Меню
Идёт набор NCT05487846

Peer Navigation for the Support of Metastatic Prostate Cancer Patients Undergoing Genetic Evaluation

Без фазы С лечением Metastatic Prostate Carcinoma Stage III 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: Patient Navigation, Genetic Counseling, Survey Administration, Best Practice.
Кому может быть актуально
Состояния в реестре: Metastatic Prostate Carcinoma, Stage III 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

ADVANTAGE: Addressing Disparities for Veterans and African Americans Through Peer-Navigation for Testing and Genetic Evaluation

Обзор

This clinical trial evaluates whether having a trained peer navigator helps African American men with prostate cancer that has spread to other parts of the body (metastatic) understand and navigate the genetic testing process better than not having a peer navigator. Genetic testing for men with prostate cancer is very important for making treatment and management decisions. However, understanding the risks, benefits, and steps of genetic counseling and testing can be very challenging for patients. African American men are especially less likely to participant in genetic testing due to lack of awareness or understanding, cultural beliefs, finances, or mistrust of the healthcare system. A peer navigator, someone who helps a patient through the information and the process, may be helpful to some men. This study evaluates whether having a peer navigator throughout the genetic evaluation process helps patients understand and engage in the process more.

Подробное описание

PRIMARY OBJECTIVES:

I. Develop a peer-based navigation program for African American (AA) men with prostate cancer (PCA).

II. Conduct a pilot study of peer-navigated genetic evaluation vs. standard clinical care and assess feasibility of peer navigation.

SECONDARY OBJECTIVE:

I. Evaluating the intervention effects on decisional conflict and PCA genetics knowledge.

EXPLORATORY OBJECTIVE:

I. Assessing trust of the healthcare system and satisfaction with the genetic evaluation process.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive assistance from a peer navigator during genetic evaluation processes. Peer navigators help patients schedule counseling appointments, discuss questions and concerns about testing, assist in saliva collection, schedule a post-test disclosure visit, and do a results and recommendations debrief.

ARM II: Patients receive standard care during genetic evaluation processes. Patients receive genetic counseling, undergo genetic testing, schedule a post-test disclosure visit, and receive their genetic test results and recommendations per standard care.

Вмешательства

  • Поведенческое Patient Navigation
    Receive peer navigation services
  • Другое Genetic Counseling
    Receive genetic counseling
  • Другое Survey Administration
    Ancillary studies
  • Другое Best Practice
    Receive standard care
  • Другое Genetic Counseling
    Receive genetic counseling
  • Другое Survey Administration
    Ancillary studies

Первичные конечные точки

  • Frequency of pretest genetic counseling engagement [Срок оценки: Up to 4 years]
Вторичные конечные точки (2)
  • Mean changes in decisional conflict for genetic testing [Срок оценки: Up to 4 years]
  • Mean changes in knowledge of cancer genetics [Срок оценки: Up to 4 years]

Критерии участия

Критерии включения

  • Provide signed and dated informed consent form
  • English speaking only
  • Willing to comply with all study procedures and be available for the duration of the study
  • Any individual >= 18 years old
  • African American men who meet National Comprehensive Cancer Network (NCCN) criteria for testing will be offered participation. These criteria include any one of the following: (1) metastatic prostate cancer (PCA); (2) intraductal or ductal pathology; (3) T3a or higher; (4) grade group 4 or Gleason 8 or higher; (5) family history of breast, ovarian, prostate, pancreatic, colorectal, or uterine cancers in 3 or more blood relatives particularly if diagnosed at age < 50. These criteria have been adapted from the NCCN Prostate Cancer (version 2.2021) and NCCN Breast, Ovarian, and Pancreatic (version 2.2021) guideline

Критерии исключения

  • Patients that do not meet the inclusion criteria and children under the age of 18 will be excluded
  • Anyone who has trouble understanding the consent or with significant anxiety detected during the consent process will also be excluded

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
Организация здравоохранения

Центры проведения

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

Идентификаторы

NCT: NCT05487846 · 21F.686 · JT 17263 · PC200282

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗