FAMILY Sleep Program

University of Miami

Status: Enrolling

Conditions: Cancer

Treatments: Behavioral: My Sleep Our Sleep (MSOS); Behavioral: Brief Behavioral Treatment for Insomnia (BBTI)

Study type: Interventional

Funder types: Other

Identifiers

NCT06571305

NCI-2024-06704 (Registry Identifier)

20231290

Details and patient eligibility

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Phase 2 BBTI Intervention Group

Experimental group

Description:

Participants (patient-sleep-partner caregiver dyads) in this group will receive the Brief Behavioral Treatment for Insomnia (BBTI). Total participation is up to 4 weeks.

Treatment:

Behavioral: Brief Behavioral Treatment for Insomnia (BBTI)

Phase 2 MSOS Intervention Group

Experimental group

Description:

Participants (patient-sleep-partner caregiver dyads) in this group will receive the My Sleep Our Sleep (MSOS) intervention. Total participation is up to 4 weeks.

Treatment:

Behavioral: My Sleep Our Sleep (MSOS)