Sleep Program for Cancer Patients and Partners

This study, called the FAMILY Sleep Program, is looking at ways to improve sleep for people with cancer and their sleep partners. It tests two different behavioral programs: Brief Behavioral Treatment for Insomnia (BBTI) and My Sleep Our Sleep (MSOS). BBTI teaches you and your partner ways to change sleep habits, while MSOS also includes understanding sleep in your relationship. To join, you must be an adult (18+) with a solid tumor cancer diagnosed in the past seven years, and have a consistent sleep partner. Your partner would also participate. The study aims to see how many people successfully use BBTI and if sleep problems improve, measured up to 4 weeks. The study is currently unclear on its recruitment status and plans to enroll 12 participant pairs.

Study design
This is an interventional study, meaning participants receive a specific treatment. It plans to enroll 12 participant pairs (patient and sleep partner).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Sleep disturbance symptoms are measured at baseline and up to 4 weeks after starting the program.

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NCT06571305

FAMILY Sleep Program

Recruiting
NAAges 18+InterventionalSupportive care
University of Miami
~18 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Brief Behavioral Treatment for Insomnia (BBTI)My Sleep Our Sleep (MSOS)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants adapting to BBTI
Measured over Up to 4 weeks
+1 more outcome measured
Cancer

NCT06571305

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Miami

    Coral Gables, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Youngmee Kim, PhD · PRINCIPAL_INVESTIGATOR · University of Miami

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Eligibility criteria

Inclusion

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.
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.

Exclusion

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.
  • Proportion of participants adapting to BBTIUp 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)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.