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Sleep Treatment Education Program for Cancer Survivors: Protocol for an Efficacy Trial
Briana L Bice1, Alexis L Michaud1,2, Katherine G McCormick1
1Perini Family Survivors' Center, Dana-Farber Cancer Institute, Boston, MA, United States.
JMIR Research Protocols
|November 28, 2024
Summary
Cancer survivors with insomnia can benefit from the Sleep Treatment Education Program (STEP-1), an online intervention improving sleep and mood. Further trials will explore its efficacy in diverse populations.
Area of Science:
- Oncology
- Sleep Medicine
- Psychology
Background:
- Cancer survivors experience chronic insomnia, increasing long-term health risks.
- Cognitive Behavioral Therapy for Insomnia (CBTI) is effective but inaccessible to many survivors due to barriers like distance and provider shortages.
- The Sleep Treatment Education Program (STEP-1) offers a low-intensity, online CBTI-based intervention to address these limitations.
Purpose of the Study:
- To evaluate the efficacy of STEP-1 in improving insomnia symptoms and mood in cancer survivors.
- To explore factors associated with treatment response, intervention acceptability, and feasibility of coaching.
- To assess participant satisfaction and gather suggestions for STEP-1 improvement.
Main Methods:
- A phase II pilot randomized controlled trial involving 70 off-treatment cancer survivors (aged 40-89) with insomnia.
- Participants were randomized to receive either the STEP-1 intervention or a relaxation education control condition via virtual sessions.
- Insomnia symptoms (Insomnia Severity Index) and mood (Profile of Mood States Short Form) were assessed at baseline and 4 and 8 weeks.
Main Results:
- Enrollment of 70 participants concluded in October 2024.
- Data analysis is scheduled for fall 2024, with results anticipated in winter 2025.
- The study is currently awaiting results to determine the efficacy of STEP-1.
Conclusions:
- Results will indicate if STEP-1 offers benefits beyond placebo effects.
- If effective, STEP-1 could be developed for larger trials in diverse cancer survivor populations.
- The study aims to establish STEP-1 as an accessible treatment for insomnia in cancer survivors.
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