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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Prostate Cancer, Sleep Disturbance, Fatigue, Cognitive Impairment

Intervention / Treatment
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* Behavioral: teleCBT-I + SH/ReadiWatchTM
* Behavioral: SH/ReadiWatchTM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SH/ReadiWatchTM<br>Participants receive real-time feedback on sleep metrics and sleep hygiene education | Behavioral: SH/ReadiWatchTM<br>* Participants receive real time feedback on sleep metrics and education on sleep hygiene<br>|
| Experimental: teleCBT-I + SH/ReadiWatchTM<br>Participants receive real-time feedback on sleep metrics and sleep hygiene education plus cognitive cognitive behavioral therapy for insomnia | Behavioral: teleCBT-I + SH/ReadiWatchTM<br>* Participants receive real time feedback on sleep metrics, education on sleep hygiene and a four-week virtual cognitive behavioral therapy for insomnia intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as measured by percentage of target sample enrolled |  | Through study completion (an average of 24 months) | 
| Feasibility as measured by percentage of adherence to ReadiWatch wear time over two months |  | Two months | 
| Feasibility as measured by percent attrition for the four teleCBT-I sessions |  | Two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Memory, Sleep Disturbance, Fatigue, Prostate Cancer, Concentration