Uncertainty About the Benefits of New Cancer Drugs and Patients' Treatment Preferences

Официальное название

Uncertainty About the Benefits of New Cancer Drugs and Patients' Treatment Preferences: a Randomized Controlled Trial

Обзор

This study of current or former cancer patients will 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.

Подробное описание

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.

Вмешательства

• Другое Control
  No uncertainty information
• Другое Unvalidates 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 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 Small magnitude of effect
  It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
• Другое Multiple uncertainties
  All 3 statements shown above

Первичные конечные точки

• Hypothetical decisions [Срок оценки: Assessed immediately after the intervention]

Вторичные конечные точки (4)

• Perceptions of treatment effectiveness [Срок оценки: Assessed immediately after the intervention]
• Understanding [Срок оценки: Assessed immediately after the intervention]
• Emotions [Срок оценки: Assessed immediately after the intervention]
• Trust [Срок оценки: Assessed immediately after the intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07694310 · 714377

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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