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)
Status
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Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
45 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Jamie Myers, PhD
Data sourced from clinicaltrials.gov
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