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

Prostate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03197948
• Other study ID #: 16G.052
• Status: Terminated
• Start date: July 28, 2016
• Est. completion date: June 8, 2018

Study information

• Verified date: June 2018
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: June 8, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate
• Prostatic Neoplasms

Intervention

Other:
• Internet-Based Intervention
Complete questionnaire via a smartphone application

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility defined as satisfactory completion (60%) of weekly questionnaires	The rate of satisfactory completion will be estimated along with a one-sided exact 95% confidence interval. The method will be considered feasible if the lower bound of the confidence interval is above 0.7 or, equivalently, if at least 49/60 (82%) of participants have satisfactory completion. Rates of completion may be estimated by levels of baseline demographic or clinical characteristics.	Up to 3 months

External Links

•   Sidney Kimmel Cancer Center
•   Thomas Jefferson University Hospital