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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Sem intervenção: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
SDM-Q-9 (9-item Shared Decision Making Questionnaire)
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 160/2023
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