Electronic Patient Reported Outcomes in Measuring Health-Related Quality of Life in Patients With Stage I-IV Prostate Cancer Undergoing Treatment
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|ClinicalTrials.gov Identifier: NCT03197948|
Recruitment Status : Terminated (slow accrual)
First Posted : June 23, 2017
Last Update Posted : June 12, 2018
|Condition or disease||Intervention/treatment|
|Prostate||Other: Internet-Based Intervention|
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.
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||A Pilot Feasibility Trial Examining the Use of Electronic Patient-Reported Outcomes in Prostate Cancer Patients With Apple ResearchKit Smartphone Application|
|Actual Study Start Date :||July 28, 2016|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||June 8, 2018|
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
Complete questionnaire via a smartphone application
- Feasibility defined as satisfactory completion (60%) of weekly questionnaires [ Time Frame: Up to 3 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03197948
|United States, Pennsylvania|
|Sidney Kimmel Cancer Center at Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Adam Dicker, MD||Sidney Kimmel Cancer Center at Thomas Jefferson University|