FAMILY Sleep Program

Part of paid clinical trials in Coral Gables, Florida.

Sponsor
University of Miami
Study ID
NCT06571305
Status
Recruiting
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Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Brief Behavioral Treatment for Insomnia (BBTI) — BEHAVIORAL
    BBTI is brief patient-focused intervention for patient-sleep-partner caregiver dyads, aimed at altering participants' sleep behaviors to improve sleep. BBTI utilizes behavioral education in sleep restriction and stimulus control. For sleep restriction, participants will be instructed to limit the time spent in bed, which serves to increase sleep efficiency. For stimulus control, participants will be instructed to go to bed only when feeling sleepy and reserve the bed for sleep and intimacy. BBTI will be delivered over four weeks, in weekly one-hour sessions, one session per week.
  • My Sleep Our Sleep (MSOS) — BEHAVIORAL
    MSOS is a sleep intervention developed by the investigator aimed at improving sleep health for patient-sleep-partner caregiver dyads using behavioral education in sleep behaviors, sleep cognition and sleep in relationship. MSOS will be delivered over four weeks, in weekly one-hour sessions, one session per week.

Study Details

The purpose of this study is to learn about sleep behaviors and test different ways to help patients with cancer and partners. Participants (patient-sleep-partner caregivers dyads as a unit) participate in the study together.

Key Dates

Start date
Aug 1, 2024
Status verified
Aug 2025
Primary completion
Oct 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Phase 2 BBTI Intervention Group
    Participants (patient-sleep-partner caregiver dyads) in this group will receive the Brief Behavioral Treatment for Insomnia (BBTI). Total participation is up to 4 weeks.
  • Experimental: Phase 2 MSOS Intervention Group
    Participants (patient-sleep-partner caregiver dyads) in this group will receive the My Sleep Our Sleep (MSOS) intervention. Total participation is up to 4 weeks.

Primary Outcome Measure

Proportion of participants adapting to BBTI [ Time Frame: Up to 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiCoral GablesFlorida33146
Youngmee Kim, PhD
[email protected]
305-284-5439
Youngmee Kim, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami· Coral Gables, FL

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