Physician- and Patient-based Barriers to NGS Testing

Официальное название

A Clinical Trial to Address Physician- and Patient-based Barriers to NGS Testing

Обзор

The goal of this study is to improve next-generation sequencing (NGS) testing rates at Johns Hopkins in patients with metastatic prostate cancer. Investigators believe by targeting two barriers, provider-level and patient-level, will improve the testing rate of NGS at Johns Hopkins.

Подробное описание

Next-generation sequencing is recommended by national guidelines in metastatic prostate cancer to inform prognosis, treatment decisions, and eligibility for clinical trials. However, rates are low nationally and around 50-60% at Johns Hopkins. Analysis found that older patients and patients who are not married are less likely to have testing performed. The goals and objectives of this proposed clinical trial are to improve NGS testing rates at Johns Hopkins using a multidisciplinary approach to improve the care of patients living with metastatic prostate cancer and reduce disparities. The hypothesis is that this initiative, which targets two barriers (provider-level and patient-level), will lead to higher rates of NGS ordering at Johns Hopkins.

Вмешательства

• Другое Provider-level and patient education at end of study
  The provider level component will involve an email to each of the genitourinary medical oncologists at Johns Hopkins with their NGS testing rate from preliminary data and compare this rate to the mean. The initial email will also include the 2025 ASCO guideline recommending somatic testing in virtually all metastatic prostate cancer patients. Providers who do not have baseline NGS testing rates available will also be emailed. Providers will subsequently be emailed their updated NGS testing rate
• Другое Provider-level and patient-level
  In addition to the provider component, patients will also receive a one-page patient educational material (via email, or mail if no email on file) on advanced prostate cancer that includes education on somatic NGS testing. The email will be sent by the MyChart Recruitment Innovation team. Those without email on file will have the same message and attachment sent via mail by our study coordinator.

Первичные конечные точки

• Rate of Next-Generation Sequencing (NGS) testing by arm [Срок оценки: 1 year]

Вторичные конечные точки (1)

• Percentage of patients with sociodemographic and clinical characteristics who have had NGS testing compared to those without NGS testing during the study period. [Срок оценки: 1 year]

Критерии участия

Критерии включения

• men diagnosed with metastatic prostate cancer
• seen by Johns Hopkins Medical Oncology as a new patient visit between January 1, 2025 and December 31, 2026

Критерии исключения

\- Patients who have already had NGS testing performed.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore

Идентификаторы

NCT: NCT07209176 · IRB00505965 · IRB00505965

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗