NCT05582759

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Sleep Disturbance
• Fatigue
• Cognitive Impairment

Interventions

Type	Name	Description
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
BEHAVIORAL	SH/ReadiWatchTM	Participants receive real time feedback on sleep metrics and education on sleep hygiene

Timeline

• Start date: 2022-10-24
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-10-17
• Last updated: 2024-05-17

Locations

1 site across 1 country: United States