RecruitingNot ApplicableNCT06181643

Innovating CBT-I for Cancer Survivors: An Optimization Trial


Sponsor

Massachusetts General Hospital

Enrollment

80 participants

Start Date

Sep 6, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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)
  • years of age or older

Exclusion Criteria4

  • 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

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Interventions

BEHAVIORALSurvivorship Sleep Program with Individual Delivery + No Booster Sessions

4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session). No booster sessions.

BEHAVIORALSurvivorship Sleep Program with Group Delivery + No Booster Sessions

4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session). No booster sessions.

BEHAVIORALSurvivorship Sleep Program with Individual Delivery + 3 Booster Sessions

4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session). 3 monthly booster sessions.

BEHAVIORALSurvivorship Sleep Program with Group Delivery + 3 Booster Sessions

4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session). 3 monthly booster sessions.


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT06181643


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