Efficacy of Synchronous, Virtual Cognitive Behavioral Therapy for Insomnia Across Phases of Cancer Survivorship

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This project is a single center, prospective randomized controlled trial (N=198) primarily evaluating the efficacy of the Survivorship Sleep Program vs. Enhanced Usual Care on insomnia severity among cancer survivors. The investigators will also examine secondary outcomes associated with cancer-related insomnia including subjective and objective sleep measures (i.e., sleep diaries, actigraphy), emotional distress, fatigue, and use of sleep medications. Notably, most CBT-I trials with cancer survivors who have completed primary treatment with curative intent (i.e., curvivors) but not those in treatment or living with metastatic cancer (i.e., metavivors). To enhance generalizability, this RCT will stratify enrollment by survivorship phase (1:1:1). This project in strengthened by partnerships with community organizations (SurvivorJourneys and Ellie Fund) and use of both quantitative (i.e., surveys, actigraphy) and qualitative methods (i.e., interviews) to inform considerations for future implementation. Collectively, the proposed project will yield multiple deliverables to innovate cancer survivorship care, namely an efficacious, virtually delivered intervention addressing chronic insomnia, one of the most deleterious concerns among the growing population of cancer survivors in the US. Findings will inform a future effectiveness trial and the expansion of the synchronous delivery of CBT-I to survivors across different phases of cancer survivorship.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Cancer survivor, defined as:

‣ (A) history of nonmetastatic, localized or regional, solid or blood malignancy(ies) and completion of primary cancer treatment (i.e., radiation, surgery, and/or chemotherapy). Use of hormonal, maintenance, oral, and immunotherapies is permitted; or

⁃ (B) history of nonmetastatic, localized or regional, solid or blood malignancy(ies) and current primary cancer treatment (i.e., radiation, surgery, and/or chemotherapy); Use of hormonal, maintenance, oral, and immunotherapies is permitted; or

⁃ (C) history of metastatic sold or blood malignancy (ies) taking hormonal, maintenance, oral, or immunotherapies to prevent further disease progression.

• Chronic insomnia (DSM-5 criteria)

• Age 18 years or older

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Daniel L Hall, PhD
hall@mgh.harvard.edu
617-724-6300
Backup
Caleb Bolden, BA
cbolden2@mgh.harvard.edu
6039697927
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2028-12-28
Participants
Target number of participants: 198
Treatments
Active_comparator: Enhance Usual Care
A sleep hygiene handout and a referral for CBT-I offered through MGH or community partners.
Experimental: Survivorship Sleep Program
4, weekly virtual sessions of the Survivorship Sleep Program plus 1 booster session
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital
Collaborators: American Cancer Society, Inc.

This content was sourced from clinicaltrials.gov