Active — Not RecruitingNot Applicable

Innovating CBT-I for Cancer Survivors: An Optimization Trial

United States80 participantsStarted 2024-09-06

Plain-language summary

The overall goal of this project is to conduct a factorial, randomized controlled trial to optimize synchronous, virtual delivery of CBT-I for cancer survivors. The proposed project will yield multiple deliverables to innovate cancer survivorship care, chiefly an optimized, scalable, virtually-delivered intervention that addresses chronic insomnia, one of the most deleterious concerns among the growing demographic of cancer survivors in the U.S. Findings will inform future considerations for delivering CBT-I to cancer survivors.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * History of nonmetastatic, localized, or regional solid or blood malignancy(ies) * Completion of primary cancer treatment (radiation, surgery, and/or chemotherapy). Use of hormonal, maintenance, oral, and immunotherapies is permitted. * Chronic insomnia (DSM-5 criteria) * 18 years of age or older Exclusion Criteria: * Self-reported inability to speak and write in English * Undertreated noninsomnia sleep disorder (e.g., sleep apnea) * Undertreated epilepsy, undertreated serious mental illness, undertreated suicidality, and/or psychiatric hospitalization in the past year * Unwilling or unable to discontinue night shift work

What they're measuring

Insomnia Severity Index (ISI) total score

Timeframe: T0 (Baseline) to T2 (week 8)

Trial details

NCT IDNCT06181643

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-31

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