FAMILY Sleep Program
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- University of Miami
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Proportion of participants adapting to BBTI
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
Youngmee Kim
Professor
University of Miami
Eligibility Criteria
Inclusion Criteria
- •The eligibility criteria for patients are
- •newly diagnosed with stage I to IV of a solid tumor
- •diagnosis in the past seven 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,
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.
Outcomes
Primary Outcomes
Proportion of participants adapting to BBTI
Time Frame: 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)
Time Frame: 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.