Findings from a randomized pilot of a full factorial trial of ASCENT: acceptability, feasibility, and intervention adherence

Abstract Background Adolescent and Young Adult Cancer Survivors (AYACS) are at a heightened risk for depressive symptoms yet tailored mental health interventions for this population remain scarce. The AYA Survivors' Coping and Emotional Needs Toolkit (ASCENT) was developed as a digitally delivered intervention explicitly designed to reduce depressive symptoms for AYACS. In preparation for a full factorial trial of ASCENT, we conducted an NCI-funded (R00248701) pilot feasibility study (NCT06420193) to evaluate the acceptability and feasibility of our study procedures and describe intervention adherence. Methods Sixteen cancer survivors aged 15–39 who had completed treatment within the last 5 years were recruited from a rural academic medical center to participate in a 6-week mixed-methods randomized pilot study of a full factorial trial. Acceptability and feasibility of study procedures were evaluated via self-report questionnaires and exit interviews. Completion of assigned intervention content was described based on back-end usage data from the ASCENT platform. To proceed with the full factorial trial, we required that at least 68% of participants provide average rating ≥ 3 on an investigator-developed acceptability survey administered at follow-up. Further, we required a minimum recruitment rate of 15% and a minimum retention rate of 68% to indicate that the planned trial will be feasible. As an exploratory aim, rate of completion of intervention content (intervention adherence) was described. Results Sixteen participants and were enrolled and randomly assigned to 1 of 16 conditions (1 participant/condition). Study procedures demonstrated high acceptability as 11/12 (91.7%) participants that completed the follow-up questionnaire had a mean acceptability score ≥ 3, exceeding the a priori benchmark of 68%. However, both qualitative and quantitative data highlighted dissatisfaction with the length of the weekly and follow-up questionnaires. Feasibility metrics (recruitment rate = 19%; retention rate = 75%) also exceeded a-priori benchmarks. On average, participants completed 42% of the lessons they were assigned. Conclusions While study procedures were rated as acceptable and recruitment and retention rates indicated the full factorial trial is feasible, the larger trial would likely benefit from fine-tuning of existing procedures. Qualitative insights also provided critical recommendations for improving recruitment and retention, such as the need for additional information pre-enrollment and reminders to complete study procedures throughout the trial. Further, modifications to study procedures are needed to ensure adequate completion of intervention content. This study identified key considerations for the conduct of future complex trials with AYACS.