New study aims to help cancer patients and their partners sleep better together
NCT ID NCT06569693
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at sleep habits in people with gastrointestinal cancer and their sleep partners. It tests two different programs to help improve sleep quality and reduce insomnia. About 152 patient-partner pairs will take part, and their sleep will be tracked using questionnaires over 13 weeks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 152 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Miami
RECRUITINGCoral Gables, Florida, 33146, United States
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University of Pittsburgh
ACTIVE_NOT_RECRUITINGPittsburgh, Pennsylvania, 15260, United States
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