Innovating CBT-I for Cancer Survivors: An Optimization Trial

Not Applicable

Recruiting

• Conditions: Cancer Survivorship; Insomnia
• Interventions: Behavioral: Survivorship Sleep Program with Group Delivery + No Booster Sessions; Behavioral: Survivorship Sleep Program with Individual Delivery + No Booster Sessions; Behavioral: Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions; Behavioral: Survivorship Sleep Program with Group Delivery + 3 Booster Sessions

• Registration Number: NCT06181643
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The overall goal of this project is to conduct a factorial, randomized controlled trial to optimize synchronous, virtual delivery of CBT-I for cancer survivors. The proposed project will yield multiple deliverables to innovate cancer survivorship care, chiefly an optimized, 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 future considerations for delivering CBT-I to cancer survivors.

Detailed Description

Insomnia is a significant issue in 30-50% of cancer survivors. Our pilot randomized controlled trial of synchronous, virtual cognitive behavioral therapy for insomnia (CBT-I) for cancer survivors suggested that a group format or booster sessions may optimize effects on insomnia and daytime functioning. The goal of this project is to conduct a factorial, randomized controlled trial to optimize synchronous, virtual delivery of CBT-I for cancer survivors. We will conduct a 2×2 factorial trial (N=80) to evaluate the optimal combination of two intervention design components: delivery (individual vs. group) and booster sessions (0 vs 3). The primary outcome is change in insomnia severity (insomnia severity index) from T0 (week 0) to T2 (week 8). The secondary outcomes are acute (T0-T1, week 4) and sustained (T0-T3, week 16) changes in insomnia severity, emotional distress, work-related functioning, use of sleep medications, and subjective and objective sleep metrics (measured with sleep diaries and Fitbit). Exploratory aim 1 is to characterize study participation and sleep outcomes among cancer survivors with insomnia. Exploratory aim 2 is to characterize the acceptability of design components using Likert ratings (very low=1 to very high=5, benchmarks=4 or higher) and exit interviews with open-ended responses with probes. This project will yield multiple deliverables to innovate cancer survivorship care, chiefly an optimized, scalable, virtually delivered intervention that addresses chronic insomnia, one of the most deleterious concerns among the among the steadily increasing number of cancer survivors.

Study Timeline

• Study First Submitted: 2023-12-13
• Study First Submitted QC: 2023-12-13
• Study First Posted: 2023-12-26
• Study Start: 2024-09-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-29
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• History of nonmetastatic, localized, or regional solid or blood malignancy(ies)
• Completion of primary cancer treatment (radiation, surgery, and/or chemotherapy). Use of hormonal, maintenance, oral, and immunotherapies is permitted.
• Chronic insomnia (DSM-5 criteria)
• 18 years of age or older

Exclusion Criteria

• Self-reported inability to speak and write in English
• Undertreated noninsomnia 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group 2: Survivorship Sleep Program with Group Delivery + No Booster Sessions	Survivorship Sleep Program with Group Delivery + No Booster Sessions	4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session). No booster sessions.
Group 1: Survivorship Sleep Program with Individual Delivery + No Booster Sessions	Survivorship Sleep Program with Individual Delivery + No Booster Sessions	4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session). No booster sessions.
Group 3: Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions	Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions	4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session), followed by 3 monthly booster sessions.
Group 4: Survivorship Sleep Program with Group Delivery + 3 Booster Sessions	Survivorship Sleep Program with Group Delivery + 3 Booster Sessions	4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session), followed by 3 monthly booster sessions.

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI) total score	T0 (Baseline) to T2 (week 8)	Changes in insomnia severity will be assessed using the validated Insomnia Severity Index (ISI). Scores of 15 or higher on the ISI indicate clinically significant insomnia, and reductions of \>8 points are considered clinically meaningful. Changes from T0-T2 are the primary outcome. Acute (T0-T1; post-SSP) and 3-month (T0-T3; 3 Month Surveillance/Booster 3) changes will be examined as secondary outcomes.

Secondary Outcome Measures

Name	Time	Method
Daytime fatigue: PROMIS Fatigue	T0 (week 0) to T3 (week 16)	PROMIS fatigue short form. Acute (T0-T1; week 4) and T0-T3 (week 16) changes will be examined as secondary outcomes.
Emotional distress: PROMIS Depression Symptoms	T0 (week 0) to T3 (week 16)	PROMIS depression short form. Acute (T0-T1; week 4) and T0-T3 (week 16) changes will be examined as secondary outcomes.
Emotional distress: PROMIS Anxiety Symptoms	T0 (week 0) to T3 (week 16)	PROMIS anxiety short form. Acute (T0-T1; week 4) and 3-month (T0-T3; week 16) changes will be examined as secondary outcomes.
Work-related functioning	T0 (week 0) to T3 (week 16)	Work-related functioning will be measured using the six-item Work Productivity and Activity Impairment: General Health (WPAI:GH), which includes scores for absenteeism, presenteeism, and total work impairment. Acute (T0-T1; week 4) and T0-T3 (week 16) changes will be examined as secondary outcomes.
Sleep diaries and actigraphy	T0 (week 0) to T3 (week 16)	Sleep diaries and actigraphy will be collected during SSP Sessions 1-4 and for 7 days at each timepoint (T0-T3) to derive sleep efficiency, sleep onset latency, and wake after sleep onset. Discrepancy scores between subjective and objective sleep metrics (e.g., sleep onset latency) will be examined. Acute (T0-T1; week 4) and T0-T3 (week 16) changes will be examined as secondary outcomes.
Use of sleep aid medications	T0 (week 0) to T3 (week 16)	Use of sleep aid medications (frequency, dose) will be evaluated via self-report surveys and electronic medical records (when possible). Acute (T0-T1; week 4) and T0-T3 (week 16) changes will be examined as secondary outcomes.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States