NCT06965192 · UNC Lineberger Comprehensive Cancer Center
Designing Visual Tools to Enhance Cancer Surgeon Decision-making
What this study is about
This forward-looking study will compare pre-post pilot test of surgeon-facing, visual decision support among urologists seeing patients with newly diagnosed localized prostate and kidney cancer. Up to 20 urologists (10 academic and 10 community) will be enrolled.
View original scientific description
This prospective study will compare pre-post pilot test of surgeon-facing, visual decision support among urologists seeing patients with newly diagnosed localized prostate and kidney cancer. Up to 20 urologists (10 academic and 10 community) will be enrolled. The goal will be to capture up to 10 pre- and 10 post-intervention patient encounters for each urologist with an accrual target of 200 unique patient visits (100 pre and 100 post-intervention) over a half-year period. Patient encounters pre- and post-intervention will be audio recorded, transcribed, and coded for discussion of risks/benefits of surgery and strength of recommendation. Patients and urologists will complete additional surveys on their perceptions of patient-provider communication. Urologists will further describe their experience and rate their satisfaction with visual decision support. Communication (content and perceived) will be compared pre- and post-intervention with secondary comparisons by race and care setting. It was hypothesized that the discussion of risks and benefits of cancer surgery will increase post-intervention and that the strength of recommendation and perceptions of patient-provider communication will change. The secondary hypothesis is that these changes will differ by patient race and care setting.
Interventions
BEHAVIORAL
Visual
Physician participants will view the visual decision support before entering the patient's room during the intervention period, with the option to share with the patient.
OTHER
No intervention
No intervention
Primary outcome measures
Discussion of Risks and Benefits
Time frame: Baseline (Patient-Physician Encounter)
The impact of visual decision support on patient-physician communication will be assessed using coding-based thematic analysis of the debriefing interviews. The Informed Decision-Making coding system, which includes 9 elements which includes the nature of the clinical problem (e.g., cancer mortality risk, life expectancy), treatment options (e.g., surgery, alternatives), risks and benefits (e.g., complications, side effects, functional outcomes), and uncertainties (e.g., range of possible outcomes). Audio-recorded patient encounters will be coded. Paired coders will score these domains as a 0 (absent), 1 (partial, brief, or one-way), or 2 (complete, two-way discussion).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- 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.
- Histologic or clinical diagnosis \>6 months before date of consent.
Where
- Chapel Hill, North Carolina
- Wilmington, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 5, 2025 · Source of record for eligibility and locations