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Completed

NCT Number: NCT04566068

Survivorship Sleep Program

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.

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Key information

Conditions

Cancer Dyssomnias Insomnia Mental Disorders Neoplasms Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Feasibility: Enrollment rate of those screened and eligible

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

    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.

  2. Acceptability: 5 item measure of enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction

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

    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.

Secondary outcomes

  1. Change in Insomnia Severity

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

    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.

Other outcomes

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

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

    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.

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

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

    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).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Official study title

Adapted Telehealth Intervention for Insomnia Among Cancer Survivors

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 28, 2020
Registry last updated
Apr 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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