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Behavioral Intervention

Sleep Programs for Cancer Patients

N/A
Recruiting
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 being 18 years or older
Patients newly diagnosed with stage I to IV of a solid tumor
Must not have
Adults unable to consent, individuals who are not yet adults, pregnant women, or prisoners
Patients and caregivers currently having narcolepsy, restless leg syndrome, or untreated sleep apnea that is screened using the Sleep Health Screen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks
Awards & highlights

Summary

This trial aims to understand sleep patterns and test ways to support cancer patients and their partners. Both the patients and their partners will take part in the study together. "This trial focuses on studying sleep behaviors

Who is the study for?
This trial is for pairs consisting of a cancer patient and their sleep-partner caregiver. They will participate together as a unit to explore sleep behaviors and test interventions aimed at improving sleep.
What is being tested?
The study is testing two different programs: 'My Sleep Our Sleep' (MSOS) and 'Brief Behavioral Treatment for Insomnia' (BBTI). These are designed to help improve the quality of sleep for both patients with cancer and their partners.
What are the potential side effects?
Since this trial involves behavioral treatments focused on improving sleep, there may not be direct side effects like those seen with medications. However, changes in sleeping patterns could potentially lead to temporary fatigue or stress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been recently diagnosed with a solid tumor at any stage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am an adult able to give consent, not pregnant, and not incarcerated.
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I or my caregiver have narcolepsy, restless leg syndrome, or untreated sleep apnea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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 Measured by Pittsburgh Sleep Quality Index (PSQI)
Proportion of participants adapting to BBTI

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 2 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 4 weeks.
Group II: Phase 2 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 4 weeks.

Find a Location

Who is running the clinical trial?

Community Foundation for BrevardUNKNOWN
University of MiamiLead Sponsor
935 Previous Clinical Trials
422,181 Total Patients Enrolled
Youngmee Kim, PhDPrincipal InvestigatorUniversity of Miami
2 Previous Clinical Trials
178 Total Patients Enrolled
~24 spots leftby Oct 2026
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