Decision Support Tool to Enhance Germline Genetic Testing for Patients With Prostate Cancer
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Behavioral Intervention, Biospecimen Collection, Electronic Health Record Review, Genetic Counseling.
- Кому может быть актуально
- Состояния в реестре: Prostate Carcinoma. Базовые параметры: от 18 лет · Мужчины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Efforts to Enhance Germline Genetic Testing at Lyndon B. Johnson Hospital
Обзор
This clinical trial identifies factors associated with completing genetic testing, aids in the development of a decision support tool, and tests how well the decision support tool works to enhance germline genetic testing in patients with prostate cancer. Germline genetic testing is a guideline-recommended standard of care for many patients with prostate cancer. Completing genetic testing can enable the use of targeted therapies, offers access to novel clinical trials, provides valuable information, and can help identify at risk family members. The decision support tool may educate patients and assist in the decision to engage with germline genetic testing.
Подробное описание
PRIMARY OBJECTIVES:
I. Identify patient, provider, and health system factors contributing to the completion of recommended germline testing for men with prostate cancer.
II. Develop a decision support tool for patients tailored to the cultural and socioeconomic context of the local community.
III. Conduct a pilot intervention trial to evaluate a point-of-care decision support tool in a public safety net hospital in Harris County, Texas.
SECONDARY OBJECTIVES:
I. Assess the feasibility of point-of-care decision support tool in a public safety net hospital in Harris County, Texas.
II. Assess the change in completion of germline genetic testing with utilization of the decision support tool.
OUTLINE: At each stage of the proposed research, patients are recruited to 1 of 3 groups. Groups 1 and 2 are observational and group 3 is a pilot interventional trial.
GROUP 1: Patients complete a qualitative interview that informs the development of the decision support tool.
GROUP 2: Patients view the draft of the decision support tool and complete cognitive interviews for the refinement of the decision support tool on study.
GROUP 3: Patients view the decision support tool that provides culturally tailored information about genetic testing and the collection process. Patients may then provide a blood sample for standard of care genetic testing and may additionally meet with a genetics counselor for additional information prior to testing. Patients with a positive germline genetic mutation will discuss results with a genetics counselor.
Вмешательства
- Поведенческое Behavioral Intervention
View decision support tool - Процедура Biospecimen Collection
Undergo blood sample collection - Другое Electronic Health Record Review
Ancillary studies - Другое Genetic Counseling
Meet with genetic counselor - Другое Genetic Testing
Undergo standard of care genetic testing - Другое Interview
Complete qualitative interview - Другое Interview
Complete cognitive interview - Другое Survey Administration
Ancillary studies
Первичные конечные точки
- Safety and Adverse Events (AEs) [Срок оценки: Through study completion; an average of 1 year]
Критерии участия
Критерии включения
- Diagnosed prostate cancer patients receiving care at Lyndon B. Johnson (LBJ) Hospital
- Were recommended for germline genetic testing by their oncology provider
- Can provide informed consent
- Can communicate in English or Spanish
Критерии исключения
- Prostate cancer patients receiving care at LBJ who are unable to participate due to a serious psychological or cognitive condition
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Последовательный дизайн
- Маскирование
- Открытое
- Основная цель
- Организация здравоохранения
Центры проведения
США · 1 центр
- M D Anderson Cancer Center — Houston
Идентификаторы
NCT: NCT07377006 · 2025-1272 · NCI-2025-06571 · 2025-1272