Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 1:08 AM
NCT ID:
NCT06569693
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 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06569693
Study Brief:
Protocol Section:
NCT06569693