A step towards equitable clinical trial recruitment: a protocol for the development and preliminary testing of an online prostate cancer health information and clinical trial matching tool

Abstract Background Recruitment of a diverse participant pool to cancer clinical trials is an essential component of clinical research as it improves the generalizability of findings. Investigating and piloting novel recruitment strategies that take advantage of ubiquitous digital technologies has become an important component of facilitating broad recruitment and addressing inequities in clinical trial participation. Equitable and inclusive recruitment improves generalizability of clinical trial outcomes, benefiting patients, clinicians, and the research community. The increasing prevalence of online connectivity in the USA and use of the Internet as a resource for medical information provides an opportunity for digital recruitment strategies in cancer clinical trials. This study aims to measure the acceptability, preliminary estimates of efficacy, and feasibility of the Trial Library intervention, an Internet-based cancer clinical trial matching tool. This study will also examine the extent to which the Trial Library website, designed to address the linguistic and literacy needs of broader patient populations, influences patient-initiated conversations with physicians about clinical trial participation. Methods This is a study protocol for a non-randomized, single-arm pilot study. This is a mixed methods study design that utilizes the statistical analysis of quantitative survey data and the qualitative analysis of interview data to assess the participant experience with the Trial Library intervention. This study will examine (1) acceptability as a measure of participant satisfaction with this intervention, (2) preliminary measure of efficacy as a measure of proportion of participants with documented clinical trial discussion in the electronic medical record, and (3) feasibility of the intervention as a measure of duration of clinical visit. Discussion The principles that informed the design of the Trial Library intervention aim to be generalizable to clinical trials across many disease contexts. From the ground up, this intervention is built to be inclusive of the linguistic, literacy, and technological needs of underrepresented patient populations. This study will collect essential preliminary data prior to a multi-site randomized clinical trial of the Trial Library intervention. Trial registration This study has received institutional approval from the Committee of Human Subjects Research at the University of California, San Francisco.

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Identifying and Overcoming Barriers in Clinical Trial Enrollment for Veterans with Blood Cancers

Blood ◽

10.1182/blood-2021-146736 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 1920-1920

Author(s):

Daphne R. Friedman ◽

Thomas D. Rodgers ◽

Leah Szumita ◽

Elisa S. Weiss

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Rural Areas ◽

Research Funding ◽

Trial Participation ◽

Cancer Clinical Trials ◽

Clinical Trial Participation ◽

Blood Cancer ◽

Specific Factors ◽

Clinical Trial Enrollment

Abstract Introduction Equitable and diverse clinical trials participation is essential for practice-changing results to be applicable to all patients. However, patients who identify as minorities, who live in rural areas, and who have low income are typically underrepresented in clinical trials. Increasing clinical trial participation in general and among underrepresented patients in particular is a goal of The Leukemia & Lymphoma Society's (LLS) Clinical Trial Support Center (CTSC), a clinical trial nurse navigation service for patients with blood cancers and their oncologists. The Veterans Health Administration (VA) is a national network of health care facilities. Approximately 3% of cancers in the United States are diagnosed in the VA. The prevalence of certain blood cancers is higher in the VA, in part due to military exposures. Veterans who receive care in the VA are more likely to have lower income, live in rural areas, and have comorbidities than patients who receive care in the private sector. Clinical trial participation among Veterans may be hampered by VA-specific factors (e.g. relatively fewer clinical trial options in the VA, lack of awareness that Veterans may be referred to participate in clinical trials outside of the VA) and patient-specific factors (e.g. income, rurality, comorbidities, and minority status). This study aimed to characterize and overcome barriers to Veteran enrollment in blood cancer clinical trials. Methods The LLS CTSC performs clinical trial searches using a database with information from clinicaltrials.gov and other proprietary data. To assess the impact of geography and rurality on the availability of clinical trials, we performed simulated searches for clinical trials in proximity of 13 VA facilities (6 rural, 7 urban), six blood cancers (AML, CLL, DLBCL, FL, MDS, MM), and two disease statuses (new diagnosis, relapsed/refractory). To further evaluate barriers to CTSC referral and clinical trial enrollment among Veterans who receive care in the VA, we collected data about referral patterns of VA hematologist-oncologists and Veterans' treatment choices at four VA facilities between September 2020 through May 2021. Results When evaluating both 100- and 200-mile radii from the VA facilities in simulated searches, there were significantly more clinical trials available for Veterans who receive care in urban compared to rural areas and on the East or West Coast compared to the Midwest, in aggregate (all cancers) and by disease type or status (p unadj < 0.0001). Forty-eight Veterans with blood cancers at the Durham NC, Salem VA, Sioux Falls SD, and Clarksburg WV VA facilities had consideration of clinical trials as a treatment option by oncology providers over a nine-month period. All Veterans were male, with 33 White/15 African-American, 47 non-Hispanic/1 Hispanic, age 41-93 years (median 71), living 0.2-186 miles from their VA facility (median 33.1), with diverse diseases and stages represented. Of the 48 patients, 14 patients were not asked if they wanted clinical trials information; reasons were need for immediate therapy, co-morbidities, or patient circumstances. Of 34 patients who were asked if they wanted clinical trials information, 14 did not agree to a referral to the CTSC; reasons were preference for immediate therapy, wanting care in the VA, wanting standard therapy, and lack of transportation. Of 20 referred Veterans, two enrolled in clinical trials outside the VA (for CLL and PMF), with investigational therapy provided by the study sponsors. Conclusions Using data from simulated and actual patient referrals to the LLS CTSC, we identified patient, provider, and location specific barriers for Veteran referral and enrollment in blood cancer clinical trials. When offered information about clinical trials, the majority of patients agreed to an LLS CTSC referral, suggesting that patients are generally willing to receive education and information about trial participation if given the opportunity. The LLS CTSC nurse navigators can overcome barriers to enrollment by providing education and identifying potential clinical trials within a desired geographic area. In addition to resources provided by the LLS CTSC, opening additional clinical trials in rural areas and within the VA system could help increase Veteran participation in clinical trials for blood cancers. Disclosures Rodgers: MJH Lifesciences: Consultancy. Weiss: AbbVie Inc.: Research Funding; Amgen Inc.: Research Funding; AstraZeneca Pharmaceuticals: Research Funding; Bristol Myers Squibb: Research Funding.

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Barriers to Recruitment of Rural Patients in Cancer Clinical Trials

Journal of Oncology Practice ◽

10.1200/jop.2010.000158 ◽

2011 ◽

Vol 7 (3) ◽

pp. 172-177 ◽

Cited By ~ 31

Author(s):

Shamsuddin Virani ◽

Lola Burke ◽

Scot C. Remick ◽

Jame Abraham

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Rural Areas ◽

Trial Participation ◽

Cancer Clinical Trials ◽

Clinical Trial Participation ◽

Rural Patients ◽

Patient Concerns

Rates of clinical trial participation are lower among patients in rural areas. Oncologists should be trained to address patient concerns regarding clinical trial availability, utility, and accessibility.

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Disparities in clinical trials participation in a vertically integrated care delivery system.

Journal of Clinical Oncology ◽

10.1200/jco.2020.39.28_suppl.128 ◽

2021 ◽

Vol 39 (28_suppl) ◽

pp. 128-128

Author(s):

Ahmed Megahed ◽

Gary L Buchschacher ◽

Ngoc J. Ho ◽

Reina Haque ◽

Robert Michael Cooper

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Healthcare System ◽

Care Delivery ◽

Trial Participation ◽

Cancer Type ◽

Clinical Trial Participation ◽

Integrated Healthcare ◽

Clinical Trial Enrollment ◽

Asian Pacific

128 Background: Sparse data exists on the diversity clinical trial enrollment in community settings. This information is important to ensure equity of care and generalizability of results. Methods: We conducted a retrospective cohort study of members of an integrated healthcare system diagnosed with invasive malignancies (excluding non-melanoma skin cancers) between 2013-2017 to examine demographics of the oncology population compared to those who enrolled in a clinical trial. Logistic regression was used to assess correlates of clinical trial participation, comparing general and screened samples to enrolled sample. Odds ratios were adjusted for gender, geocoded median household income, cancer type, and stage. Results: Of the 84,977 patients with a cancer diagnosis, N = 2606 were screened for clinical trial participation and consented, and of those N = 1372 enrolled. The percent of Latinx (25.8% vs 24.0%; OR 0.9? CI 0.72-1.05) and African American/Black (10.9% vs 11.1%; OR 0.92 CI 0.75-1.11) clinical trial participation mirrored that of the general oncology population, respectively using Non-Hispanic Whites as reference. Asian/Pacific Islander had equal odds of clinical trial enrollment (OR 1.08 CI 0.92-1.27). The enrolled population was younger than the general oncology population. Conclusions: This study suggests that in an integrated healthcare system with equal access to care, the clinical trials population is well representative of its general oncology population.[Table: see text]

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Parental perspectives long term after neonatal clinical trial participation: a survey

Trials ◽

10.1186/s13063-020-04787-0 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Thomas Salaets ◽

Emilie Lavrysen ◽

Anne Smits ◽

Sophie Vanhaesebrouck ◽

Maissa Rayyan ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Trial Participation ◽

Drug Trials ◽

Clinical Trial Participation ◽

Parental Perspectives ◽

Positive Experiences ◽

Almost All

Abstract Background Although recruiting newborns is ethically challenging, clinical trials remain essential to improve neonatal care. There is a lack of empirical data on the parental perspectives following participation of their neonate in a clinical trial, especially at long term. The objective of this study is to assess experiences and emotions of parents, long term after trial participation in an interventional drug trial. Methods Parents of former participants of five neonatal interventional drug trials were surveyed at long term (3–13 years ago) after participation. The survey assessed parental contentment with trial participation, perceived influence of the trial on care and health, emotional consequences of participation, and awareness of typical clinical trial characteristics on 6-point Likert scales. Results Complete responses were received from 123 parents (52% of involved families). Twenty percent of parents did not remember participation. Those who remembered participation reported high contentment with overall trial participation (median 5.00), but not with follow-up (median 3.00). Most parents did not perceive any influence of the trial on care (median 2.00) and health (median 2.43). Almost all parents reported satisfaction and pride (median 4.40), while a minority of parents reported anxiety and stress (median 1.44) or guilt (median 1.33) related to trial participation. A relevant minority was unaware of typical trial characteristics (median 4.20; 27% being unaware). Conclusions Overall, parents reported positive experiences and little emotional distress long term after participation. Future efforts to improve the practice of neonatal clinical trials should focus on ensuring effective communication about the concept and characteristics of a clinical trial during consent discussions and on the follow-up after the trial.

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Patient Income Level and Cancer Clinical Trial Participation

Journal of Clinical Oncology ◽

10.1200/jco.2012.45.4553 ◽

2013 ◽

Vol 31 (5) ◽

pp. 536-542 ◽

Cited By ~ 114

Author(s):

Joseph M. Unger ◽

Dawn L. Hershman ◽

Kathy S. Albain ◽

Carol M. Moinpour ◽

Judith A. Petersen ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Universal Access ◽

Participation Rate ◽

Treatment Decision ◽

Trial Participation ◽

Lower Income ◽

Clinical Trial Participation ◽

Clinical Trial Results ◽

The Impact

Purpose Studies have shown an association between socioeconomic status (SES) and quality of oncology care, but less is known about the impact of patient SES on clinical trial participation. Patients and Methods We assessed clinical trial participation patterns according to important SES (income, education) and demographic factors in a large sample of patients surveyed via an Internet-based treatment decision tool. Logistic regression, conditioning on type of cancer, was used. Attitudes toward clinical trials were assessed using prespecified items about treatment, treatment tolerability, convenience, and cost. Results From 2007 to 2011, 5,499 patients were successfully surveyed. Forty percent discussed clinical trials with their physician, 45% of discussions led to physician offers of clinical trial participation, and 51% of offers led to clinical trial participation. The overall clinical trial participation rate was 9%. In univariate models, older patients (P = .002) and patients with lower income (P = .001) and education (P = .02) were less likely to participate in clinical trials. In a multivariable model, income remained a statistically significant predictor of clinical trial participation (odds ratio, 0.73; 95% CI, 0.57 to 0.94; P = .01). Even in patients age ≥ 65 years, who have universal access to Medicare, lower income predicted lower trial participation. Cost concerns were much more evident among lower-income patients (P < .001). Conclusion Lower-income patients were less likely to participate in clinical trials, even when considering age group. A better understanding of why income is a barrier may help identify ways to make clinical trials better available to all patients and would increase the generalizability of clinical trial results across all income levels.

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Barriers to clinical trial accrual: Clinical trialists' perspectives.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e18156 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e18156-e18156

Author(s):

Edward S. Kim ◽

Dax Kurbegov ◽

Patricia A. Hurley ◽

David Michael Waterhouse

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Cost Benefit ◽

Trial Participation ◽

Clinical Trial Participation ◽

Eligibility Criteria ◽

Contract Research Organization ◽

The Public ◽

Community Forum ◽

Clinical Trial Accrual

e18156 Background: Oncology clinical trial participation rates remain at historic lows. There are many barriers that impede participation. Understanding those barriers, from the perspective of cancer clinical trialists, will help develop solutions to increase physician and site engagement, with the goal of improving accrual rates and advancing cancer treatment. Methods: Physician investigators and research staff from community-based and academic-based research sites were surveyed during ASCO’s Research Community Forum (RCF) Annual Meeting (N = 159) and through a pre-meeting survey (N = 124) in 2018. Findings and potential solutions were discussed during the meeting. Results: 84% of respondents (n = 84) reported that it took 6-8 months to open a trial and 86% (n = 81) reported that trials had unnecessary delays 70% of the time. The top 10 barriers to accrual identified were: insufficient staffing resources, restrictive eligibility criteria, physician buy-in, site access to trials, burdensome regulatory requirements, difficulty identifying patients, lack of suitable trials, sponsor and contract research organization requirements, patient barriers, and site cost-benefit. Respondents shared strategies to address these barriers. Conclusions: The current state of conducting clinical trials is not sustainable and hinders clinical trial participation. New strategies are needed to ensure patients and practices have access to trials, standardize and streamline processes, reduce inefficiencies, simplify trial activation, reduce regulatory burden, provide sufficient compensation to sites, engage the community and patients, educate the public, and increase collaborations. The ASCO RCF offers resources, available to the public, that offer practical strategies to overcome barriers to clinical trial accrual and has ongoing efforts to facilitate oncology practice participation in clinical trials.

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Transforming the site feasibility assessment process for oncology clinical trials.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e14092 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e14092-e14092

Author(s):

Dax Kurbegov ◽

Patricia A. Hurley ◽

David Michael Waterhouse ◽

Grzegorz S. Nowakowski ◽

Edward S. Kim

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Task Force ◽

Assessment Process ◽

Trial Participation ◽

Clinical Trial Participation ◽

Contract Research Organization ◽

Feasibility Assessment ◽

Oncology Research ◽

Start Up

e14092 Background: Current methods to assess trial sites for clinical trial participation are onerous, with unnecessary redundancies and no-value steps that impact research site resources and clinical trial participation. This project sought stakeholder feedback on recommendations to transform industry sponsor and contract research organization (CRO) processes for evaluating sites for trials. Methods: An ASCO task force developed recommendations to improve the feasibility assessment process and standardize and centralize questions and forms. A survey was conducted with sites, industry trial sponsors, and CROs to obtain feedback and assess buy-in for the recommendations. Results: Respondents were from 28 oncology research sites (19 academic, 9 community-based), 8 sponsors, and 4 CROs. All stakeholders agreed that the current process is burdensome (93% sites, 90% sponsors, 100% CROs), standardization will improve the process (86% sites, 87% sponsors, 75% CROs). All agreed a centralized portal will reduce burdens (93% sites, 100% sponsors, 75% CROs) and expedite trial start-up (89% sites, 100% sponsors, 75% CROs). Site certification was a viable option for sites (86%) and CROs (75%), but less so for sponsors (57%). Most respondents preferred a two-tier model: 1) a short site questionnaire followed by a pre-study visit for new interactions, and 2) only a pre-study site visit or a teleconference if there is an existing relationship. The greatest benefits were time savings, expedited start-up, reduction in personnel resources, and cost savings. The greatest barriers to adoption were buy-in and alignment from sponsors/CROs and insufficient information about site or protocol. Top predictors of a site’s success on a trial were physician engagement, available patients, and site experience. Conclusions: Site feasibility assessments are important for all stakeholders to establish trial suitability. However, current methods impose tremendous burdens on site resources (reported by authors elsewhere). While this sample is limited, the proposed process and standardization changes show promise to reduce burdens and costs for all stakeholders and expedite patient enrollment onto clinical trials.

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Clinical trial awareness in oncology patients of diverse ethnic background: A single-institution analysis.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e19217 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e19217-e19217

Author(s):

Gautam Valecha ◽

Nishitha Thumallapally ◽

Sandy El Bitar ◽

Terenig O. Terjanian ◽

Louise Madrigal ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Clin Oncol ◽

Tumor Stage ◽

Trial Participation ◽

Cancer Clinical Trials ◽

Single Institution ◽

Staten Island ◽

Enrollment Rates ◽

Zip Code

e19217 Background: Clinical trials offer several advantages to the patients including access to innovative treatments with improved survival rates, closer monitoring and follow-up with removal of health disparity; and aim to advance the science of medicine. Yet, worldwide enrollment rates in cancer clinical trials have been only about 5 percent, despite the fact that a significantly higher percentage of Americans have a desire to participate in clinical trials [1, 2]. We conducted a single institution study to gain knowledge about clinical trial awareness in our cancer patient population as well as to identify the barriers within provider-consumer communication that prevent enrollment. Methods: A 10-question survey was distributed by medical assistants and surveys (n=222) were collected at the end of each clinic visit. Responders included racial/ethnic minorities and underserved patients, representative of the ethnic diversity in the Staten Island Borough of New York City. Demographic data including age, gender, zip code, race and ethnicity were recorded. Additionally, Charlson comorbidity index and tumor stage was also recorded. Results: 159/222 patients (71.62%) completed the survey. Of these patients, 47 (29.55%) answered every question on the survey, while 112/159 patients (70.44%) answered only few of the questions. The completed surveys are linked by zip code to the different boroughs of Staten Island, which allows us to identify hubs with lack of clinical trial awareness knowledge. Conclusions: Despite the several advantages for patients and medical field, enrollment rates in clinical trials remain very low. Our study results help in gaining knowledge about clinical trial awareness among oncology patients, correlated to comorbidity and tumor stage. In addition, demographic hubs with lack of knowledge are identified as targets for community outreach and education. A multilevel approach will be developed to address identified barriers that exist for patients, and will be implemented at community level, to reduce ethnic bias in trial enrollment and increase trial participation among an ethnically diverse population. References: 1. Unger JM, Cook E, Tai E, Bleyer A: The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies. Am Soc Clin Oncol Educ Book. 2016, 35:185-198. 10.1200/EDBK_156686 2. Comis RL, Miller JD, Aldigé CR, Krebs L, Stoval E: Public attitudes toward participation in cancer clinical trials. J Clin Oncol. 2003, 21:830-835. 10.1200/JCO.2003.02.105.

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Understanding Factors That Determine Clinical Trial Enrollment for African American Patients with Lymphoma

Blood ◽

10.1182/blood-2021-152433 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 4965-4965

Author(s):

Gygeria Manuel ◽

Amy Ayers ◽

Jonathan Berman ◽

Shannon Blee ◽

Claire Sibold ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

African American ◽

African Americans ◽

Cell Lymphoma ◽

B Cell Lymphoma ◽

Trial Participation ◽

Clinical Trial Participation ◽

Large B Cell Lymphoma ◽

Emory University

Abstract Background: Although the incidence of non-Hodgkin lymphoma (NHL) is lower in minority populations, there is a difference in presentation, survivorship and participation in clinical trials (Becnel et al., 2017). African American patients with diffuse large B-cell lymphoma (DLBCL) present with more aggressive features including higher lactate dehydrogenase, increased frequency of B-symptoms, and higher rate of HIV co-infection, while also presenting at a younger age than other patients. (Tiu et al., 2020). Given the association of race with lymphoma presentation and outcomes, minority participation in clinical trials is of vital importance when developing novel therapies. There have been efforts to increase participation of African Americans in cancer clinical trials including patient navigation outreach which resulted in improvement of 9% to 16% of patients approached (Fouad et al., 2016). However, a recent study illustrated that for DLBCL, acute myeloid leukemia, and acute lymphoblastic leukemia, individuals of African descent represented 1.5%, 2.3%, and 6.7% of clinical trial participants, respectively (Gopishetty et al., 2020). We are conducting the current study to identify factors that influence decisions regarding clinical trial participation in African American patients with NHL. Methods: We are identifying African American patients with diffuse large B cell lymphoma and follicular lymphoma who enrolled in a therapeutic clinical trial at Emory University between 2010-2020. We will utilize the electronic medical record to identify patient characteristics such as distance from medical facility, insurance status, type of insurance, comorbidities, education status, type of diagnosis, and race of diagnosing physician. This data will compare African American patients who participated in clinical trials to those who did not participate as part of their initial treatment, specifically comparing baseline characteristics of interest between the groups. Furthermore, the data mention above will be compared between African American and white patients. We are also conducting interviews with a selected group of African American patients that have opted to participate in therapeutic clinical trials to gain a thorough understanding of the barriers and benefits they endured during their experience. The interview questions are based on prior knowledge of clinical trials, distance to facility, religious/ spiritual belief, trust of the physician, additional expenses, and time corresponded to treatment. Patients are asked to rate the importance each factor in their decision to participate and elaborate on points most specific to them. In addition, the interview allows for discussion of possible factors that challenged their participation in clinical trials which may allow for insight on low participation levels nationally. Furthermore, we are going to target patients who enrolled on clinical trials and will subsequently identify patients who did not participate in studies to identify differences in perception of treatment and clinical investigation. This project is partnered with Accounting for the High Enrollment of African Americans in Winship Cancer Institute's Clinical Trials, at Emory University. Conclusions:This study is currently enrolling patients and will answer key questions related to clinical trial participation in African American patients with lymphoma. We aim for the data collected from this study to assist in creating lymphoma clinical trials that better cater to the unique needs and considerations of African Americans. Disclosures Cohen: Genentech, Takeda, BMS/Celgene, BioInvent, LAM, Astra Zeneca, Novartis, Loxo/Lilly: Research Funding; Janssen, Adaptive, Aptitude Health, BeiGene, Cellectar, Adicet, Loxo/Lilly, AStra ZenecaKite/Gilead: Consultancy.

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A Pilot Study of a Culturally-Appropriate, Educational Intervention to Increase Participation in Cancer Clinical Trials Among African Americans and Latinos

10.21203/rs.3.rs-461056/v1 ◽

2021 ◽

Author(s):

Jennifer Cunningham-Erves ◽

Tilicia Mayo-Gamble ◽

Pamela C Hull ◽

Tao Lu ◽

Claudia Barajas ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

African Americans ◽

Educational Program ◽

Trial Participation ◽

Willingness To Participate ◽

Culturally Appropriate ◽

Clinical Trial Participation ◽

Medical Researchers ◽

Town Halls

Abstract Aim: Culturally-appropriate, educational programs are recommended to improve cancer clinical trial participation among African Americans and Latinos. This study investigated the effect of a culturally-appropriate, educational program on knowledge, trust in medical researchers, and intent for clinical trial participation among African Americans and Latinos in Middle Tennessee.Method: Trained community health educators delivered a 30-minute presentation with video testimonials to 198 participants in 13 town halls. A pre-post survey design was used to evaluate the intervention among 102 participants who completed both pre- and post-surveys one to two weeks after the session. Results: Paired-sample t-test showed significant increases in unadjusted mean scores for knowledge (p < .001), trust in medical researchers (p < .001), and willingness to participate in clinical trials (p = .003) after the town halls in the overall sample. After adjusting for gender and education, all three outcomes remained significant for the overall sample (knowledge: p < .001; trust in medical researchers: p < .001; willingness: p = .001) and for African Americans (knowledge: p < .001; trust in medical researchers: p = .007; willingness: p = .005). However, willingness to participate was no longer significant for Latinos (knowledge: p < .001; trust in medical researchers: p = .034; willingness: p = .084).Conclusions: The culturally-appropriate, educational program showed promising results for short-term, clinical trial outcomes. Further studies should examine efficacy to improve research participation outcomes.

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