FAMILY Sleep Program

Overview

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.

Interventions

• Behavioral Brief Behavioral Treatment for Insomnia (BBTI)
  BBTI is brief patient-focused intervention for patient-sleep-partner caregiver dyads, aimed at altering participants' sleep behaviors to improve sleep. BBTI utilizes behavioral education in sleep restriction and stimulus control. For sleep restriction, participants will be instructed to limit the time spent in bed, which serves to increase sleep efficiency. For stimulus control, participants will be instructed to go to bed only when feeling sleepy and reserve the bed for sleep and intimacy. BBT
• Behavioral My Sleep Our Sleep (MSOS)
  MSOS is a sleep intervention developed by the investigator aimed at improving sleep health for patient-sleep-partner caregiver dyads using behavioral education in sleep behaviors, sleep cognition and sleep in relationship. MSOS will be delivered over four weeks, in weekly one-hour sessions, one session per week.

Primary outcome measures

• Proportion of participants adapting to BBTI [Time frame: Up to 4 weeks]
• Change in Sleep Disturbance Symptoms Measured by Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline, Up to 4 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• University of Miami — Coral Gables

Identifiers

NCT: NCT06571305 · 20231290 · NCI-2024-06704

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗