Findings from a Randomized Pilot of a Full Factorial Trial of ASCENT: Acceptability, Feasibility, and Intervention Adherence

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. To address this critical need, 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. 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, feasibility, and adherence to study procedures were evaluated via self-report questionnaires, interviews, and usage data. 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. Results Thirty-eight AYACS completed screening, 33 of whom were eligible and 16 of whom enrolled and were randomly assigned to 1 of 16 conditions (1 participant/condition). Participants were blinded to which condition they had been assigned. Study procedures demonstrated high acceptability that exceeded the a-priori benchmark, as 11/12 (91.67%) 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%) exceeded a-priori benchmarks. Conclusions While recruitment and retention 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 the existing recruitment and retention strategies. 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. This study identified key considerations for the conduct of future complex trials with AYACS.