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

University of Kansas Medical Center45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Prostate Cancer Sleep Disturbance Fatigue Cognitive Impairment

Interventions

teleCBT-I + SH/ReadiWatchTMBEHAVIORAL

Participants receive real time feedback on sleep metrics, education on sleep hygiene and a four-week virtual cognitive behavioral therapy for insomnia intervention

SH/ReadiWatchTMBEHAVIORAL

Participants receive real time feedback on sleep metrics and education on sleep hygiene

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Kansas Cancer Center

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

Feasibility as measured by percentage of target sample enrolled

Time frame: Through study completion (an average of 24 months)

Feasibility as measured by percentage of adherence to ReadiWatch wear time over two months

Time frame: Two months

Feasibility as measured by percent attrition for the four teleCBT-I sessions

Time frame: Two months

Secondary Outcomes

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)

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: one months, two months

Data from ClinicalTrials.gov

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