Feasibility and Acceptability Study of My Sleep Our Sleep (MSOS) Program

Study Overview
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Brief Summary
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The purpose of this study is to test feasibility and acceptability of a psycho-behavioral intervention on sleep in cancer patients and their partners.

Official Title
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Feasibility and Acceptability Study of My Sleep Our Sleep (MSOS) Program

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: My Sleep Our Sleep (MSOS) Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MSOS Group<br>The participants in this group will receive the MSOS Intervention for 4 consecutive weeks. | Behavioral: My Sleep Our Sleep (MSOS) Program<br>* MSOS Program is a weekly one-hour Zoom session that focuses on psychoeducation on sleep health for both patients and their sleep partners.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the intervention | Feasibility of the intervention will be reported as the percentage of participants who enroll and complete all the sessions of the study. | 4 weeks | 
| Acceptability of the intervention | Acceptability of the intervention will be reported as the percentage of participants who evaluated the intervention and the interventionist as satisfactory or better. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep disturbance | 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. | Baseline, 4 weeks | 
| Change in quality of life | 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. | Baseline, 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep disturbance in GI cancer patients and their sleep partner