Innovating CBT-I for Cancer Survivors: An Optimization Trial
2 other identifiers
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2023
CompletedFirst Posted
Study publicly available on registry
December 26, 2023
CompletedStudy Start
First participant enrolled
September 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
CompletedMay 8, 2026
May 1, 2026
1.7 years
December 13, 2023
May 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Insomnia Severity Index (ISI) total score
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 Outcomes (6)
Emotional distress: PROMIS Anxiety Symptoms
T0 (week 0) to T3 (week 16)
Emotional distress: PROMIS Depression Symptoms
T0 (week 0) to T3 (week 16)
Daytime fatigue: PROMIS Fatigue
T0 (week 0) to T3 (week 16)
Work-related functioning
T0 (week 0) to T3 (week 16)
Use of sleep aid medications
T0 (week 0) to T3 (week 16)
- +1 more secondary outcomes
Study Arms (4)
Group 1: Survivorship Sleep Program with Individual Delivery + No Booster Sessions
EXPERIMENTAL4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session). No booster sessions.
Group 2: Survivorship Sleep Program with Group Delivery + No Booster Sessions
EXPERIMENTAL4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session). No booster sessions.
Group 3: Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions
EXPERIMENTAL4 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
EXPERIMENTAL4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session), followed by 3 monthly booster sessions.
Interventions
4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session). No booster sessions.
4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session). No booster sessions.
4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session). 3 monthly booster sessions.
4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session). 3 monthly booster sessions.
Eligibility Criteria
You may qualify if:
- 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)
- years of age or older
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Hall, PhD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Harvard Medical School
Study Record Dates
First Submitted
December 13, 2023
First Posted
December 26, 2023
Study Start
September 6, 2024
Primary Completion
May 31, 2026
Study Completion
May 31, 2026
Last Updated
May 8, 2026
Record last verified: 2026-05