|

Dyadic Sleep Study

RECRUITINGN/ASponsored by University of Miami
Actively Recruiting
PhaseN/A
SponsorUniversity of Miami
Started2024-10-22
Est. completion2026-12-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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 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.

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.

Conditions2

CancerGastrointestinal Cancer

Locations2 sites

Florida

1 site
University of Miami
Coral Gables, Florida, 33146
Youngmee Kim, PhD305-284-5439ykim@miami.edu

Pennsylvania

1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.