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

NCT05582759 | Completed

• 1 other identifier: STUDY00148836
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Sleep Disturbance; Fatigue; Cognitive Impairment

Keywords

Prostate Cancer; Sleep Disturbance; Fatigue; Memory; Concentration

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Change from baseline for participants' ReadiScores

  one month, two months

• Change from baseline for participants' sleep metrics for total sleep time (hours per night)

  one month, two months

• Change from baseline for participants' sleep metrics for sleep efficiency (total sleep time divided by time in bed)

  one month, two months

• Change from baseline in insomnia severity

  one months, two months

• Change from baseline in sleep quality

  one months, two months

Study Arms (2)

SH/ReadiWatchTM

ACTIVE COMPARATOR

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

Behavioral: SH/ReadiWatchTM

teleCBT-I + SH/ReadiWatchTM

EXPERIMENTAL

Participants receive real-time feedback on sleep metrics and sleep hygiene education plus cognitive cognitive behavioral therapy for insomnia

Behavioral: teleCBT-I + SH/ReadiWatchTM

Interventions

teleCBT-I + SH/ReadiWatchTM BEHAVIORAL

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

teleCBT-I + SH/ReadiWatchTM

SH/ReadiWatchTM BEHAVIORAL

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

SH/ReadiWatchTM

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Oncology Nursing Society: collaborator

Study Sites (1)

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Parasomnias; Fatigue; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders

Study Officials

• Jamie Myers, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: October 17, 2022
• Study Start: October 24, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)