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Набор скоро начнётся NCT07731425

Patients' Expectations About the Survival Benefits of Cancer Drugs Approved Based on Progression-Free Survival

Без фазы С лечением Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: FDA explanation for progression-free survival (control), FDA explanation for progression-free survival with overall survival data, NCI explanation for progression-free survival, NCI explanation for progression-free survival with overall survival data.
Кому может быть актуально
Состояния в реестре: Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Patients' Expectations About the Survival Benefits of Cancer Drugs Approved Based on Progression-Free Survival: a Randomized Controlled Trial

Обзор

This study of current or former cancer patients 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

Подробное описание

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.

Вмешательства

  • Другое FDA explanation for progression-free survival (control)
    Progression-free survival
  • Другое FDA explanation for progression-free survival with overall survival data
    The description, 'progression-free survival', along with data on overall survival.
  • Другое NCI explanation for progression-free survival
    The description, 'the length of time during and after treatment that a patient lived with the cancer but it did not get worse'.
  • Другое 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.
  • Другое Plain-language explanation of progression-free survival
    The description, 'the length of time until a test showed the cancer grew, spread, or worsened'.
  • Другое 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.

Первичные конечные точки

  • Accuracy of expectations about the survival benefits of a new cancer drug approved based on progression-free survival [Срок оценки: Assessed immediately after the intervention]
Вторичные конечные точки (1)
  • Perceptions of drug benefits and risks [Срок оценки: Assessed immediately after the intervention]

Критерии участия

Критерии включения

  • 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.

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 other 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

США · 1 центр
  • Harvard Medical School and Harvard Pilgrim Health Care Institute — Boston

Идентификаторы

NCT: NCT07731425 · 714377A

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗