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Dyadic Sleep Study

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University of Miami

Status

Enrolling

Conditions

Gastrointestinal Cancer

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06569693
20240214
R21NR021083 (U.S. NIH Grant/Contract)

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 caregiver partners.

Enrollment

152 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 GI cancer (anus, colon, esophagus, gallbladder, large and small intestine, liver, pancreas, rectum, stomach, other biliary or digestive organs)
    • diagnosis in the past 12 months 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,
    • > 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

Single Blind

152 participants in 2 patient groups

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 13 weeks.
Treatment:
Behavioral: My Sleep Our Sleep (MSOS) Program
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 13 weeks.
Treatment:
Behavioral: Brief Behavioral Treatment for Insomnia (BBTI)

Trial contacts and locations

1

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Central trial contact

Youngmee Kim, PhD

Data sourced from clinicaltrials.gov

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