African American Cancer Survivors’ Perspectives on Cancer Clinical Trial Participation in a Safety-Net Hospital: Considering the Role of the Social Determinants of Health

Abstract

Although there has been an increase focus on recruitment of minority populations at safety-net hospitals into cancer clinical trials, there is still a paucity of research exploring minority participation in cancer clinical trials at safety-net settings. The study utilized a multi-level, qualitative approach to assess the clinical and non-clinical facilitators and barriers to African American participation in cancer clinical trials at a safety-net hospital. From June 2018 to July 2019, cancer survivors (n = 25) were recruited from a cancer center at a safety-net hospital in the southeastern USA and participated in a 60-min focus group. Data was coded and analyzed to identify the most prominent themes. Most participants were female (78%), with a mean age of 56 years. The majority were diagnosed with breast cancer (68%) and disabled or unemployed (55%). Major themes identified were (1) lack of understanding of cancer clinical trials, (2) perceptions and fears of cancer clinical trials, and (3) preferred role and characteristics of patient navigator. The barriers and facilitators to enrollment in cancer clinical trials were more pronounced in the safety-net setting, given the overdue burden of social determinants of health. Study findings yield important insights and essential practices for recruiting and engaging underrepresented Black cancer patients into cancer clinical trials, specifically for safety-net settings. Including patient navigators may help traverse potential barriers to cancer clinical trial participation and will allow for the attention to social determinants of health, and ultimately increase the number of African Americans participating in cancer clinical trials.

Introduction

Participation of racial/ethnic minorities in cancer clinical trials offers the promise of new, effective treatments, and increases access to potentially life-saving or life-prolonging therapies to traditionally underserved groups [1]. Cancer clinical trials also help us to understand how and why different treatments may have distinct effects on diverse populations [1]. Despite efforts to increase racial/ethnic minority participation in cancer clinical trials, their participation remains disproportionately low, thus limiting the generalizability of study findings [1–3].

Barriers to the recruitment of racial/ethnic minorities to clinical trials have been widely documented [2, 4, 5]. Ford et al. theorized that recruitment barriers occur at three junctures along the potential participants’ paths to enrollment in clinical trials: (1) awareness of clinical trials, (2) opportunity to participate, and (3) acceptance or refusal of enrollment [4]. Although distrust of clinical research may predispose some potential participants to refuse trial participation when offered, African Americans (AAs) may be less aware of clinical research or less likely than Whites to be offered opportunities for trial participation [6].

Safety-net practices, often in inner-city communities, provide a disproportionate share of care to low-income, and uninsured, populations [7, 8]. Because of their obligation to serve poor and uninsured patient populations, safety-net settings are different from traditional practices. Patients have distinctive needs that affect healthcare providers’ approach to patient engagement and intervention. Many patients who receive care through safety-net hospitals present with complicated cases, in part, emergent from social determinants of health (SDH) including poverty, housing insecurity, food insecurity, exposure to violence and trauma, cognitive and mental health issues, and substance abuse. Patients are also diverse with different cultural health beliefs and practices, limited-English proficiency, and health literacy challenges. Interventions that work with wealthy, health literate, or cultural majority populations may not work with patients from a safety-net practice. Historically, most minority patients receive care at institutions serving predominantly minority patients and experience less than favorable quality of care [9].

Since the NIH Revitalization Act of 1993 was signed into law, which directed the NIH to establish guidelines for inclusion of women and minorities into clinical research, there has been an increased focus and effort on recruitment of minority populations at safety-net hospitals into cancer clinical trials. However, to date, there is still a paucity of research exploring minority participation in cancer clinical trials at these types of institutions [10–12], which may be a missed opportunity. While patient-centered research in safety-net hospitals is an understudied area, there is a unique opportunity to understand and characterize the barriers and facilitators to cancer clinical trial participation and to identify optimal recruitment strategies for medically underserved populations. Additionally, there is a need to understand which culturally relevant approaches are needed to recruit and retain racial/ethnic minority populations in cancer clinical trials in safety-net clinical settings.

The purpose of our study was to implement a qualitative research framework with cancer survivors who received treatment at a safety-net hospital that would inform the components of a clinical-community based, multi-level intervention. The study sought to (1) assess the clinical and non-clinical facilitators and barriers to minority participation in cancer clinical trials in safety-net settings and (2) elicit feedback on preferences and characteristics of the use of patient navigators in safety-net settings for recruitment to, and retention in, cancer clinical trials.

Methods

Between June 2018 and July 2019, three focus groups were conducted with African American cancer survivors to elicit the clinical and non-clinical facilitators and barriers to cancer clinical trial participation. Participants included adult cancer survivors who received treatment from a cancer center in a safety-net hospital located in Atlanta, Georgia. This study was reviewed and approved by the Institutional Review Board of an affiliated US southeastern university, the safety-net hospital’s internal research oversight committee, and the cancer center’s clinical research committee.

Study Population and Setting

All focus group participants were past or current patients of the cancer center at the safety-net hospital. Eligibility criteria included (1) self-identified as African American, (2) 18–75 years old, (3) spoke and read English, (4) have ever been diagnosed with cancer, (5) had no functional limitations that would interfere with participation in a 60-min focus group, and (6) capable of providing written consent for study participation. Inclusion criteria did not include anything about previous or current participation in a cancer clinical trial and/or having been offered to participate in a cancer clinical trial. Study investigators did not want to hinder the interest of participants and their valuable feedback. All focus groups were conducted in a conference room in the safety-net hospital near the cancer center.

Recruitment

Participants were recruited into the current study using both convenience and purposive sampling methods. Passive and active recruitment strategies were employed. Study flyers were distributed at community-based outreach and/or health-related events, such as the safety-net hospital cancer center’s Annual Cancer Survivors’ Celebration. The flyers described the study’s purpose and procedures. Individuals interested in participating were asked to provide their name and contact information on a sign-up sheet. The safety-net hospital cancer center also provided the research team with a list of cancer survivors’ names and contact information treated within the last 5 years. The research team contacted individuals, by phone, from the sign-up sheets, and the list of cancer survivors provided by the cancer center. Individuals interested in participating were screened to determine eligibility. All participants provided written informed consent and were remunerated with a $25 gift card for their participation.

Moderator Training

To minimize interviewer bias during the focus groups, a triangulation of observers’ approaches was used. This method involved using multiple observers or researchers during the conduct of data collection to reduce bias by adding alternative perspectives, backgrounds, and social characteristics. Focus group moderators and research team members involved in data collection completed a 2-day qualitative methods training led by one of the study’s multiple principal investigators (MPIs). The training covered the fundamentals of qualitative interviewing and focus group moderation and included sessions focused on how to follow a moderator guide, role-playing, and feedback.

Data Collection

The moderator guide was based on an adaptation of the Ford Model for minority recruitment [4]. The model describes two categories of factors that can affect accrual during distinct and consecutive phases of the recruitment process: (1) awareness barriers or promoters and (2) acceptance or refusal barriers or promoters. In addition, the model specifies two general types of moderators that can affect the utility of various recruitment strategies used throughout the phases: sociodemographic factors and opportunity barriers/promoters [4]. The study’s semi-structured moderator guide included open-ended questions and probes that covered topics such as participant knowledge of cancer diagnosis, awareness and perceptions of clinical trials, and patient navigation for cancer clinical trials.

Each focus group was conducted by 2–3 research team members: one team member served as the moderator for all the sessions, and the remaining team members operated the audio recording device and/or took detailed field notes. The number of participants in each of the focus groups varied. The first focus group had 6 participants, the second focus group had 9 participants, and the last focus group had 10 participants. Prior to the focus group, participants completed a one-page demographic questionnaire. At the start of each focus group, the research team explained the purpose of the study and informed participants that the session would be audio-recorded for transcription purposes only. Each participant was instructed to choose a unique identifier to maintain their anonymity and protect their identities during data analysis. All focus groups were audio-recorded on two separate passcode-protected devices. Focus groups 1 and 2 were transcribed verbatim by an external transcription company, and focus group 3 was transcribed verbatim by the research team.

Data Analysis

To analyze the data, the study team employed a content-based thematic analysis that involved inductive and deductive approaches to transcribing the data. Based on the literature regarding barriers to recruitment of racial/ethnic minorities to clinical trials, deductive codes were identified, along with factors that affect the significance of this study. Based on responses of the focus group participants, inductive codes were identified and labeled as open codes (unstructured). These codes went through a process of axial coding, making relationships and connections to formulate categories. These categories were aligned with participants’ responses until the end of the focus group transcripts. Final themes were developed from the frequency of codes and the prevalence across all focus groups. All codes, categories, and themes were discussed between two independent coders, reviewed, and finalized by the research team. We report only the analysis of those codes that were categorized as barriers or facilitators of minority recruitment according to the organizational scheme of the codebook. Additional codes were added to the codebook during the coding process. The final codebook and coded transcripts were entered into NVivo QSR version 11 (QSR International, Melbourne, Australia, http://www.qsrinternational.com). Descriptive statistics were calculated to describe sample demographic characteristics.

Results

Participants

Participating in the focus groups were 25 cancer survivors with a mean age of 56.78 (SD = 11.18) years. Of those who responded to the demographic questionnaire, 78.3% (n = 18) identified as female. Sixty-eight percent of respondents (n = 17) reported that they were diagnosed with breast cancer; the remaining respondents reported that they were diagnosed with cancer of the bone, lung, prostate, colon, or nasopharynx. For participants, the average time since receiving cancer treatment was 3 years. A total of 54.5% of respondents (n = 12) reported that they were disabled or unemployed; 56.5% (n = 13) had an annual income of less than $20,000; and 76.2% (n = 16) had public insurance, such as Medicaid or Medicare (see Table 1).

Table 1.

Demographic characteristics of participants (n = 25)

Variables	n (%)
Age (mean ± SD)	56.78 ± 11.18
Gender
Male	5 (21.7)
Female	18 (78.3)
Race
Black/African American	23 (100.00)
Hispanic/Latino
Yes	0 (0.0)
No	7 (100.0)
Marital status
Single	11 (45.8)
Married	2 (8.3)
Widow	3 (12.5)
Separated/divorced	8 (33.3)
Lives with partner	0 (0.0)
Education
8th grade or less	0 (0.0)
9th grade to 11th grade	1 (4.2)
High school diploma or GED	6 (25.0)
Some college	4 (16.7)
Community college/technical	5 (20.8)
Bachelor’s degree	4 (16.7)
Master’s degree	2 (8.3)
Doctoral degree	2 (8.3)
Have health insurance?
Yes	22 (91.7)
No	2 (8.3)
Insurance type
Private	2 (9.5)
Medicare	11 (52.4)
Medicaid	5 (23.8)
Uninsured	0 (0.0)
Other	3 (14.3)
Employment status
Part-time h/wk.	2 (9.1)
Full time	1 (4.5)
Unemployed	1 (4.5)
Retired	7 (31.8)
Disabled	11 (50.0)
Never worked	0 (0.0)
Total annual household income
No income	1 (4.3)
Less than $20,000	13 (56.5)
$20,001–$40,000	1 (4.3)
$40,001–$60,000	2 (8.7)
$60,001–$80,000	2 (8.7)
$80,001–$100,000	0 (0.0)
$100,001 or more	0 (0.0)
Declined	4 (17.4)
Cancer type
Bone cancer	1 (4.0)
Breast cancer	17 (68.0)
Lung cancer	2 (8.0)
Prostate cancer	1 (4.0)
Nasopharyngeal carcinoma	1 (4.0)
Colon	3 (12.0)

Categories may not add to 100% due to missing data

Qualitative Themes

Themes from the focus groups were grouped into three categories: (1) lack of understanding of cancer clinical trials (barrier), (2) perceptions and fears of cancer clinical trials (barrier), and (3) preferred role and characteristics of patient navigator (facilitator) (See Table 2 for themes and sample questions). Representative quotes are presented for each theme.

Table 2.

Focus group domains and sample questions

Domain/themes	Sample questions
Level of understanding of cancer clinical trials	• What do you know about the cancer you have? What type is it? • What type of treatment have you been offered for the cancer you have?
Perceptions and fears of cancer clinical trials	• Prior to your cancer diagnoses, please tell me what you all knew about cancer clinical trials? • Since your diagnosis, what have you all learned about clinical trials? • Have any of you previously participated in a clinical trial? If so, please tell me about that experience?
Preferred role and characteristics of patient navigator	• Would you be willing to work with a patient navigator, who is not a doctor or nurse, to assist you with both the process of being enrolled in clinical trial and the actual participation in the clinical trial? Why or why not? • How would you expect a patient navigator to assist you? • What questions would you need answered before working with a patient navigator?

Lack of Understanding of Cancer Clinical Trials (barrier)

Having limited information and understanding about cancer clinical trials was a major barrier for study participants. For many cancer survivors in the study, there was a lack of understanding of cancer clinical trials and what they entailed. Many survivors were confused and could not differentiate between a cancer clinical trial and treatment of cancer. All treatment discussions, whether experimental or standard, seemed to stream together. Participants often spoke of their cancer treatment as participation in a cancer clinical trial. When asked specifically about what they knew about cancer clinical trials, many participants responded with, “I don’t know” or “nothing.” Those that indicated they knew something about clinical trials could not define or clearly express what is a cancer clinical trial. One participant thought that standard treatment for his relatives with cancer represented clinical trials.

You don’t hear about clinical [trials] about cancer, clinical like I have, like I said, I got my cousins that got cancer, but I have a cousin that she died from cancer. My other uncle, he’s currently doing a chemo, radiation, and everything, right now.

Another participant had heard of cancer clinical trials but could not clearly articulate what they were or entailed, although they knew that, because of trials, she got the right treatment.

I heard of clinical trials before I was diagnosed with breast cancer, and I’ve seen people participate in clinical trials. Now when, after I had my biopsy, and they sent that test out to me to get the type of blood, and my medical oncologist told me that the pill that I’m on, it wasn’t around 10 years ago. So, someone had to do clinical trials of those pills. That’s why it’s recommended to me from my results of my genotype.

Other participants more frequently characterized cancer clinical trials as “free service” or “options.” Even when information was provided to the participants about a cancer clinical trial, they still misunderstood the premise of clinical trials. When probed about where they received information about cancer clinical trials, only a couple of study participants mentioned a healthcare provider. Generally, participants stated that their healthcare providers did not discuss a cancer clinical trial or did not recruit them to participate in one.

Perceptions and Fears of Cancer Clinical Trials (barrier)

Overall, participants reported varied perceptions of cancer clinical trials, but variation was based on generational status and gender. Older male participants reported greater mistrust and fear of participating in a cancer clinical trial. The negative perceptions from participants were influenced by historical abuses and stories shared from other participants and community experiences, such as the US Public Health Service Syphilis Study at Tuskegee and the commercial appropriation of Henrietta Lacks’ tumor cells. One of the participants strongly suggested,

I had a lot of reservations about clinical trials because of how they’ve done the Black community, I mean look at [the] history with Tuskegee. I mean look at all the different experiments that are done on Black people…But I’m nervous about clinical trials because of the history that has been exacted on us as experiments. That’s the only thing that holds me back, from jumping in full throttle.

Other participants also mentioned fear as a common barrier to participation in cancer clinical trials.

People my age are afraid sometimes of studies, cause if you don’t understand something, you’ re more careful about it, I’ll put. But one of the reasons why being that back during my early years, they used to use Black people for guinea pigs. Namely the Tuskegee stuff. That deterred a lot of Black people from wanting to be in studies…

Many participants thought of clinical trials as a ploy to get the Black community to serve as guinea pigs. This level of distrust was expressed in all three focus groups and was a dominant theme. One participant exclaimed,

“about the trials that people sometimes do not want to be, like was said about being a guinea pig and that’s why they don’t want to [participate] … cause that’s what was in my mind when I always thought about trials. Am I going be tested like a guinea pig, and what are the negative effects going to be?

Interpersonal aspects of health care and the roles of healthcare providers were also associated with mixed perceptions regarding cancer clinical trials. Participants who had negative interactions with healthcare providers gave adverse reactions to participation in cancer clinical trials, whereas those who had more positive experiences with a healthcare provider were more willing and open to participating in a cancer clinical trial. A willing participant attributed her positive experience with her physician as she described how the physician took time to explain her cancer diagnosis.

They made you feel like you know what I’m saying that you’re going to be alright. You know what I’m saying. Like she explained to me, like when she was explaining, I didn’t even know what colon cancer WAS or none of that. So she took a big marker, and wrote on the sheet, and she draw the rectum and everything and a circle where we are got to cut right here for it.”

Participants also discussed fear and deference to spiritual or religious beliefs as a factor related to participation of cancer clinical trials. They often discussed their perceptions of cancer clinical trials in relation to their personal cancer experience and the fact that their destinies were in the hands of God or a higher power. When discussing cancer and participation in research studies, participants discussed their spiritual connection with a higher power. A higher power directed their fate in relation to their experience with cancer and whether they would even consider participating in a cancer clinical trial. When asked to clarify why they did not want to participate in a cancer clinical trial, a study participant responded,

I trust him. It wasn’t them. It wasn’t the medicine or nothing. I trust God. And I knew he wasn’t going to do that to my body.

For many of the participants, the diagnosis of cancer and associated fears precluded thinking about clinical trials or even treatment. Conversations in the focus group represented the first time many participants were able to talk openly about their cancer diagnoses and experiences to someone outside of their family. Rather than even being open to the idea of cancer clinical trials, participants were more concerned about processing their cancer diagnosis and what they would do.

Participants expressed concern and apprehension about participating in an experimental treatment option or, “worse,” for many, receiving the placebo. Some participants mistakenly believed that cancer clinical trials used a “placebo versus new treatment” design and were concerned that they could have cancer and receive no treatment if they chose to participate. One survivor described, “But I’m nervous about it because there’s so many things about placebos you hear things—I’ve heard things about people getting stuff that’s contradictory to uh treatment”

Preferred Role and Characteristics of Patient Navigator (facilitator)

When discussing facilitators to cancer clinical trials or what would encourage patients to participate in cancer clinical trials, patient navigation was discussed. The definition of a PN was read, and all participants agreed that they would be willing to work with a PN to assist with the process of being enrolled in a cancer clinical trial and the actual participation in the clinical trial. Many stated that the role of a PN should be to provide social and emotional support, to direct survivors to community resources, to provide understandable information about cancer clinical trials, and to be the communication bridge between them and their healthcare providers. Participants were specific about the qualifications or requirements of a PN. One participant described the ideal PN as,

Someone who would know about the clinical trial because I think that would be a qualification in order to be a navigator. That’ s my primary goal cause I would want to have someone with some type of information that would have a beginning and middle and ending that’s been or that’s walking through the different procedures that the clinical trial and what to expect and not to expect.

Another participant described her current experience with a PN who was provided emotional support and who had been a survivor themselves.

I would call and- just wanting to know that she’s there for me, and she can tell me the steps that I’m going through. Because when I had chemo, no one told me the side effects. It was trial and error. I would wake up in the morning, and something new had happened, it’s like “what the heck is going on-“no one told me, so with that navigator, if they’ve gone through it, they can tell you what to expect and what to look for. And you won’t be out there like “I’m just out here by myself

For other survivors, their requirement or what they would prefer in a PN was more personal characteristics such as being spiritual, relatable, compassionate, and being the same ethnic/racial background. They believed that PNs should not only focus on recruiting participants to cancer clinical trials but also offer a wide array of clinical and support services such as counseling, coordination of care, and health education and facilitate communication between patient and healthcare provider and social support. Many participants described that they would feel comfortable talking to a PN who either was a peer (cancer survivor) or had participated in a cancer clinical trial. One participant described their ideal navigator as the following,

What you were saying about the doctors and the nurses. They see things as a medical situation. See we don’t see it as medical. We see it as personal. A navigator would probably feel more on our side of it. Then see the doctor, they can go into their book, and they look into a book or whatever because that’s how they deal. That’s how they go to do something. A navigator or a person that a lay person, or a person, however you want to say, would deal with it my point of view, without the medical stuff involved in it.

Discussion

This study used qualitative methods to explore barriers and facilitators to participation in cancer clinical trials among African American cancer survivors who receive care at a safety-net hospital in a large urban city. The current study revealed barriers and facilitators that have been well documented; however, these factors still pose significant issues for patients when trying to recruit them into cancer clinical trials especially in a safety-net setting with vulnerable populations. The barriers and facilitators to enrollment in cancer clinical trials were similar to those reported in other studies with minority patients across the USA, however, more pronounced [12, 13] in the safety-net setting, given the overdue burden of SDH.

One of the primary barriers reported was the lack of knowledge and minimal understanding of not only a cancer clinical trial but also even of their cancer diagnosis. Information about cancer clinical trials and treatment were viewed by patients’ as the same or no real difference. When asked about the term “cancer clinical trials,” few participants could convey what a cancer clinical trial was or entailed. Some participants, instead, presented the research team with their perceptions of cancer clinical trials, informed in part by information they acquired from the media, family, or other community members. Many times, these perceptions were either inaccurate or pessimistic. For example, many participants interpreted their personal experience with “trial and error” for cancer treatment as participating in a cancer clinical trial. These findings mirror a previous study with Black men and women on perceptions of clinical trials in the South who found Black men and women to have limited knowledge and understanding of cancer clinical trials [14].

Participants in this study reported that they were not given much information about cancer clinical trials and had lower levels of awareness and knowledge of those trials. Many of the participants expressed difficulty in understanding the cancer treatment-related information provided to them and often struggled to make informed decisions regarding their cancer diagnosis. These findings underscore the importance of health literacy and culturally and linguistically tailored health communication strategies to ensure understanding of what a cancer clinical trial entails, its purpose, the various types, and which cancer clinical trials are right for which patient. Foundational to any health communication approach is health literacy or the degree to which an individual has the capacity to obtain, communicate, process, and understand basic health information and services to make appropriate health decisions. A host of studies have found that patients with low-literacy skills were more likely to have negative attitudes toward engagement with health services such as mammograms [15, 16]. Our findings are commensurate with these studies and suggest the need to provide culturally and linguistically appropriate cancer clinical trial information to African American cancer survivors treated in a safety-net hospital to ensure understanding of important clinical trial terms/concepts as well as their role as research participants. Previous studies have demonstrated that, when there is clear and understandable shared communication between the physician and patient, decisions to enroll in cancer clinical trials are greatly enhanced [17].

As previous studies have found, participants in our study had high levels of mistrust of cancer clinical trials [5, 18]. Participants discussed dissatisfied interactions they had directly or indirectly with healthcare providers and how this influenced their skepticism regarding cancer clinical trials. Participants noted that a trusting relationship with a healthcare provider would be a facilitator to participate in a cancer clinical trial. As a recent study found, healthcare providers are the first to refer patients to a cancer clinical trial; thus, it is important for healthcare providers, research staff, and others involved in the research to build and establish trust and rapport with patients [19]. Some also referenced that their mistrust stemmed from historical events of Blacks who have participated in research, particularly the US Public Health Service Syphilis Study at Tuskegee and Henrietta Lacks. Although this has been reported extensively in studies investigating barriers and facilitators to medical research, this barrier is still pervasive [20]. Participants were clear that they did not want to feel like undergoing an experiment, especially when they are already sick and trying to fight cancer, even if the medical research could lead to better outcomes.

Our data support existing literature and demonstrates that the lack of trust in research among Blacks may be multi-generational. Research conducted with Native populations expressed that multi-generational mistrust may be expressed through recollections rooted in social and cultural histories [21]. Additionally, personal mistrust was found to be related to parents, family, and community mistrust. In the current study, participants responses mirrored these findings. Patients discussed mistrust through common interpretation of relevant historical biomedical incidents in which Black communities were abused or exposed to biases. They also shared encounters of friends and family members who had negative experiences in health care. Cancer clinical trial efforts to reduce mistrust among minority communities may require follow-up with participants at all age levels, to determine if trust in cancer clinical research is improving among older generations and strengthening among younger generations. Development of trusting relationships between healthcare providers, researchers, and future generations may be the key to disrupting persistent multi-generational mistrust. Based on these findings, the “mistrust” should be considered and incorporated into the recruitment approaches for research studies being implemented with Black populations. Although mistrust was a barrier to participation in cancer clinical trials, study participants were more concerned about their cancer diagnosis and if they would survive. This study population discussed many other life events that precluded the thought of participating in research, such as the impact of multiple SDH. For many participants, this was the first time that they were able to discuss their cancer journey with someone without competing demands on their time and attention.

Incorporating PNs into the clinical and research infrastructure at safety-net hospitals could address clinical and non-clinical barriers to African Americans participation in cancer clinical trials. PNs have been instrumental in reducing gaps in care by improving access and timeliness of medical care, including cancer services. The PN model has also been used for the recruitment of racial/ethnic minorities into research studies and has shown to be effective [22]. A recent study found urban and rural safety-net providers were interested in being involved in clinical trials; however, they lacked the time to identify studies and explain them to patients [23]. The providers suggested the use of multiple approaches to disseminate information on clinical trials, such as webinars, info graphics with talking points, and on-site services.

Most focus group participants in our study believed that PNs would be a viable intervention strategy to overcoming barriers to minority participation in cancer clinical trials. This is consistent with studies that have found success in increasing racial/ethnic minority clinical trial enrollment through implementation of a clinical trials PN [22, 24]. Additionally, Fouad and colleagues discovered the clinical trials PN model successfully retained African Americans in cancer clinical trials compared with non-patient navigation trial participation [22]. Study participants underscored the important roles a PN should fulfill. In addition to recruitment into cancer clinical trials, participants noted that emotional and social support for patients was just as important. Participants felt that fulfilling this additional role could ease fears and mistrust because it would make them feel like the researchers were really invested in them and their community. Additionally, in the current study, rather than being open to the idea of cancer clinical trials, participants were more concerned about processing their cancer diagnosis and what they would do. This is a role that PNs can fulfill. They can provide support and assist patients in processing their cancer diagnosis, especially if the PN is a survivor herself. Research has demonstrated that social support can reduce anxiety, stress, fear, and other negative assumptions associated with a cancer diagnosis, and, therefore, is involved in the healing and treatment process of cancer. When the patient is ready, the PN can then help them to understand the value of participation in cancer clinical trials and what it might mean for them.

Participants discussed the need for PNs to address logistical barriers, such as childcare and transportation and unmet SDH, as it relates to participation in cancer clinical trials. Recruiting minorities into cancer clinical trials from safety-net settings may require accounting for and addressing the SDH. Many PN models are focused on navigating the healthcare system, but they often lack the necessary tools and strategies to identify, document, and respond to the SDH of their patients. If patients from safety-net settings, who are often marginalized and underserved, are to be recruited to cancer clinical trials, researchers should consider accounting for and addressing both patient-identified barriers and other known SDH. Minority recruitment and retention into cancer clinical trials in safety-net settings may require PNs to account for barriers related to SDH. Researchers/physicians can then acknowledge that transportation, childcare, and reading level may prevent individuals from accessing and understanding cancer clinical trials. Although PNs may not be able to address all unmet needs, they can be a conduit and provide coordination and linkages to others in the care team (i.e., social workers) who can address unmet needs directly. Rapport and trust are essential when recruiting racial/ethnic minorities into cancer clinical trials. Trust is gained only over time, based on the level of success the PNs have with meeting the needs of patients. In a safety-net setting, trust is a currency, and PNs are skilled in this currency.

As such, we need to rethink cancer clinical trial protocols to provide adequate material resources and assistance with community resources, to mitigate some of the financial consequences of cancer, and to address inadequate support, among others [23–25]. Attending to these unmet needs may establish trust and increase participation of minority patients in cancer clinical trials. Participants recommended that the PNs address fears and mistrust of cancer clinical trials by discussing past unethical practices and the safeguards to alleviate them. Additionally, they preferred PNs to be cancer survivors who participated in cancer clinical trials so that they can discuss their own lived experience with the research process and make them more relatable.

Limitations

While the study provided the research team with a wealth of information, the study is not without limitations. The sample consisted of a small number of participants from a single site and may not represent other clinical settings, other racial or ethnic subgroups, or other cities or regions of the country. Participants were conveniently selected. Despite these limitations, this study provided valuable information that can help researchers and others understand barriers and facilitators to recruitment of minorities in safety-net settings. Identifying and addressing specific SDH of patients in safety-net settings will engage participants more readily in cancer clinical trials. Based on the experiences and perceptions of Black cancer survivors at a safety-net setting, they are likely to respond to cancer clinical trials from trusted sources like a PN rather than a healthcare provider. System barriers like the high literacy level of recruitment materials and verbal communication about clinical trials continue to restrict minorities from participation in research, especially those who obtain care in safety-net setting. Study findings suggest that multi-level interventions are needed to increase minority participation into cancer clinical trials. Improving participation of racial/ethnic minorities in such trials, particularly at safety-set settings, will contribute to greater equity in advancing treatment therapies for populations who often do not become engaged in research.