Recruiting

Observational Study

Sponsor:

University of Miami

Code:

NCT06569693

Conditions

Gastrointestinal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

My Sleep Our Sleep (MSOS) Program

Brief Behavioral Treatment for Insomnia (BBTI)

Study Details

Brief summary:

The purpose of this study is to learn about sleep behaviors and test different ways to help patients with cancer and caregiver partners.

Conditions

Gastrointestinal Cancer

Study ID

NCT06569693

Start date

Oct 22, 2024

Status verified date

Mar, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 72 months at the time of enrollment
  • having a consistent sleep partner.
  • The eligibility criterion for caregivers is:

  • a sleep partner of the patient or partner who wish to resume sleeping together with 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.

Study Design

Enrollment

152 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: MSOS Intervention Group

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.

experimental: BBTI Intervention Group

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.

Interventions

My Sleep Our Sleep (MSOS) Program

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.

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 they spend 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.

BBTI will be delivered over four weeks, in weekly one-hour sessions, one session per week.

Primary outcome measure

  • Change in sleep disturbance symptoms as measured by scores on the Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, Up to 13 weeks ]

Central Contacts and Locations

Central contacts

Youngmee Kim, PhD

305-284-5439ykim@miami.edu

Locations

University of Miami

Recruiting

Coral Gables, Florida, United States, 33146

Contacts

Youngmee Kim, PhD

305-284-5439ykim@miami.edu

Principal Investigator:

Youngmee Kim, PhD

More Information

Sponsor

University of Miami

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-03-09.