- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01686360
Communicating Objective Risk for Personalized Decision Making About Mammography
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
This study will compare alternative strategies for the presentation of individualized information about the risks and benefits of mammography screening. The purpose of this study is to understand how objective risk information influences outcomes including behavioral intentions, attitudes about mammography, and emotional responses.
After participants view objective risk information, a post-test survey will measure outcome variables including behavioral intentions, knowledge, and emotional responses.
After reading information based on their condition, study participants will be asked to complete a series of questions to measure their reactions based on their condition. Specifically, the investigators will be measuring the following dependent variables (primary outcomes): behavioral intentions to receive mammograms, attitudes about mammography, subjective norms about mammography and breast cancer screening, knowledge about mammography outcomes and screening recommendations, and emotional responses to the material including psychological reactance. These outcomes will be measured using self-reported questionnaire items.
In this project, the investigators will compare alternative communication strategies to determine which strategy or strategies result in the greatest level of understanding. The investigators also will examine if the various strategies differentially affect the primary outcomes listed above.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
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Pennsylvania
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Philadelphia, Pennsylvania, Соединенные Штаты, 19104
- University of Pennsylvania
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Adult women between the ages of 35 and 49 will be invited to participate in this study.
Exclusion Criteria:
- Women who have been previously diagnosed with breast cancer or have tested positive for the breast cancer gene will not be included.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Факторное присвоение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Без вмешательства: Control group 1: pre/post-test
Group receives pre and post test questions only.
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|
Экспериментальный: Control group 2: tool and pre/post-test
Group receives decision tool without personalized information.
(Behavioral: Decision Aid)
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Экспериментальный: Gail score in a percentage format
Group receives Gail score in a percentage format.
(Behavioral: Decision Aid)
|
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Экспериментальный: Gail score in a frequency format
Group receives Gail score in a frequency format.
(Behavioral: Decision Aid)
|
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Экспериментальный: Frequency + Average 50 year old
Group receives Gail score in a frequency format as well as information about risk of breast cancer for the average 50 year old woman.
(Behavioral: Decision Aid)
|
|
Экспериментальный: Frequency + Mammography Data
Group receives Gail score in a frequency format as well as information about the risks of mammography.
(Behavioral: Decision Aid)
|
|
Экспериментальный: Frequency + Mortality Data
Group receives Gail score in a frequency format as well as information about mortality benefit of mammography.
(Behavioral:Decision Aid)
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|
Экспериментальный: Frequency + Avg 50 year old + Mamm Data + Mortality Data
Group receives Gail score in a frequency format as well as information about breast cancer risk for the average 50 year old woman, information about the risks of mammography, risk of breast cancer for the average 50 year old woman, and information about the mortality benefit associated with mammography.
(Behavioral: Decision Aid)
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Behavioral intentions to get a mammogram
Временное ограничение: immediately following intervention (time 0)
|
All participants will be asked to report their behavioral intentions to obtain mammograms in their 40s and at age 50.
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immediately following intervention (time 0)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Attitude about mammography
Временное ограничение: immediately following intervention (time 0)
|
Participants will be asked to report their attitudes about mammography (i.e., is a mammogram useful, harmful, etc.)
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immediately following intervention (time 0)
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Injunctive and descriptive norms about mammography
Временное ограничение: immediately following intervention (time 0)
|
Participants will be asked to report their perceived norms about mammography, what they think important others would expect them to do and what they think other women their age or older are doing.
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immediately following intervention (time 0)
|
Decisional satisfaction
Временное ограничение: immediately following intervention (time 0)
|
This variable assesses how satisfied participants feel about making a decision about mammography given the information they have been provided.
Items include, "The information in the decision aid made me feel the choice to get a mammogram is being taken away from me by the groups that make screening recommendations."
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immediately following intervention (time 0)
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Risk perception
Временное ограничение: immediately before and after intervention (time 0)
|
This variable includes perceived severity and perceived susceptibility of breast cancer.
Items include, "What is the chance that an average 40-49 year old woman will develop breast cancer in the next 10 years?
Please choose a number between 0 (no chance of breast cancer) and 100 (definitely will get breast cancer)."
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immediately before and after intervention (time 0)
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Clarity of the information being presented
Временное ограничение: immediately following intervention (time 0)
|
These items assess how easy it is for participants to understand the numerical information that is provided in the decision aid.
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immediately following intervention (time 0)
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Credibility of the information
Временное ограничение: immediately following intervention (time 0)
|
These items measure the perceived trustworthiness, credibility, and accuracy of the information provided in the decision aid.
Items include, "How credible did you find the information presented in the decision aid?"
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immediately following intervention (time 0)
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Emotional reactions
Временное ограничение: immediately following intervention (time 0)
|
The outcome includes measures of psychological reactance, anger, and fear that may be possible reactions to the decision aid.
Items include, "How much do each of the following words (i.e., angry, worried) describe how you felt while reading the decision aid?"
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immediately following intervention (time 0)
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Joseph N Cappella, PhD, University of Pennsylvania
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- 816186
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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