Tumor Genomic Pre-test Counseling Tool for Black or African-American Men 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: Counseling Tool, Questionnaires.
- Кому может быть актуально
- Состояния в реестре: Prostate Cancer, Prostate Cancer Metastatic. 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
Developing and Testing a Patient-centered Tumor Genomic Pre-test Counseling Tool for Black or African-American Men With Metastatic Prostate Cancer
Обзор
The overall goal of the study is to improve equitable delivery of pre-Tumor genetic testing (TGT) counseling tool for Black or African American men with metastatic prostate cancer and evaluating the tool for implementation.
Подробное описание
PRIMARY OBJECTIVES:
Stage 1: To evaluate education quality of the intervention in Black or African American men with prostate cancer.
Stage 2: To evaluate feasibility of the TGT intervention among Black or African American men with prostate cancer
SECONDARY OBJECTIVES:
Stage 1:
1. To evaluate completeness of the intervention content. 2. To identify barriers and facilitators for using the intervention.
Stage 2:
1. To evaluate the acceptability of the intervention among Black or African American men with prostate cancer. 2. To evaluate change in participant knowledge about tumor genetic testing among Black or African American men with prostate cancer. 3. To evaluate change in patient attitudes toward tumor genetic testing among Black or African American men with prostate cancer. 4. To evaluate change in participant expectations of tumor genetic testing among Black or African American men with prostate cancer. 5. To evaluate patient perspectives on the intervention. 6. To evaluate the rate of TGT among Black or African American men with prostate cancer who have received the tumor genetic pre-test counseling tool.
OUTLINE:
This is a two-stage study. In Stage 1, Adult Black or African American men with metastatic prostate cancer who have not made a decision about TGT, or who have decided to undergo TGT, or patients who have decline TGT about tumor genetic testing will participate in development by answering questionnaires and utilizing the pilot application for up to 60 days. The investigators will then refine the tool to be piloted in Stage 2.
Stage 2: A pilot study of participants who are planning to have a discussion about undergoing tumor genetic testing with their oncology provider will be invited to join and utilize the tool, and answer questionnaires about the tool.
Вмешательства
- Другое Counseling Tool
Non-therapeutic educational intervention - Другое Questionnaires
Participants will complete questionnaires online, via mail, by telephone, or in person per participant preference.
Первичные конечные точки
- Frequency of participant responses (Stage 1) [Срок оценки: 1 day]
- Proportion of enrolled participants (Stage 2) [Срок оценки: 1 day]
- Proportion of enrolled participants who review all educational materials (Stage 2) [Срок оценки: Up to 60 days]
- Mean score of Feasibility of Intervention Measure (FIM) (Stage 2) [Срок оценки: Up to 60 days]
Вторичные конечные точки (8)
- Mean score of Acceptability of Intervention Measure (AIM) (Stage 2) [Срок оценки: Up to 60 days]
- Mean score of investigator-developed, measure of acceptability items (Stage 2) [Срок оценки: Up to 60 days]
- Mean score of cancer genomic testing knowledge (Stage 2) [Срок оценки: Up to 60 days]
- Proportion of participants who select correct response in each genomic testing knowledge instrument item (Stage 2) [Срок оценки: Up to 60 days]
- Proportion of participants who answer "Yes" to each attitude item in the Attitude and expectations for tumor genetic testing survey (Stage 2) [Срок оценки: Up to 60 days]
- Proportion of participants who answer "Strongly Agree" or "Agree" to the expectation item in the Attitude and expectations for tumor genetic testing survey (Stage 2) [Срок оценки: Up to 60 days]
- Participant-reported perspectives of intervention in a semi-structured interview. (Stage 2) [Срок оценки: Up to 60 days]
- Proportion of participants who have received the tumor genetic pre-test counseling tool who undergo TGT by chart review (Stage 2) [Срок оценки: Up to 90 days]
Критерии участия
Критерии включения
Stage 1:
- Age 18-years-old or older
- Identifies as Black or African American, by either chart documentation or participant self-report. Mixed-race, including Black or African American, is included.
- Metastatic prostate cancer, by either chart documentation or participant self-report. Pathology report not needed.
- Able to understand study procedures and to comply with them for the entire length of the study.
- Able to understand a written information sheet and willing to verbally consent.
- Fluent in English (reading, writing, and speaking)
Stage 2:
- Age 18-years-old or older
- Identifies as Black or African American, by either chart documentation or participant self-report. Mixed-race, including Black or African American, is included.
- Metastatic prostate cancer, by either chart documentation or participant self-report. Pathology report not needed.
- Able to understand study procedures and to comply with them for the entire length of the study.
- Fluent in English (reading, writing, and speaking).
- Anticipated discussion of TGT within 0-365 days of enrollment, per treating oncology provider's discretion. TGT involves the use of any cancer genetic sequencing (whether standard-of-care or part of a research protocol) via any one of the following:
- Somatic DNA testing of already-collected tissue.
- Somatic DNA testing of tissue to be collected in the future via biopsy, surgery, or other procedure.
- Blood-based DNA testing to evaluate for circulating tumor DNA.
- Able to understand a written informed consent document and willing to sign it.
Критерии исключения
Contraindication to any study-related procedure or assessment in either stage.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Организация здравоохранения
Центры проведения
США · 1 центр
- University of California — San Francisco
Идентификаторы
NCT: NCT06171139 · 23553 · NCI-2023-10339