Clinical trial NCT06181643: Innovating CBT-I for Cancer Survivors: An Optimization Trial
Official title: Innovating CBT-I for Cancer Survivors: An Optimization Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Survivorship
Insomnia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Insomnia Severity Index (ISI) total score
timeFrame: T0 (Baseline) to T2 (week 8)
Secondary outcomes:
measure: Emotional distress: PROMIS Anxiety Symptoms
timeFrame: T0 (week 0) to T3 (week 16)
measure: Emotional distress: PROMIS Depression Symptoms
timeFrame: T0 (week 0) to T3 (week 16)
measure: Daytime fatigue: PROMIS Fatigue
timeFrame: T0 (week 0) to T3 (week 16)
measure: Work-related functioning
timeFrame: T0 (week 0) to T3 (week 16)
measure: Use of sleep aid medications
timeFrame: T0 (week 0) to T3 (week 16)
measure: Sleep diaries and actigraphy
timeFrame: T0 (week 0) to T3 (week 16)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Daniel Hall, PhD
role: PRINCIPAL_INVESTIGATOR
References: