JMIR Publications

ABSTRACT

Background:

Adolescents and young adults (AYAs) with cancer experience unique developmental and psychosocial needs that place them at risk of poor psychosocial outcomes. AYAs are digital natives who grew up with the internet and digital technology, and mobile health (mHealth) psychosocial interventions have the potential to overcome access barriers for psychosocial care.

Objective:

This pilot randomized trial aims to establish the feasibility, acceptability, and preliminary efficacy of a mobile version of the Promoting Resilience in Stress Management intervention (mPRISM). PRISM is an evidence-based intervention developed in collaboration with AYAs, based on stress and coping theory, resilience theory, and evidence-based coping strategies in the domains of stress management, goal setting, cognitive restructuring, and benefit finding. We hypothesize that mPRISM will be feasible, acceptable, and appropriate. We will also summarize digital usage metrics and engagement patterns.

Methods:

This is a parallel, two-arm, single-site pilot randomized controlled trial with a waitlist control design. The study will recruit 80 AYAs with cancer. Eligible AYAs are aged 12 to 25 years, within 12 months of a new cancer diagnosis, receiving chemotherapy and/or radiation therapy, speak/read/write in English, and are cognitively able to participate in all study procedures. Recruitment by clinical research coordinators will occur remotely by phone/video/text. Participants will be randomized to psychosocial usual care alone (UC) or UC plus mPRISM for an 8-week intervention period. Enrolled participants will complete surveys at baseline before randomization, 8 weeks, and 3-month follow-up. Using a waitlist design, the UC arm will receive mPRISM upon completion of 3-month follow-up surveys. Those in the UC arm of the study will complete two additional measurement points at immediate post-treatment and 3 months later. The primary outcomes of interest are feasibility, defined as ≥60% enrollment, ≥70% retention (i.e., % of participants who completed the study), and feasibility, acceptability, and appropriateness as defined by cut-off scores ≥4/5 on three brief validated implementation outcome measures (Feasibility of Implementation Measure, Acceptability of Intervention Measure, Intervention Appropriateness Measure). We will apply top-box scoring for the implementation measures. Exploratory outcomes of interest include patient-reported health-related quality of life, resilience, distress, anxiety, depression, pain, and sleep. We will conduct intention-to-treat analysis to compare outcomes of the mPRISM arm versus the control arm with covariate-adjusted regression models. We will summarize individual digital usage metrics using descriptive statistics and graphical tools.

Results:

The study is open for recruitment and data collection is ongoing.

Conclusions:

Although our prior work suggests AYAs with cancer are interested in mHealth psychosocial interventions, such interventions have not yet been sufficiently evaluated or implemented among AYA oncology patients. mPRISM may serve as a potential mHealth intervention to fill this gap. In this study, we will test the feasibility, acceptability, and preliminary efficacy of mPRISM. This work will inform future larger-scale randomized trials powered for efficacy outcomes. Clinical Trial: ClinicalTrials.gov NCT05842902; https://clinicaltrials.gov/study/NCT05842902