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

NCT ID: NCT06807086

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2028-12-28

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.

Detailed Description

Background: 30-50% of cancer survivors have untreated insomnia. Cognitive behavioral therapy for insomnia (CBT-I) is a first line, evidence-based treatment that is currently limited by few delivery options, lack of targeted content addressing cancer-related barriers to sleep, and limited testing by survivorship phase. With ACS pilot funding, the investigators previously developed a synchronous, virtual CBT-I program for cancer survivors (Survivorship Sleep Program; SSP) and conducted a pilot RCT demonstrating its feasibility, acceptability, and preliminary efficacy vs. enhanced usual care (EUC; CBT-I referral + sleep hygiene handout). The SSP, delivered in 6 weeks via 4 sessions + 1 booster session, is now ready for efficacy testing with a large, diverse sample including survivors who have completed primary treatment with curative intent (i.e., curvivors), survivors currently in treatment, and survivors living with metastatic cancer (i.e., metavivors).

Objective/Hypothesis: Our primary hypothesis is that the SSP (vs. EUC) will lead to significant reductions in cancer survivors' insomnia severity and secondary sleep-related outcomes.

Specific Aims: Aim 1 is to evaluate the efficacy of the SSP (vs. EUC) on the primary outcome change in insomnia severity (Insomnia Severity Index) from T0 (baseline) to T2 (4-week follow-up/10 weeks). Aim 2 is to examine changes from T0 though T3 (12-week follow-up/18 weeks) in outcomes commonly associated with cancer-related insomnia, including sleep diary and actigraphy sleep metrics (e.g., sleep efficiency), emotional distress (i.e., PROMIS depression and anxiety), daytime fatigue, use of sleep medications. Aim 3 is to characterize potential differences by cancer survivorship phase.

Study Design: The investigators propose to conduct a fully powered efficacy RCT (N=198, 1:1) evaluating the SSP (n=99) vs. EUC (n=99) among cancer survivors with insomnia. All study delivery and data collection will be conducted virtually and in close partnership with SurvivorJourneys and Ellie Fund, our community partners on this proposal. Enrollment will be stratified by 3 phases of cancer survivorship (n=66/phase, balanced between study arms). Assessments will occur at T0, T1 (6 weeks), T2, and T3. Group-by-time effects will be explicated by survivorship phase. Exit interviews assessing acceptability (enjoyableness, convenience, helpfulness, overall satisfaction) will be coded deductively (e.g., most/least) and inductively (e.g., preferences, challenges, and future delivery considerations) to extract themes by survivorship phase.

Relevance: Collectively, the proposed project will yield multiple deliverables to innovate cancer survivorship care, chiefly an efficacious, scalable, virtually-delivered intervention that addresses chronic insomnia, one of the most deleterious concerns among the growing demographic of cancer survivors in the U.S. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Enhance Usual Care

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

Group Type: ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type: BEHAVIORAL

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

Survivorship Sleep Program

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

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy - Insomnia

Intervention Type: 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.

Interventions

Cognitive Behavioral Therapy - Insomnia

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.

Intervention Type: BEHAVIORAL

Enhanced Usual Care

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Cancer survivor, defined as:

1. (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

2. (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

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

2. Chronic insomnia (DSM-5 criteria)

3. Age 18 years or older

Exclusion Criteria

1. Self-reported inability to speak and write in English

2. Undertreated non-insomnia sleep disorder (e.g., sleep apnea)

3. Undertreated epilepsy, undertreated serious mental illness, undertreated suicidality, and/or psychiatric hospitalization in the past year

4. Unwilling or unable to discontinue night shift work

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Daniel L Hall, PhD

Assistant Professor of Psychology, Associate Director of Utilization & Evaluation Research, Health Promotion & Resiliency Intervention Research Center, Psychologist, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Daniel L Hall, PhD

Role: CONTACT

hall@mgh.harvard.edu

617-724-6300 ext. 111-133-1766

Caleb Bolden, BA

Role: CONTACT

cbolden2@mgh.harvard.edu

6039697927

Facility Contacts

Daniel Hall, PhD

Role: primary

hall@mgh.harvard.edu

617-724-6300 ext. 111-133-1766

Other Identifiers

RSG-24-1247084-01-CTPS

Identifier Type: -

Identifier Source: org_study_id