Optimizing Surgical Decisions in Young Adults With Breast Cancer
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: CONSYDER decision aid.
- Кому может быть актуально
- Состояния в реестре: Breast Cancer Stage 0, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III. Базовые параметры: 18 лет — 44 лет · Женщины.
- 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 goal of this study is to understand and improve the breast surgical decision-making process for young women newly diagnosed with breast cancer. As part of this study, the investigators will evaluate the impact and use a web-based tool called CONSYDER that is designed to provide useful information to young breast cancer patients. It is also meant to improve communication between young women and their surgeons with the purpose of helping patients make appropriate surgical decisions. Participants will complete surveys approximately within 1 week of the surgical consult and approximately 6 months after surgery. Patients who receive neoadjuvant chemotherapy will also be surveyed after the completion of neoadjuvant treatment but prior to surgery. Some patients will be invited for an interview after their surgery as part of the evaluation. A subset of patients/surgeons will also have their surgical consultation audio-recorded.
Подробное описание
Primary objectives:
* To test the effectiveness of the CONSYDER decision support tool on reducing decisional conflict prior to breast cancer surgery. * To evaluate the implementation of and mechanisms of use for CONSYDER.
Secondary Objectives:
* To determine the impact of CONSYDER on decision-making preferences, breast cancer knowledge, treatment goals and preferences, anxiety, decisional regret, and self-efficacy in communication.
Exploratory Objectives:
* To explore whether CONSYDER impacts surgical choice.
OUTLINE: This is a multi-site cluster randomized trial using a stepped wedge design. Approximately 800 women will be recruited at 4 study sites (Weill Cornell Medicine, Yale Cancer Center, Dana-Farber Cancer Institute, Duke Cancer Institute), including network affiliate sites, over an approximate 30-month period. All sites will have a 6-month "run-in" period where patients will not be sent CONSYDER. The 6-month blocks may be extended if recruitment targets are not met. Sites will be randomized to begin delivery of CONSYDER to all newly diagnosed women, age ≤44, with Stage 0-III breast cancer as part of routine clinical care; young women will have access to the website whether or not they consent to research study participation.
Вмешательства
- Другое CONSYDER decision aid
Web-based breast cancer surgery decision aid
Первичные конечные точки
- Pre-surgical decisional conflict as measured by the Decisional Conflict Scale (DCS) [Срок оценки: pre-surgery]
- Use of CONSYDER pre-consult [Срок оценки: pre-surgery]
Вторичные конечные точки (10)
- Knowledge as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS -DQI) [Срок оценки: pre-surgery]
- Treatment goals and preferences as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS-DQI) [Срок оценки: pre-surgery]
- Anxiety, as measured with the 8-item Patient Reported Outcomes Measurement Information System (PROMIS) - Anxiety - Short Form [Срок оценки: pre-surgery and 6 months post-surgery]
- Self-efficacy in communication as measured by the Perceived Efficacy in Patient-Physician Interactions scale (PEPPI). [Срок оценки: pre-surgery]
- Decisional regret as measured by the Decision Regret Scale (DRS) [Срок оценки: 6 months post-surgery]
- Receipt of contralateral prophylactic mastectomy [Срок оценки: 6 months post-surgery]
- Fidelity of implementation of CONSYDER via patient portal email [Срок оценки: pre-surgical consult]
- Use of CONSYDER post-consult [Срок оценки: up to 6 months post-surgical consult]
- Frequency of CONSYDER use pre-consult [Срок оценки: pre consult]
- Frequency of CONSYDER use post-consult [Срок оценки: up to 6 months post-surgical consult]
Критерии участия
Критерии включения
- Female aged 18-44
- New diagnosis of Stage 0, 1, 2, or 3 unilateral breast cancer
- English or Spanish speaking
Критерии исключения
- Diagnosis of de novo Stage 4 breast cancer
- Recurrent early-stage breast cancer
- Bilateral breast cancer
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Открытое
- Основная цель
- Организация здравоохранения
Центры проведения
США · 4 центра
- Yale Cancer Center — New Haven
- Dana-Farber Cancer Institute — Boston
- Weill Cornell Medicine — New York
- Duke Cancer Institute — Durham
Идентификаторы
NCT: NCT06275126 · 23-08026433 · R01CA256877-01A1