Commerce . https://www.census.gov/content/dam/Census/library/publications/2015/demo/p25-1143.pdf. Accessed January 15, 2022. 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