Grant Number:	1R21CA267857-01A1 Interpret this number
Primary Investigator:	Recklitis, Christopher
Organization:	Dana-Farber Cancer Inst
Project Title:	Sleep Treatment Education Program-1 (Step-1): a Randomized Trial of a Self-Management Insomnia Intervention for Cancer Survivors
Fiscal Year:	2022

Project Summary Insomnia is one of the most common problems associated with cancer therapy; as many as 1 in 4 long-term survivors report chronic insomnia even years after therapy completion.1, 2 As untreated insomnia is associated with an extensive list of health problems (e.g., heart disease, hypertension, diabetes),3-12 the NCI emphasizes the importance of addressing sleep in survivors,13 yet insomnia remains “under-recognized and undertreated”14 in survivorship care. Cognitive-behavioral therapy for insomnia (CBTI) is a well-established and empirically supported treatment for insomnia. Multiple randomized trials have demonstrated its effectiveness in the general population and in cancer survivors,15-22 and professional guidelines endorse CBTI as “front-line” insomnia treatment.23 Yet, despite compelling evidence, CBTI is largely unavailable to the growing population of cancer survivors who need it.24 Barriers to delivering CBTI to survivors include the significant burdens of conventional CBTI leading to low adherence, and limited access. 25, 26 To address these challenges and deliver effective insomnia treatment to cancer survivors, we developed the Sleep Treatment Education Program-1 (STEP-1), by refining brief insomnia interventions found successful in an NIH-funded trial (R03CA201459). STEP-1 is a self-management CBTI intervention delivered as a single online educational session. Delivered in a 75-minute, 1 on 1 session by an instructor, STEP-1 educates survivors about causes of insomnia after cancer and introduces them to CBTI principles and methods. Using a symptom self-management approach, STEP-1 supports survivors in implementing program recommendations into their daily lives with guided behavioral planning and take-home materials. STEP-1 represents a significant innovation in CBTI treatment and addresses barriers to treatment for cancer survivors because it is brief, low cost, and less burdensome than currently available CBTI treatments. Based on single-arm trial results showing STEP-1 significantly reduces survivors' insomnia, we propose a randomized controlled trial (RCT) of 70 cancer survivors evaluating efficacy of STEP-1 to improve insomnia compared to an enhanced usual care control condition. Consenting survivors ≥ 6 months off-therapy will be scheduled for an individual videoconference session in which they will complete baseline measures using the Qualtrics web-based platform27 before being randomized (1:1) and receiving their assigned intervention via live videoconference. At 4- & 8-weeks post-intervention, participants will enter follow-up data directly into Qualtrics, with study staff assistance as needed, and receive a $25 gift card for each follow-up assessment. We hypothesize insomnia symptoms (primary outcome) and mood (secondary outcome) will improve significantly in STEP-1 participants relative to control participants (primary aim). Secondary aims include identifying participant and intervention factors associated with clinically significant response to STEP-1, evaluating acceptability of the control intervention, and exploring feasibility of providing individualized coaching for participants without a significant response to the STEP-1 intervention.





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