JMIR Publications

ABSTRACT

Background:

Young adult cancer survivors (YACS) are at elevated risk for chronic insomnia, even years after they complete treatment. In addition to potential health consequences, insomnia can interrupt social, educational, and vocational development for YACS just as they are trying to “make up” for time lost to cancer. Cognitive Behavioral Therapy for Insomnia (CBTI) is recommended as the first-line treatment for insomnia, but remains largely unavailable to YACS due to several barriers (i.e., shortage of trained providers, geographic limitations, financial limitations). Traditional CBTI has not been adapted to meet the unique developmental and circadian challenges of YACS. To address this, we developed the Sleep Treatment Education Program for Young Adults (STEP-YA), a low-intensity educational intervention delivered virtually.

Objective:

In this study, we aim to test the efficacy of STEP-YA to improve insomnia symptoms and mood in YACS, and assess the utility of individualized coaching to improve treatment effects.

Methods:

74 off-treatment YACS aged 20-39 with clinically significant insomnia are eligible and expected to be enrolled. Each participant completes the STEP-YA session in a synchronous, 90-minute virtual session. After the session, participants are randomized to either the coaching condition, which delivers two telephone coaching sessions, or the no coaching condition, which involves STEP-YA only. The Insomnia Severity Index (ISI) is used to measure insomnia symptoms, and the Profile of Mood States: Short Form (POMS-SF) is used to measure mood. Follow-up measures are collected four- and eight-weeks post-intervention.

Results:

nrollment began in November 2022, with 24 participants currently enrolled. We anticipate recruitment will be completed in 2024. Primary endpoint is change in ISI score from baseline to eight-weeks post-intervention. Secondary endpoint is change in mood symptoms on the POMS-SF from baseline to eight-weeks post-intervention. Change scores will be treated as continuous variables, and primary analyses will employ analysis of variance methods A within-subjects analysis will examine if the STEP-YA intervention is associated with significant changes in insomnia and mood over time. A 2-way analysis of variance will be used to evaluate the utility of coaching sessions to improve treatment effects.

Conclusions:

Chronic insomnia has significant negative effects on YACS’ medical, educational, and psychological functioning. STEP-YA aims to address their needs; study results will determine if the intervention warrants future effectiveness and dissemination studies, and if individualized coaching is necessary for adequate treatment response. Clinical Trial: NCT05358951