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

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

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: My Sleep Our Sleep (MSOS) Program

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2021
• Primary Completion (Actual): January 25, 2022
• Study Completion (Actual): January 25, 2022

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: February 22, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Sleep disturbance in GI cancer patients and their sleep partner
• Other Study ID Numbers: 20201067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No