Dyadic Sleep Study

NCT06569693 | Recruiting DMC

• 2 other identifiers: 20240214R21NR021083
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Change in sleep disturbance symptoms as measured by scores on the Pittsburgh Sleep Quality Index (PSQI)

  Change in sleep disturbance symptoms (patient-sleep-partner caregiver dyads) among participants will be compared and reported for both intervention groups, BBTI and MSOS, as measured by scores on the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-reported, 19-item questionnaire health-related quality of life (HRQOL) questionnaire which assesses sleep quality and disturbances at baseline, week 5 and week 13. Questions generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. A decrease of ≥ 5 points on the PSQI) will be considered as clinical improvement of symptoms.

  Baseline, Up to 13 weeks

Secondary Outcomes (1)

• Change in insomnia symptoms as measured by scores on the Insomnia Severity Index (ISI)

  Baseline, Up to 13 weeks

Study Arms (2)

MSOS Intervention Group

EXPERIMENTAL

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.

Behavioral: My Sleep Our Sleep (MSOS) Program

BBTI Intervention Group

EXPERIMENTAL

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.

Behavioral: Brief Behavioral Treatment for Insomnia (BBTI)

Interventions

My Sleep Our Sleep (MSOS) Program BEHAVIORAL

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.

Also known as: MSOS

MSOS Intervention Group

Brief Behavioral Treatment for Insomnia (BBTI) BEHAVIORAL

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.

Also known as: BBTI

BBTI Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (2)

University of Miami

Coral Gables, Florida, 33146, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

ACTIVE NOT RECRUITING

Related Publications (1)

• Kim Y, Tsai TC, Steel JL, Ramos AR, Laurenceau JP, Troxel WM. Protocol of testing the feasibility and acceptability of two brief dyadic sleep interventions for adults with cancer and their bedpartner caregivers. Pilot Feasibility Stud. 2025 Jun 14;11(1):82. doi: 10.1186/s40814-025-01671-z.

  PMID: 40514758 DERIVED

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Youngmee Kim, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Youngmee Kim, PhD

CONTACT

305-284-5439; ykim@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: October 22, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)