Visual decision tools to support urologists treating prostate and kidney cancer
Designing Visual Tools to Enhance Cancer Surgeon Decision-making
This project will test whether giving urologists visual decision-support tools changes how they talk with patients newly diagnosed with localized prostate or kidney cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Locations | 2 sites (Chapel Hill, North Carolina and 1 other locations) |
| Trial ID | NCT06965192 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal participants are adults (≥18) with a new diagnosis (within 6 months) of localized prostate cancer or a T1 renal mass, and urologists who practice at participating North Carolina sites.
Not a fit: Patients with advanced or metastatic disease, diagnoses older than six months, or those treated outside the participating sites are unlikely to benefit from this pilot.
Why it matters
Potential benefit: If successful, the tools could make surgical discussions clearer and help patients make more informed treatment choices.
How similar studies have performed: Patient-facing decision aids in prostate cancer have improved knowledge and shared decision making, but surgeon-facing visual decision-support tools are less studied and this pilot is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chapel Hill, North Carolina and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.