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FAMILY Sleep Program
RECRUITINGN/ASponsored by University of Miami
Actively Recruiting
PhaseN/A
SponsorUniversity of Miami
Started2024-08-01
Est. completion2026-10-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06571305
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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
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, * 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.
Conditions1
Cancer
Locations1 site
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Actively Recruiting
PhaseN/A
SponsorUniversity of Miami
Started2024-08-01
Est. completion2026-10-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06571305