Clinical trial 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
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
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Sleep Disturbance
Fatigue
Cognitive Impairment
Keywords: Prostate Cancer
Sleep Disturbance
Fatigue
Memory
Concentration
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Oncology Nursing Society
First posted: 2022-10-17
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Feasibility as measured by percentage of target sample enrolled
timeFrame: Through study completion (an average of 24 months)
measure: Feasibility as measured by percentage of adherence to ReadiWatch wear time over two months
timeFrame: Two months
measure: Feasibility as measured by percent attrition for the four teleCBT-I sessions
timeFrame: Two months
Secondary outcomes:
measure: Change from baseline for participants' ReadiScores
timeFrame: one month, two months
measure: Change from baseline for participants' sleep metrics for total sleep time (hours per night)
timeFrame: one month, two months
measure: Change from baseline for participants' sleep metrics for sleep efficiency (total sleep time divided by time in bed)
timeFrame: one month, two months
measure: Change from baseline in insomnia severity
timeFrame: one months, two months
measure: Change from baseline in sleep quality
timeFrame: one months, two months
measure: Change from baseline in cancer related fatigue, anxiety, depression, and health related quality of life
timeFrame: one months, two months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Cancer Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jamie Myers, PhD
role: PRINCIPAL_INVESTIGATOR
References: