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Recruiting NCT06569693

Dyadic Sleep Study

Trial Parameters

Condition Gastrointestinal Cancer
Sponsor University of Miami
Study Type INTERVENTIONAL
Phase N/A
Enrollment 152
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-10-22
Completion 2026-12-01
Interventions
My Sleep Our Sleep (MSOS) ProgramBrief Behavioral Treatment for Insomnia (BBTI)

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. Ex

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