Grant Number:	5R21CA261863-02 Interpret this number
Primary Investigator:	Recklitis, Christopher
Organization:	Dana-Farber Cancer Inst
Project Title:	STEP-YA: an Online Self-Management Intervention for Young Adult Cancer Survivors with Insomnia
Fiscal Year:	2023

Project Summary Young adult cancer survivors (YACS) are particularly vulnerable to late-effects of cancer therapy including insomnia:1-8 1 in 4 YACS reports significant insomnia even years after completing treatment.5-7, 9 Chronic insomnia is associated with significant health problems (e.g., heart disease, obesity, hypertension, diabetes, depression, and anxiety).10-19 As YACS are vulnerable to many of these same conditions, providing them with effective insomnia treatment is critically important to their health and development.20-22 Cognitive-behavioral therapy for insomnia (CBTI) is a well-established, empirically supported treatment for insomnia. Multiple randomized trials have demonstrated its effectiveness in the general population and in cancer survivors,23-25 26 and professional guidelines endorse CBTI as “front-line treatment” for insomnia.27 Unfortunately, despite compelling evidence, this empirically validated treatment is largely unavailable to the growing population of YACS who need it.28, 29 Barriers include lack of trained providers,30 high burden of conventional CBTI, and lack of CBTI treatments targeting their specific needs. To address these barriers and deliver effective insomnia treatment to YACS, empirically supported CBTI interventions for survivors of adult cancers were used to develop the Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA) as a brief online CBTI intervention. Delivered in a 90-minute, synchronous 1:1 session led by an instructor, STEP-YA explains causes of insomnia, introduces CBTI principles and methods, and addresses developmental, social, and health factors specifically affecting YACS's sleep. Using a symptom self-management approach, STEP-YA supports survivors in implementing program recommendations into their daily lives with guided behavioral planning. Following recommendations for development and early testing of behavioral interventions,31 an optimization trial is proposed to evaluate efficacy of STEP-YA to improve insomnia in YACS. In this trial, 94 off- treatment YACS (ages 20-39) will be randomized (1:1) to receive the STEP-YA intervention either, 1) alone (non-coaching condition), or 2) with the addition of 2 remote coaching sessions (coaching condition). All study activities will be completed remotely. Specific aims are: 1) To test the hypothesis that STEP-YA improves insomnia symptoms (primary outcome) and mood (secondary outcome), and 2) To compare the improvement in these outcomes in the coaching versus non-coaching conditions. A secondary aim will explore participant factors associated with clinically significant response to the intervention. STEP-YA addresses barriers to insomnia treatment for YACS survivors because it is brief, low cost, low burden, and targets their specific needs. STEP-YA is the first brief CBTI intervention develop specifically for YACS. Evaluating the efficacy of STEP-YA and the utility of individualized coaching in this trial are critical next steps for optimizing the intervention, planning future large scale trials, and ultimately insuring that STEP-YA is effective and widely available to improve the health and quality-of-life of YACS suffering from chronic insomnia.





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