Exploring sleep behaviors in cancer patients and their caregivers

Dyadic Sleep Study

This study is testing two different programs to see if they can help improve sleep quality for people recently diagnosed with gastrointestinal cancer and their caregivers.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 152 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Miami (Academic / other)
• Locations: 2 sites (Coral Gables, Florida and 1 other locations)
• Trial ID: NCT06569693 on ClinicalTrials.gov

What this trial studies

This study aims to investigate sleep behaviors among patients newly diagnosed with gastrointestinal cancer and their caregiver partners. It will test the effectiveness of two interventions: the My Sleep Our Sleep (MSOS) Program and Brief Behavioral Treatment for Insomnia (BBTI) to improve sleep quality. Participants will include both patients and their sleep partners, focusing on those who have been diagnosed within the last year and are willing to change their sleep habits. The study will assess the impact of these interventions on sleep quality and overall well-being.

Who should consider this trial

Good fit: Ideal candidates are adults newly diagnosed with stage I to IV gastrointestinal cancer who have a consistent sleep partner.

Not a fit: Patients who are not newly diagnosed with gastrointestinal cancer or do not have a sleep partner may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve sleep quality and overall health for cancer patients and their caregivers.

How similar studies have performed: While there is limited information on similar studies, interventions targeting sleep in cancer patients have shown promise in improving quality of life.

Eligibility criteria

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.

Where this trial is running

Coral Gables, Florida and 1 other locations

• University of Miami — Coral Gables, Florida, United States (Recruiting)
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Active_not_recruiting)

Study contacts

• Principal investigator: Youngmee Kim, PhD — University of Miami
• Study coordinator: Youngmee Kim, PhD

Conditions Gastrointestinal Cancer