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

University of Miami

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: My Sleep Our Sleep (MSOS) Program

Study type: Interventional

Funder types: Other

Identifiers

NCT04712604

20201067

Details and patient eligibility

About

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

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

MSOS Group

Experimental group

Description:

The participants in this group will receive the MSOS Intervention for 4 consecutive weeks.

Treatment:

Behavioral: My Sleep Our Sleep (MSOS) Program