Efficacy of Synchronous, Virtual Cognitive Behavioral Therapy for Insomnia Across Phases of Cancer Survivorship
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Behavioral Therapy - Insomnia, Enhanced Usual Care.
- Who it may be relevant to
- Registry conditions: Insomnia Chronic. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
This project is a single center, prospective randomized controlled trial (N=198) primarily evaluating the efficacy of the Survivorship Sleep Program vs. Enhanced Usual Care on insomnia severity among cancer survivors. The investigators will also examine secondary outcomes associated with cancer-related insomnia including subjective and objective sleep measures (i.e., sleep diaries, actigraphy), emotional distress, fatigue, and use of sleep medications. Notably, most CBT-I trials with cancer survivors who have completed primary treatment with curative intent (i.e., curvivors) but not those in treatment or living with metastatic cancer (i.e., metavivors). To enhance generalizability, this RCT will stratify enrollment by survivorship phase (1:1:1). This project in strengthened by partnerships with community organizations (SurvivorJourneys and Ellie Fund) and use of both quantitative (i.e., surveys, actigraphy) and qualitative methods (i.e., interviews) to inform considerations for future implementation. Collectively, the proposed project will yield multiple deliverables to innovate cancer survivorship care, namely an efficacious, virtually delivered intervention addressing chronic insomnia, one of the most deleterious concerns among the growing population of cancer survivors in the US. Findings will inform a future effectiveness trial and the expansion of the synchronous delivery of CBT-I to survivors across different phases of cancer survivorship.
Detailed description
Background: 30-50% of cancer survivors have untreated insomnia. Cognitive behavioral therapy for insomnia (CBT-I) is a first line, evidence-based treatment that is currently limited by few delivery options, lack of targeted content addressing cancer-related barriers to sleep, and limited testing by survivorship phase. With ACS pilot funding, the investigators previously developed a synchronous, virtual CBT-I program for cancer survivors (Survivorship Sleep Program; SSP) and conducted a pilot RCT demonstrating its feasibility, acceptability, and preliminary efficacy vs. enhanced usual care (EUC; CBT-I referral + sleep hygiene handout). The SSP, delivered in 6 weeks via 4 sessions + 1 booster session, is now ready for efficacy testing with a large, diverse sample including survivors who have completed primary treatment with curative intent (i.e., curvivors), survivors currently in treatment, and survivors living with metastatic cancer (i.e., metavivors).
Objective/Hypothesis: Our primary hypothesis is that the SSP (vs. EUC) will lead to significant reductions in cancer survivors' insomnia severity and secondary sleep-related outcomes.
Specific Aims: Aim 1 is to evaluate the efficacy of the SSP (vs. EUC) on the primary outcome change in insomnia severity (Insomnia Severity Index) from T0 (baseline) to T2 (4-week follow-up/10 weeks). Aim 2 is to examine changes from T0 though T3 (12-week follow-up/18 weeks) in outcomes commonly associated with cancer-related insomnia, including sleep diary and actigraphy sleep metrics (e.g., sleep efficiency), emotional distress (i.e., PROMIS depression and anxiety), daytime fatigue, use of sleep medications. Aim 3 is to characterize potential differences by cancer survivorship phase.
Study Design: The investigators propose to conduct a fully powered efficacy RCT (N=198, 1:1) evaluating the SSP (n=99) vs. EUC (n=99) among cancer survivors with insomnia. All study delivery and data collection will be conducted virtually and in close partnership with SurvivorJourneys and Ellie Fund, our community partners on this proposal. Enrollment will be stratified by 3 phases of cancer survivorship (n=66/phase, balanced between study arms). Assessments will occur at T0, T1 (6 weeks), T2, and T3. Group-by-time effects will be explicated by survivorship phase. Exit interviews assessing acceptability (enjoyableness, convenience, helpfulness, overall satisfaction) will be coded deductively (e.g., most/least) and inductively (e.g., preferences, challenges, and future delivery considerations) to extract themes by survivorship phase.
Relevance: Collectively, the proposed project will yield multiple deliverables to innovate cancer survivorship care, chiefly an efficacious, 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 a future effectiveness trial and the expansion of the synchronous delivery of CBT-I to survivors across different phases of cancer survivorship.
Interventions
- Behavioral Cognitive Behavioral Therapy - Insomnia
The Survivorship Sleep Program is a virtual program based on cognitive behavioral therapy for insomnia (CBT-I), which teaches evidence based skills to improve sleep-related behaviors, expectations, and environment, to promote relaxation, and to reduce worry. It also involves reducing the time spent in bed in order to improve the quantity and quality of sleep over time. The Survivorship Sleep Program is delivered in 4 weekly sessions by a trained facilitator and includes considerations specific t - Behavioral Enhanced Usual Care
A sleep hygiene handout and a referral for CBT-I offered through MGH or community partners.
Primary outcome measures
- Insomnia Severity Index [Time frame: Screening, baseline, week 6, week 10, and week 18]
Secondary outcome measures (10)
- PROMIS anxiety short form [Time frame: Baseline, Week 6, week 10, and week 18]
- PROMIS depression short form [Time frame: Baseline, week 6, week 10, and week 18]
- PROMIS fatigue short form [Time frame: baseline, week 6, week 10, and week 18]
- Use of sleep aid meditations [Time frame: baseline, week 6, week 10, and week 18]
- Perceived Cognitive Impairment subscale of The Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) [Time frame: baseline, week 6, week 10, and week 18]
- Sleep diaries and actigraphy/Fitbit [Time frame: baseline, week 6, week 10, and week 18]
- Smoking [Time frame: baseline, week 6, week 10, and week 18]
- International Physical Activity Questionnaire [Time frame: baseline, week 6, week 10, and week 18]
- Perceived weight changes [Time frame: baseline, week 6, week 10, and week 18]
- Fear of Cancer Recurrence Inventory-Severity subscale [Time frame: baseline, week 6, week 10, and week 18]
Eligibility criteria
Inclusion criteria
- Cancer survivor, defined as:
- (A) history of nonmetastatic, localized or regional, solid or blood malignancy(ies) and completion of primary cancer treatment (i.e., radiation, surgery, and/or chemotherapy). Use of hormonal, maintenance, oral, and immunotherapies is permitted; or
- (B) history of nonmetastatic, localized or regional, solid or blood malignancy(ies) and current primary cancer treatment (i.e., radiation, surgery, and/or chemotherapy); Use of hormonal, maintenance, oral, and immunotherapies is permitted; or
- (C) history of metastatic sold or blood malignancy (ies) taking hormonal, maintenance, oral, or immunotherapies to prevent further disease progression.
- Chronic insomnia (DSM-5 criteria)
- Age 18 years or older
Exclusion criteria
- Self-reported inability to speak and write in English
- Undertreated non-insomnia 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT06807086 · RSG-24-1247084-01-CTPS · RSG-24-1247084-01-CTPS