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Dyadic Sleep Study

Dyadic Sleep Study

Recruiting
18 years and older
All
Phase N/A

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Overview

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

Eligibility

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 12 months 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,
    • > 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.

Study details
    Gastrointestinal Cancer

NCT06569693

University of Miami

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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