FAMILY Sleep Program

Not Applicable

Recruiting

• Conditions: Cancer
• Interventions: Behavioral: My Sleep Our Sleep (MSOS); Behavioral: Brief Behavioral Treatment for Insomnia (BBTI)

• Registration Number: NCT06571305
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-22
• Last Update Submitted: 2024-08-22
• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-26
• Study Start: 2024-10-01
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• The eligibility criteria for patients are

  • newly diagnosed with stage I to IV of a solid tumor
  • diagnosis in the past three years at the time of enrollment
  • having a consistent sleep partner.

• The eligibility criterion for caregivers is

  • a sleep partner of the patient.

• Additional eligibility criteria for both patients and caregivers are

  • Pittsburgh Sleep Quality Index (PSQI) ≥ 5,
  • willing to change sub-optimal sleep habits,
  • 18 years or older,
  • able to speak/listen English at the 8th grade level for intervention sessions,
  • able to read English or Spanish at the 8th grade for self-reported questionnaires, reside in Brevard County, Florida (FL),
  • only for participants of Aim 2, > 4 weeks after surgery, if any, prior to enrollment, and no surgery planned in the next 5 weeks during the study period because surgery affects sleep.

Exclusion Criteria

• Exclusion criteria for both patients and caregivers are:

  • having had a diagnosis of major depressive disorder, psychosis, or bipolar disorder that is not currently treated;
  • active suicidality, or substance or alcohol dependency in the past year;
  • currently have narcolepsy, restless leg syndrome, or untreated sleep apnea that is screened using the Sleep Health Screen;
  • both patients and caregivers have an extreme chronotype, or do shift work to have no overlap in sleep schedule between them; and
  • plan trans-meridian travel during the period of data collection blocks; and
  • having hearing or visual impairment, dementia, or cognitive dysfunction.

• Adults unable to consent, individuals who are not yet adults, pregnant women, or prisoners will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase 2 MSOS Intervention Group	My Sleep Our Sleep (MSOS)	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.
Phase 2 BBTI Intervention Group	Brief Behavioral Treatment for Insomnia (BBTI)	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.

Primary Outcome Measures

Name	Time	Method
Proportion of participants adapting to BBTI	Up to 4 weeks	The proportion of participants (patient--sleep-partner caregiver dyads) who adapt to Brief Behavioral Treatment for Insomnia (BBTI).
Change in Sleep Disturbance Symptoms Measured by Pittsburgh Sleep Quality Index (PSQI)	Baseline, Up to 4 weeks	The proportion of participants (patient-sleep-partner caregiver dyads) experiencing a change in sleep disturbance symptoms will be compared and reported for both intervention groups, BBTI and MSOS, as measured by scores on the Pittsburgh Sleep Quality Index (PSQI) health-related quality of life HRQOL) questionnaire. The PSQI is a self-reported, 19-item questionnaire which assesses sleep quality and disturbances at baseline and over a four week period. Questions generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. The PSQI global score has a possible range of 0-21 points. A total score of 5 or above indicates overall poor sleep quality.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Coral Gables, Florida, United States