Uncertainty About the Benefits of New Cancer Drugs and Patients' Treatment Preferences
Uncertainty About the Benefits of New Cancer Drugs and Patients' Treatment Preferences: a Randomized Controlled Trial
調査の概要
状態
条件
詳細な説明
Many new cancer drugs are approved based on uncertain benefits. Without knowledge of this information, patients may overestimate the benefits of new cancer drugs, resulting in decisions that are not reflective of their individual treatment preferences. A previous study found that learning about uncertainties with a new cancer drug's benefits (such as the drug's small magnitude of effect or limited trial population) reduced the proportion of people who were willing to take the drug. It is unclear whether these findings are generalizable to patients with cancer, who may have different treatment preferences, and may weigh uncertainty about the benefits of new cancer drugs differently from the general public.
In this study, US adults with a current or former cancer diagnosis will be recruited to evaluate the effect of learning about uncertainties with the benefits of a new cancer drug on their hypothetical decisions to take the drug and their perceptions of the drug's effectiveness. Patients will be randomized to 1 of 5 interventions: (1) no uncertainty information (control); or plain-language statements about uncertainties with (2) an unvalidated surrogate endpoint (unknown effect of the drug on survival or quality of life); (3) limited study population (the drug was not studied in patients of similar race or ethnicity); (4) small magnitude of effect (it is unknown whether patients would notice an improvement with the drug), or (5) a combination of all three uncertainties.
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
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),
- 18 years of age and older
- Fluent in English
- 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 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：Control
No uncertainty information
|
No uncertainty information
|
|
アクティブコンパレータ：Unvalidated surrogate endpoint
Zenova has only been shown to shrink the size of tumors.
It is unknown whether Zenova improves how patients feel or how long they live.
|
Zenova has only been shown to shrink the size of tumors.
It is unknown whether Zenova improves how patients feel or how long they live.
|
|
アクティブコンパレータ：Limited study population
Zenova has not been studied in patients similar to Alex (patients with her race and ethnicity).
It is unknown whether Zenova will work and what harms it will have for patients like her.
|
Zenova has not been studied in patients similar to Alex (patients with her race and ethnicity).
It is unknown whether Zenova will work and what harms it will have for patients like her.
|
|
アクティブコンパレータ：Small magnitude of effect
It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
|
It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
|
|
アクティブコンパレータ：Multiple uncertainties
All 3 statements shown above
|
All 3 statements shown above
|
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 |
|---|---|---|
|
Hypothetical decisions
時間枠：Assessed immediately after the intervention
|
Imagine you were Alex and diagnosed with non-small cell lung cancer. How likely would you be to take the new drug, Zenova?
|
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 treatment effectiveness
時間枠：Assessed immediately after the intervention
|
Imagine you were Alex and diagnosed with non-small cell lung cancer. How likely would you be to take the new drug, Zenova? - Response options: Very unlikely, somewhat unlikely, somewhat likely, very likely |
Assessed immediately after the intervention
|
|
Understanding
時間枠：Assessed immediately after the intervention
|
Please rate your agreement with the following statement
|
Assessed immediately after the intervention
|
|
Emotions
時間枠：Assessed immediately after the intervention
|
If you were Alex, how worried would you feel about taking Zenova? - Response options: Very worried, slightly worried, not very worried, not worried at all. |
Assessed immediately after the intervention
|
|
Trust
時間枠：Assessed immediately after the intervention
|
To what extent do you think the information about Zenova is trustworthy? To what extent do you think the FDA, which approved Zenova and produced this information, is trustworthy? To what extent do you think Alex's doctor, who recommended and prescribed Zenova, is trustworthy? - Response options: Not at all trustworthy, somewhat untrustworthy, somewhat trustworthy, very trustworthy |
Assessed immediately after the intervention
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Perceived importance in knowing about uncertainty
時間枠：Assessed immediately after the intervention
|
Please rate your agreement with the following: The information about Zenova was helpful. Uncertainties about drug benefits and harms should always be communicated. - Response options: Strongly disagree, somewhat disagree, somewhat agree, strongly agree. |
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
- 714377
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
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。