Feasibility and Acceptability Study of My Sleep Our Sleep (MSOS) Program
NCT ID: NCT04712604
Last Updated: 2022-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
26 participants
INTERVENTIONAL
2021-03-14
2022-01-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
FAMILY Sleep Program
NCT06571305
Dyadic Sleep Study
NCT06569693
Sleep Treatment Education Program for Cancer Survivors: STEP-Together
NCT06736548
Pilot Study of App-delivered Sleep Coaching Among Cancer Survivors and Their Partners
NCT06938802
Survivorship Sleep Program
NCT04566068
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MSOS Group
The participants in this group will receive the MSOS Intervention for 4 consecutive weeks.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Miami
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Youngmee Kim
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Youngmee Kim, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Miami
Miami, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kim Y, Ting A, Tsai TC, Carver CS. Dyadic sleep intervention for adult patients with cancer and their sleep-partner caregivers: A feasibility study. Palliat Support Care. 2024 Apr;22(2):226-235. doi: 10.1017/S1478951523000627.
Kim Y, Ting A, Steel JL, Tsai TC. Protocol of a dyadic sleep intervention for adult patients with cancer and their sleep-partner caregivers. Contemp Clin Trials Commun. 2023 Jan 16;32:101064. doi: 10.1016/j.conctc.2023.101064. eCollection 2023 Apr.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20201067
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.