NCT06569693 · University of Miami
Dyadic Sleep Study
What this study is about
The purpose of this study is to learn about sleep behaviors and test different ways to help patients with cancer and caregiver partners.
View original scientific description
The purpose of this study is to learn about sleep behaviors and test different ways to help patients with cancer and caregiver partners.
Interventions
BEHAVIORAL
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.
BEHAVIORAL
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 measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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.
Where
- Coral Gables, Florida
- Pittsburgh, Pennsylvania
Collaborators
National Institute of Nursing Research (NINR)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 9, 2026 · Source of record for eligibility and locations