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:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT04712604
Eligibility Criteria:
Inclusion Criteria:
Patients:
1. newly diagnosed with a gastrointestinal cancer (stage I to IV) 12 months or less prior to participating
2. 18 years or older
3. able to speak/read English at the 5th grade level
4. having a consistent partner who is involved in daily activities including sleep
5. having 5 or greater score on the Pittsburgh Sleep Quality Index.
Sleep partners:
1. 18 years or older
2. able to speak/read English at the 5th grade level
3. a partner of the patient who is involved in the patient's daily activities including sleep
4. having similar circadian rhythm/sleep patterns with the patient
5. having 5 or greater score on the Pittsburgh Sleep Quality Index.
Exclusion Criteria:
Patients and their sleep partners:
1. having had a diagnosis of dementia, psychotic disorder, major depressive disorder, bipolar disorder, which currently has not been treated
2. having active suicidality in the past year
3. currently having an untreated diagnosed sleep disorder (narcolepsy, restless leg syndrome)
4. currently having have a poor physical functioning status as measured by an Eastern Cooperative Oncology Group (ECOG) score of 3 or higher and Karnofsky grade of 50 or lower
5. having poor cognitive function status as measured by the Mini Mental State Examination score of 24 or less
6. unable to see or hear
7. at the end of life (life expectancy of less than a month)
8. unwilling to change their current sleep-related habits in near future.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04712604
Study Brief:
Protocol Section:
NCT04712604