Decision Support Tool for Patients With Advanced Breast Cancer (COAST)
Communicating Options for Advanced Breast Cancer Support and Treatment (COAST)
The goal of this pilot study is to understand and improve the shared decision-making process between people with advanced breast cancer and their providers regarding their care and treatment. As part of this study, the researchers will evaluate a decision support tool called COAST that was designed to support patients and providers in having meaningful conversations. The main questions it aims to answer are:
- Can the COAST tool improve the quality of communication between patients and their oncology providers?
- Is the COAST tool acceptable, appropriate, and easy to use at NYP-Weill Cornell Medicine, NYP-Brooklyn Methodist Hospital and NYP-Queens?
Participants will be asked to fill out two surveys: one before they use the COAST tool and another about 2 - 4 weeks later. Some patients will also be invited for an interview.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Darima Dorzhieva
- Número de telefone: 646-962-8666
- E-mail: dad4011@med.cornell.edu
Estude backup de contato
- Nome: Zori K Hamilton, MA
- Número de telefone: 646-962-3694
- E-mail: zkh4001@med.cornell.edu
Locais de estudo
-
-
New York
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Brooklyn, New York, Estados Unidos, 11215
- NewYork-Presbyterian Brooklyn Methodist Hospital
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Contato:
- Zori K Hamilton, MA
- Número de telefone: 646-962-3694
- E-mail: zkh4001@med.cornell.edu
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Investigador principal:
- Evelyn Taiwo, MD
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New York, New York, Estados Unidos, 10065
- NewYork-Presbyterian David H. Koch Center
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Investigador principal:
- Shoshana Rosenberg, ScD, MPH
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Contato:
- Zori K Hamilton, MA
- Número de telefone: 646-962-3694
- E-mail: zkh4001@med.cornell.edu
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New York, New York, Estados Unidos, 11355
- NewYork-Presbyterian Medical Group Queens
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Contato:
- Zori K Hamilton, MA
- Número de telefone: 646-962-3694
- E-mail: zkh4001@med.cornell.edu
-
Investigador principal:
- Pooja Murthy, MD
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Male or female 18 years and older
- Diagnosis of Stage IV breast cancer
- English, Spanish or Mandarin speaking
Exclusion Criteria:
- Early breast cancer
- Individuals speaking languages other than English, Spanish, or Mandarin as their primary language
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: COAST intervention
|
The COAST decision support tool will be available in two formats: a booklet and a website.
It will provide information about advanced breast cancer and the available treatment options.
Participants will be guided through questions designed to clarify their goals and preferences, identify support needs, and concerns they may have.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patient-reported acceptability of the COAST decision support tool
Prazo: 2-4 weeks after exposure to COAST
|
The proportion of patients who agree with the acceptability of the COAST decision support tool is measured by the Acceptability of Intervention Measure (AIM). This tool consists of four items designed to monitor and evaluate the success of implementation efforts. Respondents can rate each item on a scale from 1 (completely disagree) to 5 (completely agree). Higher scores reflect greater agreement with the acceptability of the intervention. Patients with a score of 4 or higher will be included in the numerator, while all patients who complete the measure will be included in the denominator. We will define COAST as "acceptable" if this proportion is greater than 70%. |
2-4 weeks after exposure to COAST
|
|
Patient-reported appropriateness of the COAST decision support tool
Prazo: 2-4 weeks after exposure to COAST
|
The proportion of patients who agree with the appropriateness of the COAST decision support tool is measured using the Intervention Appropriateness Measure (IAM). This tool consists of four items designed to evaluate the suitability and relevance of an intervention. Respondents can rate each item on a scale from 1 (completely disagree) to 5 (completely agree). Higher scores reflect greater agreement with the appropriateness of the intervention. Patients with a score of 4 or higher will be included in the numerator, while all patients who complete the measure will be included in the denominator. We will define COAST as "appropriate" if this proportion is greater than 70%. |
2-4 weeks after exposure to COAST
|
|
Provider-reported feasibility of the COAST decision support tool
Prazo: At the conclusion of participant enrollment, approximately 1 month after the last patient is enrolled.
|
The proportion of healthcare providers who care for adult patients with metastatic breast cancer (MBC) and agree on the feasibility of the COAST decision support tool is measured using the Feasibility of Intervention Measure (FIM). This tool consists of four items designed to measure the feasibility or extent to which an intervention can be successfully used or carried out within a given setting. Respondents can rate each item on a scale from 1 (completely disagree) to 5 (completely agree). Higher scores reflect greater agreement with the feasibility of implementing the COAST tool. Providers with a score of 4 or higher will be included in the numerator, while all providers who complete the measure will be included in the denominator. We will define COAST as "feasible" if this proportion is 70% or greater. |
At the conclusion of participant enrollment, approximately 1 month after the last patient is enrolled.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Baseline Decisional Conflict Scale Score
Prazo: Baseline and follow-up (2-4 weeks after exposure to COAST)
|
Mean change from baseline in patient decisional conflict will be assessed via Decisional Conflict Scale (DCS), which includes 5 subscales (uncertainty, informed, values clarity, support, effective decision).
Each item is rated on a scale of 0 (strongly agree) to 4 (strongly disagree).
Scores range from 0-100 with higher scores indicating more decisional conflict.
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Baseline and follow-up (2-4 weeks after exposure to COAST)
|
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Change in patient-centered communication
Prazo: Baseline and follow-up (2-4 weeks after exposure to COAST)
|
Mean change from baseline in patient-centered communication score will be assessed via Patient-Centered Communication (PCC) in cancer care.
The purpose of the measure is to assess PCC in six core domains: 1) exchanging information, 2) making decisions, 3) fostering healing relationships, 4) enabling patient self-management, 5) managing uncertainty, and 6) responding to emotions.
Respondents can rate each item on a scale, where higher scores indicate better patient-centered communication and greater perceived support from the healthcare team.
|
Baseline and follow-up (2-4 weeks after exposure to COAST)
|
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Change in decisional self-efficacy score
Prazo: Baseline and follow-up (2-4 weeks after exposure to COAST)
|
Mean Change from Baseline in patient self-efficacy for making decisions will be assessed via the Decisional Self-Efficacy Scale.
The Scale measures self-confidence or belief in one's abilities in decision making, including shared decision-making.
Respondents can rate each item on a scale from 0 (not at all confident) to 4 (very confident).
A score of 0 means "extremely low self-efficacy" and a score of 100 means "extremely high self-efficacy".
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Baseline and follow-up (2-4 weeks after exposure to COAST)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Shoshana Rosenberg, ScD, MPH, Weill Medical College of Cornell University
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 25-07029092
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