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Идёт набор NCT05627219

Extending Prostate Genetic Awareness, Navigation, and Delivery: The EXPAND Network

— Наблюдательное Metastatic Prostate Carcinoma Stage IIIB Prostate Cancer AJCC v8 Stage IIIC Prostate Cancer AJCC v8 Stage IV Prostate Cancer AJCC v8

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: Training and Education, Educational Intervention, Discussion.
Кому может быть актуально
Состояния в реестре: Metastatic Prostate Carcinoma, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8. 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
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Официальное название

Peer Genetic Coaches for Enhancing Genetic Testing Awareness, Navigation, and Delivery Among African American Men With Metastatic Prostate Cancer, The EXPAND Network

Обзор

This trial evaluates whether a network of peer genetic coaches is useful for addressing disparities in genetic testing and screening among African American men with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). While genetic testing has become central to prostate cancer care, African American men are less likely seek testing due to lack of awareness, cultural beliefs, financial limitations, fear of discrimination, and mistrust in the healthcare system. A network of peer genetic coaches may help address barriers, beliefs, and needs of African American men in the community and provide navigation to increase engagement in genetic testing.

Подробное описание

PRIMARY OBJECTIVES:

I. Identify and train 6 African American (AA) men as peer genetic coaches (PGCs) for the Extending Prostate Genetic Awareness, Navigation, and Delivery (EXPAND) Network. (Train peer genetic coaches) II. Conduct a feasibility study of peer genetic coaching. (Provide individual coaching)

SECONDARY OBJECTIVE:

I. Patient-related outcomes will include change in decisional conflict for genetic counseling, acceptability/attitude toward genetic counseling and testing, and change of genetics knowledge.

OUTLINE:

AIM 1: Peer genetic coaches undergo training and education on study.

AIM 2: Patients receive an educational booklet and attend a discussion with a peer genetic coach on study.

Вмешательства

  • Поведенческое Training and Education
    Undergo training and education
  • Другое Educational Intervention
    Receive educational booklet
  • Процедура Discussion
    Attend discussion with peer genetic coach

Первичные конечные точки

  • Number of inquiries to the central number (feasibility) [Срок оценки: Up to 1 year]
  • Percent of callers screened and eligible to participate (feasibility) [Срок оценки: Up to 1 year]
  • Percent of eligible callers who enroll in the study (feasibility) [Срок оценки: Up to 1 year]
  • Percent who complete the endpoint assessment (feasibility) [Срок оценки: Up to 1 year]
  • Number and percent of men making genetic counseling appointments [Срок оценки: Up to 1 year]
Вторичные конечные точки (3)
  • Change in decisional conflict for genetic counseling [Срок оценки: Baseline up to 1 year]
  • Change in acceptability/attitude toward genetic counseling and testing [Срок оценки: Baseline up to 1 year]
  • Change of genetics knowledge [Срок оценки: Baseline up to 1 year]

Критерии участия

Критерии включения

  • AIM 1: Are 18 years old or older
  • AIM 1: Are able to read and speak English comfortably
  • AIM 1: Men who have experience with both prostate cancer (PCA) and genetic counseling and testing will be a priority for training, as well as men who have considerable peer education or navigation experience
  • AIM 2: Are 18 years old or older
  • AIM 2: Are African American
  • AIM 2: Are able to read and speak English comfortably
  • AIM 2: Men who meet any one of the following criteria: (1) metastatic prostate cancer; (2) prostate cancer with high-risk features (T3 or higher, Gleason 8 or higher, node positive disease); (3) with or without a diagnosis of prostate cancer with strong family history (2 or more first-degree or second-degree relatives) with prostate cancer (particularly metastatic prostate cancer or died from prostate cancer), breast cancer, ovarian cancer, pancreatic cancer, colorectal cancer, uterine cancer, renal cancer, urothelial cancer, or upper bowel cancer

Критерии исключения

  • Patients that do not meet the inclusion criteria
  • Children under the age of 18
  • Anyone who has trouble understanding the consent or with significant anxiety detected during the consent process

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia

Идентификаторы

NCT: NCT05627219 · 22C.423 · JT 22046

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗