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Идёт набор NCT06910670

Implementing a Randomized Control Trial to Test the Expanded Web-based Decision Aid

Без фазы С лечением Cholangiocarcinoma Colorectal Cancer Multiple Myeloma

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: Standard developed materials, Genetics Advisor Decision Aid.
Кому может быть актуально
Состояния в реестре: Cholangiocarcinoma, Colorectal Cancer, Multiple Myeloma. Базовые параметры: от 18 лет · Все.
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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Обзор

The overall goal of the randomized control trial (RCT) will be to evaluate the efficacy of modifications to a web-based tool for patient decision-making regarding return of genomic results that will more closely focus on rare cancers. Participants will be given access to a web-based decision aid (or a standard control) that guides participants in making decisions about what type of genomic results they would like to receive from testing performed in the PE-CGS study (NCT06340646).

Вмешательства

  • Другое Standard developed materials
    Participants will be given the option to receive different types of results from genomic sequencing. The choices available to them will be explained by research staff following a script that describes what each type of result means. Participants will be able to choose to receive: (1) no results, or any combination of (2) biomarker information from cancer cells, (3) inherited mutations related to cancer, and (4) inherited mutations related to other medical issues. These choices will be presented
  • Другое Genetics Advisor Decision Aid
    Participants will be given the option to receive different types of results from genomic sequencing. The participants will be given access to a web-based decision aid that elicits participants' values and preferences for receiving results from cancer genomic sequencing to guide them making a decision about what types of results they would like to receive. Participants will be able to choose to receive: (1) no results, or any combination of (2) biomarker information from cancer cells, (3) inherit

Первичные конечные точки

  • Change in self-efficacy about genomic test results [Срок оценки: Baseline, after viewing assigned materials (day 1), and 3-months after enrollment]
Вторичные конечные точки (11)
  • Change in decisional conflict [Срок оценки: After viewing assigned materials (day 1) and 3-months after enrollment]
  • Change in knowledge of clinical genetic testing [Срок оценки: After viewing assigned materials (day 1) and 3-months after enrollment]
  • Change in expectations for potential benefits of cancer genomic sequencing [Срок оценки: After viewing assigned materials (day 1) and 3-months after enrollment]
  • Decisional conflict scores categorized by demographic factors [Срок оценки: After viewing assigned materials (day 1) and 3-months after enrollment]
  • Knowledge scores categorized by demographic factors [Срок оценки: After viewing assigned materials (day 1) and 3-months after enrollment]
  • Decisional conflict scores categorized by genomic literacy [Срок оценки: After viewing assigned materials (day 1) and 3-months after enrollment]
  • Knowledge scores categorized by genomic literacy [Срок оценки: After viewing assigned materials (day 1) and 3-months after enrollment]
  • Decisional conflict scores categorized by genomic sequencing testing attitudes [Срок оценки: After viewing assigned materials (day 1) and 3-months after enrollment]
  • Knowledge scores categorized by genomic sequencing testing attitudes [Срок оценки: After viewing assigned materials (day 1) and 3-months after enrollment]
  • Decisional conflict scores categorized by clinical characteristics [Срок оценки: After viewing assigned materials (day 1) and 3-months after enrollment]
  • Knowledge scores categorized by clinical characteristics [Срок оценки: After viewing assigned materials (day 1) and 3-months after enrollment]

Критерии участия

Eligibility Criteria:

  • Enrolled in the WU-PE-CGS study (IRB#202106129); that eligibility entails:
  • Diagnosis of cholangiocarcinoma
  • Diagnosis of multiple myeloma, must be African American
  • Diagnosis of colorectal cancer, must be African American and age 65 or older at time of diagnosis
  • At least 18 years old.
  • Able to understand an IRB-approved informed consent document and agree to participation
  • Have access to a personal computer, tablet or mobile device

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
  • Washington University School of Medicine — St Louis

Идентификаторы

NCT: NCT06910670 · 202409214 · U2CCA252981

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗