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Cognitive Behavioral Therapy for Insomnia in Prostate Cancer (SHERE-Relief 2 Trial)

N/A

Recruiting

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 ~ one month, two months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one month, two months

This trial's timeline: 3 weeks for screening, Varies for treatment, and one month, two months for reporting.

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 more

SHERE-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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Oncology Nursing SocietyOTHER

10 Previous Clinical Trials

459 Total Patients Enrolled

University of Kansas Medical CenterLead Sponsor

463 Previous Clinical Trials

169,230 Total Patients Enrolled

10 Trials studying Prostate Cancer

577 Patients Enrolled for Prostate Cancer

Jamie Myers, PhDPrincipal InvestigatorUniversity of Kansas Medical Center

Media Library

SH/ReadiWatchTM Clinical Trial Eligibility Overview. Trial Name: NCT05582759 — N/A

Prostate Cancer Research Study Groups: SH/ReadiWatchTM, teleCBT-I + SH/ReadiWatchTM

Prostate Cancer Clinical Trial 2023: SH/ReadiWatchTM Highlights & Side Effects. Trial Name: NCT05582759 — N/A

SH/ReadiWatchTM 2023 Treatment Timeline for Medical Study. Trial Name: NCT05582759 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What conclusions is this research attempting to reach?

"The primary aim of this trial, to be evaluated over a two month window, is the feasibility as measured by enrolment rate. Additional metric will include ReadiScores (used in assessing fatigue/cognitive function from 0-100) captured with SAFTE algorithm developed by DoD, total sleep time per night calculated through SAFFE software and Insomnia Severity Index scores that range between 0-28; higher values indicating worse insomnia symptoms."

Answered by AI

Is enrollment in this scientific investigation still open?

"The clinical trial posted on October 1st 2022 is no longer recruiting participants, according to data found at clinicaltrials.gov. The last update was made on the 12th of October, and 1788 other trials are presently open for participant recruitment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sleep Hygiene Education, ReadiWatchTM Actigraphy, and Telehealth Cognitive Behavioral Training for Insomnia Effect, on Symptom Relief for Men With Prostate Cancer Receiving Androgen Deprivation Therapy

2022. "Sleep Hygiene Education, ReadiWatchTM Actigraphy, and Telehealth Cognitive Behavioral Training for Insomnia Effect, on Symptom Relief for Men With Prostate Cancer Receiving Androgen Deprivation Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05582759.

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