CancerNCT06571305
FAMILY Sleep Program
A study testing Brief Behavioral Treatment for Insomnia (BBTI) and My Sleep Our Sleep (MSOS) in people with Cancer, run by University of Miami at 1 site 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 partners. Participants (patient-sleep-partner caregivers dyads as a unit) participate in the study together. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Brief Behavioral Treatment for Insomnia (BBTI) and My Sleep Our Sleep (MSOS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 1 Oct 2027
- 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 solid tumor
- diagnosis in the past seven years at the time of enrollment
- having a consistent sleep partner.
- The eligibility criterion for caregivers is
- a sleep partner of 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, reside in Brevard County, Florida (FL),
- only for participants of Aim 2, > 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
- 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Coral Gables, Florida, 33146
Youngmee Kim, PhD, 305-284-5439, ykim@miami.edu
Youngmee Kim, PhD
About this study
The purpose of this study is to learn about sleep behaviors and test different ways to help patients with cancer and partners. Participants (patient-sleep-partner caregivers dyads as a unit) participate in the study together.
- Conditions
- Cancer
- Being tested
- Brief Behavioral Treatment for Insomnia (BBTI), My Sleep Our Sleep (MSOS)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Behavioral Treatment for Insomnia (BBTI)Behavioural
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 spent 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.
My Sleep Our Sleep (MSOS)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase 2 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 4 weeks. Receives: Behavioral: Brief Behavioral Treatment for Insomnia (BBTI) |
| Phase 2 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 4 weeks. Receives: Behavioral: My Sleep Our Sleep (MSOS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants adapting to BBTI
The proportion of participants (patient--sleep-partner caregiver dyads) who adapt to Brief Behavioral Treatment for Insomnia (BBTI).
Measured: Up to 4 weeks
Change in Sleep Disturbance Symptoms Measured by Pittsburgh Sleep Quality Index (PSQI)
The proportion of participants (patient-sleep-partner caregiver dyads) experiencing a change in sleep disturbance symptoms will be compared and reported for both intervention groups, BBTI and MSOS, as measured by scores on the Pittsburgh Sleep Quality Index (PSQI) health-related quality of life HRQOL) questionnaire. The PSQI is a self-reported, 19-item questionnaire which assesses sleep quality and disturbances at baseline and over a four week period. 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. The PSQI global score has a possible range of 0-21 points. A total score of 5 or above indicates overall poor sleep quality.
Measured: Baseline, Up to 4 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 start1 Aug 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Community Foundation for Brevard
- 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
- NCT06571305
- Sponsor's protocol ID
- 20231290
- Other IDs
- NCI-2024-06704
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FAMILY Sleep Program
- ClinicalTrials.gov ID
- NCT06571305
- Acronym / sponsor ID
- 20231290
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Community Foundation for Brevard
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (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 partners. Participants (patient-sleep-partner caregivers dyads as a unit) participate in the study together.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 2 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 4 weeks. |
| Phase 2 MSOS Intervention Group | Experimental | Behavioral: My Sleep Our Sleep (MSOS)Participants (patient-sleep-partner caregiver dyads) in this group will receive the My Sleep Our Sleep (MSOS) intervention. Total participation is up to 4 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 (7 listed)
- 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 |
|---|---|---|
| Brief Behavioral Treatment for Insomnia (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 spent 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 | Phase 2 BBTI Intervention Group |
| My Sleep Our Sleep (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. | Behavioural | Phase 2 MSOS Intervention Group |
Primary outcome
Proportion of participants adapting to BBTI
Time frame: Up to 4 weeks
The proportion of participants (patient--sleep-partner caregiver dyads) who adapt to Brief Behavioral Treatment for Insomnia (BBTI).
Change in Sleep Disturbance Symptoms Measured by Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, Up to 4 weeks
The proportion of participants (patient-sleep-partner caregiver dyads) experiencing a change in sleep disturbance symptoms will be compared and reported for both intervention groups, BBTI and MSOS, as measured by scores on the Pittsburgh Sleep Quality Index (PSQI) health-related quality of life HRQOL) questionnaire. The PSQI is a self-reported, 19-item questionnaire which assesses sleep quality and disturbances at baseline and over a four week period. 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. The PSQI global score has a possible range of 0-21 points. A total score of 5 or above indicates overall poor sleep quality.
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 14 Aug 2026.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Behavioral Treatment for Insomnia (BBTI) and My Sleep Our Sleep (MSOS) in people with Cancer, 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 13 inclusion and 7 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 14 Aug 2026. 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?
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?
Proportion of participants adapting to BBTI (time frame: Up to 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?
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 14 Aug 2026.