Designing Visual Tools to Enhance Cancer Surgeon Decision-making

UNC Lineberger Comprehensive Cancer Center

Status: Enrolling

Conditions: Kidney Cancer; Prostate Cancer

Treatments: Behavioral: Visual; Other: No intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06965192

LCC2321Aim3

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Patient participants

Experimental group

Description:

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

Treatment:

Other: No intervention

Physician participants

Experimental group

Description:

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

Treatment:

Behavioral: Visual