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

NCT03197948 | Terminated

• 2 other identifiers: 16G.052JT 8603
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Health Services Research (electronic patient reported outcome)

Patients complete questionnaires over 15 minutes once a week over 3 months via a smartphone application. Patients rate urinary function, bowel habits, sexual function, hormonal function, and overall satisfaction. Patients with advanced disease also answer questions related to pain, fatigue/lack of energy, weight loss, and worry domains.

Other: Internet-Based Intervention

Interventions

Internet-Based Intervention OTHER

Complete questionnaire via a smartphone application

Health Services Research (electronic patient reported outcome)

Eligibility Criteria

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

Study Population

The participants will consist of adult male volunteers, all of whom will be participating in a prostate cancer treatment clinical trial at Thomas Jefferson University Sidney Kimmel Cancer Center.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Thomas Jefferson University Hospital

Study Officials

• Adam Dicker, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: June 23, 2017
• Study Start: July 28, 2016
• Primary Completion: December 31, 2017
• Study Completion: June 8, 2018
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

US (1)