Dyadic Sleep Study
- Conditions
- Gastrointestinal Cancer
- Registration Number
- NCT06569693
- Lead Sponsor
- University of Miami
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 152
Inclusion Criteria:<br><br> - The eligibility criteria for patients are:<br><br> - newly diagnosed with stage I to IV of a GI cancer (anus, colon, esophagus,<br> gallbladder, large and small intestine, liver, pancreas, rectum, stomach, other<br> biliary or digestive organs)<br><br> - diagnosis in the past 12 months at the time of enrollment<br><br> - having a consistent sleep partner.<br><br> - The eligibility criterion for caregivers is:<br><br> - a sleep partner of the patient.<br><br> - Additional eligibility criteria for both patients and caregivers are:<br><br> - Pittsburgh Sleep Quality Index (PSQI) = 5,<br><br> - willing to change sub-optimal sleep habits,<br><br> - 18 years or older,<br><br> - able to speak/listen English at the 8th grade level for intervention sessions,<br><br> - able to read English or Spanish at the 8th grade for self-reported<br> questionnaires,<br><br> - > 4 weeks after surgery, if any, prior to enrollment, and no surgery planned in<br> the next 5 weeks during the study period because surgery affects sleep.<br><br>Exclusion Criteria:<br><br> - Exclusion criteria for both patients and caregivers are having had a diagnosis of<br> major depressive disorder, psychosis, or bipolar disorder that is not currently<br> treated;<br><br> - Active suicidality, or substance or alcohol dependency in the past year;<br><br> - Currently have narcolepsy, restless leg syndrome, or untreated sleep apnea that is<br> screened using the Sleep Health Screen;<br><br> - Both patients and caregivers have an extreme chronotype, or do shift work to have no<br> overlap in sleep schedule between them; and plan trans-meridian travel during the<br> period of data collection blocks; and having hearing or visual impairment, dementia,<br> or cognitive dysfunction.<br><br> - Adults unable to consent, individuals who are not yet adults, pregnant women, or<br> prisoners will be excluded.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in sleep disturbance symptoms as measured by scores on the Pittsburgh Sleep Quality Index (PSQI)
- Secondary Outcome Measures
Name Time Method Change in insomnia symptoms as measured by scores on the Insomnia Severity Index (ISI)