Status:
COMPLETED
Feasibility and Acceptability Study of My Sleep Our Sleep (MSOS) Program
Lead Sponsor:
University of Miami
Conditions:
Insomnia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to test feasibility and acceptability of a psycho-behavioral intervention on sleep in cancer patients and their partners.
Eligibility Criteria
Inclusion
- Patients:
- newly diagnosed with a gastrointestinal cancer (stage I to IV) 12 months or less prior to participating
- 18 years or older
- able to speak/read English at the 5th grade level
- having a consistent partner who is involved in daily activities including sleep
- having 5 or greater score on the Pittsburgh Sleep Quality Index.
- Sleep partners:
- 18 years or older
- able to speak/read English at the 5th grade level
- a partner of the patient who is involved in the patient's daily activities including sleep
- having similar circadian rhythm/sleep patterns with the patient
- having 5 or greater score on the Pittsburgh Sleep Quality Index.
Exclusion
- Patients and their sleep partners:
- having had a diagnosis of dementia, psychotic disorder, major depressive disorder, bipolar disorder, which currently has not been treated
- having active suicidality in the past year
- currently having an untreated diagnosed sleep disorder (narcolepsy, restless leg syndrome)
- 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
- having poor cognitive function status as measured by the Mini Mental State Examination score of 24 or less
- unable to see or hear
- at the end of life (life expectancy of less than a month)
- unwilling to change their current sleep-related habits in near future.
Key Trial Info
Start Date :
March 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2022
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04712604
Start Date
March 14 2021
End Date
January 25 2022
Last Update
March 10 2022
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136