JMIR Publications

ABSTRACT

Background:

Adolescent and young adult (AYA) cancer survivors face a high burden of psychological late effects, with cancer-related anxiety being a prevalent mental health concern. Despite the significant need for care, over half of AYA survivors requiring psychosocial services remain untreated. Digital health interventions offer a promising solution to bridge this care gap.

Objective:

This protocol describes a pilot randomized controlled trial (RCT) designed to evaluate a novel digital anxiety intervention for this at-risk population.

Methods:

This is a single-site, two-arm, pilot RCT enrolling 60 AYA cancer survivors (ages 15-29). Participants will be randomized 1:1 to the Attention Bias in Cancer survivors (ABCs) intervention or a sham control condition. The ABCs intervention combines an Attention Bias Modification (ABM) mobile intervention with daily gratitude and savoring text messages over a four-week period. The sham condition consists of sham ABM and daily mood monitoring text messages. The primary objectives are to evaluate intervention feasibility (defined as ≥50% enrollment and ≥70% retention) and acceptability (defined by cut-off scores on the Client Satisfaction Questionnaire and System Usability Scale). Secondary exploratory outcomes include patient-reported measures of attention bias, anxiety, fear of recurrence, pain, resilience, and other psychosocial outcomes.

Results:

The trial is ongoing.

Conclusions:

This pilot trial examines the feasibility and acceptability of a digital positive psychological intervention targeting anxiety in AYA cancer survivors. Exploratory outcomes will inform sample size calculations for a future powered multi-site clinical trial. The ABCs intervention may have the potential to provide scalable and accessible evidence-based psychosocial care and improve health outcomes. Clinical Trial: ClinicalTrials.gov NCT06682039