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| ID | Type | Description | Link |
|---|---|---|---|
| 853844 | Other Identifier | University of Pennsylvania IRB |
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| Name | Class |
|---|---|
| National Comprehensive Cancer Network | NETWORK |
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The overarching goal of this trial is to develop mechanisms to improve cardiovascular care among such prostate cancer patients receiving ADT by increasing patient awareness of individualized cardiovascular risk estimates and mitigation opportunities. Patients will be given access to a web-based quality improvement tool to educate patients of cardiovascular risks in prostate cancer and to inform them of their individualized, estimated cardiovascular risk and guideline-based risk mitigation recommendations.
The study will assess the feasibility of this web-based application as a cardiovascular education tool for patients with prostate cancer.
The study will also evaluate if completion of the web-based tool improves cardiovascular care access and risk mitigation for patients with prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Men With Prostate Cancer Planned for Receiving ADT | Other | Men with prostate cancer > 18 years of age who are currently receiving or will be receiving treatment with ≥ 6 months of systemic androgen deprivation therapy (ADT). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CARE-PC Web-Based Application | Behavioral | The CARE-PC app is a pragmatic, patient-oriented, web-based application that enables the education of patients regarding cardiovascular (CV) risks and collects CV and prostate cancer-related risk variables and CV care access data from prostate cancer patients receiving ADT. |
| Measure | Description | Time Frame |
|---|---|---|
| CARE-PC Web-Based Application Completion Rate | Completion rate measured as the proportion of participants successfully completing the web-based application out of the total number of subjects approached. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient acceptance and perception of the web-based application | Acceptance/perception measured by brief embedded survey following participation in the web-based application | 18 months |
| Percent accuracy of patient-derived CV- and prostate cancer-related data elements |
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Inclusion Criteria:
Exclusion Criteria: n/a
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Doyle | Contact | 610-357-6354 | matthew.doyle@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Vivek Narayan, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 13, 2023 | Sep 19, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Accuracy assessed through parallel medical chart review by cardiology and oncology clinicians |
| 18 months |
| Prevalence of CV risk factors/disease at the time of CARE-PC web-based application participation | Prevalence assessed through parallel medical chart review by cardiology and oncology clinicians | 18 months |
| Proportion of participants with current cardiologist involvement in CV care at the time of web-based application participation | Patient reported cardiologist involvement via CARE-PC application at time of application survey completion | 18 months |
| Proportion of participants engaging in CV care within 6 months of CARE-PC web application participation | CV care engagement assessed through medical chart review by investigators within 6 months post-application survey completion | 18 months |
| Proportion of participants having changes in CV risk-reducing medications within 6 months of CARE-PC application participation. | Proportion of participants having changes in CV risk-reducing medications assessed through parallel medical chart review by cardiology and oncology clinicians within 6 months post-application survey completion | 18 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |