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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Darima Dorzhieva
- 电话号码：646-962-8666
- 邮箱：dad4011@med.cornell.edu
研究联系人备份
- 姓名：Zori K Hamilton, MA
- 电话号码：646-962-3694
- 邮箱：zkh4001@med.cornell.edu
学习地点
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New York
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Brooklyn、New York、美国、11215
- 招聘中
- NewYork-Presbyterian Brooklyn Methodist Hospital
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首席研究员：
- Evelyn Taiwo, MD
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接触：
- Zori K Hamilton, MA
- 电话号码：6469623694
- 邮箱：zkh4001@med.cornell.edu
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Flushing、New York、美国、11355
- 招聘中
- NewYork-Presbyterian Medical Group Queens
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接触：
- Zori K Hamilton, MA
- 电话号码：646-962-3694
- 邮箱：zkh4001@med.cornell.edu
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首席研究员：
- Pooja Murthy, MD
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New York、New York、美国、10065
- 招聘中
- NewYork-Presbyterian David H. Koch Center
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首席研究员：
- Shoshana Rosenberg, ScD, MPH
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接触：
- Zori K Hamilton, MA
- 电话号码：646-962-3694
- 邮箱：zkh4001@med.cornell.edu
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient-reported acceptability of the COAST decision support tool
大体时间：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
大体时间：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
大体时间：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.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Baseline Decisional Conflict Scale Score
大体时间：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
大体时间：Baseline and follow-up (2-4 weeks after exposure to COAST)
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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.
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Baseline and follow-up (2-4 weeks after exposure to COAST)
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Change in decisional self-efficacy score
大体时间：Baseline and follow-up (2-4 weeks after exposure to COAST)
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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)
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合作者和调查者
合作者
调查人员
- 首席研究员：Shoshana Rosenberg, ScD, MPH、Weill Medical College of Cornell University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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