Actively Recruiting

Phase Not Applicable
All Genders
NCT06807086

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

All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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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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