Clinical trial · Interventional
Feasibility and Acceptability Study of My Sleep Our Sleep (MSOS) Program
NCT04712604CI-TRIAL-00057020completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to test feasibility and acceptability of a psycho-behavioral intervention on sleep in cancer patients and their partners.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| My Sleep Our Sleep (MSOS) Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MSOS Group
- description
- The participants in this group will receive the MSOS Intervention for 4 consecutive weeks.
- interventionNames
- Behavioral: My Sleep Our Sleep (MSOS) Program
Primary outcomes (2)
- measure
- Feasibility of the intervention
- timeFrame
- 4 weeks
- description
- Feasibility of the intervention will be reported as the percentage of participants who enroll and complete all the sessions of the study.
- measure
- Acceptability of the intervention
- timeFrame
- 4 weeks
- description
- Acceptability of the intervention will be reported as the percentage of participants who evaluated the intervention and the interventionist as "satisfactory" or better.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDKim 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. PMID 37312582
- DERIVEDKim 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. PMID 36704757