Electronic Patient Reported Outcomes in Measuring Health-Related Quality of Life in Patients With Stage I-IV Prostate Cancer Undergoing Treatment



Status:Terminated
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/14/2018
Start Date:July 28, 2016
End Date:June 8, 2018

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A Pilot Feasibility Trial Examining the Use of Electronic Patient-Reported Outcomes in Prostate Cancer Patients With Apple ResearchKit Smartphone Application

This pilot clinical trial studies how well electronic patient reported outcomes work in
measuring health-related quality of life in patients with stage I-IV prostate cancer
undergoing treatment. Using a smartphone application to measure and monitor symptoms before,
during, and after treatment may help patients better detect, understand, and manage their
health.

PRIMARY OBJECTIVES:

I. To explore the feasibility of collecting electronic patient-reported outcome data using
validated health-related quality of life (HRQOL) assessment tools at baseline, during, and
after treatment through a smartphone application in adult men throughout their course of
treatment for prostate cancer.

Inclusion Criteria:

- Self-reported ability to speak and read English

- Be able to communicate on a touch screen iPhone

- Willing to provide signed informed consent

- Willing and able to comply with all study activities

- Access to WiFi connection or cellular data

- An established clinical history of prostate cancer in a spectrum of severity (all
stages)

Exclusion Criteria:

- A subject will not be eligible for inclusion in this study if in the investigator's
opinion the patient has any concurrent medical or psychiatric condition that may
preclude participation in this study or completion of self-administered questionnaires
(e.g., moderate to severe dementia and/or severe, uncontrolled schizophrenia, or other
condition that would render them unable to complete a questionnaire)

- Cognitive or other impairment (e.g., visual) that would interfere with completing a
self- administered questionnaire and with participating in a group discussion
We found this trial at
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