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

• Sponsor: University of Miami (Other)
• Overall Status: Completed
• CT.gov ID: NCT04712604
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arm: 1
• Actual Duration (Months): 10.4
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia	Behavioral: My Sleep Our Sleep (MSOS) Program	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Feasibility and Acceptability Study of My Sleep Our Sleep (MSOS) Program
• Actual Study Start Date: Mar 14, 2021
• Actual Primary Completion Date: Jan 25, 2022
• Actual Study Completion Date: Jan 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MSOS Group The participants in this group will receive the MSOS Intervention for 4 consecutive weeks.	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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami

Investigators

• Principal Investigator: Youngmee Kim, PhD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Youngmee Kim, Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT04712604
• Other Study ID Numbers: 20201067
• First Posted: Jan 15, 2021
• Last Update Posted: Mar 10, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Youngmee Kim, Professor, University of Miami: Sleep disturbance in GI cancer patients and their sleep partner
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Mar 10, 2022