Survivorship Sleep Program

Study Overview
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Brief Summary
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This is a randomized pilot trial to test the feasibility and acceptability (primary outcomes) of a virtual cognitive behavioral program for insomnia for survivors of various cancer types. Secondary outcomes are to examine the preliminary effects on reducing insomnia severity from baseline to post-intervention.

Detailed Description
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Cognitive Behavioral Therapy for insomnia (CBT-I), is an evidenced-based insomnia program that is recommended by the American College of Physicians and can be delivered using session-by-session treatment manuals. Among cancer survivors, CBT-I has only yielded small-to-moderate sized improvements in several aspects of sleep, including sleep efficiency, sleep onset latency, and wake after sleep onset as compared with inactive control conditions. Moreover, systematic reviews of CBT-I with cancer survivors have found high rates of attrition and low attendance. Thus, while CBT-I for cancer survivors is promising, further adaptation is needed to demonstrate greater feasibility and larger effects. Additionally, CBT-I is traditionally delivered in-person, which is not feasible for many cancer survivors. Barriers include time limitations, travel, and illness burden constraints, as well as a paucity of trained CBT-I providers. Telehealth delivery of CBT-I is an innovative approach to address these barriers to care and enhance uptake. The intervention being tested in this study was informed by a 4-10 session CBT-I protocol and adapted based on interviews the investigators conducted with cancer survivors with insomnia to learn about their sleep-related challenges, suggestions, and preferences for intervention delivery, as well as a systematic review and meta-analysis the investigators published in Sleep Medicine Reviews in 2020. The research study procedures include screening for eligibility and randomization into 1 of 2 study arms: the Adapted Virtual Intervention Group or a Control Group (Enhanced Usual Care; referral for behavioral sleep medicine and sleep hygiene handout). Participants will be in this research study for approximately 2 months. It is expected that about 40 people will take part in this research study.

Official Title
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Adapted Telehealth Intervention for Insomnia Among Cancer Survivors

Conditions
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Cancer, Insomnia

Intervention / Treatment
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* Behavioral: Intervention- Adapted Virtual Insomnia Program
* Behavioral: Control- Enhanced usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of nonmetastatic, localized, or regional solid or blood malignancy(ies) Completion of primary cancer treatment (i.e., radiation, surgery, and/or chemotherapy) Chronic insomnia Age ≥18 years Exclusion Criteria: Self-reported inability to speak and write in English Undertreated noninsomnia sleep disorder (e.g., sleep apnea) Undertreated epilepsy, serious mental illness, or suicidality, and/or psychiatric hospitalization in the past year Unwilling or unable to discontinue night shift work

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention- Adapted Virtual Insomnia Program<br>4 sessions (approximately 45 min/each, weekly) plus 3 check-ins (approximately 15 min/each, between-sessions) delivered virtually. Sessions are modeled after a published, evidence-based CBT-I protocol and adapted to target needs and preferences identified by cancer survivors. Interventionists will participate in weekly supervision. Approximately half of participants will be asked to wear sleep trackers for one-week prior to starting the intervention (T0) and one-week after completing the intervention (T1). | Behavioral: Intervention- Adapted Virtual Insomnia Program<br>* 4 sessions (approximately 45 min/each, weekly) plus 3 check-ins (approximately 15 min/each, between-sessions) delivered virtually. Sessions are modeled after a published, evidence-based CBT-I protocol and adapted to target needs and preferences identified by cancer survivors.<br>|
| Placebo Comparator: Control- Enhanced usual care<br>Enhanced usual care. Referral to the Massachusetts General Hospital Behavioral Sleep Medicine service plus an educational handout on the topic of sleep hygiene. | Behavioral: Control- Enhanced usual care<br>* Enhanced usual care. Referral to the Massachusetts General Hospital Behavioral Sleep Medicine service plus an educational handout on the topic of sleep hygiene.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: Enrollment rate of those screened and eligible | Percent of those screened and eligible who enroll (i.e., sign consent and complete baseline). Reasons for ineligibility, refusal, or drop out, will also be measured along with session attendance. | T0 (Baseline)- T2(1 Month Post-Intervention Follow Up): 2 Months | 
| Acceptability: 5 item measure of enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction | Participants will be asked to rate the enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction (1=very low to 5=very high) of the program in exit interviews, which will use open-ended questions and response probes to explicate each rating. | T0 (Baseline)- T1 (Post-Intervention): 1 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insomnia Severity | Change in insomnia severity (T0-T1) will be assessed using the validated Insomnia Severity Index (ISI). Scores of 15 or higher on the ISI indicate clinically significant insomnia. | T0 (Baseline)- T1(Post-Intervention): 1 Month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Cancer Survivors