Sage Journals: Discover world-class research

Abstract

Introduction

Clinical research participation is under-represented among minoritized groups (eg, Black Americans) leading to suboptimal generalizability of findings and likely propagating inequities in cancer outcomes. Offices of Community Outreach and Engagement at comprehensive cancer centers establish bidirectional relationships between institutions and communities to facilitate catchment-concordant clinical research. We describe a program to educate and empower community health workers (CHWs) to act as clinical research advocates within their communities.

Methods

Academic and community stakeholders adapted existing evidence-based educational materials addressing importance of clinical research. The resulting program was entitled Community Research Academy to Foster RepresenTation (CRAFT). CRAFT is a 3-hour “train the trainer” session including introduction to clinical trials with “myth busters”, “Ask the Participant” panel, and hands-on experience finding a clinical trial. CRAFT was evaluated for acceptability, change in knowledge/perception, maintenance, and suggestions for curriculum improvement.

Results

Training was held in December 2023 with 21 CHWs, with a refresher training in July 2024 with 19 CHWs. At initial training, all participants reported ‘excellent’ or ‘good’ satisfaction with CRAFT. Results indicate 48% reported increased knowledge and 33% improved perception, and 21% demonstrated increased objective knowledge of clinical trials. At refresher training, 94% reported ‘excellent’ or ‘good’ satisfaction with CRAFT, 47% reported increased knowledge and 73% increased objective knowledge of clinical trials. Of those completing both sessions and all objective knowledge questions, 50% maintained or improved their score. Qualitative feedback indicated need for additional training (eg, more testimonials, more facts to supplement “myth busting”, more trainings, additional information on how to present to the public, and collaboration with academic health system staff during future CHW-facilitated programs).

Conclusion

CRAFT increased awareness, knowledge, and perception of clinical research among diverse CHWs with maintenance over time. Next steps include refining CRAFT, administering CRAFT to volunteer community health advisors, continuing evaluation, and sharing with other institutions.

Keywords

clinical trials community outreach and engagement community health workers

Introduction

Participation in cancer clinical trials by members of minoritized groups (eg, Black Americans) is vastly under-represented. In fact, Black Americans comprise only about 5% of adult patients with cancer participating in clinical trials, but represent approximately 14% of the United States population and about 11.7% of new cancer cases.^1-4 Lack of representation by these groups in clinical research is a result of patient-related, clinician/academician-related, and system-related factors.^5,6

Patient-related factors may include, but are not limited to, medical mistrust, ineligibility due to prior or current cancer therapy and disease stage, decision-making style, lack of access to clinical trials, financial burden, and/or lack of knowledge of policies, procedures, and processes surrounding clinical trials.^5-7 Clinician/academicians may offer clinical trials to minoritized groups in a limited capacity, forego offering clinical trials as options based on personal preferences for treatment options even forego, and even omit discussions due to limited time or knowledge of available clinical trials.⁵ System-related factors can include lack of health insurance coverage for study drugs and clinical research being offered only at academic medical centers.^5,6 Moreover, the eligibility criteria for clinical trials may systematically exclude individuals in minoritized groups, and informed consent materials may be written in ways that prevent understanding among individuals with low health literacy.^5,6

Particularly in cancer clinical trials, it is essential for the clinical research community to overcome these barriers and increase participation in these studies by diverse cohorts of patients. Greater diversity in research participation improves generalizability of clinical trial findings, without which, existing inequities in cancer outcomes between Black and White patients will be propagated; evidence suggests that those who participate in clinical trials have better outcomes than those who do not.^1,8 Moreover, clinical trial participation results in a sense of shared ownership of the trial outcomes and future impacts.^9,10 Participation also cultivates motivation for further participation in future studies.¹¹ Consequently, lack of representation of minoritized populations in clinical trials prevents a nuanced and fully informed approach to cancer drug development, clinical standards for best practice, and other important deliverables such as accuracy of race or ethnicity-specific subgroup analyses.¹²

Given the importance of clinical trial participation in cancer, the National Cancer Institute¹³ (NCI)-designated Comprehensive Cancer Centers are required to have an Office of Community Outreach and Engagement (OCOE) to establish bidirectional relationships between the institution and the community to facilitate catchment-concordant clinical research, to disseminate research findings to the community, and to foster a symbiotic relationship between communities and institutions. A major role of the OCOE has become the facilitation of diverse accrual in clinical trials.^14,15 The OCOE of the O’Neal Comprehensive Cancer Center at the University of Alabama at Birmingham (UAB), the only NCI-designated comprehensive cancer center in Alabama, works to achieve these goals through deployment of a volunteer community health advisor model of engagement, facilitated by oversight of a cadre (n = 24) of part-time community health workers (CHWs).^16,17 To facilitate greater ability to meet OCOE goals and be responsive to catchment area feedback, UAB OCOE created a program to educate and empower CHWs with awareness and education to act as clinical research advocates within their communities (Community Research Academy to Foster RepresenTation: CRAFT). Here, we describe the CRAFT program and results evaluating its reach, effectiveness, acceptability, and maintenance.

Methods

Program Description

CRAFT is a “train the trainer”, low-intensity program specifically developed to educate and empower CHWs to use culturally relevant techniques to engage diverse communities on clinical trials. It was co-developed with academic and community stakeholders, including faculty/researchers and the UAB O’Neal community advisory board members (cancer survivors and community advocates), and informed by existing evidence-based materials.^5,18-21 Initial iterations of this program were previously deployed in an OCOE collaboration with the GO2 Foundation for Lung Cancer’s LungMATCH program (a targeted, culturally appropriate clinical trial outreach effort to educate African American communities in Alabama) and UAB Division of Hematology & Oncology’s cancer agnostic clinical trial education campaign (aimed at increasing clinical trial education and accrual).^20-23

The CRAFT program is delivered by 2 program managers and a clinical scientist, who are all trained in clinical research coordination and cultural humility, via an in person three-hour interactive PowerPoint presentation and printed materials. Other assistants in the delivery of the program include community-engaged researchers and participants who have previously participated in therapeutic clinical trials and in behavioral research studies. Components of the CRAFT program include an introduction to clinical trials with “myth busters”, an “Ask the Clinical Research Participant” panel, and a hands-on experience finding a clinical trial on electronic platforms (ie, https://httpClinicalTrials.gov, UAB Reporter, and ResearchMatch). Following the program, CHWs are encouraged to continue engaging with 1 or more of the platforms (eg, visiting the websites, clicking on trials, etc.) However, engagement with the websites is unable to be tracked. This study involved program development and evaluation, which was not intended as research. No participant identifiers were collected and informed consent was not required. The University of Alabama at Birmingham IRB also determined that the training program reported in the manuscript was not human subjects research (IRB-300012608). Rather than formal written consent, which was accordingly waived, participants gave verbal approval to participate and share the reported results.

CRAFT Evaluation

All OCOE CHWs (n = 24) were invited to participate. The only inclusion criteria was being an OCOE CHW. Three were unable to participate due to unforeseen circumstances such as illness or other conflicts. All participants had prior long-standing relationships with the OCOE. There were 2 CRAFT sessions. First, CRAFT was administered in December 2023 to 21 OCOE CHWs as a part of their regular curriculum. A refresher training was administered in July 2024 to 19 OCOE CHWs (2 CHWs from the initial training were absent due to unforeseen circumstances). CRAFT was evaluated for reach, effectiveness, acceptability, implementation, and maintenance, and suggestions for curriculum improvement using a pre-test and post-test at each administration.²⁴ For implementation, sessions were started at a pre-specified time and concluded when all components of the program were administered (approximately 3 hours in duration). There was no within-session sampling or between-session sampling. The refresher training was again offered to all OCOE CHWs and administered to those who were able to participate. Between-session consistency was ensured by keeping the program content the same between sessions. Some additional objective knowledge questions were added at the second session, but the content remained the same. Time-related disruptions (eg, breaks) were also kept consistent between sessions (eg, a 15 minute restroom/coffee break between the first and second program components). Since this was program development and evaluation and not human subjects research, no participant identifiers were collected and informed consent was not required.

Reach is defined as the number, proportion, and representativeness of those willing to participate in a program.²⁵ In this study, reach was evaluated using CHW demographics and county of residence. Within Reach, acceptability was defined as the extent to which those receiving the program consider it appropriate based on pre-conceived cognitive and emotional responses to the intervention.^24,26 In this study, acceptability was evaluated via post-test evaluation of the perceived quality of the program and qualitative (free-text entry) suggestions for improvement.

Effectiveness is the impact of the program on pre-determined outcomes.²⁵ In this study, CRAFT was evaluated for effectiveness at improved self-reported knowledge and perception and objective knowledge of clinical trials from pre- to post-test (at both initial and refresher training). CHWs responded to a pre-test of their knowledge and perception of clinical trials. Questions were based on prior assessments including Health Information National Trends Survey (HINTS) 5, Cycle 4, and the SubjectWell Survey of Clinical Trial Awareness and Attitudes.^27-29

Maintenance is defined as the 6-month or more period where knowledge gains or behavior changes as a result of the program were sustained post-implementation.²⁵ In this study, maintenance was assessed based on change in knowledge (or lack of change) from the initial training post-test to the refresher training pre-test. Participants responded to a post-test including the same questions from the pre-test, in addition to questions related to acceptability of the program and suggestions for curriculum improvement.

Statistically, we evaluated whether changes in metrics differed significantly from 0 using two-sided tests of location (t test). All analyses were conducted using SAS Version 9.4 (SAS Institute, Inc, Cary, NC).

Results

Initial Training: December 2023

Among those responding to each question, the median age of CHWs (n = 21) at the initial training was 57 years, 81% identified as Black or African American, 14.3% identified as White, and 4.8% identified as Asian. No participants identified as Hispanic/Latinx. All CHWs were female except for 1 male participant, and all identified as heterosexual. A majority of CHWs (71.4%) indicated that they were living comfortably on their present income, 19.1% indicated that they were getting by on their present income, and 9.5% indicated that they were finding it difficult on their present income. A majority of CHWs (71.4%) were employed full-time and the remainder were employed part-time; 30% had some college education, 40% had a bachelor’s degree, 25% had a master’s degree, and 5% (1 CHW) had a doctoral degree. All CHWs indicated that they had some kind of healthcare insurance coverage. Two CHWs were cancer survivors (Table 1).

Table 1.

Participant Characteristics of the Study Sample

Variable	Summary measure^a
Initial training: Dec 2023 (n = 21)	Summary measure^a
Age, median (IQR)	57.0 (47.0, 66.0)
Race, n (%)
Black	17 (81.0)
White	3 (14.3)
Other	1 (4.8)
Sex, n (%)
Male	20 (95.2)
Female	1 (4.8)
Sexual orientation, heterosexual, n (%)	21 (100.0)
Feelings about household income, n (%)
Living comfortably on present income	15 (71.4)
Getting by on present income	4 (19.1)
Finding it difficult on present income	2 (9.5)
Employment status, n (%)
Full-time	15 (71.4)
Part-time	6 (28.6)
Education level, n (%)
Some college	6 (30.0)
Bachelor’s degree	8 (40.0)
Master’s degree	5 (25.0)
Doctoral degree	1 (5.0)
Healthcare coverage, n (%)	20 (100.0)
Cancer survivor, n (%)
Yes	2 (10.0)
No	18 (90.0)

Refresher training: Jul 2024 (n = 19)
Age, median (IQR)	60.5 (53.5, 67.0)
Race, Black, n (%)	18 (100.0)
Sex, n (%)
Female	17 (94.4)
Prefer not to answer	1 (5.6)
Sexual orientation, n (%)
Heterosexual	17 (94.4)
Bisexual	1 (5.6)
Feelings about household income, n (%)
Living comfortably on present income	9 (52.9)
Getting by on present income	5 (29.4)
Finding it difficult on present income	3 (17.7)
Employment status, n (%)
Full-time	10 (55.6)
Part-time	8 (44.4)
Education level, n (%)
Some college	6 (33.3)
Bachelor’s degree	7 (39.9)
Master’s degree	4 (22.2)
Doctoral degree	1 (5.6)
Healthcare coverage, n (%)	18 (100.0)
Cancer survivor, n (%)
Yes	4 (22.2)
No	14 (44.8)

^aDue to missing data, not all categories sum to the total sample size. Percentages are reported with a denominator consisting of those answering the question. Participants at the refresher training are not the exact same group of participants completing the initial training.

At the initial training, all CHWs reported ‘excellent’ or ‘good’ satisfaction with all aspects of CRAFT after the program was completed. Following program completion, of those who answered both the pre- and post-test (n = 19), nearly half (48%) demonstrated increased self-reported knowledge and one-third (33%) increased self-reported perception of clinical trials (Table 2). These changes were statistically significantly different from 0 (Knowledge mean change 0.5 [SD: 0.5], P-value: <0.001; Perception mean change: 0.5 [SD: 0.9], P-value: 0.029) (Table 3). Prior to the training session, 45% of participants completing all objective knowledge questions on the pre-test answered all objective knowledge questions correctly. After the training session, 32% of CHWs of those completing all objective knowledge questions on the post-test answered all objective knowledge questions correctly (Table 2). The objective knowledge change was not statistically different from 0 (mean change: –0.2 [SD: 1.2], P-value: 0.578) (Table 3). Additionally, 21.1% of CHWs completing both the pre-test and post-test demonstrated an increase in objective knowledge following the CRAFT session (Table 2). Qualitative feedback (via free-text entry) indicated a need for “additional training” including “to hear more testimonials”, “more facts and concrete statements in objection to the myths. Truly break them down so people can explain why not just that it's not true”, offering “another [CRAFT] session”, additional information on “how to present to public”, and collaboration with academic health system staff during future CHW-facilitated programs.

Table 2.

Summary Characteristics of Program Evaluation

Variable	Summary measure
Initial Training: December 2023 (n=21)	Summary measure
Satisfaction
How satisfied were you with CRAFT presenters?
Excellent	19 (90.5)
Good	2 (9.5)
How satisfied were you with the CRAFT panel?
Excellen	18 (85.7)
Good	3 (14.3)
Overall, how would you rate the CRAFT program?
Excellent	19 (90.5)
Good	2 (9.5)
Self-reported knowledge of clinical trials
Decrease	0 (0)
No change	11 (52.4)
Increase	10 (47.6)
Self-reported perception of clinical trials
Decrease	1 (4.8)
No change	13 (61.9)
Increase	7 (33.3)
Objective knowledge of clinical trials
Decrease	9 (47.4)
No change	6 (31.6)
Increase	4 (21.1)
All questions correct (pre-test)	9 (45.0)
All questions correct (post-test)	6 (31.6)

Refresher training: Jul 2024 (n = 19)
Satisfaction
Overall, how would you rate the CRAFT program?
Excellent	12 (75.0)
Good	3 (18.8)
Neutral	1 (6.3)
How likely are you to recommend the CRAFT program to a friend or colleague?
Very likely	6 (40.0)
Likely	5 (33.3)
Neither likely nor unlikely	3 (26.7)
Self-reported knowledge of clinical trials
Decrease	0 (0)
No change	9 (52.9)
Increase	8 (47.1)
Objective knowledge of clinical trials
Decrease	1 (9.1)
No change	2 (18.2)
Increase	8 (72.7)
All questions correct (pre-test)	0 (0)
All questions correct (post-test)	4 (28.6)

Due to missing data, not all categories sum to the total sample size.

Table 3.

Mean Change From Zero of Program Evaluation Scores

Mean change (standard deviation)	P-value
Initial training: Dec 2023 (n = 21)	P-value
Self-reported knowledge of clinical trials: 0.48 (0.51)	<0.001
Self-reported perception of clinical trials: 0.48 (0.93)	0.029
Objective knowledge of clinical trials: −0.16 (1.21)	0.578
Refresher training: Jul 2024 (n = 18)
Self-reported knowledge of clinical trials: 0.47 (0.51)	0.002
Objective knowledge of clinical trials: 1.36 (1.69)	0.023

Estimated using two-sided tests of location (t test). Significance set at α = 0.05.

Refresher training: July 2024

Among those responding to each question, the median age of CHWs (n = 19) at the refresher training was 60.5 years, 100% identified as Black or African American; 1 person chose not to disclose their race. No participants identified as Hispanic/Latinx. All CHWs were female except for 1 who chose not to disclose their sexual identity, and 94.4% identified as heterosexual. A majority of CHWs (52.9%) indicated that they were living comfortably on their present income, 29.4% indicated that they were getting by on their present income, and 17.7% indicated that they were finding it difficult on their present income. A majority (55.6%) were employed full-time and the remainder were employed part-time; 33.3% had some college education, 38.9% had a Bachelor’s degree, 22.2% had a master’s degree, and 5.6% (1 participant) had a doctoral degree. All CHWs indicated that they had some kind of healthcare insurance coverage. Four CHWs were cancer survivors (Table 1). A majority of these CHWs had also participated in the initial training (n = 11), but the participants in the initial and the refresher trainings did not completely overlap.

Overall, 93.8% reported ‘excellent’ or ‘good’ satisfaction with the CRAFT training (Table 2). Additionally, 73.3% indicated that they were likely or very likely to recommend CRAFT to a friend (Table 2). About half (47.1%) demonstrated increased self-reported knowledge of clinical trials and this change was statistically different from 0 (mean change: 0.5 [SD: 0.5], p-value: 0.002) (Table 2, Table 3). All but one CHW in the remaining 53.0% reported that they ‘know a little about clinical trials’ in both the pre-test and the post-test. Prior to the CRAFT session, of those completing all objective knowledge questions (n = 16), no CHWs answered all questions correctly (Table 2). However, 3 CHWs (18.8%) each answered 8 of 10 or 9 of 10 questions correctly. Post-session, of those answering all objective knowledge questions in the post-test (n = 14), 4 CHWs (28.6%) answered all questions correctly and all CHWs answered at least 7 of 10 questions correctly (Table 2). Following the session, 72.7% of CHWs increased their objective knowledge of clinical trials. Only 1 CHW demonstrated a decrease in knowledge. The change in objective knowledge was statistically different from 0 (mean change: 1.4 [SD: 1.0], p-value: 0.023) (Table 2, Table 3). Finally, of those present at both sessions and fully completing the objective knowledge questions (n = 8), 50% maintained the same score or an improved score from the December to the July training. Qualitative feedback (via free-text entry) still indicated the need for “additional training” and “more information”. Some CHWs also indicated the need for “more time to study the information” and the need to “go slower…” through the content. CHWs also suggested that CRAFT be improved by adding additional topics providing “more information on encouraging African Americans” and “more info[rmation] on how to get people involved” in general. Lastly, in relation to educating others about clinical trials, CHWs believed the CRAFT program would be most effective if delivered by a trained CHW that is confident in the subject matter and clinician scientist.

Discussion

The CRAFT program is an example of a preliminarily effective and acceptable program to prepare CHWs as clinical research advocates to educate and empower individuals within their communities. CRAFT resulted in increased knowledge and perception of clinical trials which was maintained over time. Given that diverse clinical trial representation is an essential characteristic to ensure generalizable findings and avoid propagation of health disparities, CHWs can be useful resources as clinical research advocates to empower community members to participate in clinical trials. These findings are similar to a 2011 study of another cancer-related clinical trial education program for CHWs in the Boston, Massachusetts area which indicated that their CHW education program was satisfactory to the CHWs and resulted in increased knowledge of clinical trials.³⁰

CHW-led interventions have demonstrated efficacy in randomized trials to improve various cancer-related outcomes among minoritized adults.^31,32 It is our belief that CHWs should have an understanding of the clinical trial process in order to not only guide interventions, but also to facilitate community understanding and uptake of the clinical research process. Moreover, trust is an important potential barrier to clinical trial participation.^5-7 CHWs (who typically share background, culture, and experiences with the communities they serve) have the necessary trust and rapport with the community.³³ A prior study from New York University Langone Health developed a training to increase knowledge and ability of CHWs to engage their communities around discussion and understanding of clinical research.³⁴ The NYU program was co-developed with input from the CHWs regarding gaps in knowledge of clinical trials through the lens of the underserved communities the CHWs served. This program resulted in increased knowledge, awareness, and abilities of CHWs to engage and educate their communities on clinical trials. However, the program was administered to CHWs across almost 200 institutions throughout the United States and involved 28 online modules about 5 minutes each with multiple choice quizzes following the modules.³⁴ While the NYU training was a similar length to our CRAFT program, it was not specific to cancer-related clinical trials. Moreover, the online format was administered to CHWs across the country and may not be appropriate for the CHWs who have low technology literacy and live in areas that are underserved by internet connectivity. Thus, similar programs developed at other institutions should be tailored to the context of the communities CHWs serve.

It should be noted that in our study, a lower percentage of participants answered all objective knowledge questions correctly at the post-test of the initial training compared to the pre-test. This may be because not all participants who answered all questions at the pre-test also answered all questions at the post-test. When looking at the change in objective knowledge, there was no statistically significant difference in pre- vs post-test scores indicating that there was neither an increase nor a decrease of those completing all objective questions. Moreover, 50% maintained their scores from the initial to the refresher training indicating some level of maintenance.

Importantly, engagement around clinical trials may require multiple opportunities for CHWs to be prepared to act as clinical research advocates. Pilot data from our CRAFT program showed that CHWs expressed the desire for additional training and information, even after the refresher training and despite relatively high objective knowledge of clinical trials prior to the training sessions. This demonstrates some of the complexity of the clinical research process and difficulty of community members in understanding the process especially given that a majority of these CHWs were highly educated.

Furthermore, in contrast to the NYU study, our data suggest that in addition to providing education to CHWs and/or community members, we must provide strategies for them to engage and empower their communities to participate. This is noteworthy since a majority of these CHWs identified as Black or African American and despite their personal favorable view of clinical trials, they understood the difficulty of encouraging participation in clinical trials given historical injustices experienced by African Americans in the context of clinical research.

There are several next steps resulting from the development and evaluation of the CRAFT program. First, we must refine delivery of the program to address the needs expressed by participants for additional training. Secondly, we will expand the program to volunteer community health advisors. The CHWs will administer the CRAFT program to volunteer community health advisors who aid the CHWs in providing education and raising awareness about cancer screening, prevention, and research in the community. The CHWs and their community health advisors will provide additional education and information on cancer research and how to find clinical trials. The CHWs and the community health advisors engage with the community irrespective of cancer diagnosis. However, disseminating knowledge on the clinical research process may encourage community member participation should the need arise and/or may promote participation among family members or acquaintances of community members who were not directly engaged, but who are eligible or in need of cancer clinical research. Finally, as the CHWs administer the CRAFT program to community health advisors, community health advisors will complete the pre- and post-tests which will provide greater understanding of the baseline knowledge and effectiveness of the program in improving knowledge and perception of clinical research in the general community.

Additionally, to assist others with empowering their communities for clinical trial advocacy, we must share the CRAFT program with other organizations including other comprehensive cancer centers and OCOE offices. To assess longitudinal impact, we must also integrate with clinical trial offices at these organizations to track the impact of the program on accrual to clinical trials as outlined in NCI priorities for OCOE offices.¹⁵ Finally, we must also involve our community-based organizations, industry partners, and government partners in this training so that these entities may utilize the training with those they serve as well.

Limitations

There are several limitations to the development and evaluation of the CRAFT program. First, there was very little diversity in the demographics of our CHWs. Thus, CRAFT should be administered and evaluated among a more diverse group of CHWs especially as the program is expanded to other institutions such that the CHWs are reflective of the relevant catchment areas. Additionally, the sample size for this program evaluation was small. As the program is expanded to include the volunteer community health advisors, a greater understanding of its effect on our outcomes (eg, increased knowledge, acceptability, etc.) will be appreciated.

Conclusions

The UAB OCOE co-developed a clinical research education program (CRAFT) to prepare CHWs as clinical research advocates. CRAFT increased awareness, knowledge, and perception of clinical trials among diverse CHWs. This three-hour program is a promising intervention to expand upon the success of the community health advisor model, with the ultimate goal of ensuring communities perceive cancer clinical trials positively and potentially increase rates of participation in cancer clinical trials.

Supplemental Material

Supplemental Material - Refining Our “CRAFT”: The Community Research Academy to Foster RepresenTation (CRAFT) Program

Supplemental Material for Refining Our “CRAFT”: The Community Research Academy to Foster RepresenTation (CRAFT) Program by Mackenzie E. Fowler, Oluseun Akinyele, Francine Walton, Rochelle Wallace, Stacey A. Ingram, Yu-Mei Schoenberger, Soumya J. Niranjan, Ritika R. Samant, Claudia Hardy, Silvia Gisiger-Camata, and Timiya S. Nolan in Cancer Control.

Footnotes

ORCID iD

Mackenzie E. Fowler

Ethical Approval

This study involved program development and evaluation, which was not intended as research. No participant identifiers were collected and informed consent was not required. The University of Alabama at Birmingham IRB also determined that the training program reported in the manuscript was not human subjects research (IRB-300012608). Rather than formal written consent, which was accordingly waived, participants gave verbal approval to participate and share the reported results.

Author Contributions

Mackenzie E. Fowler, PhD contributed to conception and design of the study, analysis and interpretation of data, drafting and revising the article, and final approval of the version to be submitted. Oluseun Akinyele, MPH contributed to conception and design of the study, acquisition and analysis of data, revising the article for content, and final approval of the version to be submitted. Francine Walton, MPH contributed to conception and design of the study, acquisition of data, revising the article for content, and final approval of the version to be submitted. Rochelle Wallace, MS contributed to conception and design of the study, acquisition of data, revising the article for content, and final approval of the version to be submitted. Stacey A. Ingram, MEd contributed to conception and design of the study, acquisition of data, revising the article for content, and final approval of the version to be submitted. Yu-Mei Schoenberger, PhD contributed to conception and design of the study, acquisition of data, revising the article for content, and final approval of the version to be submitted. Soumya J. Niranjan, BPharm, MS, PhD contributed to conception and design of the study, acquisition and interpretation of data, revising the article for content, and final approval of the version to be submitted. Ritika R. Samant, MPH contributed to conception and design of the study, interpretation of data, revising the article for content, and final approval of the version to be submitted. Claudia Hardy, MPA contributed to conception and design of the study, acquisition of data, revising the article for content, and final approval of the version to be submitted. Silvia Gisiger-Camata, MPH, Pharm, RN contributed to conception and design of the study, acquisition of data, revising the article for content, and final approval of the version to be submitted. Timiya S. Nolan, PhD, APRN-CRNP, ANP-BC, FAAN contributed to conception and design of the study, acquisition and interpretation of data, revising the article for content, and final approval of the version to be submitted.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by National Cancer Institute (P30CA013148).

Declaration of Conflict Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Data Availability Statement

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.*

Supplemental Material

Supplemental Material is available online for this article.

References

Pittell

Calip

Pierre

, et al. Racial and ethnic inequities in US Oncology clinical trial participation from 2017 to 2022. JAMA Netw Open. 2023;6(7):e2322515. doi:10.1001/jamanetworkopen.2023.22515

United States Census Bureau . QuickFacts. https://www.census.gov/quickfacts/fact/table/US/PST045223. Accessed June 13, 2024.

American Cancer Society instead of Society AC . Cancer facts & figures 2022. CA Cancer J Clin. 2022;72(1):7-33.

American Cancer Society instead of Society AC . Cancer facts & figures for african American/Black people 2022-2024. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/cancer-facts-and-figures-for-african-americans/2022-2024-cff-aa.pdf.

Unger

Vaidya

Hershman

Minasian

Fleury

. Systematic review and meta-analysis of the magnitude of structural, clinical, and physician and patient barriers to cancer clinical trial participation. J Natl Cancer Inst. 2019;111(3):245-255. doi:10.1093/jnci/djy221

Hamel

Penner

Albrecht

Heath

Gwede

Eggly

. Barriers to clinical trial enrollment in racial and ethnic minority patients with cancer. Cancer Control. 2016;23(4):327-337. doi:10.1177/107327481602300404

National Institutes of Health Offoice of Research on Women's Health

Review of the literature: primary barriers and facilitators to participation in clinical research. https://orwh.od.nih.gov/sites/orwh/files/docs/orwh_outreach_toolkit_litreview.pdf. Accessed November 18, 2024.

Bouzalmate-Hajjaj

Massó Guijarro

Khan

Bueno-Cavanillas

Cano-Ibáñez

. Benefits of participation in clinical trials: an umbrella review. Int J Environ Res Publ Health. 2022;19(22):15368. doi:10.3390/ijerph192215368

Shelly

Logan

Skorochod

, et al. Creating a best practice template for participant communication plans in global health clinical studies. Trials. 2023;24(1):158. doi:10.1186/s13063-023-07185-4

10.

McDavitt

Bogart

Mutchler

, et al. Dissemination as dialogue: building trust and sharing research findings through community engagement. Prev Chronic Dis. 2016;13:E38. doi:10.5888/pcd13.150473

11.

Schwarz

Parasuraman

Singh

Horowitz

Dawson

Frenneaux

. The unspoken benefit of participation in a clinical trial. Clin Med. 2021;21(6):e645-e647. doi:10.7861/clinmed.2021-0292

12.

George

Duran

Norris

. A systematic review of barriers and facilitators to minority research participation among African Americans, Latinos, Asian Americans, and Pacific Islanders. Am J Publ Health. 2014;104(2):e16-31. doi:10.2105/ajph.2013.301706

13.

National Cancer Institute . Supporting community outreach and engagement. NCI Division of Cancer Control & Population Sciences, 2023. https://cancercontrol.cancer.gov/research-emphasis/supplement/coe. Accessed June 17, 2024.

14.

Thompson

Ashing

Barrett

, et al. The state of cancer-focused community outreach and engagement (COE): reflections of Black COE directors. J Natl Cancer Inst. 2024;116(10):1549-1554. doi:10.1093/jnci/djae138

15.

Hiatt

Kobetz

Paskett

. Catchment Areas, Community outreach and engagement revisited: the 2021 guidelines for cancer center support grants from the national cancer Institute. Cancer Prev Res. 2022;15(6):349-354. doi:10.1158/1940-6207.Capr-22-0034

16.

Partridge

Fouad

Hinton

, et al. The deep South network for cancer control: eliminating cancer disparities through community-academic collaboration. Fam Community Health. 2005;28(1):6-19. doi:10.1097/00003727-200501000-00004

17.

Hardy

Wynn

Huckaby

Lisovicz

White-Johnson

. African American community health advisors trained as research partners: recruitment and training. Fam Community Health. 2005;28(1):28-40. doi:10.1097/00003727-200501000-00006

18.

Coakley

Fadiran

Parrish

Griffith

Weiss

Carter

. Dialogues on diversifying clinical trials: successful strategies for engaging women and minorities in clinical trials. J Womens Health (Larchmt). 2012;21(7):713-716. doi:10.1089/jwh.2012.3733

19.

Reopell

Nolan

Gray

2nd , et al. Community engagement and clinical trial diversity: navigating barriers and co-designing solutions-A report from the “Health Equity through Diversity” seminar series. PLoS One. 2023;18(2):e0281940. doi:10.1371/journal.pone.0281940

20.

LungMATCH . 2023. https://store.go2.org/wp-json/go2/v1/pdf/265?token=YzJlNTNiM2ExMmRlZTdjOTc0MGE2MjViN2M0OTc4NzYzOGE5N2I1MzQwOWZmMmE4NTFkNDE5M2EzODExZjAwYw==. Accessed March 31, 2025.

21.

Clinical trials . 2024. https://store.go2.org/wp-json/go2/v1/pdf/257?token=ZWRhNDRhYWYzNzAyODU0OWU3MTQxZmJiMDhjNGE1OWExYzgwNWM5NjNmZjA4YTkzNTkwOTY3Y2MyMjRmMjQyYQ==. Accessed March 31, 2025.

22.

Felder

Pena

Chapital

. Disparities in cancer clinical trials: an analysis of comprehensive cancer control plans. Prev Chronic Dis. 2009;6(4):A116.

23.

Kwiatkowski

Coe

Bailar

Swanson

. Inclusion of minorities and women in cancer clinical trials, a decade later: have we improved? Cancer. 2013;119(16):2956-2963. doi:10.1002/cncr.28168

24.

Reilly

Kennedy

Porter

Estabrooks

. Comparing, contrasting, and integrating dissemination and implementation outcomes included in the RE-AIM and implementation outcomes frameworks. Front Public Health. 2020;8:430. doi:10.3389/fpubh.2020.00430

25.

Glasgow

Harden

Gaglio

, et al. RE-AIM planning and evaluation framework: adapting to new science and practice with a 20-year review. Front Public Health. 2019;7:64. doi:10.3389/fpubh.2019.00064

26.

Sekhon

Cartwright

Francis

. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017;17(1):88. doi:10.1186/s12913-017-2031-8

27.

Cameron

Pond

Ellis

Goffin

. A comparison of patient knowledge of clinical trials and trialist priorities. Curr Oncol. 2013;20(3):e193-205. doi:10.3747/co.20.1323

28.

National Cancer Institute . Health information national Trends Survey Cycle 4 full content English instrument annotated. 2020. https://hints.cancer.gov/docs/Instruments/HINTS5_Cycle4_AnnotatedInstrumentEnglish.pdf. Accessed November 18, 2024.

29.

SubjectWell . SubjectWell Survey of clinical trial awareness and Attitudes. 2016. https://www.subjectwell.com/clinical_trial_awareness_attitudes_2016

30.

Schapira

Schutt

. Training community health workers about cancer clinical trials. J Immigr Minority Health. 2011;13(5):891-898. doi:10.1007/s10903-010-9432-7

31.

Kangovi

Mitra

Grande

, et al. Patient-centered community health worker intervention to improve posthospital outcomes: a randomized clinical trial. JAMA Intern Med. 2014;174(4):535-543. doi:10.1001/jamainternmed.2013.14327

32.

Patel

Kapphahn

Wood

, et al. Effect of a community health worker-led intervention among low-income and minoritized patients with cancer: a randomized clinical trial. J Clin Oncol. 2024;42(5):518-528. doi:10.1200/jco.23.00309

33.

United States Department of Health and Human Services Health Resources and Services Administration, Bureau of Health Professions not United States Department of Health and Human Services HRaSA, Bureau of Health Professions . Community health worker national workforce study. 2007. https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/data-research/community-health-workforce.pdf

34.

Yakubov

Pimenova

Ahmed

, et al. The development of a clinical research educational training for community health workers using the joint task force for clinical trial competency framework. Front Pharmacol. 2023;14:1295281. doi:10.3389/fphar.2023.1295281

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.00 MB

0.05 MB