Mobile App Promoting Resilience in Stress Management for Adolescents and Young Adults With Cancer: Protocol for a Pilot Randomized Controlled Trial
ABSTRACT
Adolescents and young adults (AYAs) with cancer often face significant psychosocial challenges. This pilot randomized controlled trial (RCT) aimed to assess the feasibility, acceptability, and preliminary efficacy of a mobile app version of the Promoting Resilience in Stress Management intervention (mPRISM) for AYAs with cancer.
This study is a parallel, 2-arm, single-site pilot RCT with a waitlist control design. The goal is to recruit 80 AYAs with cancer aged 12 to 25 years, within 12 months of a new cancer diagnosis, and receiving chemotherapy or radiation therapy. Participants will be randomized to receive either psychosocial usual care alone or usual care plus mPRISM for an 8-week intervention period.
The primary outcomes of interest include feasibility, acceptability, and appropriateness, as well as patient-reported health-related quality of life, resilience, distress, anxiety, depression, pain, and sleep. The study will also evaluate digital usage metrics and conduct an intention-to-treat analysis to compare the outcomes of the mPRISM arm versus the control arm.
As of September 2023, 20 participants have been enrolled, and recruitment is ongoing.
This study aims to address the lack of evaluation and implementation of mHealth psychosocial interventions among AYA oncology patients. The results will inform future larger-scale RCTs powered for efficacy outcomes.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05842902; https://clinicaltrials.gov/study/NCT05842902
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/57950
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