Designing Visual Tools to Enhance Cancer Surgeon Decision-making

Обзор

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.

Вмешательства

• Поведенческое 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.
• Другое No intervention
  No intervention

Первичные конечные точки

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

Вторичные конечные точки (10)

• The impact of the visual decision support on the strength of the recommendations - observer [Срок оценки: Baseline (Patient-Physician Encounter)]
• The impact of the visual decision support on the strength of the recommendations - surgeon rated [Срок оценки: Baseline (After-Visit)]
• Patient-Centered Communication [Срок оценки: Baseline (After-Visit)]
• Physician Satisfaction Scale [Срок оценки: Baseline (After-Visit)]
• Patient-Physician Communication [Срок оценки: Baseline (After-Visit)]
• Patient Decision-Making [Срок оценки: Up to 6 months]
• Physician Decision-Making [Срок оценки: Baseline (After-Visit)]
• Treatment Selection/Quality [Срок оценки: Up to12 months]
• Perceived Usability Ratings [Срок оценки: Up to 6 months]
• Physician Debriefing Interview [Срок оценки: Up to 6 months]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• UNC Lineberger Comprehensive Cancer Center — Chapel Hill
• New Hanover Regional Medical Center — Wilmington

Идентификаторы

NCT: NCT06965192 · LCC2321Aim3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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