← Back to Search

Behavioral Intervention

Sleep Treatments for Gastrointestinal Cancer

N/A
Waitlist Available
Led By Youngmee Kim, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Both patients and caregivers must be 18 years or older
Be older than 18 years old
Must not have
Adults unable to consent, individuals who are not yet adults, pregnant women, or prisoners
Patients and caregivers with a diagnosis of major depressive disorder, psychosis, or bipolar disorder that is not currently treated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to 13 weeks
Awards & highlights

Summary

"This trial aims to understand how people with cancer and their caregivers sleep, and to test various methods to improve their sleep."

Who is the study for?
This trial is for adult patients recently diagnosed with stages I-IV gastrointestinal cancer and their sleep partners who are willing to improve sub-optimal sleep habits. Both must read and speak English or Spanish at an 8th grade level, have a PSQI score ≥ 5, be over 4 weeks post-surgery with no upcoming surgeries planned during the study.
What is being tested?
The study aims to understand sleep behaviors in cancer patients and their caregivers by testing two programs: 'My Sleep Our Sleep' (MSOS) and 'Brief Behavioral Treatment for Insomnia' (BBTI). Participants will learn ways to manage insomnia related to cancer care.
What are the potential side effects?
Since this trial involves behavioral interventions rather than medications, traditional side effects like those seen with drugs are not expected. However, participants may experience changes in mood or stress levels due to alterations in sleep patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am an adult capable of giving consent, not pregnant, and not incarcerated.
Select...
I have depression, psychosis, or bipolar disorder that is not being treated.
Select...
I have been diagnosed with narcolepsy, restless leg syndrome, or untreated sleep apnea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 13 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to 13 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in sleep disturbance symptoms as measured by scores on the Pittsburgh Sleep Quality Index (PSQI)
Secondary study objectives
Change in insomnia symptoms as measured by scores on the Insomnia Severity Index (ISI)

Trial Design

2Treatment groups
Experimental Treatment
Group I: MSOS Intervention GroupExperimental Treatment1 Intervention
Participants (patient-sleep-partner caregiver dyads) in this group will receive the My Sleep Our Sleep (MSOS) intervention. Total participation is up to 13 weeks.
Group II: BBTI Intervention GroupExperimental Treatment1 Intervention
Participants (patient-sleep-partner caregiver dyads) in this group will receive the Brief Behavioral Treatment for Insomnia (BBTI). Total participation is up to 13 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
My Sleep Our Sleep (MSOS) Program
2021
N/A
~30

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
935 Previous Clinical Trials
422,065 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
598 Previous Clinical Trials
10,378,010 Total Patients Enrolled
Youngmee Kim, PhDPrincipal InvestigatorUniversity of Miami
2 Previous Clinical Trials
62 Total Patients Enrolled
~101 spots leftby Oct 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top