Survivorship Sleep Program

Cancer Clinical Trial

Official title:

Adapted Telehealth Intervention for Insomnia Among Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04566068
• Other study ID #: 20-170
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: June 16, 2021

Study information

• Verified date: April 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 16, 2021
• Est. primary completion date: June 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Intervention- Adapted Virtual Insomnia Program
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.
• Control- Enhanced usual care
Enhanced usual care. Referral to the Massachusetts General Hospital Behavioral Sleep Medicine service plus an educational handout on the topic of sleep hygiene.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 pi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Outcome: Change in nightly subjective sleep and covariance with objective sleep	Subjective Sleep: Measured via sleep diary (T0-T2). Total sleep time, sleep latency, sleep efficiency, and wake after sleep onset will be assessed using a sleep diary (i.e., timings of sleep/wake, timings of being in bed) for 1-2 weeks to achieve 7 consecutive days of sleep reporting at each timepoint.	T0 (Baseline)- T2(1 Month Post-Intervention Follow Up): 2 Months
Other	Exploratory Outcome: Change in nightly objective sleep and covariance with subjective sleep	Objective Sleep: Measured via actigraphy data collection (T0-T1). During the same time period as participants complete the sleep diary, objective sleep will be assessed among a subgroup of approximately 10 participants in the intervention arm (counterbalanced) using actigraphy devices to calculate: total sleep time, sleep latency, sleep efficiency, wake after sleep onset, and a Mean Activity Score (actigraph counts/min).	T0 (Baseline)- T1(Post-Intervention): 1 Month
Primary	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
Primary	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	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