FAMILY Sleep Program

Recruiting now · Not applicable

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT06571305

Run by

University of Miami

People needed

12

Starts

2024-08-01

Expected to finish

2026-10-01

Last updated by the study team

2025-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Miami — Coral Gables, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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