InsomniaNCT04712604
Feasibility and Acceptability Study of My Sleep Our Sleep (MSOS) Program
A study testing My Sleep Our Sleep (MSOS) Program in people with Insomnia, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- My Sleep Our Sleep (MSOS) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2021to 25 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients:
- newly diagnosed with a gastrointestinal cancer (stage I to IV) 12 months or less prior to participating
- 18 years or older
- able to speak/read English at the 5th grade level
- having a consistent partner who is involved in daily activities including sleep
- having 5 or greater score on the Pittsburgh Sleep Quality Index.
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- Sleep partners:
- 18 years or older
- able to speak/read English at the 5th grade level
- a partner of the patient who is involved in the patient's daily activities including sleep
- having similar circadian rhythm/sleep patterns with the patient
- having 5 or greater score on the Pittsburgh Sleep Quality Index.
Who cannot join
- Patients and their sleep partners:
- having had a diagnosis of dementia, psychotic disorder, major depressive disorder, bipolar disorder, which currently has not been treated
- having active suicidality in the past year
- currently having an untreated diagnosed sleep disorder (narcolepsy, restless leg syndrome)
- 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
- having poor cognitive function status as measured by the Mini Mental State Examination score of 24 or less
Show all 9Show fewer
- unable to see or hear
- at the end of life (life expectancy of less than a month)
- unwilling to change their current sleep-related habits in near future.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Insomnia
- Being tested
- My Sleep Our Sleep (MSOS) Program
- Keywords
- Sleep disturbance in GI cancer patients and their sleep partner
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Sleep Our Sleep (MSOS) ProgramBehavioural
MSOS Program is a weekly one-hour Zoom session that focuses on psychoeducation on sleep health for both patients and their sleep partners.
| Study group | Role | What they receive |
|---|---|---|
| MSOS Group | Experimental | The participants in this group will receive the MSOS Intervention for 4 consecutive weeks. Receives: Behavioral: My Sleep Our Sleep (MSOS) Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start14 Mar 2021
- Primary completion25 Jan 2022
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youngmee Kim, University of Miami
- Investigators
- Youngmee Kim, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712604
- Sponsor's protocol ID
- 20201067
- Status last verified
- Feb 2022
- First submitted
- 13 Jan 2021
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37312582Kim 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.
PubMed 36704757
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability Study of My Sleep Our Sleep (MSOS) Program
- ClinicalTrials.gov ID
- NCT04712604
- Acronym / sponsor ID
- 20201067
- Conditions
- Insomnia
- Keywords
- Sleep disturbance in GI cancer patients and their sleep partner
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 14 Mar 2021 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSOS Group | Experimental | Behavioral: My Sleep Our Sleep (MSOS) ProgramThe participants in this group will receive the MSOS Intervention for 4 consecutive weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- newly diagnosed with a gastrointestinal cancer (stage I to IV) 12 months or less prior to participating
- 18 years or older
- able to speak/read English at the 5th grade level
- having a consistent partner who is involved in daily activities including sleep
- having 5 or greater score on the Pittsburgh Sleep Quality Index.
Key exclusion criteria (9 listed)
- having had a diagnosis of dementia, psychotic disorder, major depressive disorder, bipolar disorder, which currently has not been treated
- having active suicidality in the past year
- currently having an untreated diagnosed sleep disorder (narcolepsy, restless leg syndrome)
- 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
- having poor cognitive function status as measured by the Mini Mental State Examination score of 24 or less
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| My Sleep Our Sleep (MSOS) ProgramMSOS Program is a weekly one-hour Zoom session that focuses on psychoeducation on sleep health for both patients and their sleep partners. | Behavioural | MSOS Group |
Primary outcome
Feasibility of the intervention
Time frame: 4 weeks
Feasibility of the intervention will be reported as the percentage of participants who enroll and complete all the sessions of the study.
Acceptability of the intervention
Time frame: 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.
2 secondary outcomes
Change in sleep disturbance
Time frame: Baseline, 4 weeks
Change in quality of life
Time frame: Baseline, 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Derived from this study: PubMed 37312582Kim 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.
- Derived from this study: PubMed 36704757Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Youngmee Kim, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My Sleep Our Sleep (MSOS) Program in people with Insomnia, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the intervention (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04712604, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.