Communicating Uncertainties Associated With the Benefits and Risks of New Cancer Drugs

Обзор

This nationally representative randomized survey of US adults will evaluate the effect of using brief statements to communicate different sources of uncertainty about the benefits and harms of new cancer drugs on participants' decisions and understanding.

Подробное описание

Many newer cancer drugs are approved before uncertainties with their underlying clinical trial evidence have been adequately studied, in turn making it difficult to accurately determine the drug's benefits and harms. Prescription drug information rarely communicates these uncertainties. In a nationally representative sample of US adults, this study will evaluate the effect of using brief statements to communicate different sources of uncertainty about the benefits and harms of new cancer drugs on participants' decisions and understanding.

In the pre-intervention phase, participants will be given information about a hypothetical new drug approved for the treatment of non-small cell lung cancer. Participants will be asked how likely they would be to take the drug, and how certain they are that the drug will work. Participants will then be randomized to 1 of 5 statements about a source of uncertainty with the drug's evidence that were based on the most common sources of uncertainties with new cancer drugs that are cited in FDA approval decisions: (1) single-arm trial designs, (2) limited study populations (i.e., generalizability of clinical trial evidence), and (3) limited study durations (i.e., long-term benefits and harms). Two additional uncertainties were also included that are frequently mentioned in the scientific literature: (4) the use of unvalidated surrogate endpoints to support new cancer drug approvals, and (5) uncertain treatment effect size (i.e., the magnitude of therapeutic benefit). The post-intervention questions will re-assess participants' decision making and perceptions of uncertainty, as well as their understanding of the uncertainty communicated in the statement.

Вмешательства

• Другое Statement communicating uncertainty with a single arm trial
  Because Zenova has not been compared to other treatments, it is unknown if Zenova is better, the same, or worse than other treatments for non-small cell lung cancer.
• Другое Statement communicating uncertainty with limited study duration
  Since patients given Zenova were followed for a short time, the longer-term benefits and harms of taking Zenova are unknown.
• Другое Statement communicating uncertainty with a 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.
• Другое Statement communicating uncertainty with an 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.
• Другое Statement communicating uncertainty with treatment effect size
  It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.

Первичные конечные точки

• Change in decisions [Срок оценки: 15-minute survey. Change in decisions is assessed by participants answers to the question pre- and post-intervention.]
• Understanding [Срок оценки: 15-minute survey. Assessed post-intervention.]

Вторичные конечные точки (1)

• Change in perception of uncertainty [Срок оценки: 15-minute survey. Change in perception of uncertainties is assessed by participants answers to the question pre- and post-intervention.]

Критерии участия

Критерии включения

• Adults 18 years of age and older
• Adults fluent in English
• Adults residing in the United States

Критерии исключения

• Participants who do not meet each of the 3 inclusion criteria

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Harvard Medical School and Harvard Pilgrim Health Care Institute — Boston

Идентификаторы

NCT: NCT06997185 · 540788

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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