FAMILY Sleep Program

Launched by UNIVERSITY OF MIAMI · Aug 22, 2024

Keywords

ClinConnect Summary

The FAMILY Sleep Program is a clinical trial designed to improve sleep for cancer patients and their partners. The study focuses on understanding how sleep behaviors affect both the patient and their caregiver. Together, they will explore different ways to enhance their sleep quality. This trial is currently recruiting participants in Brevard County, Florida, and is open to anyone aged 18 and older. To be eligible, patients must have recently been diagnosed with a solid tumor (stages I to IV) within the last three years and have a consistent sleep partner. Caregivers must be the patient's sleep partner and both must be willing to work on improving their sleep habits.

Participants in this study can expect to engage in discussions and activities aimed at changing their sleep habits, as well as completing some questionnaires to track their progress. It's important to note that individuals with certain mental health conditions, severe sleep disorders, or those who have recently had surgery may not be eligible. This trial aims to support both patients and their caregivers, helping them to better manage sleep challenges during a difficult time.

Gender

ALL

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 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.