Exploring sleep behaviors in cancer patients and their caregivers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: ykim@miami.edu
• Phone: 305-284-5439

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.