Dyadic Sleep Study
Overview
- Phase
- Not Applicable
- Intervention
- My Sleep Our Sleep (MSOS) Program
- Conditions
- Gastrointestinal Cancer
- Sponsor
- University of Miami
- Enrollment
- 152
- Locations
- 2
- Primary Endpoint
- Change in sleep disturbance symptoms as measured by scores on the Pittsburgh Sleep Quality Index (PSQI)
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief Summary
The purpose of this study is to learn about sleep behaviors and test different ways to help patients with cancer and caregiver partners.
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 GI cancer (anus, colon, esophagus, gallbladder, large and small intestine, liver, pancreas, rectum, stomach, other biliary or digestive organs)
- •diagnosis in the past 72 months at the time of enrollment
- •having a consistent sleep partner.
- •The eligibility criterion for caregivers is:
- •a sleep partner of the patient or partner who wish to resume sleeping together with 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.
Arms & Interventions
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 13 weeks.
Intervention: My Sleep Our Sleep (MSOS) Program
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 13 weeks.
Intervention: Brief Behavioral Treatment for Insomnia (BBTI)
Outcomes
Primary Outcomes
Change in sleep disturbance symptoms as measured by scores on the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, Up to 13 weeks
Change in sleep disturbance symptoms (patient-sleep-partner caregiver dyads) among participants will be compared and reported for both intervention groups, BBTI and MSOS, as measured by scores on the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-reported, 19-item questionnaire health-related quality of life (HRQOL) questionnaire which assesses sleep quality and disturbances at baseline, week 5 and week 13. 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. A decrease of ≥ 5 points on the PSQI) will be considered as clinical improvement of symptoms.
Secondary Outcomes
- Change in insomnia symptoms as measured by scores on the Insomnia Severity Index (ISI)(Baseline, Up to 13 weeks)