Innovating CBT-I for Cancer Survivors: An Optimization Trial

May 7, 2026 updated by: Daniel L Hall, PhD, Massachusetts General Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: 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.
Behavioral: 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.
Experimental: Group 2: 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.
Behavioral: 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.
Experimental: Group 3: 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.
Behavioral: Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions
4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session). 3 monthly booster sessions.
Experimental: Group 4: 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.
Behavioral: Survivorship Sleep Program with Group Delivery + 3 Booster Sessions
4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session). 3 monthly booster sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia Severity Index (ISI) total score
Time Frame: 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.
T0 (Baseline) to T2 (week 8)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotional distress: PROMIS Anxiety Symptoms
Time Frame: 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.
T0 (week 0) to T3 (week 16)
Emotional distress: PROMIS Depression Symptoms
Time Frame: 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.
T0 (week 0) to T3 (week 16)
Daytime fatigue: PROMIS Fatigue
Time Frame: 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.
T0 (week 0) to T3 (week 16)
Work-related functioning
Time Frame: 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.
T0 (week 0) to T3 (week 16)
Use of sleep aid medications
Time Frame: 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.
T0 (week 0) to T3 (week 16)
Sleep diaries and actigraphy
Time Frame: 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.
T0 (week 0) to T3 (week 16)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Daniel Hall, PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

December 13, 2023

First Submitted That Met QC Criteria

December 13, 2023

First Posted (Actual)

December 26, 2023

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-681
  • 5R21CA279248-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Insomnia

Clinical Trials on Survivorship Sleep Program with Individual Delivery + No Booster Sessions

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe