Clinical trial · Interventional
Survivorship Sleep Program
Adapted Telehealth Intervention for Insomnia Among Cancer Survivors
NCT04566068CI-TRIAL-00057705completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control- Enhanced usual care | Behavioral | — | UNRESOLVED |
| Intervention- Adapted Virtual Insomnia Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention- Adapted Virtual Insomnia Program
- 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).
- interventionNames
- Behavioral: Intervention- Adapted Virtual Insomnia Program
- type
- PLACEBO_COMPARATOR
- label
- Control- Enhanced usual care
- description
- Enhanced usual care. Referral to the Massachusetts General Hospital Behavioral Sleep Medicine service plus an educational handout on the topic of sleep hygiene.
- interventionNames
- Behavioral: Control- Enhanced usual care
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTHall 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
- DERIVEDCai 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