Grant Details
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 |
Abstract
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.
Publications
Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA): Protocol for an Efficacy Trial.
Authors: Michaud A.L.
, Bice B.
, Miklos E.
, McCormick K.
, Medeiros-Nancarrow C.
, Zhou E.S.
, Recklitis C.J.
.
Source: Jmir Research Protocols, 2023-11-29 00:00:00.0; 12, p. e52315.
EPub date: 2023-11-29 00:00:00.0.
PMID: 38019571
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