Shared Decision Making for Patients With HER2-negative Metastatic Breast Cancer (SDM-01) (SDM-01)
Implementing Shared Decision Making (SDM) For HER2 Negative Metastatic Breast Cancer Patients (SDM-01 Study)
Background and Purpose:
Deciding on the best treatment for HER2-negative metastatic breast cancer (MBC) is a complex process. Patients often have unique values and preferences regarding their care and quality of life. Shared Decision Making (SDM) is a communication process where doctors and patients work together to make healthcare choices. This study aims to evaluate whether providing specific SDM training to oncologists and educational materials to patients can improve the quality of these conversations and make the treatment process feel more focused on patient goals.
Study Design and Procedures:
This is a prospective, randomized multicenter study involving oncology centers in Italy. A total of 120 patients starting their first-line therapy for HER2-negative metastatic breast cancer will participate. Participants and their oncologists will be assigned to one of two main study arms:
The SDM Trained Group: This group includes different approaches, such as formal SDM training for oncologists, providing educational materials (booklet and video) to patients, or a combination of both.
The Usual Care Group: In this group, patients and oncologists follow standard care processes without specific SDM training or additional educational materials.
What to Expect:
Patients in all groups will be asked to complete standardized questionnaires (such as CollaboRATE, SURE, and SDM-Q-9) at two time points: on Day 1 after the first encounter with the oncologist and at a 6-month follow-up. These surveys will measure the patient's perception of the decision-making process, their satisfaction with the treatment choice, and their overall quality of life.
Goal:
The researchers hypothesize that educational training for patients and/or physicians will improve the quality of conversations about MBC therapy. If successful, this study may provide tools to enhance patient adherence to treatment and overall well-being.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
Confirmed diagnosis of metastatic breast cancer (MBC).
HER2-negative status (as per ASCO/CAP guidelines).
Patients scheduled to receive or currently receiving their first-line therapy for metastatic disease.
Age ≥ 18 years.
Willingness to participate in the study and provide written informed consent.
Exclusion Criteria:
Diagnosis of early-stage breast cancer (non-metastatic).
HER2-positive metastatic breast cancer.
Age < 18 years.
Refusal to sign the study-specific informed consent form.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Physician and Patient Trained
|
Comprehensive Shared Decision Making (SDM) program.
No drug treatment will be administered in this study.
The intervention consists of two components: 1) A virtual training program for oncologists on SDM communication skills; 2) Educational materials for patients (booklet and video) to support treatment choice.
Depending on the assigned study arm, participants may receive one, both, or neither of these components.
|
|
Экспериментальный: Physician Only Trained
|
Comprehensive Shared Decision Making (SDM) program.
No drug treatment will be administered in this study.
The intervention consists of two components: 1) A virtual training program for oncologists on SDM communication skills; 2) Educational materials for patients (booklet and video) to support treatment choice.
Depending on the assigned study arm, participants may receive one, both, or neither of these components.
|
|
Экспериментальный: Patient Only Educated
|
Comprehensive Shared Decision Making (SDM) program.
No drug treatment will be administered in this study.
The intervention consists of two components: 1) A virtual training program for oncologists on SDM communication skills; 2) Educational materials for patients (booklet and video) to support treatment choice.
Depending on the assigned study arm, participants may receive one, both, or neither of these components.
|
|
Без вмешательства: Usual Care
Patients and oncologists follow standard care processes.
No specific training on Shared Decision Making (SDM) is provided to the oncologist, and no additional educational materials are given to the patient.
Both parties will only complete the study questionnaires to evaluate the baseline quality of decision-making.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
SDM-Q-9 (9-item Shared Decision Making Questionnaire)
Временное ограничение: Baseline and 6 months
|
A 9-item scale used to measure the level of shared decision-making from the patient's perspective.
Each item is scored on a 6-point Likert scale from 0 (completely disagree) to 5 (completely agree).
The total score is transformed to a scale of 0 to 100, where higher scores indicate a higher level of involvement in the decision-making process.
|
Baseline and 6 months
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
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
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 160/2023
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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