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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Darima Dorzhieva
- 電話番号：646-962-8666
- メール：dad4011@med.cornell.edu
研究連絡先のバックアップ
- 名前：Zori K Hamilton, MA
- 電話番号：646-962-3694
- メール：zkh4001@med.cornell.edu
研究場所
-
-
New York
-
Brooklyn、New York、アメリカ、11215
- NewYork-Presbyterian Brooklyn Methodist Hospital
-
コンタクト：
- Zori K Hamilton, MA
- 電話番号：646-962-3694
- メール：zkh4001@med.cornell.edu
-
主任研究者：
- Evelyn Taiwo, MD
-
New York、New York、アメリカ、10065
- NewYork-Presbyterian David H. Koch Center
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主任研究者：
- Shoshana Rosenberg, ScD, MPH
-
コンタクト：
- Zori K Hamilton, MA
- 電話番号：646-962-3694
- メール：zkh4001@med.cornell.edu
-
New York、New York、アメリカ、11355
- NewYork-Presbyterian Medical Group Queens
-
コンタクト：
- Zori K Hamilton, MA
- 電話番号：646-962-3694
- メール：zkh4001@med.cornell.edu
-
主任研究者：
- Pooja Murthy, MD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient-reported acceptability of the COAST decision support tool
時間枠：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
時間枠：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
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Baseline Decisional Conflict Scale Score
時間枠：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)
|
|
Change in patient-centered communication
時間枠：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)
|
|
Change in decisional self-efficacy score
時間枠：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".
|
Baseline and follow-up (2-4 weeks after exposure to COAST)
|
協力者と研究者
協力者
捜査官
- 主任研究者：Shoshana Rosenberg, ScD, MPH、Weill Medical College of Cornell University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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