| NCT ID | NCT06569693 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Miami |
| Condition | Gastrointestinal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 152 participants |
| Start Date | 2024-10-22 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 152 participants in total. It began in 2024-10-22 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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 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.
Contact & Investigator
Youngmee Kim, PhD
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT06569693 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastrointestinal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06569693 currently recruiting?
Yes, NCT06569693 is actively recruiting participants. Contact the research team at ykim@miami.edu for enrollment information.
Where is the NCT06569693 trial being conducted?
This trial is being conducted at Coral Gables, United States, Pittsburgh, United States.
Who is sponsoring the NCT06569693 clinical trial?
NCT06569693 is sponsored by University of Miami. The principal investigator is Youngmee Kim, PhD at University of Miami. The trial plans to enroll 152 participants.
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