Abstract
PURPOSE: Achieving demographically representative samples remains a challenge in oncology trials but is essential for generalizable findings. We describe recruitment and enrollment to a decentralized trial for an online sexual health intervention for breast cancer survivors, evaluating differences by race, ethnicity, and age. METHODS: Partnered breast cancer survivors with sexual concerns were recruited to the Sexual Health and Intimacy Enhancement (SHINE) trial (WF-2202, NCT06216574) via the Wake Forest NCI Community Oncology Research Program (NCORP) Research Base. Sites identified potentially eligible survivors; recorded their race, ethnicity, and age; and sent them online eligibility screeners. Eligible, consenting survivors were enrolled. RESULTS: Screener completion (78.3%, n = 557/711), eligibility (66.6%, n = 371/557), and enrollment (91.9%, n = 341/371) rates were high, but there were discrepancies by race and age. Eligible White survivors were more likely to enroll than eligible survivors from other races (94.4% vs. 87.0%, p = .03). Survivors who completed screeners were younger on average than those who did not (age M = 52.6 vs. 54.5, p = .05); eligible survivors were also younger on average than ineligible survivors (age M = 51.9 vs. 54.6, p = .004). There were no other differences in screener completion, eligibility, or enrollment by race, ethnicity, or age (ps > .06). CONCLUSIONS: Differences in screener completion and enrollment by age and race suggest younger, White breast cancer survivors may have had the greatest interest in this trial of an online sexual health intervention. Overall, however, screener completion, eligibility, and enrollment rates were substantially higher for this trial than past clinical trials in oncology, demonstrating the benefits of decentralized trials through the NCORP network. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT06216574 (Registered: January 22, 2024).