Prostate Cancer Clinical Trial

Clinical Utility Study for MyProstateScore+

Summary

This is a national-level research study of urologists. The purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling and other) of a subset of common patient care indications.

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Full Description

The results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidance. The data from this study will be submitted to a national journal for publication. The study plans to enroll up to 250 physicians.

Upon consenting and agreeing to participate in this study, participants will be asked to care for 3 simulated patient cases, known as Clinical Performance and Value Vignettes (CPV®). CPVs describe patients physicians typically encounter in their daily practice and are not meant to be difficult. In each vignette, physicians are asked to share their expected care through 5 domains: 1) history, 2) physical exam, 3) diagnostic workup, 4) diagnosis and 5) treatment and follow-up. Each case takes approximately 15-20 minutes to complete and we estimate the time commitment for each round of CPV administration to be approximately 45 - 60 minutes. All responses to the cases will be completed online and will be kept confidential. Over 2 CPV administration rounds, the total time to care for the simulated patients is estimated at 1.5-2 hours.

If physicians are randomized to an intervention group in this study, they will receive education materials on a novel diagnostic test after the first round of CPV administration. They are asked to review these materials before moving to the next CPV administration round. Time to review education materials is estimated to be approximately 15 minutes.

Depending on the results of this randomized controlled trial, there may be an opportunity for physicians to re-enroll into a follow-on study. If they choose to participate in this second study, they will be asked to identify and send de-identified records of patients in their practice that are similar to the simulated patients they previously cared for in this study.

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Eligibility Criteria

Inclusion Criteria:

Board-certified urologists for at least two years
Averaging at least 20 hours per week of clinical and patient care duties over the last six months
Routinely evaluate patients at risk for prostate cancer in their practice
Practicing in the U.S.
English speaking
Access to the internet
Informed, signed and voluntarily consented to be in the study

Exclusion Criteria:

Non-English speaking
Unable to access the internet
Not practicing in the U.S.
Not averaging at least 20 hours per week of clinical or patient care duties over the last six months
Previous exposure to the MyProstateScore test
Do not voluntarily consent to be in the study

Study is for people with:

Prostate Cancer

Estimated Enrollment:

249

Study ID:

NCT05525806

Recruitment Status:

Recruiting

Sponsor:

Qure Healthcare, LLC

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There is 1 Location for this study

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QURE Healthcare
San Francisco California, 94109, United States More Info
John W Peabody, MD
Contact
415-321-3388
[email protected]
John W Peabody, MD
Principal Investigator

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

249

Study ID:

NCT05525806

Recruitment Status:

Recruiting

Sponsor:


Qure Healthcare, LLC

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