Innovating CBT-I for Cancer Survivors: An Optimization Trial

December 13, 2023 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, and racially and ethnically diverse, demographic of cancer survivors in the U.S. Findings will inform future considerations for delivering CBT-I to cancer survivors.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Guided by the multiphase optimization strategy (MOST) and findings from our pilot RCT (Hall et al., 2022), the 4-session Survivorship Sleep Program will be the used as the basis for optimization. Primary Aim: Optimize the SSP in a 2x2 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). Primary hypothesis: At T2, the combination group delivery + 3 booster sessions will yield larger effects on insomnia vs. individual delivery + no booster sessions. Secondary outcomes are acute (T0-T1; week 4) and 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 actigraphy). Exploratory Aim 1: Characterize study participation and sleep outcomes among racial and ethnic minority cancer survivors with insomnia will be examined by race and by ethnicity (Primary feasibility benchmark: 56% enrolled/eligible). Primary and secondary outcomes across T0-T3 (week 16) will be explored by race and by ethnicity. Exploratory Aim 2: Characterize the acceptability of the SSP design components. Exit interviews (T1) will assess acceptability (enjoyableness, convenience, helpfulness, overall satisfaction) using both Likert ratings (very low=1 to very high=5; benchmarks=4 or higher) and open-ended responses with probes (e.g., most/least for each acceptability item). Exit interviews will also be coded for emergent themes about race and ethnicity to characterize preferences, challenges, and future intervention delivery considerations.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

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 include: (1) History of nonmetastatic, localized, or regional solid or blood malignancy(ies); (2) Completion of primary cancer treatment (radiation, surgery, and/or chemotherapy); (3) 18 years of age or older; and (4) Chronic insomnia (DSM-5 criteria and elevated Insomnia Severity Index score >= 15). Exclusion criteria include: (1) Self-reported inability to speak and write in English; (2) Undertreated noninsomnia sleep disorder (e.g., sleep apnea); (3) Undertreated epilepsy, serious mental illness, or suicidality, and/or psychiatric hospitalization in the past year; and/or (4) 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

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 (Estimated)

June 1, 2024

Primary Completion (Estimated)

February 26, 2025

Study Completion (Estimated)

February 28, 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)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 23-681

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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