Retention of Black and White Participants in the Selenium and Vitamin E Cancer Prevention Trial (SWOG-Coordinated Intergroup Study S0000)

Abstract

Background Disproportionally low retention of minority populations can adversely affect the generalizability of clinical research trials. We determine the overall retention rates for White and Black participants from the Selenium and Vitamin E Cancer Prevention Trial (SELECT) and explore participant and site characteristics associated with retention failure (study disengagement)for these groups. Methods A secondary analysis of 28,118 White (age ≥55), and 4,322 Black (age ≥ 50) SELECT participants used multivariate Cox regression to estimate overall retention rates and to calculate hazard ratios (HR) and 95% confidence intervals (CI). Results Blacks had higher age-adjusted risk of disengagement than Whites (HR=1.92; 95% CI,1.77-2.08). Among Black participants, those age 50-54 were at three times the risk of disengagement than those age ≥65 (HR=3.61; 95%CI,2.41-5.41). Blacks age ≥65 had 1.6 times the risk of disengagement than Whites age ≥65 (HR=1.60; 95%CI,1.38-1.87). By six years post-randomization, 84% of Whites and 69% of Blacks remained engaged in the study. Current smoking status was an independent risk factor for study disengagement for both White and Black participants. For both groups, sites whose staffs missed SELECT training sessions or who received SELECT Retention and Adherence grants were associated with increased and decreased disengagement risks, respectively. Conclusions SELECT retention was disproportionately lower for Blacks than for Whites. Impact The observed difference in retention rates for Blacks and Whites and factors identified by race for study disengagement in SELECT may inform retention efforts for future long-term, cancer prevention trials.

Participation of Black Americans in Cancer Clinical Trials: Current Challenges and Proposed Solutions

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Charting the Future of Cancer Health Disparities Research: A Position Statement from the American Association for Cancer Research, the American Cancer Society, the American Society of Clinical Oncology, and the National Cancer Institute

“…Similarly, lower rates exist for those patients who transition from pediatric to adolescent and youngadult cancers. Many issues, such as prevailing sociodemographics, trust issues, comorbidity burdens, and competing priorities, contribute to the situation (50). However, community engagement is vital to address the fundamental recruitment and retention challenges that cloud the clinical trials setting.…”

Charting the future of cancer health disparities research: A position statement from the American Association for Cancer Research, the American Cancer Society, the American Society of Clinical Oncology, and the National Cancer Institute

“…Similarly, lower rates exist for those patients who transition from pediatric to adolescent and young adult cancers. Many issues, such as prevailing sociodemographics, trust issues, comorbidity burdens, and competing priorities, contribute to the situation . However, community engagement is vital to address the fundamental recruitment and retention challenges that cloud the clinical trials setting.…”