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Completed

NCT Number: 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

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.

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Key information

Conditions

Prostate Cancer Cognition Disorders Cognitive Dysfunction Cognitive Impairment Fatigue Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Neurocognitive Disorders Parasomnias Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Sleep Disturbance Sleep Wake Disorders Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

SH/ReadiWatchTM

Behavioral

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

Primary outcomes

  1. Feasibility as measured by percentage of target sample enrolled

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

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

    Time frame: Two months

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

    Time frame: Two months

Secondary outcomes

  1. Change from baseline for participants' ReadiScores

    Time frame: one month, two months

    ReadiScores are measured by the SAFTE algorithm developed by the Department of Defense and reflect fatigue and cognitive function (range 0 to 100)

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

    Time frame: one month, two months

    total sleep time in hours per night measured by the SAFTE algorithm.

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

    Time frame: one month, two months

    sleep efficiency equals total sleep time in hours per night divided by time in bed as measured by the SAFTE algorithm.

  4. Change from baseline in insomnia severity

    Time frame: one months, two months

    Measured by the Insomnia Severity Index (total score ranges from 0-28 with higher scores indicating worse insomnia severity.

  5. Change from baseline in sleep quality

    Time frame: one months, two months

    Measured by Pittsburgh Sleep Quality Index (7 component scores calculated from 18 items yielding a global score. Higher scores indicate worse sleep quality

  6. Change from baseline in cancer related fatigue, anxiety, depression, and health related quality of life

    Time frame: one months, two months

    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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Oncology Nursing Society

Registry information

Official study 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)

Acronym: SHERE-Relief 2

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 17, 2022
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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