Survivorship Sleep Program

Mass General Brigham

Status: Completed

Conditions: Insomnia; Cancer

Treatments: Behavioral: Intervention- Adapted Virtual Insomnia Program; Behavioral: Control- Enhanced usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT04566068

20-170

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

Intervention- Adapted Virtual Insomnia Program

Experimental group

Description:

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).

Treatment:

Behavioral: Intervention- Adapted Virtual Insomnia Program

Control- Enhanced usual care

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Control- Enhanced usual care