Recruiting

Visual Decision Support

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT06965192

Conditions

Prostate Cancer

Kidney Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Visual

No intervention

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Kidney Cancer

Study ID

NCT06965192

Start date

Apr 24, 2025

Status verified date

Dec, 2025

Completion date

Jan 30, 2028

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

220 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Patient participants

Patient participants will complete a 10-minute baseline survey, 15-minute after-visit survey and 5-minute 6-month survey.

experimental: Physician participants

Physician participants seeing patients with newly diagnosed localized prostate cancer and clinical T1 renal masses suspicious for kidney cancer.

Interventions

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.

No intervention

No intervention

Primary outcome measure

  • Discussion of Risks and Benefits [ Time Frame: Baseline (Patient-Physician Encounter) ]

Central Contacts and Locations

Central contacts

Locations

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Principal Investigator:

Hung-Jui Tan, MD, MSHPM

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Dec 5, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2025-12-05.