Clinical trial NCT06965192: Designing Visual Tools to Enhance Cancer Surgeon Decision-making
Official title: Designing Visual Tools to Enhance Cancer Surgeon Decision-making
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Kidney Cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Discussion of Risks and Benefits
timeFrame: Baseline (Patient-Physician Encounter)
Secondary outcomes:
measure: The impact of the visual decision support on the strength of the recommendations - observer
timeFrame: Baseline (Patient-Physician Encounter)
measure: The impact of the visual decision support on the strength of the recommendations - surgeon rated
timeFrame: Baseline (After-Visit)
measure: Patient-Centered Communication
timeFrame: Baseline (After-Visit)
measure: Physician Satisfaction Scale
timeFrame: Baseline (After-Visit)
measure: Patient-Physician Communication
timeFrame: Baseline (After-Visit)
measure: Patient Decision-Making
timeFrame: Up to 6 months
measure: Physician Decision-Making
timeFrame: Baseline (After-Visit)
measure: Treatment Selection/Quality
timeFrame: Up to12 months
measure: Perceived Usability Ratings
timeFrame: Up to 6 months
measure: Physician Debriefing Interview
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Hung-Jui Tan, MD
role: PRINCIPAL_INVESTIGATOR
References: