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Идёт набор NCT07413757

CHOICE:Decision Factor of EGFR-TKI in Chinese IV NSCLC

Наблюдательное Non-Small Cell Lung 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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Non-Small Cell Lung 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Cross-sectional Survey-based Study Using Preference Elicitation Method to Assess Decision-making Impact Factor of Chinese Patients and Physicians for First-line EGFR-TKIs Treatment of Stage IV NSCLC (CHOICE)

Обзор

This non-interventional, cross-sectional study aims to investigate treatment preferences from a sample of physicians and patients with experience of 1L EGFR-TKI for stage IV NSCLC by administering a survey, which primarily includes a DCE approach.

Подробное описание

This non-interventional, cross-sectional study aims to investigate treatment preferences from a sample of physicians and patients with experience of 1L EGFR-TKI for stage IV NSCLC by administering a survey, which primarily includes a DCE approach.

The study will collect data from participants via the questionnaire developed by the research team. This study will be conducted in two stages. Stage 1 is the study design phase (i.e., qualitative stage and questionnaire development), which includes the development of the questionnaire, identification of key attributes and levels for the Discrete Choice Experiment (DCE), creation of hypothetical patient profiles to explore high-risk factors in physician decision-making beyond the DCE, as well as questionnaire programming, internal review, pilot testing, revisions, and finalization. Stage 2 involves the implementation of the quantitative survey using the finalized questionnaire and the subsequent data analysis to generate insights into treatment preferences.

Первичные конечные точки

  • Preferences weights for each attribute level evaluated in the DCE [Срок оценки: Day of interview/survey completion(Day1)]
  • Relative attribute importance (RAI) [Срок оценки: Day of interview/survey completion(Day1)]
Вторичные конечные точки (3)
  • Maximum acceptable risks (MAR) and minimum acceptable benefit (MAB) [Срок оценки: Day of interview/survey completion(Day1)]
  • RAI, MAR, and MAB by patient and physician characteristics subgroups [Срок оценки: Day of interview/survey completion(Day1)]
  • Odds ratios (ORs) for the association between patient characteristics and the likelihood of physicians recommending combination therapy (EGFR-TKI plus platinum/pemetrexed chemotherapy or EGFR-TKI plus bispecific antibody) versus EGFR-TKI monotherapy [Срок оценки: Day of interview/survey completion(Day1)]

Критерии участия

Критерии включения

The following inclusion criteria must be met in order to be enrolled in the stage 1:

Patient:

  • Provide informed consent
  • 18 years or older
  • Diagnosed with stage IV NSCLC
  • Currently receiving or previously received 1L EGFR-TKI treatment
  • Without communication barrier
  • Do not exhibit signs of cognitive impairment that would prevent participation in an interview, as informally assessed during screening by the recruiter

Physician:

  • Provide informed consent
  • Specialized in departments of medical oncology, respiratory medicine, or thoracic surgery at tertiary hospitals
  • Manage at least 3 stage IV NSCLC patients with 1L EGFR-TKI per month
  • Holding the title of associate chief physician or higher

The following inclusion criteria must be met in order to be enrolled in the stage 2:

Patient:

  • Provide informed consent
  • 18 years or older
  • Diagnosed with stage IV NSCLC
  • Currently receiving or previously received 1L EGFR-TKI treatment
  • Without communication barrier
  • Do not exhibit signs of cognitive impairment that would prevent participation in a survey, as informally assessed during screening by the recruiter

Physician:

  • Provide informed consent
  • Specialized in departments of medical oncology, respiratory medicine, or thoracic surgery at tertiary hospitals
  • Manage at least 3 stage IV NSCLC patients with 1L EGFR-TKI per month
  • Holding the title of attending physician or higher

Критерии исключения

Not applicable.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Китай · 1 центр
  • Research Site — Чэнду

Идентификаторы

NCT: NCT07413757 · D5161R00072

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗