Designing Visual Tools to Enhance Cancer Surgeon Decision-making

NCT06965192 | Recruiting DMC

• 1 other identifier: LCC2321Aim3
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Discussion of Risks and Benefits

  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).

  Baseline (Patient-Physician Encounter)

Secondary Outcomes (10)

• The impact of the visual decision support on the strength of the recommendations - observer

  Baseline (Patient-Physician Encounter)

• The impact of the visual decision support on the strength of the recommendations - surgeon rated

  Baseline (After-Visit)

• Patient-Centered Communication

  Baseline (After-Visit)

• Physician Satisfaction Scale

  Baseline (After-Visit)

• Patient-Physician Communication

  Baseline (After-Visit)

Study Arms (2)

Patient participants

EXPERIMENTAL

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

Other: No intervention

Physician participants

EXPERIMENTAL

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

Behavioral: Visual

Interventions

Visual BEHAVIORAL

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.

Physician participants

No intervention OTHER

No intervention

Patient participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (2)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

RECRUITING

New Hanover Regional Medical Center

Wilmington, North Carolina, 28401, United States

NOT YET RECRUITING

Related Links

• Clinical trials at UNC Lineberger

MeSH Terms

Conditions

Prostatic Neoplasms; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Diseases; Urologic Diseases

Study Officials

• Hung-Jui Tan, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah Usinger

CONTACT

(919) 962-5431; dusinger@unc.edu

Taylor Greene

CONTACT

taylor_greene@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 11, 2025
• Study Start: April 24, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)