Survivorship Sleep Program

NCT04566068 | Completed DMC

• 1 other identifier: 20-170
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Insomnia

Keywords

Insomnia; Cancer Survivors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in Insomnia Severity

  T0 (Baseline)- T1(Post-Intervention): 1 Month

Other Outcomes (2)

• Exploratory Outcome: Change in nightly subjective sleep and covariance with objective sleep

  T0 (Baseline)- T2(1 Month Post-Intervention Follow Up): 2 Months

• Exploratory Outcome: Change in nightly objective sleep and covariance with subjective sleep

  T0 (Baseline)- T1(Post-Intervention): 1 Month

Study Arms (2)

Intervention- Adapted Virtual Insomnia Program

EXPERIMENTAL

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

Control- Enhanced usual care

PLACEBO COMPARATOR

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

Interventions

Intervention- Adapted Virtual Insomnia Program BEHAVIORAL

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.

Intervention- Adapted Virtual Insomnia Program

Control- Enhanced usual care BEHAVIORAL

Enhanced usual care. Referral to the Massachusetts General Hospital Behavioral Sleep Medicine service plus an educational handout on the topic of sleep hygiene.

Control- Enhanced usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• 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.

  PMID: 34914845 RESULT

• Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.

  PMID: 41170811 DERIVED

MeSH Terms

Conditions

Neoplasms; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Daniel L Hall, Ph.D

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 28, 2020
• Study Start: October 1, 2020
• Primary Completion: June 16, 2021
• Study Completion: June 16, 2021
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)