Innovating CBT-I for Cancer Survivors: An Optimization Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-06

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cancer Survivorship Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Survivorship Sleep Program with Individual Delivery + No Booster Sessions

Intervention Type BEHAVIORAL

4 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

4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session). No booster sessions.

Group Type EXPERIMENTAL

Survivorship Sleep Program with Group Delivery + No Booster Sessions

Intervention Type BEHAVIORAL

4 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

4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session), followed by 3 monthly booster sessions.

Group Type EXPERIMENTAL

Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions

Intervention Type BEHAVIORAL

4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session). 3 monthly booster sessions.

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.

Group Type EXPERIMENTAL

Survivorship Sleep Program with Group Delivery + 3 Booster Sessions

Intervention Type BEHAVIORAL

4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session). 3 monthly booster sessions.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No