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| ID | Type | Description | Link |
|---|---|---|---|
| JT 8603 | Other Identifier | JeffTrial Number |
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slow accrual
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-Based Intervention | Other | Complete questionnaire via a smartphone application |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Adam Dicker, MD | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| Label | URL |
|---|---|
| Thomas Jefferson University Hospital | View source |
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