Innovating CBT-I for Cancer Survivors: An Optimization Trial

Insomnia Clinical Trial

Official title:

Innovating CBT-I for Cancer Survivors: An Optimization Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06181643
• Other study ID #: 23-681
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: February 28, 2026

Study information

• Verified date: December 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: February 28, 2026
• Est. primary completion date: February 26, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria include: (1) History of nonmetastatic, localized, or regional solid or blood malignancy(ies); (2) Completion of primary cancer treatment (radiation, surgery, and/or chemotherapy); (3) 18 years of age or older; and (4) Chronic insomnia (DSM-5 criteria and elevated Insomnia Severity Index score >= 15). Exclusion criteria include: (1) Self-reported inability to speak and write in English; (2) Undertreated noninsomnia sleep disorder (e.g., sleep apnea); (3) Undertreated epilepsy, serious mental illness, or suicidality, and/or psychiatric hospitalization in the past year; and/or (4) Unwilling or unable to discontinue night shift work.

Related Conditions & MeSH terms

• Cancer Survivorship
• Insomnia

Intervention

Behavioral:
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Emotional distress: PROMIS Anxiety Symptoms	PROMIS anxiety short form. Acute (T0-T1; week 4) and 3-month (T0-T3; week 16) changes will be examined as secondary outcomes.	T0 (week 0) to T3 (week 16)
Secondary	Emotional distress: PROMIS Depression Symptoms	PROMIS depression short form. Acute (T0-T1; week 4) and T0-T3 (week 16) changes will be examined as secondary outcomes.	T0 (week 0) to T3 (week 16)
Secondary	Daytime fatigue: PROMIS Fatigue	PROMIS fatigue short form. Acute (T0-T1; week 4) and T0-T3 (week 16) changes will be examined as secondary outcomes.	T0 (week 0) to T3 (week 16)
Secondary	Work-related functioning	Work-related functioning will be measured using the six-item Work Productivity and Activity Impairment: General Health (WPAI:GH), which includes scores for absenteeism, presenteeism, and total work impairment. Acute (T0-T1; week 4) and T0-T3 (week 16) changes will be examined as secondary outcomes.	T0 (week 0) to T3 (week 16)
Secondary	Use of sleep aid medications	Use of sleep aid medications (frequency, dose) will be evaluated via self-report surveys and electronic medical records (when possible). Acute (T0-T1; week 4) and T0-T3 (week 16) changes will be examined as secondary outcomes.	T0 (week 0) to T3 (week 16)
Secondary	Sleep diaries and actigraphy	Sleep diaries and actigraphy will be collected during SSP Sessions 1-4 and for 7 days at each timepoint (T0-T3) to derive sleep efficiency, sleep onset latency, and wake after sleep onset. Discrepancy scores between subjective and objective sleep metrics (e.g., sleep onset latency) will be examined. Acute (T0-T1; week 4) and T0-T3 (week 16) changes will be examined as secondary outcomes.	T0 (week 0) to T3 (week 16)