RECRUITING

FAMILY Sleep Program

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Conditions

Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

FAMILY Sleep Program

Quick Facts

Study Start:2024-08-01
Study Completion:2026-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06571305

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * The eligibility criteria for patients are
  2. * newly diagnosed with stage I to IV of a solid tumor
  3. * diagnosis in the past three years at the time of enrollment
  4. * having a consistent sleep partner.
  5. * The eligibility criterion for caregivers is
  6. * a sleep partner of the patient.
  7. * Additional eligibility criteria for both patients and caregivers are
  8. * Pittsburgh Sleep Quality Index (PSQI) ≥ 5,
  9. * willing to change sub-optimal sleep habits,
  10. * 18 years or older,
  11. * able to speak/listen English at the 8th grade level for intervention sessions,
  12. * able to read English or Spanish at the 8th grade for self-reported questionnaires, reside in Brevard County, Florida (FL),
  13. * 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.
  1. * Exclusion criteria for both patients and caregivers are:
  2. * having had a diagnosis of major depressive disorder, psychosis, or bipolar disorder that is not currently treated;
  3. * active suicidality, or substance or alcohol dependency in the past year;
  4. * currently have narcolepsy, restless leg syndrome, or untreated sleep apnea that is screened using the Sleep Health Screen;
  5. * both patients and caregivers have an extreme chronotype, or do shift work to have no overlap in sleep schedule between them; and
  6. * plan trans-meridian travel during the period of data collection blocks; and
  7. * having hearing or visual impairment, dementia, or cognitive dysfunction.
  8. * Adults unable to consent, individuals who are not yet adults, pregnant women, or prisoners will be excluded.

Contacts and Locations

Study Contact

Youngmee Kim, PhD
CONTACT
305-284-5439
ykim@miami.edu

Principal Investigator

Youngmee Kim, PhD
PRINCIPAL_INVESTIGATOR
University of Miami

Study Locations (Sites)

University of Miami
Coral Gables, Florida, 33146
United States

Collaborators and Investigators

Sponsor: University of Miami

  • Youngmee Kim, PhD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-01
Study Completion Date2026-10-01

Study Record Updates

Study Start Date2024-08-01
Study Completion Date2026-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Cancer