Набор скоро начнётся NCT07542210

Barriers and Facilitators of Persistence With Adjuvant Osimertinib

— 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 →

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Официальное название

Cross-sectional Qualitative Study to Identify Barriers and Facilitators of Persistence With 3rd Generation EGFR-TKI Osimertinib as Adjuvant Treatment (SECURE)

Обзор

This is a cross-sectional, non-interventional qualitative study using individual interviews to investigate determinants of persistence with 3rd generation EGFR-TKI osimertinib as adjuvant therapy among patients with early-stage NSCLC in China. Approximately 100 participants will be enrolled, comprising around 85 patients and 15 physicians. All participants will be interviewed online or in-person using a COM-B (Capability, Opportunity, Motivation - Behaviour) based guide. Interviews will be conducted in waves, recorded, transcribed, and analysed using both deductive and inductive methods.

Первичные конечные точки

Barriers to persistence [Срок оценки: Day of interview completion]
Facilitators of persistence [Срок оценки: Day of interview completion]

Вторичные конечные точки (2)

Barriers and facilitators of persistence in different treatment duration cohorts [Срок оценки: Day of interview completion]
Support needed by patients during their long-term treatment journey [Срок оценки: Day of interview completion]

Критерии участия

For patient

Критерии включения

Adults (≥18 years) with NSCLC who have received osimertinib as the 3rd generation EGFR-TKI adjuvant therapy and meet one of the following: Patients who received adjuvant osimertinib for less than 34 months and discontinued treatment (off treatment), or Patients who received adjuvant osimertinib for at least 34 months (either off treatment or still on treatment).
For off treatment patients, discontinuation or completion of osimertinib is required to occur within 6 months by screening.
Willing and able to provide informed consent, participate in an online or in-person qualitative interview, and permit audio recording for research purposes.

Критерии исключения

Prior receipt of 3rd generation EGFR-TKI as adjuvant therapy as part of any interventional clinical trial.
Prior receipt of 1st generation EGFR-TKIs as adjuvant therapy.
Evidence of cognitive impairment that would likely to interfere with participation in an interview, as informally assessed during screening.
Unaware of or do not understand their own medical condition.

For physicians

Критерии включения

Licensed medical oncologists, thoracic surgeons, or pulmonologists with experience of prescribing osimertinib as adjuvant treatment and actively managing patients who will participate the interview.
Managed 5 patients with early-stage NSCLC receiving osimertinib within the past 6 months.
Holding a professional title equivalent to or higher than attending physician.
Willing and able to provide informed consent, participate in an online or in-person qualitative interview, and permit audio recording for research purposes.