Проведение скрининга рака молочной железы: рандомизированное контролируемое исследование, оценивающее эффект принятия решения (DEDICACES2)
Совместное принятие решений о скрининге рака молочной железы в первичной медико-санитарной помощи
Shared decision-making for organised breast cancer screening (OBCS) could be improved by fostering interaction and exchanges of information between women and General Practitioners (GPs), for instance by including an assistance tool in the dispatch of the invitation letter for Organised Screening for breast cancer. In 2018 the national cancer Institute funded the development of a decisional aid (DA) on the theme of whether or not to take part in breast cancer screening, specific to the French setting. It is the website lamammo-etvous.fr DEDICACES project 1.
DEDICACES 2 is a population-based trial with a cluster design. It studies humans, without modifying their usual care. The experiment assesses the effect of the lamammo-etvous.fr/ tool on the decision to take part (or not) in OBCS among women who are invited for screening.
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Nantes, Франция, 44093
- University Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria :
- General practitioners (GPs):
The following GPs will be included:
1) Practicing in one of the French départements (administrative area) covered by the study.
- Women:
The following women will be included:
- Invited to participate in OBCS by the National Health Insurance Agency (Caisse Nationale d'Assurance Maladie; CNAM) during the studied month: eligible for OBCS, therefore aged between 50 and 74 at the time of inclusion;
- On the patient list of a GP who is covered by the study at the time of inclusion;
- Covered by one of the CPAM (Caisse Primaire d'Assurance Maladie) in the participating departments.
Exclusion Criteria :
- General practitioners (GPs) :
The following GPs will be excluded:
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Those who do not have any patients invited for OBCS in the studied month;
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Those whose practice does not correspond to the usual activities of a GP (known as a Mode d'Exercice Particulier), or who have very few patients (who have seen fewer than 100 different patients in the year preceding the experiment);
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Those who practice within a health centre (as it is impossible to evaluate the activity of an individual practitioner in health insurance databases);
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Those who explicitly state that they do not want to take part in the study, in response to an initial letter of invitation. This letter will inform them that the study is being run, and will inform them of the option to refuse to participate if they so wish;
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Those who are participating in the MyPEBS study (the only national study of OBCS at the time the present protocol was drawn up).
- Women:
The following women will not be included:
- Participants in the MyPEBS study ( the only national study of OBCS at the time the present protocol was drawn up); or,
- If their GP refuses to participate in the study; or,
- women under guardianship.
The following women will be excluded:
- Those who object to the study in accordance with regulatory procedures issued by the Data Protection Officer (DPO),
- Those who do not respond within 1 month after the questionnaire has been sent.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Decisional aid for organised cancer screening
Women will receive a leaflet that presents the tool. The leaflet includes a link to access the tool, and encourages the person to consult their GP to initiate the shared decision-making process. GPs will receive a letter presenting the study that includes: a) information about shared decision-making and how to implement it; b) the letter that is sent to their patients, and c) a recommendation to implement shared decision-making with their patients. |
The leaflet will include a link to access the https://lamammo-etvous.fr DA aid tool, and will inform women about shared decision-making. The GPs of women who are sent the leaflet will also be sent a letter encouraging shared decision-making. This material will be sent 3 months after women have received their breast cancer screening invitation letter. Data related to primary and secondary objectives will be collected by questionnaire from the 2 groups. The questionnaire will be sent 2 months after participants are informed about the tool. |
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Без вмешательства: Standard organised cancer screening
Women and their GPs will continue to carry out usual screening. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Evaluation of the effectiveness of the /lamammo-etvous.fr/ DA tool on decision-making concerning the choice of whether or not to participate in OBCS among women who are invited for screening.
Временное ограничение: 2 months
|
Overall score on the 16-item Decisional Conflict Scale (DCS). Measured 2 months after participants are informed about the tool, in both arms. 5 response categories: 1 = strongly agree; 5 = strongly disagree. Scores range from 0 [no decisional conflict] to 100 [extremely high decisional conflict]. |
2 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Evaluation of the effect of the presentation of the /lamammo-etvous.fr/ tool on the intention to participate in OBCS.
Временное ограничение: 2 months
|
Score on a one-item (Measures of Decision) scale measuring intention to participate in OBCS. Measured 2 months after participants are informed about the tool, in both arms. Respondents check a box lying on a 15-point scale ranging from "I wish to participate in breast cancer screening" to "I do not wish to participate in breast cancer screening", with "I'm not sure" in the middle. Scores will be reclassified as follows: 1-5 (yes); 6-10 (unsure); 11-15 (no). |
2 months
|
|
Evaluation of the effect of presenting the /lamammo-etvous.fr/ DA tool on the implementation of shared decision-making.
Временное ограничение: 2 months
|
Scores on the 9-item Shared Decision Making Questionnaire (SDM Q9). Measured 2 months after presentation of the tool, in both arms. Six response categories: 10 = completely disagree; 5 = completely agree. Scores are reported on a scale ranging from 0 (the lowest possible level of SDM) to 100 ( the highest extent of SDM). |
2 months
|
|
Evaluation of the effect of presenting the /lamammo-etvous.fr/ DA tool on women's knowledge of OBCS.
Временное ограничение: 2 months
|
Number of correct responses to a 10-item questionnaire that tests OSBC-related knowledge. The questionnaire was developed in the context of the DEDICACES project (part 1) and is based on items included in the IPDAS (International Patient Decision Aid Standards) score. Measured 2 months after presentation of the support tool, in both arms. |
2 months
|
|
Evaluation of the effect of the presentation of the /lamammo-etvous.fr/ DA tool on women's care pathways following an invitation to participate in OBCS.
Временное ограничение: 2 months
|
Data related to care pathways 2 months after presentation of the DA tool, in both arms: mammograms completed; appointments made to undergo mammography; appointments made to discuss screening; type of professionals contacted by participants (GP, midwife, gynaecologist, other). |
2 months
|
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Evaluation of the effect of presenting the /lamammo-etvous.fr/ DA tool on decisional conflict in subgroups characterized by lower participation in OBCS.
Временное ограничение: 2 months
|
Collection of socio-demographic patient data (home, work, marital status, in receipt of state aid) and health data (long-term illness, history of participation in OBCS, history of participation in colon cancer screening). Data collected 2 months after presentation of the DA tool, in both arms. |
2 months
|
Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Cédric Rat, M.D. PhD., Nantes University Hospital, Faculty of medicine, General Practice Department, Nantes, France
- Главный следователь: Sandrine Hild, M.D., Nantes University Hospital, Faculty of medicine, General Practice Department, Nantes, France
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- RC20_0532
- 2024-A00987-40 (Другой номер гранта/финансирования: National Cancer Institute)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
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