Actively Recruiting
Efficacy of Synchronous, Virtual Cognitive Behavioral Therapy for Insomnia Across Phases of Cancer Survivorship
Led by Massachusetts General Hospital · Updated on 2026-03-13
198
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
A
American Cancer Society, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Synchronous, Virtual Cognitive Behavioral Therapy for Insomnia Across Phases of Cancer Survivorship
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Cancer survivor with history of nonmetastatic localized or regional solid or blood malignancy and completed primary cancer treatment (radiation, surgery, chemotherapy); use of hormonal, maintenance, oral, and immunotherapies allowed
- Cancer survivor with history of nonmetastatic localized or regional solid or blood malignancy currently receiving primary cancer treatment (radiation, surgery, chemotherapy); use of hormonal, maintenance, oral, and immunotherapies allowed
- Cancer survivor with history of metastatic solid or blood malignancy receiving hormonal, maintenance, oral, or immunotherapies to prevent progression
- Diagnosed with chronic insomnia based on DSM-5 criteria
You will not qualify if you...
- Unable to speak and write in English
- Having an undertreated non-insomnia sleep disorder such as sleep apnea
- Having undertreated epilepsy, serious mental illness, suicidality, or psychiatric hospitalization within the past year
- Unwilling or unable to stop working night shifts
AI-Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
D
Daniel L Hall, PhD
CONTACT
C
Caleb Bolden, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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