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 (SHERE-Relief 2)

May 15, 2024 updated by: University of Kansas Medical Center

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 (ADT) (SHERE-Relief 2)

Many treatments for prostate cancer can cause significant fatigue and/or problems with memory and concentration. Many treatments for prostate cancer also result in disturbed sleep. Improving sleep may reduce feelings of fatigue and improve memory and concentration. The purpose of this study is to test a wearable device that provides real-time feedback on sleep patterns, instruction on how to improve sleep, and a score that indicates periods of time when fatigue and issues with memory and concentration may be most troublesome. The study also is designed to test a type of treatment (cognitive behavioral therapy for insomnia, CBT-I) that is helpful for people who are experiencing disturbed sleep.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • At least 18 years old
  • Diagnosed with any stage of prostate cancer
  • Receiving androgen deprivation therapy
  • Able to speak and read English
  • Score >/= 8 on Insomnia Severity Index

Exclusion Criteria:

  • Diagnosis of Alzheimer's Disease or related dementias, or other conditions that would prevent informed consent
  • Sleep apnea not utilizing/or adherent to CPAP
  • Uncontrolled restless legs syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SH/ReadiWatchTM
Participants receive real-time feedback on sleep metrics and sleep hygiene education
Behavioral: SH/ReadiWatchTM
Participants receive real time feedback on sleep metrics and education on sleep hygiene
Experimental: teleCBT-I + SH/ReadiWatchTM
Participants receive real-time feedback on sleep metrics and sleep hygiene education plus cognitive cognitive behavioral therapy for insomnia
Behavioral: teleCBT-I + SH/ReadiWatchTM
Participants receive real time feedback on sleep metrics, education on sleep hygiene and a four-week virtual cognitive behavioral therapy for insomnia intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility as measured by percentage of target sample enrolled
Time Frame: Through study completion (an average of 24 months)
Through study completion (an average of 24 months)
Feasibility as measured by percentage of adherence to ReadiWatch wear time over two months
Time Frame: Two months
Two months
Feasibility as measured by percent attrition for the four teleCBT-I sessions
Time Frame: Two months
Two months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline for participants' ReadiScores
Time Frame: one month, two months
ReadiScores are measured by the SAFTE algorithm developed by the Department of Defense and reflect fatigue and cognitive function (range 0 to 100)
one month, two months
Change from baseline for participants' sleep metrics for total sleep time (hours per night)
Time Frame: one month, two months
total sleep time in hours per night measured by the SAFTE algorithm.
one month, two months
Change from baseline for participants' sleep metrics for sleep efficiency (total sleep time divided by time in bed)
Time Frame: one month, two months
sleep efficiency equals total sleep time in hours per night divided by time in bed as measured by the SAFTE algorithm.
one month, two months
Change from baseline in insomnia severity
Time Frame: one months, two months
Measured by the Insomnia Severity Index (total score ranges from 0-28 with higher scores indicating worse insomnia severity.
one months, two months
Change from baseline in sleep quality
Time Frame: one months, two months
Measured by Pittsburgh Sleep Quality Index (7 component scores calculated from 18 items yielding a global score. Higher scores indicate worse sleep quality
one months, two months
Change from baseline in cancer related fatigue, anxiety, depression, and health related quality of life
Time Frame: one months, two months
Measured by items and total score on the Patient Reported Outcomes Management System-29+2 (PROPr). Likert style items with variable ranges, raw scores converted to T-scores and standard deviations.
one months, two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

Oncology Nursing Society

Investigators

  • Principal Investigator: Jamie Myers, PhD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2022

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

September 15, 2022

First Submitted That Met QC Criteria

October 12, 2022

First Posted (Actual)

October 17, 2022

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00148836

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fatigue

Clinical Trials on SH/ReadiWatchTM

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe