Dyadic Sleep Study

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

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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)