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

NCT06807086 | Recruiting DMC

• 1 other identifier: RSG-24-1247084-01-CTPS
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia Chronic

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index

  A 7-item self-report questionnaire measuring changes in insomnia severity. Response options range from 0 (None) to 4 (Very severe). Items include "How NOTICEABLE to others do you think your sleep problem is in terms of impairing the quality of your life?"

  Screening, baseline, week 6, week 10, and week 18

Secondary Outcomes (10)

• PROMIS anxiety short form

  Baseline, Week 6, week 10, and week 18

• PROMIS depression short form

  Baseline, week 6, week 10, and week 18

• PROMIS fatigue short form

  baseline, week 6, week 10, and week 18

• Use of sleep aid meditations

  baseline, week 6, week 10, and week 18

• Perceived Cognitive Impairment subscale of The Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog)

  baseline, week 6, week 10, and week 18

Study Arms (2)

Enhance Usual Care

ACTIVE COMPARATOR

A sleep hygiene handout and a referral for CBT-I offered through MGH or community partners.

Behavioral: Enhanced Usual Care

Survivorship Sleep Program

EXPERIMENTAL

4, weekly virtual sessions of the Survivorship Sleep Program plus 1 booster session

Behavioral: Cognitive Behavioral Therapy - Insomnia

Interventions

Enhanced Usual Care BEHAVIORAL

A sleep hygiene handout and a referral for CBT-I offered through MGH or community partners.

Enhance Usual Care

Cognitive Behavioral Therapy - Insomnia BEHAVIORAL

The Survivorship Sleep Program is a virtual program based on cognitive behavioral therapy for insomnia (CBT-I), which teaches evidence based skills to improve sleep-related behaviors, expectations, and environment, to promote relaxation, and to reduce worry. It also involves reducing the time spent in bed in order to improve the quantity and quality of sleep over time. The Survivorship Sleep Program is delivered in 4 weekly sessions by a trained facilitator and includes considerations specific to managing insomnia after cancer diagnosis and treatment. Additionally, 1 booster session is offered at week 6.

Survivorship Sleep Program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Self-reported inability to speak and write in English
• Undertreated non-insomnia sleep disorder (e.g., sleep apnea)
• Undertreated epilepsy, undertreated serious mental illness, undertreated suicidality, and/or psychiatric hospitalization in the past year
• Unwilling or unable to discontinue night shift work

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Daniel L Hall, PhD

CONTACT

617-724-6300; hall@mgh.harvard.edu

Caleb Bolden, BA

CONTACT

6039697927; cbolden2@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology, Associate Director of Utilization & Evaluation Research, Health Promotion & Resiliency Intervention Research Center, Psychologist, Principal Investigator

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 4, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): December 28, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (1)