Visual decision tools to support urologists treating prostate and kidney cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective pre-post pilot will enroll up to 20 urologists (10 academic, 10 community) and capture up to 10 patient encounters before and after introducing surgeon-facing visual decision support, targeting 200 unique visits over six months. Patient visits will be audio-recorded, transcribed, and coded for discussion of surgical risks and benefits and strength of recommendation. Patients and urologists will complete surveys about communication and urologists will rate their experience and satisfaction with the visual tool. Secondary analyses will compare communication outcomes by race and care setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

In order to participate in this study, a subject must meet all of the eligibility criteria outlined below.

* Verbal informed consent was obtained to participate in the study.
* Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
* Age ≥ 18 years at the time of consent.
* For patient subjects, HIPAA authorization for the release of personal health information and a new histologic diagnosis of localized prostate cancer based on prostate biopsy or clinical diagnosis of T1 renal mass (≤7 cm in diameter) Suspicion for kidney cancer based on cross-sectional imaging. New diagnosis is defined as within 6 months of consent. T1 renal masses include solid masses or Bosniak III/IV cystic masses.
* For physician subjects, practicing urologist in North Carolina at UNC Health, Novant Health, or an affiliated site and sees patients with suspected or confirmed prostate or kidney cancer.

Exclusion Criteria:

The subjects meeting the following criteria will be excluded from study participation:

* Non-English speaking.
* Unwilling or unable to complete informed consent.
* For patient subjects:

  1. Has staging information indicating locally advanced or metastatic disease. This would include PSA \>50 ng/ml, imaging suggestive of distant metastasis, or lymph node involvement, renal masses \>7 cm or invading in renal sinus or tumor thrombus.
  2. Histologic or clinical diagnosis \>6 months before date of consent.

Where it's running

• UNC Lineberger Comprehensive Cancer Center
  Chapel Hill, North Carolina, United States Recruiting
• New Hanover Regional Medical Center
  Wilmington, North Carolina, United States Not yet recruiting

Study contacts

• Principal investigator: Hung-Jui Tan, MD — UNC Lineberger Comprehensive Cancer Center
• Study coordinator: Deborah Usinger
• Email: dusinger@unc.edu
• Phone: (919) 962-5431

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.