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

Prostate Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05582759
• Other study ID #: STUDY00148836
• Status: Completed
• Phase: N/A
• Start date: October 24, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2024
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Impairment
• Dyssomnias
• Fatigue
• Parasomnias
• Prostate Cancer
• Prostatic Neoplasms
• Sleep Disturbance

Intervention

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
• SH/ReadiWatchTM
Participants receive real time feedback on sleep metrics and education on sleep hygiene

Locations

Country	Name	City	State
United States	University of Kansas Cancer Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Oncology Nursing Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as measured by percentage of target sample enrolled		Through study completion (an average of 24 months)
Primary	Feasibility as measured by percentage of adherence to ReadiWatch wear time over two months		Two months
Primary	Feasibility as measured by percent attrition for the four teleCBT-I sessions		Two months
Secondary	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)	one month, two months
Secondary	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.	one month, two months
Secondary	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.	one month, two months
Secondary	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.	one months, two months
Secondary	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	one months, two months
Secondary	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.	one months, two months