Insomnia
Conditions
Keywords
Sleep disturbance in GI cancer patients and their sleep partner
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.
Interventions
BEHAVIORALMy Sleep Our Sleep (MSOS) Program
MSOS Program is a weekly one-hour Zoom session that focuses on psychoeducation on sleep health for both patients and their sleep partners.
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the intervention | 4 weeks | Feasibility of the intervention will be reported as the percentage of participants who enroll and complete all the sessions of the study. |
| Acceptability of the intervention | 4 weeks | Acceptability of the intervention will be reported as the percentage of participants who evaluated the intervention and the interventionist as satisfactory or better. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in sleep disturbance | Baseline, 4 weeks | Change in sleep disturbance as measured by the Pittsburgh Sleep Quality Index (PSQI). PSQI has a total score ranging from 0 to 21, where lower score indicates healthier sleep quality. |
| Change in quality of life | Baseline, 4 weeks | Change in quality of life as measured by the Patient-reported Outcomes Measurement Information System (PROMIS-29). PROMIS-29 has a total score ranging from 20-80, with lower scores indicating better quality of life. |
Countries
United States
Outcome results
None listed