Patients' Expectations About the Survival Benefits of Cancer Drugs Approved Based on Progression-Free Survival
Patients' Expectations About the Survival Benefits of Cancer Drugs Approved Based on Progression-Free Survival: a Randomized Controlled Trial
調査の概要
状態
条件
介入・治療
- 他の:FDA explanation for progression-free survival (control)
- 他の:FDA explanation for progression-free survival with overall survival data
- 他の:NCI explanation for progression-free survival
- 他の:NCI explanation for progression-free survival with overall survival data
- 他の:Plain-language explanation of progression-free survival
- 他の:Plain-language explanation of progression-free survival with overall survival data
詳細な説明
Progression-free survival (PFS) (the time until a tumour grows, spreads, or the patient dies) is among the most common outcomes supporting the approval of new cancer drugs. Likely owing to similar terminology and the use of the word 'survival', patients often confuse PFS with overall survival, which may lead to treatment decisions that are not aligned with patients' individual preferences. Alternative descriptions of PFS that acknowledge the absence of a survival benefit may improve understanding.
This randomized controlled trial will evaluate whether communicating data on overall survival data in addition to information on progression-free improves the accuracy of cancer patients' expectations about the survival benefits of new cancer drugs, since patients may only understand the distinction between these outcomes when they are presented with data on both. Three alternative descriptions for PFS will be compared, including those used by the FDA, the National Cancer Institute, and a plain-language version that was developed drawing on prior work about communicating PFS. This study will also compare the additive effect of overall survival data for each alternative description of PFS.
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:Avi Cherla
- 電話番号:020 7955 7975
- メール:avi_cherla@hphci.harvard.edu
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02215
- Harvard Medical School and Harvard Pilgrim Health Care Institute
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コンタクト:
- Avi Cherla
- 電話番号:020 7852 3727
- メール:avi_cherla@hphci.harvard.edu
-
-
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:
- US adults with a current or former cancer diagnosis (excluding nonmelanoma skin cancer)
- US adults 18 years of age and older, fluent in English, and residing in the United States.
Exclusion Criteria:
- Adults who do not have a former cancer diagnosis or who were diagnosed with nonmelanoma skin cancer; adults who complete the survey in under 150 seconds, and who do not meet the other inclusion criteria.
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:他の
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター:FDA explanation for progression-free survival (control)
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Progression-free survival
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|
実験的:FDA explanation for progression-free survival with overall survival data
|
The description, 'progression-free survival', along with data on overall survival.
|
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実験的:NCI explanation for progression-free survival
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The description, 'the length of time during and after treatment that a patient lived with the cancer but it did not get worse'.
|
|
実験的:NCI explanation for progression-free survival with overall survival data
|
The description, 'the length of time during and after treatment that a patient lived with the cancer but it did not get worse', along with data on overall survival.
|
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実験的:Plain-language explanation of progression-free survival
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The description, 'the length of time until a test showed the cancer grew, spread, or worsened'.
|
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実験的:Plain-language explanation of progression-free survival with overall survival data
|
The description, 'the length of time until a test showed the cancer grew, spread, or worsened', along with data on overall survival.
|
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 |
|---|---|---|
|
Accuracy of expectations about the survival benefits of a new cancer drug approved based on progression-free survival
時間枠:Assessed immediately after the intervention
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Compared to standard treatment, do patients with advanced kidney cancer live longer when treated with Velotrex? - Response options: definitely yes, probably yes, probably no, definitely no |
Assessed immediately after the intervention
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Perceptions of drug benefits and risks
時間枠:Assessed immediately after the intervention
|
How would you describe the benefits of Velotrex? - Very large, large, moderate, small, very small to none Do you think the benefits of Velotrex outweigh the side effects? - Response options: definitely yes, probably yes, probably no, definitely no Which treatment would you recommend to a patient with kidney cancer - Response options: Velotrex, standard treatment |
Assessed immediately after the intervention
|
協力者と研究者
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 714377A
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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