Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06571305 | RECRUITING | Cancer

FAMILY Sleep Program
Sponsor:

University of Miami

Information provided by (Responsible Party):

Youngmee Kim

Brief 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.

Condition or disease

Cancer

Intervention/treatment

Brief Behavioral Treatment for Insomnia (BBTI)

My Sleep Our Sleep (MSOS)

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 12 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : FAMILY Sleep Program
Actual Study Start Date : 2024-08-01
Estimated Primary Completion Date : 2026-10-01
Estimated Study Completion Date : 2026-10-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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.
FAMILY Sleep Program

Location Details

NCT06571305

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

University of Miami

Coral Gables, florida, United States, 33146