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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04712604
• Other study ID #: 20201067
• Status: Completed
• Phase: N/A
• Start date: March 14, 2021
• Est. completion date: January 25, 2022

Study information

• Verified date: February 2022
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 25, 2022
• Est. primary completion date: January 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• My 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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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