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NCT06569693 | RECRUITING | Gastrointestinal Cancer

Dyadic Sleep Study
Sponsor:

University of Miami

Information provided by (Responsible Party):

Youngmee Kim

Brief Summary:

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

Condition or disease

Gastrointestinal Cancer

Intervention/treatment

My Sleep Our Sleep (MSOS) Program

Brief Behavioral Treatment for Insomnia (BBTI)

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 152 participants
Masking : SINGLE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Dyadic Sleep Study
Actual Study Start Date : 2024-10-22
Estimated Primary Completion Date : 2026-12-01
Estimated Study Completion Date : 2026-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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.
Dyadic Sleep Study

Location Details

NCT06569693

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

University of Miami

Coral Gables, florida, United States, 33146