Gastrointestinal CancerNCT06569693
Dyadic Sleep Study
A study testing My Sleep Our Sleep (MSOS) Program and Brief Behavioral Treatment for Insomnia (BBTI) in people with Gastrointestinal Cancer, run by University of Miami at 2 sites in United States.
Trial summary
The purpose of this study is to learn about sleep behaviors and test different ways to help patients with cancer and caregiver partners. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- My Sleep Our Sleep (MSOS) Program and Brief Behavioral Treatment for Insomnia (BBTI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Oct 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- The eligibility criteria for patients are:
- newly diagnosed with stage I to IV of a GI cancer (anus, colon, esophagus, gallbladder, large and small intestine, liver, pancreas, rectum, stomach, other biliary or digestive organs)
- diagnosis in the past 72 months at the time of enrollment
- having a consistent sleep partner.
- The eligibility criterion for caregivers is:
- a sleep partner of the patient or partner who wish to resume sleeping together with the patient
Show all 13Show fewer
- Additional eligibility criteria for both patients and caregivers are:
- Pittsburgh Sleep Quality Index (PSQI) ≥ 5,
- willing to change sub-optimal sleep habits,
- 18 years or older,
- able to speak/listen English at the 8th grade level for intervention sessions,
- able to read English or Spanish at the 8th grade for self-reported questionnaires,
- > 4 weeks after surgery, if any, prior to enrollment, and no surgery planned in the next 5 weeks during the study period because surgery affects sleep.
Who cannot join
- Exclusion criteria for both patients and caregivers are having had a diagnosis of major depressive disorder, psychosis, or bipolar disorder that is not currently treated;
- Active suicidality, or substance or alcohol dependency in the past year;
- Currently have narcolepsy, restless leg syndrome, or untreated sleep apnea that is screened using the Sleep Health Screen;
- Both patients and caregivers have an extreme chronotype, or do shift work to have no overlap in sleep schedule between them; and plan trans-meridian travel during the period of data collection blocks; and having hearing or visual impairment, dementia, or cognitive dysfunction.
- Adults unable to consent, individuals who are not yet adults, pregnant women, or prisoners will be excluded.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Recruiting
University of Miami
Coral Gables, Florida, 33146
Youngmee Kim, PhD, 305-284-5439, ykim@miami.edu
Youngmee Kim, PhD
- Active, not recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
The purpose of this study is to learn about sleep behaviors and test different ways to help patients with cancer and caregiver partners.
- Conditions
- Gastrointestinal Cancer
- Being tested
- My Sleep Our Sleep (MSOS) Program, Brief Behavioral Treatment for Insomnia (BBTI)
- Medical subject headings
- Gastrointestinal Neoplasms
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
Also called MSOS
MSOS is a sleep intervention developed by the investigator aimed at improving sleep health for patient-sleep-partner caregiver dyads using behavioral education in sleep behaviors, sleep cognition and sleep in relationship.
MSOS will be delivered over four weeks, in weekly one-hour sessions, one session per week.
Brief Behavioral Treatment for Insomnia (BBTI)Behavioural
Also called BBTI
BBTI is brief patient-focused intervention for patient-sleep-partner caregiver dyads, aimed at altering participants' sleep behaviors to improve sleep. BBTI utilizes behavioral education in sleep restriction and stimulus control. For sleep restriction, participants will be instructed to limit the time they spend in bed, which serves to increase sleep efficiency. For stimulus control, participants will be instructed to go to bed only when feeling sleepy and reserve the bed for sleep and intimacy.
BBTI will be delivered over four weeks, in weekly one-hour sessions, one session per week.
| Study group | Role | What they receive |
|---|---|---|
| MSOS Intervention Group | Experimental | Participants (patient-sleep-partner caregiver dyads) in this group will receive the My Sleep Our Sleep (MSOS) intervention. Total participation is up to 13 weeks. Receives: Behavioral: My Sleep Our Sleep (MSOS) Program |
| BBTI Intervention Group | Experimental | Participants (patient-sleep-partner caregiver dyads) in this group will receive the Brief Behavioral Treatment for Insomnia (BBTI). Total participation is up to 13 weeks. Receives: Behavioral: Brief Behavioral Treatment for Insomnia (BBTI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep disturbance symptoms as measured by scores on the Pittsburgh Sleep Quality Index (PSQI)
Change in sleep disturbance symptoms (patient-sleep-partner caregiver dyads) among participants will be compared and reported for both intervention groups, BBTI and MSOS, as measured by scores on the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-reported, 19-item questionnaire health-related quality of life (HRQOL) questionnaire which assesses sleep quality and disturbances at baseline, week 5 and week 13. Questions generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. A decrease of ≥ 5 points on the PSQI) will be considered as clinical improvement of symptoms.
Measured: Baseline, Up to 13 weeks
Secondary outcomes (1)
Change in insomnia symptoms as measured by scores on the Insomnia Severity Index (ISI)
Change in insomnia symptoms among participants (patient-sleep-partner caregiver dyads) will be compared and reported for both intervention groups, BBTI and MSOS, as measured by scores on the 7-item Insomnia Severity Index (ISI). The ISI is a self-reported, health-related quality of life (HRQOL) questionnaire used to assess insomnia symptoms at baseline, week 5 and week 13. The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, notice ability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item, ranging from 0 to 4 (e.g., 0 = no problem; 4 = very severe problem). The total score ranges from 0 to 28, the lower total score indicates a lower level of insomnia. Greater than a 6-point decrease on the ISI is considered substantial reduction in insomnia symptoms.
Measured: Baseline, Up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start22 Oct 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- 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
- NCT06569693
- Sponsor's protocol ID
- 20240214
- Other IDs
- R21NR021083
- Status last verified
- Mar 2026
- First submitted
- 22 Aug 2024
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim Y, Tsai TC, Steel JL, Ramos AR, Laurenceau JP, Troxel WM. Protocol of testing the feasibility and acceptability of two brief dyadic sleep interventions for adults with cancer and their bedpartner caregivers. Pilot Feasibility Stud. 2025 Jun 14;11(1):82. doi: 10.1186/s40814-025-01671-z.
PubMed 40514758
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyadic Sleep Study
- ClinicalTrials.gov ID
- NCT06569693
- Acronym / sponsor ID
- 20240214
- Conditions
- Gastrointestinal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 26 Aug 2024 (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 learn about sleep behaviors and test different ways to help patients with cancer and caregiver partners.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSOS Intervention Group | Experimental | Behavioral: My Sleep Our Sleep (MSOS) ProgramParticipants (patient-sleep-partner caregiver dyads) in this group will receive the My Sleep Our Sleep (MSOS) intervention. Total participation is up to 13 weeks. |
| BBTI Intervention Group | Experimental | Behavioral: Brief Behavioral Treatment for Insomnia (BBTI)Participants (patient-sleep-partner caregiver dyads) in this group will receive the Brief Behavioral Treatment for Insomnia (BBTI). Total participation is up to 13 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The eligibility criteria for patients are:
- The eligibility criterion for caregivers is:
- Additional eligibility criteria for both patients and caregivers are:
Key exclusion criteria (5 listed)
- Exclusion criteria for both patients and caregivers are having had a diagnosis of major depressive disorder, psychosis, or bipolar disorder that is not currently treated;
- Active suicidality, or substance or alcohol dependency in the past year;
- Currently have narcolepsy, restless leg syndrome, or untreated sleep apnea that is screened using the Sleep Health Screen;
- Both patients and caregivers have an extreme chronotype, or do shift work to have no overlap in sleep schedule between them; and plan trans-meridian travel during the period of data collection blocks; and having hearing or visual impairment, dementia, or cognitive dysfunction.
- Adults unable to consent, individuals who are not yet adults, pregnant women, or prisoners will be excluded.
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) ProgramAlso: MSOSMSOS is a sleep intervention developed by the investigator aimed at improving sleep health for patient-sleep-partner caregiver dyads using behavioral education in sleep behaviors, sleep cognition and sleep in relationship. MSOS will be delivered over four weeks, in weekly one-hour sessions, one session per week. | Behavioural | MSOS Intervention Group |
| Brief Behavioral Treatment for Insomnia (BBTI)Also: BBTIBBTI is brief patient-focused intervention for patient-sleep-partner caregiver dyads, aimed at altering participants' sleep behaviors to improve sleep. BBTI utilizes behavioral education in sleep restriction and stimulus control. For sleep restriction, participants will be instructed to limit the time they spend in bed, which serves to increase sleep efficiency. For stimulus control, participants will be instructed to go to bed only when feeling sleepy and reserve the bed for sleep and intimacy. BBTI will be delivered over four weeks, in weekly one-hour sessions, one session per week. | Behavioural | BBTI Intervention Group |
Primary outcome
Change in sleep disturbance symptoms as measured by scores on the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, Up to 13 weeks
Change in sleep disturbance symptoms (patient-sleep-partner caregiver dyads) among participants will be compared and reported for both intervention groups, BBTI and MSOS, as measured by scores on the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-reported, 19-item questionnaire health-related quality of life (HRQOL) questionnaire which assesses sleep quality and disturbances at baseline, week 5 and week 13. Questions generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. A decrease of ≥ 5 points on the PSQI) will be considered as clinical improvement of symptoms.
1 secondary outcome
Change in insomnia symptoms as measured by scores on the Insomnia Severity Index (ISI)
Time frame: Baseline, Up to 13 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Derived from this study: PubMed 40514758Kim Y, Tsai TC, Steel JL, Ramos AR, Laurenceau JP, Troxel WM. Protocol of testing the feasibility and acceptability of two brief dyadic sleep interventions for adults with cancer and their bedpartner caregivers. Pilot Feasibility Stud. 2025 Jun 14;11(1):82. doi: 10.1186/s40814-025-01671-z.
- 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.
Youngmee Kim, PhD principal investigator
University of Miami
2 sites 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 and Brief Behavioral Treatment for Insomnia (BBTI) in people with Gastrointestinal Cancer, run by University of Miami at 2 sites 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 13 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youngmee Kim, PhD (305-284-5439, ykim@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleep disturbance symptoms as measured by scores on the Pittsburgh Sleep Quality Index (PSQI) (time frame: Baseline, Up to 13 weeks). 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 NCT06569693, which also lists 1 linked publication.
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 9 Mar 2026.