Clinical trial NCT04566068: Survivorship Sleep Program
Official title: Adapted Telehealth Intervention for Insomnia Among Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Insomnia
Keywords: Insomnia
Cancer Survivors
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2020-09-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility: Enrollment rate of those screened and eligible
timeFrame: T0 (Baseline)- T2(1 Month Post-Intervention Follow Up): 2 Months
measure: Acceptability: 5 item measure of enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction
timeFrame: T0 (Baseline)- T1 (Post-Intervention): 1 Month
Secondary outcomes:
measure: Change in Insomnia Severity
timeFrame: T0 (Baseline)- T1(Post-Intervention): 1 Month
Other outcomes:
measure: Exploratory Outcome: Change in nightly subjective sleep and covariance with objective sleep
timeFrame: T0 (Baseline)- T2(1 Month Post-Intervention Follow Up): 2 Months
measure: Exploratory Outcome: Change in nightly objective sleep and covariance with subjective sleep
timeFrame: T0 (Baseline)- T1(Post-Intervention): 1 Month
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Daniel L Hall, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hall DL, Arditte Hall KA, Gorman MJ, Comander A, Goldstein MR, Cunningham TJ, Wieman S, Mizrach HR, Juhel BC, Li R, Markowitz A, Grandner M, Park ER. The Survivorship Sleep Program (SSP): A synchronous, virtual cognitive behavioral therapy for insomnia pilot program among cancer survivors. Cancer. 2022 Apr 1;128(7):1532-1544. doi: 10.1002/cncr.34066. Epub 2021 Dec 16.