Cancer-related Fatigue During Maintenance Immunotherapy for Non-small Cell Lung Cancer (NSCLC): a Qualitative Study
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: Interviews.
- 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
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The purpose of this research is to understand cancer related fatigue in patients with non-small cell lung cancer (NSCLC), who are being treated with an immune checkpoint inhibitor.
Подробное описание
This is an observational pilot study. The target population includes adult patients diagnosed with NSCLC receiving an immune checkpoint inhibitor and reporting concerns of fatigue to their provider. This study will be conducted at Levine Cancer Institute (LCI) and Atrium Health Wake Forest Baptist Comprehensive Cancer Center (AHWFBCCC). This study consists of qualitative interviews at two-time points, the primary, and the follow-up. During the primary interview, patients with NSCLC will be asked to complete the PROMIS® Fatigue-Short Form 7a consisting of seven items. During the follow-up interviews, participants will be asked about any change in their fatigue and views on physical activity.
Вмешательства
- Поведенческое Interviews
Interviews
Первичные конечные точки
- Themes from qualitative interviews with patients [Срок оценки: At 3 months]
Вторичные конечные точки (1)
- Severity and impact of cancer-related fatigue (CRF) [Срок оценки: At 3 months]
Критерии участия
Критерии включения
- ≥ 18 years of age at the time of consent.
- Must be able to speak, read, and understand English.
- Participants diagnosed with NSCLC, and:
- have advanced/metastatic disease who are currently receiving immunotherapy monotherapy, or
- have locally advanced disease who are currently receiving immunotherapy monotherapy after completing thoracic radiation therapy, or
- who underwent resection and are currently receiving immunotherapy monotherapy after completing all other perioperative treatment
- Immunotherapy planned to continue for at least three months after the time of study enrollment (to ensure participant remains on IO long enough to obtain study assessments)
- Have completed at least two cycles of immunotherapy.
- Self-reported cancer-related fatigued that impacts daily function.
Критерии исключения
- Participants who have received a dose of chemotherapy (including maintenance pemetrexed) within the past 3 months
- Participants who have received radiation therapy within the past 3 months. Note: a short course of palliative radiation therapy within up to 20 Gy and up to 5 fractions is permissible.
- Diagnosis of dementia.
- Anemia Hgb <10 g/dL.
- Sarcopenia which is being pharmacologically treated with a prescribed appetite stimulant (e.g., megestrol).
- Untreated hypothyroidism.
- Symptomatic heart failure.
- Oxygen dependent lung disease.
- Cognitively unable to complete interviews per investigator.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
США · 2 центра
- Atrium Health Levine Cancer — Charlotte
- Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem
Идентификаторы
NCT: NCT06567704 · IRB00116521 · ONC-LUN-2401