Program to improve sleep for cancer patients and their partners

FAMILY Sleep Program

This study tests a program to help newly diagnosed cancer patients and their sleep partners improve their sleep quality through different treatments and activities.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Miami (Academic / other)
• Locations: 1 site (Coral Gables, Florida)
• Trial ID: NCT06571305 on ClinicalTrials.gov

What this trial studies

This program aims to understand sleep behaviors and test interventions designed to improve sleep quality for patients diagnosed with cancer and their sleep partners. Participants, consisting of patient-caregiver dyads, will engage in interventions such as Brief Behavioral Treatment for Insomnia (BBTI) and My Sleep Our Sleep (MSOS). The study focuses on newly diagnosed cancer patients with a consistent sleep partner, assessing their sleep quality and habits through structured sessions and self-reported questionnaires.

Who should consider this trial

Good fit: Ideal candidates include newly diagnosed cancer patients with stage I to IV solid tumors who have a consistent sleep partner and are willing to improve their sleep habits.

Not a fit: Patients who do not have a sleep partner or those who are not newly diagnosed with cancer may not benefit from this program.

Why it matters

Potential benefit: If successful, this program could significantly enhance sleep quality and overall well-being for cancer patients and their caregivers.

How similar studies have performed: While similar approaches to improving sleep in cancer patients have been explored, this specific program's combined focus on patient-caregiver dyads is relatively novel.

Eligibility 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.

Where this trial is running

Coral Gables, Florida

• University of Miami — Coral Gables, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Youngmee Kim, PhD — University of Miami
• Study coordinator: Youngmee Kim, PhD

Conditions Cancer