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
47 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
Researchers are evaluating the effectiveness of a virtual cognitive behavioral therapy program called the Survivorship Sleep Program (SSP) compared to Enhanced Usual Care (EUC) for reducing insomnia severity in cancer survivors. This trial focuses on survivors across different phases, including those who have completed primary treatment, are currently in treatment, or living with metastatic cancer. The study aims to address chronic insomnia, a common and serious issue among cancer survivors, by testing the SSP's impact on sleep and related outcomes. The trial involves two groups: one receiving the SSP, which includes four weekly virtual sessions plus one booster session at week 6, and the other receiving Enhanced Usual Care consisting of a sleep hygiene handout and a referral for cognitive behavioral therapy for insomnia. All intervention delivery and data collection are conducted virtually. Participants are randomized equally between these groups and stratified by survivorship phase to ensure balanced representation. Participants will be followed over 18 weeks with assessments at baseline, 6 weeks, 10 weeks, and 18 weeks. Researchers will collect data using insomnia severity questionnaires, sleep diaries, actigraphy devices, and surveys measuring emotional distress, fatigue, sleep medication use, and other health indicators. Exit interviews will be conducted to assess participant satisfaction and gather feedback to inform future program improvements. The total study duration per participant spans approximately 18 weeks.
CONDITIONS
Brief 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...
- Cancer survivor with either completed primary treatment, current treatment, or metastatic disease managed with hormonal, maintenance, oral, or immunotherapies
- Chronic insomnia diagnosed by DSM-5 criteria
- Age 18 years or older
You will not qualify if you...
- Unable to speak or write in English
- Untreated non-insomnia sleep disorders such as sleep apnea
- Untreated epilepsy, serious mental illness, suicidality, or psychiatric hospitalization in the past year
- Unwilling or unable to discontinue night shift work
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (virtual)
Duration - 6 weeks
Participants receive either 4 weekly virtual sessions of the Survivorship Sleep Program plus 1 booster session or enhanced usual care consisting of a sleep hygiene handout and referral for CBT-I through community partners.
5 virtual sessions
Duration - 12 weeks
Participants are followed for additional assessments to measure changes in insomnia severity, sleep-related outcomes, emotional distress, fatigue, and other health-related metrics.
Assessments at 4, 10, and 18 weeks from baseline (virtual)
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
D
Daniel L Hall, PhD
C
Caleb Bolden, BA
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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