Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06571305

FAMILY Sleep Program

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Coral Gables, Florida, 33146, United States

Location status: Recruiting

Location contact

Youngmee Kim, PhD

CONTACT

[email protected]

305-284-5439

Youngmee Kim, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Brief Behavioral Treatment for Insomnia (BBTI)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. 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).

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Youngmee Kim, PhD

CONTACT

[email protected]

305-284-5439

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Community Foundation for Brevard

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2024
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.