Innovating CBT-I for Cancer Survivors: An Optimization Trial

Status Not yet recruiting

Clinical Trial 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, 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06181643
Study type	Interventional
Source	Massachusetts General Hospital
Contact
Status	Not yet recruiting
Phase	N/A
Start date	June 1, 2024
Completion date	February 28, 2026

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04512768` - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy	N/A
Recruiting	`NCT05963542` - Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia	N/A
Completed	`NCT06339853` - Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia	N/A
Recruiting	`NCT04069247` - Effectiveness of eCBT-I on Improving Mental Health in Chinese Youths With Insomnia	N/A
Completed	`NCT04493593` - Internet-delivered CBT-I (Space for Sleep): Pilot and Feasibility	N/A
Recruiting	`NCT06278077` - Neurexan - a Clinical Trial in Short-Term Insomnia Patients	Phase 2
Recruiting	`NCT05956886` - Sleep Chatbot Intervention for Emerging Black/African American Adults	N/A
Completed	`NCT04661306` - The Better Sleep for Supporters With Insomnia Study	N/A
Recruiting	`NCT06207279` - Preliminary Study on the Development and Reliability and Validity of Attention Rating Scale
Recruiting	`NCT06006299` - Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC)	N/A
Completed	`NCT03683381` - App-based Intervention for Treating Insomnia Among Patients With Epilepsy	N/A
Completed	`NCT04564807` - Testing an Online Insomnia Intervention	N/A
Completed	`NCT03673397` - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression	N/A
Completed	`NCT04035200` - Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation	Phase 2
Active, not recruiting	`NCT05027438` - Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention	N/A
Recruiting	`NCT06053840` - An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients With Severe Insomnia	Phase 4
Not yet recruiting	`NCT06348082` - Project Women's Insomnia Sleep Health Equity Study (WISHES)	N/A
Not yet recruiting	`NCT06363799` - Osteopathic Protocol for Insomnia in College Students	N/A
Not yet recruiting	`NCT05991492` - Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application	N/A
Not yet recruiting	`NCT06025968` - Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.