Recruitment strategies for a multisite telehealth trial for rural cancer survivors with ostomies

PURPOSE: Ostomies, the surgical exteriorization of bowel for urine or stool, are part of the treatment of some cancers. We completed a randomized clinical trial testing a curriculum to help cancer survivors with ostomies in rural areas delivered by telehealth. The aim of this report is to describe modifications necessary to complete accrual in this population of cancer survivors. METHODS: Rural cancer survivors with ostomies at least 6 weeks postoperatively were randomized to group educational sessions via telehealth versus usual care. The curriculum was delivered once per week over 5 weeks; primary patient reported endpoints were at 6 months. Initial sites were University of North Carolina, City of Hope National Medical Center, and Geisinger Medical Center. Rurality was initially defined utilizing the rural-urban commuting area (RUCA) codes as 4+ (excluding RUCA 1, 2, 3). RESULTS: This study was open from August 16, 2019, to February 9, 2024. Accrual was more challenging after the COVID pandemic began in March 2020. Multiple modifications were needed to address trial recruitment challenges. Our amendments included adding six sites across the USA, expanding inclusion criteria to include RUCA 3 and then RUCA 2, and adding distance from ostomy nursing care, first to those living greater than 45 miles, and subsequently more than 25 miles. CONCLUSIONS: Accrual to cancer survivorship trials may be difficult, and unpredictable circumstances such as the worldwide pandemic may require research teams to be flexible and creative with recruitment strategies. Modifications may be necessary to ensure accrual yet maintain study integrity. TRIAL REGISTRATION: This study was registered on Clinicaltrials.gov (NCT # 03913715) on 5/29/2019.