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.
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
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