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

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.

Clinical trials-related knowledge, attitudes, and behaviors among Black and Latina women: A randomized controlled trial of the Women United: Clinical Trials and the Fight Against Breast Cancer Program

“…While this increase was statistically significant, it is worth noting that this was a small practical change (approximately 1 additional item answered correctly). This finding parallels several pre-post designed studies of cancer clinical trial educational interventions that have also reported minor improvements for total knowledge [13,14] and individual questions [15] among ethnic minority community respondents. Moreover, the prior samples of Black and Latino respondents demonstrated identical knowledge improvements across ethnicity [13,14], as in the current study.…”

“…This finding parallels several pre-post designed studies of cancer clinical trial educational interventions that have also reported minor improvements for total knowledge [13,14] and individual questions [15] among ethnic minority community respondents. Moreover, the prior samples of Black and Latino respondents demonstrated identical knowledge improvements across ethnicity [13,14], as in the current study. It is notable that the one other randomized controlled trial of a cancer clinical trials education program did not yield any improvement in knowledge [16].…”

“…However, there were no changes in perceived community support for clinical trials, which is not surprising given that the program addressed individual barriers to participation, and would not be expected to change perceptions of community attitudes about clinical trials. Similarly, other studies have noted small improvements in attitudes towards clinical trials including: trust in medical researchers and willingness to participate in clinical trials for Black (but not Latino) respondents [13], and perceived benefits and barriers of clinical trials participation for both Black and Latino respondents [14]; the one previous randomized controlled trial did not yield any change in perceived barriers [16].…”

“…Cancer education programs designed specifically to address individual-level barriers to clinical trials participation through culturally appropriate strategies may increase enrollment in clinical trials [12]. Pre-post studies of Black and Latino [13,14] and Chinese American [15] community participants have evaluated culturally tailored interventions about cancer clinical trials using small group education sessions [13,15] and self-paced slide presentations [14], with some demonstrated improvements in both knowledge and attitudes about clinical trials at post-test. Studies that have evaluated clinical trials education programs using a gold-standard randomized controlled trial methodology are sparse, although one recent randomized controlled trial of ethnic minority (Black, Asian, Latino, Native American; 48.4% of sample) and White (51.6% of sample) oncology patients was conducted wherein respondents were allocated to either an intervention (in-office viewing of a cancer clinical trials education video and receiving an education booklet) or usual care (receiving the same materials to take home with no instructions) without specific cultural tailoring of the curriculum [16].…”

The Problem of Hispanic/Latinx Under-Representation in Cancer Clinical Trials

“…40 Successful efforts to increase Hispanic/Latinx accrual to clinical trials include culturally appropriate outreach and education, improving the informed consent process, use of patient navigators, and building community partnerships. [41][42][43][44] In addition, the representation of diverse voices among patient advocates is imperative to the design of patient-centered and culturally appropriate studies.…”