Clinical trial · Observational
Electronic Patient Reported Outcomes in Measuring Health-Related Quality of Life in Patients With Stage I-IV Prostate Cancer Undergoing Treatment
A Pilot Feasibility Trial Examining the Use of Electronic Patient-Reported Outcomes in Prostate Cancer Patients With Apple ResearchKit Smartphone Application
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Internet-Based Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Health Services Research (electronic patient reported outcome)
- description
- 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.
- interventionNames
- Other: Internet-Based Intervention
Primary outcomes (1)
- measure
- Feasibility defined as satisfactory completion (60%) of weekly questionnaires
- timeFrame
- Up to 3 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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