Dyadic Sleep Study

Recruiting now · Not applicable

Conditions studied: Gastrointestinal Cancer

In brief

The purpose of this study is to learn about sleep behaviors and test different ways to help patients with cancer and caregiver partners.

Key facts

Study ID

NCT06569693

Run by

University of Miami

People needed

152

Starts

2024-10-22

Expected to finish

2026-12-01

Last updated by the study team

2026-03-09

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 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,
• 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,
• > 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)
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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