Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06571305

FAMILY Sleep Program

Led by University of Miami · Updated on 2025-08-26

12

Participants Needed

1

Research Sites

113 weeks

Total Duration

On this page

Sponsors

U

University of Miami

Lead Sponsor

C

Community Foundation for Brevard

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

FAMILY Sleep Program

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients newly diagnosed with stage I to IV solid tumor
  • Diagnosis made within the past seven years
  • Having a consistent sleep partner
  • Caregivers must be the patient's sleep partner
  • Both patients and caregivers with a Pittsburgh Sleep Quality Index (PSQI) score of 5 or higher
  • Willing to change sub-optimal sleep habits
  • Age 18 years or older
  • Able to speak and listen in English at an 8th grade level for sessions
  • Able to read English or Spanish at an 8th grade level for questionnaires
  • Reside in Brevard County, Florida
  • For participants of Aim 2, more than 4 weeks after surgery, if any, before enrollment
  • No planned surgery in the next 5 weeks during the study period
Not Eligible

You will not qualify if you...

  • Diagnosis of untreated major depressive disorder, psychosis, or bipolar disorder
  • Active suicidality or substance/alcohol dependency in the past year
  • Currently have narcolepsy, restless leg syndrome, or untreated sleep apnea
  • Extreme chronotype or shift work causing no sleep schedule overlap between patient and caregiver
  • Plans for trans-meridian travel during data collection
  • Hearing or visual impairments, dementia, or cognitive dysfunction
  • Adults unable to consent
  • Individuals under 18 years of age
  • Pregnant women
  • Prisoners

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Miami

Coral Gables, Florida, United States, 33146

Actively Recruiting

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Research Team

Y

Youngmee Kim, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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