Designing Visual Tools to Enhance Cancer Surgeon Decision-making

NCT ID: NCT06965192

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-24
• Study Completion Date: 2028-01-30

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 Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patient participants

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

Group Type: EXPERIMENTAL

No intervention

Intervention Type: OTHER

No intervention

Physician participants

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

Group Type: EXPERIMENTAL

Visual

Intervention Type: 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.

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.

Intervention Type: BEHAVIORAL

No intervention

No intervention

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hung-Jui Tan, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Locations

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

New Hanover Regional Medical Center

Wilmington, North Carolina, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Deborah Usinger

Role: CONTACT

dusinger@unc.edu

(919) 962-5431

Taylor Greene

Role: CONTACT

taylor_greene@med.unc.edu

Facility Contacts

Deborah M Usinger

Role: primary

dusinger@email.unc.edu

919-962-0000

Taylor L Greene

Role: backup

taylor_greene@med.unc.edu

(919) 962-0000

Natara Dulaney

Role: primary

natara.dulaney@novanthealth.org

Related Links

http://unclineberger.org/patientcare/clinical-trials/clinical-trials

Clinical trials at UNC Lineberger

Other Identifiers

LCC2321Aim3

Identifier Type: -

Identifier Source: org_study_id