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NCT Number: NCT06569693

Dyadic Sleep Study

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

Recruiting

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Key information

Conditions

Gastrointestinal Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami, Coral Gables, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: MSOS

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.

Other names: BBTI

Primary outcomes

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

    Time frame: Baseline, Up to 13 weeks

    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.

Secondary outcomes

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

    Time frame: Baseline, Up to 13 weeks

    Change in insomnia symptoms among participants (patient-sleep-partner caregiver dyads) will be compared and reported for both intervention groups, BBTI and MSOS, as measured by scores on the 7-item Insomnia Severity Index (ISI). The ISI is a self-reported, health-related quality of life (HRQOL) questionnaire used to assess insomnia symptoms at baseline, week 5 and week 13. The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, notice ability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item, ranging from 0 to 4 (e.g., 0 = no problem; 4 = very severe problem). The total score ranges from 0 to 28, the lower total score indicates a lower level of insomnia. Greater than a 6-point decrease on the ISI is considered substantial reduction in insomnia symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Youngmee Kim, PhD

CONTACT

[email protected]

305-284-5439

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2024
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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