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Cognitive Behavioral Therapy for Insomnia in Prostate Cancer (SHERE-Relief 2 Trial)
N/A
Waitlist Available
Led By Jamie Myers, PhD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one months, two months
Awards & highlights
SHERE-Relief 2 Trial Summary
This trial studies how a wearable device and CBT-I can help reduce fatigue, memory and concentration issues linked to prostate cancer treatments.
Who is the study for?
Men over 18 with any stage of prostate cancer on androgen deprivation therapy, who can speak/read English and have significant insomnia (score ≥8 on Insomnia Severity Index). Excludes those with Alzheimer's/dementia, untreated sleep apnea, or uncontrolled restless legs syndrome.Check my eligibility
What is being tested?
The trial is testing a wearable device (ReadiWatchTM) that tracks sleep patterns and provides feedback alongside sleep improvement education. It also evaluates telehealth cognitive behavioral therapy for insomnia to see if it reduces fatigue and improves memory/concentration.See study design
What are the potential side effects?
Potential side effects are not explicitly mentioned for the interventions in this study; however, participants may experience discomfort from wearing the device or stress/anxiety from behavior change techniques used in CBT-I.
SHERE-Relief 2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ two months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility as measured by percent attrition for the four teleCBT-I sessions
Feasibility as measured by percentage of adherence to ReadiWatch wear time over two months
Feasibility as measured by percentage of target sample enrolled
Secondary outcome measures
Change from baseline for participants' ReadiScores
Change from baseline for participants' sleep metrics for sleep efficiency (total sleep time divided by time in bed)
Change from baseline for participants' sleep metrics for total sleep time (hours per night)
+3 moreSHERE-Relief 2 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: teleCBT-I + SH/ReadiWatchTMExperimental Treatment1 Intervention
Participants receive real-time feedback on sleep metrics and sleep hygiene education plus cognitive cognitive behavioral therapy for insomnia
Group II: SH/ReadiWatchTMActive Control1 Intervention
Participants receive real-time feedback on sleep metrics and sleep hygiene education
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
teleCBT-I + SH/ReadiWatchTM
2022
N/A
~50
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Who is running the clinical trial?
Oncology Nursing SocietyOTHER
10 Previous Clinical Trials
459 Total Patients Enrolled
University of Kansas Medical CenterLead Sponsor
470 Previous Clinical Trials
171,377 Total Patients Enrolled
10 Trials studying Prostate Cancer
577 Patients Enrolled for Prostate Cancer
Jamie Myers, PhDPrincipal InvestigatorUniversity of Kansas Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have restless legs syndrome that isn't managed by treatment.I am currently on hormone therapy for cancer.I have been diagnosed with prostate cancer.
Research Study Groups:
This trial has the following groups:- Group 1: SH/ReadiWatchTM
- Group 2: teleCBT-I + SH/ReadiWatchTM
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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