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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
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

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.

Condition or disease Intervention/treatment
Prostate Other: Internet-Based Intervention

Detailed 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.


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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
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Principal Investigator: Adam Dicker, MD Sidney Kimmel Cancer Center at Thomas Jefferson University

Additional Information:
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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03197948     History of Changes
Other Study ID Numbers: 16G.052
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases