Shared Decision Making for Patients With HER2-negative Metastatic Breast Cancer (SDM-01)

Официальное название

Implementing Shared Decision Making (SDM) For HER2 Negative Metastatic Breast Cancer Patients (SDM-01 Study)

Обзор

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.

Вмешательства

• Поведенческое Shared Decision Making (SDM) Support Program
  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.

Первичные конечные точки

• SDM-Q-9 (9-item Shared Decision Making Questionnaire) [Срок оценки: Baseline and 6 months]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07578415 · 160/2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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