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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)

Primary Purpose

Prostate Cancer, Sleep Disturbance, Fatigue

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
teleCBT-I + SH/ReadiWatchTM
SH/ReadiWatchTM
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring Prostate Cancer, Sleep Disturbance, Fatigue, Memory, Concentration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

SH/ReadiWatchTM

teleCBT-I + SH/ReadiWatchTM

Arm Description

Participants receive real-time feedback on sleep metrics and sleep hygiene education

Participants receive real-time feedback on sleep metrics and sleep hygiene education plus cognitive cognitive behavioral therapy for insomnia

Outcomes

Primary Outcome Measures

Feasibility as measured by percentage of target sample enrolled
Feasibility as measured by percentage of adherence to ReadiWatch wear time over two months
Feasibility as measured by percent attrition for the four teleCBT-I sessions

Secondary Outcome Measures

Change from baseline for participants' ReadiScores
ReadiScores are measured by the SAFTE algorithm developed by the Department of Defense and reflect fatigue and cognitive function (range 0 to 100)
Change from baseline for participants' sleep metrics for total sleep time (hours per night)
total sleep time in hours per night measured by the SAFTE algorithm.
Change from baseline for participants' sleep metrics for sleep efficiency (total sleep time divided by time in bed)
sleep efficiency equals total sleep time in hours per night divided by time in bed as measured by the SAFTE algorithm.
Change from baseline in insomnia severity
Measured by the Insomnia Severity Index (total score ranges from 0-28 with higher scores indicating worse insomnia severity.
Change from baseline in sleep quality
Measured by Pittsburgh Sleep Quality Index (7 component scores calculated from 18 items yielding a global score. Higher scores indicate worse sleep quality
Change from baseline in cancer related fatigue, anxiety, depression, and health related quality of life
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.

Full Information

First Posted
September 15, 2022
Last Updated
May 8, 2023
Sponsor
University of Kansas Medical Center
Collaborators
Oncology Nursing Society
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1. Study Identification

Unique Protocol Identification Number
NCT05582759
Brief Title
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
Acronym
SHERE-Relief 2
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
Oncology Nursing Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Sleep Disturbance, Fatigue, Cognitive Impairment
Keywords
Prostate Cancer, Sleep Disturbance, Fatigue, Memory, Concentration

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SH/ReadiWatchTM
Arm Type
Active Comparator
Arm Description
Participants receive real-time feedback on sleep metrics and sleep hygiene education
Arm Title
teleCBT-I + SH/ReadiWatchTM
Arm Type
Experimental
Arm Description
Participants receive real-time feedback on sleep metrics and sleep hygiene education plus cognitive cognitive behavioral therapy for insomnia
Intervention Type
Behavioral
Intervention Name(s)
teleCBT-I + SH/ReadiWatchTM
Intervention Description
Participants receive real time feedback on sleep metrics, education on sleep hygiene and a four-week virtual cognitive behavioral therapy for insomnia intervention
Intervention Type
Behavioral
Intervention Name(s)
SH/ReadiWatchTM
Intervention Description
Participants receive real time feedback on sleep metrics and education on sleep hygiene
Primary Outcome Measure Information:
Title
Feasibility as measured by percentage of target sample enrolled
Time Frame
Through study completion (an average of 24 months)
Title
Feasibility as measured by percentage of adherence to ReadiWatch wear time over two months
Time Frame
Two months
Title
Feasibility as measured by percent attrition for the four teleCBT-I sessions
Time Frame
Two months
Secondary Outcome Measure Information:
Title
Change from baseline for participants' ReadiScores
Description
ReadiScores are measured by the SAFTE algorithm developed by the Department of Defense and reflect fatigue and cognitive function (range 0 to 100)
Time Frame
one month, two months
Title
Change from baseline for participants' sleep metrics for total sleep time (hours per night)
Description
total sleep time in hours per night measured by the SAFTE algorithm.
Time Frame
one month, two months
Title
Change from baseline for participants' sleep metrics for sleep efficiency (total sleep time divided by time in bed)
Description
sleep efficiency equals total sleep time in hours per night divided by time in bed as measured by the SAFTE algorithm.
Time Frame
one month, two months
Title
Change from baseline in insomnia severity
Description
Measured by the Insomnia Severity Index (total score ranges from 0-28 with higher scores indicating worse insomnia severity.
Time Frame
one months, two months
Title
Change from baseline in sleep quality
Description
Measured by Pittsburgh Sleep Quality Index (7 component scores calculated from 18 items yielding a global score. Higher scores indicate worse sleep quality
Time Frame
one months, two months
Title
Change from baseline in cancer related fatigue, anxiety, depression, and health related quality of life
Description
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.
Time Frame
one months, two months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamie Myers, PhD
Phone
9134495996
Email
jmyers@kumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie Myers, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Myers, PhD
Phone
913-449-5996
Email
jmyers@kumc.edu
First Name & Middle Initial & Last Name & Degree
Jamie Myers, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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