Innovating CBT-I for Cancer Survivors: An Optimization Trial

Mass General Brigham

Status: Enrolling

Conditions: Cancer Survivorship; Insomnia

Treatments: Behavioral: Survivorship Sleep Program with Group Delivery + 3 Booster Sessions; Behavioral: Survivorship Sleep Program with Group Delivery + No Booster Sessions; Behavioral: Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions; Behavioral: Survivorship Sleep Program with Individual Delivery + No Booster Sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT06181643

23-681

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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80 participants in 4 patient groups

Group 1: Survivorship Sleep Program with Individual Delivery + No Booster Sessions

Experimental group

Description:

4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session). No booster sessions.

Treatment:

Behavioral: Survivorship Sleep Program with Individual Delivery + No Booster Sessions

Group 2: Survivorship Sleep Program with Group Delivery + No Booster Sessions

Experimental group

Description:

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

Treatment:

Behavioral: Survivorship Sleep Program with Group Delivery + No Booster Sessions

Group 3: Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions

Experimental group

Description:

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

Treatment:

Behavioral: Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions

Group 4: Survivorship Sleep Program with Group Delivery + 3 Booster Sessions

Experimental group

Description:

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

Treatment:

Behavioral: Survivorship Sleep Program with Group Delivery + 3 Booster Sessions