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NCT05582759Completed

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)

Source: ClinicalTrials.gov · Last updated 17 May 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
45 (actual)
First submitted
15 Sept 2022
Start date
24 Oct 2022
Primary completion date
1 Dec 2023
Lead sponsor
University of Kansas Medical Center
NCT number
NCT05582759

What you commit to

  • Study type: Interventional
  • Participants enrolled: 45
  • From 24 Oct 2022 to the primary completion date, 1 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Diagnosis of Alzheimer's Disease or related dementias, or other conditions that would prevent informed consent
  • Uncontrolled restless legs syndrome

Other

  • Sleep apnea not utilizing/or adherent to CPAP

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University of Kansas Cancer Center
Coordinator of this site? Confirm its status
Kansas CityUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.