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Effects of Risk Presentation Format and Frequently Asked Questions on Breast Cancer Risk Skepticism

26 августа 2026 г. обновлено: University of Colorado, Denver
The purpose of this study is to find out whether the way a breast cancer risk estimate is presented affects how women feel about their risk and whether they believe the estimate is accurate for them. Women aged 39-74 will complete an online survey in which they receive a personalized breast cancer risk estimate using the Breast Cancer Risk Assessment Tool (BCRAT). The study includes two experiments. In the first experiment, women are randomly assigned to receive their estimate in different formats: some will see their risk over 5 years, 10 years, or a lifetime, and some will see their risk expressed out of 100 women or out of 1,000 women. In the second experiment, women receive their estimate and then have the opportunity to read answers to frequently asked questions about how breast cancer risk is calculated and what the estimate means. In both experiments, women are asked whether they believe the estimate reflects their true risk. Both experiments are conducted online through a national survey panel.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

3000

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Учебное резервное копирование контактов

Места учебы

  • Соединенные Штаты
    • Colorado
      • Aurora, Colorado, Соединенные Штаты, 80045
        • University of Colorado Anschutz Medical Campus
        • Контакт:
        • Контакт:
        • Главный следователь:
          • Laura D Scherer, PhD

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Да

Описание

Inclusion Criteria:

  1. Female sex
  2. Age 39-74 (i.e., people who are eligible for routine breast cancer screening and for whom guidelines recommend an informed, risk-based decision)
  3. English literacy

Exclusion Criteria:

1. Prior diagnosis of

  1. breast cancer
  2. Ductal carcinoma in situ (DCIS)
  3. Lobular carcinoma in situ (LCIS)
  4. Known BRCA1/2 gene mutation
  5. Cowan syndrome
  6. Li-Fraumeni syndrome
  7. Having received previous chest radiation for treatment of Hodgkin's lymphoma.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Исследования в области здравоохранения
  • Распределение: Рандомизированный
  • Интервенционная модель: Факторное присвоение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 5 Year Risk AND N-in-100 Presentation
Поведенческий: Risk Presentation Format
Participants receive a personalized breast cancer risk estimate generated by the Gail Model. The format of the estimate varies by random assignment across two dimensions: temporal framing (5-year, 10-year, or lifetime risk) and denominator (risk expressed out of 100 women or out of 1,000 women). All other elements of the risk presentation are held constant across conditions.
Поведенческий: Frequently Asked Questions Exposure
Participants receive a personalized breast cancer risk estimate generated by the Gail Model and then view an interactive FAQ document. The FAQ document was developed from qualitative interviews with women who had previously rejected their risk estimates and addresses common questions about how breast cancer risk is calculated, what factors the model does and does not include, what different risk levels mean, and how to discuss results with a physician. FAQ items are displayed as expandable questions; participants click to reveal answers. All participants receive the same FAQ document.
Экспериментальный: 10 Year Risk AND N-in-100 Presentation
Поведенческий: Risk Presentation Format
Participants receive a personalized breast cancer risk estimate generated by the Gail Model. The format of the estimate varies by random assignment across two dimensions: temporal framing (5-year, 10-year, or lifetime risk) and denominator (risk expressed out of 100 women or out of 1,000 women). All other elements of the risk presentation are held constant across conditions.
Поведенческий: Frequently Asked Questions Exposure
Participants receive a personalized breast cancer risk estimate generated by the Gail Model and then view an interactive FAQ document. The FAQ document was developed from qualitative interviews with women who had previously rejected their risk estimates and addresses common questions about how breast cancer risk is calculated, what factors the model does and does not include, what different risk levels mean, and how to discuss results with a physician. FAQ items are displayed as expandable questions; participants click to reveal answers. All participants receive the same FAQ document.
Экспериментальный: Lifetime Risk AND N-in-100 Presentation
Поведенческий: Risk Presentation Format
Participants receive a personalized breast cancer risk estimate generated by the Gail Model. The format of the estimate varies by random assignment across two dimensions: temporal framing (5-year, 10-year, or lifetime risk) and denominator (risk expressed out of 100 women or out of 1,000 women). All other elements of the risk presentation are held constant across conditions.
Поведенческий: Frequently Asked Questions Exposure
Participants receive a personalized breast cancer risk estimate generated by the Gail Model and then view an interactive FAQ document. The FAQ document was developed from qualitative interviews with women who had previously rejected their risk estimates and addresses common questions about how breast cancer risk is calculated, what factors the model does and does not include, what different risk levels mean, and how to discuss results with a physician. FAQ items are displayed as expandable questions; participants click to reveal answers. All participants receive the same FAQ document.
Экспериментальный: 5 Year Risk AND N-in-1000 Presentation
Поведенческий: Risk Presentation Format
Participants receive a personalized breast cancer risk estimate generated by the Gail Model. The format of the estimate varies by random assignment across two dimensions: temporal framing (5-year, 10-year, or lifetime risk) and denominator (risk expressed out of 100 women or out of 1,000 women). All other elements of the risk presentation are held constant across conditions.
Поведенческий: Frequently Asked Questions Exposure
Participants receive a personalized breast cancer risk estimate generated by the Gail Model and then view an interactive FAQ document. The FAQ document was developed from qualitative interviews with women who had previously rejected their risk estimates and addresses common questions about how breast cancer risk is calculated, what factors the model does and does not include, what different risk levels mean, and how to discuss results with a physician. FAQ items are displayed as expandable questions; participants click to reveal answers. All participants receive the same FAQ document.
Экспериментальный: 10 Year Risk AND N-in-1000 Presentation
Поведенческий: Risk Presentation Format
Participants receive a personalized breast cancer risk estimate generated by the Gail Model. The format of the estimate varies by random assignment across two dimensions: temporal framing (5-year, 10-year, or lifetime risk) and denominator (risk expressed out of 100 women or out of 1,000 women). All other elements of the risk presentation are held constant across conditions.
Поведенческий: Frequently Asked Questions Exposure
Participants receive a personalized breast cancer risk estimate generated by the Gail Model and then view an interactive FAQ document. The FAQ document was developed from qualitative interviews with women who had previously rejected their risk estimates and addresses common questions about how breast cancer risk is calculated, what factors the model does and does not include, what different risk levels mean, and how to discuss results with a physician. FAQ items are displayed as expandable questions; participants click to reveal answers. All participants receive the same FAQ document.
Экспериментальный: Lifetime Risk AND N-in-1000 Presentation
Поведенческий: Risk Presentation Format
Participants receive a personalized breast cancer risk estimate generated by the Gail Model. The format of the estimate varies by random assignment across two dimensions: temporal framing (5-year, 10-year, or lifetime risk) and denominator (risk expressed out of 100 women or out of 1,000 women). All other elements of the risk presentation are held constant across conditions.
Поведенческий: Frequently Asked Questions Exposure
Participants receive a personalized breast cancer risk estimate generated by the Gail Model and then view an interactive FAQ document. The FAQ document was developed from qualitative interviews with women who had previously rejected their risk estimates and addresses common questions about how breast cancer risk is calculated, what factors the model does and does not include, what different risk levels mean, and how to discuss results with a physician. FAQ items are displayed as expandable questions; participants click to reveal answers. All participants receive the same FAQ document.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Risk Skepticism
Временное ограничение: Day 1
Participants' perception of their Gail model risk estimate is trichotomized into three categories: Underestimator (believed risk is lower than estimate), Agreer (believed risk equals estimate), and Overestimator (believed risk is higher than estimate).
Day 1
Risk Perception
Временное ограничение: Day 1
This measure includes two Likert scale questions assessing the perceived likelihood of developing cancer and the level of worry about getting cancer.
Day 1

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

University of Colorado, Denver

Соавторы

National Cancer Institute (NCI)

Следователи

  • Главный следователь: Laura D Scherer, PhD, University of Colorado, Denver

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 сентября 2026 г.

Первичное завершение (Оцененный)

1 февраля 2027 г.

Завершение исследования (Оцененный)

1 апреля 2027 г.

Даты регистрации исследования

Первый отправленный

18 августа 2026 г.

Впервые представлено, что соответствует критериям контроля качества

26 августа 2026 г.

Первый опубликованный (Действительный)

28 августа 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

28 августа 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

26 августа 2026 г.

Последняя проверка

1 августа 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 26-1163
  • R01CA279953 (Грант/контракт NIH США)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

The protocol, code books, and data set associated with this study will be shared on the Open Science Framework after ensuring that it is completely anonymized.

Сроки обмена IPD

IPD and supporting information will be made available when the first manuscript is submitted to a journal for review.

Критерии совместного доступа к IPD

Anyone will be able to access the IPD and supporting information by downloading it from OSF.

Совместное использование IPD Поддерживающий тип информации

  • STUDY_PROTOCOL
  • САП
  • АНАЛИТИЧЕСКИЙ_КОД

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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