Digital Lifestyle Intervention for Lung Cancer Survivors
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: Lifestyle.
- Кому может быть актуально
- Состояния в реестре: Non-Small Cell Lung Cancer (NSCLC). 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
- Швейцария
- 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
Effect of a Digital Lifestyle Intervention on Health-Related Quality of Life in Non-Small Cell Lung Cancer Survivors (QUALUCA): a Multicenter Randomized Controlled Trial
Обзор
The aim of this study is to assess the efficacy of a digital lifestyle intervention in non-small cell lung cancer (NSCLC) survivors on health-related quality of life (HRQoL) over three months.
Подробное описание
Lung cancer survivors suffer from reduced physical and psychological functioning as well as decreased overall health-related quality of life (HRQoL) due to cancer symptoms, cancer treatments, and comorbidities. Experienced symptoms by lung cancer survivors, such as cancer-related fatigue or dyspnea, persist after active treatment ends. Therefore, lung cancer survivors should receive continuous attention regarding their health and HRQoL beyond the expected cancer cure.
Physical activity, healthy nutrition, and breathing/relaxation exercises before, during, and after cancer treatments can increase physical as well as psychological functioning and HRQoL. Thus, the adhesion to an appropriate healthy lifestyle is crucial and represents an effective adjunctive strategy in the management of lung cancer survivors. Most lung cancer survivors, however, are sedentary and fail to meet official lifestyle recommendations, for instance, of the American Cancer Society or the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR).
The present project evaluates a mobile application for non-small cell lung cancer (NSCLC) survivors that will be used for three months after rehabilitation or treatment has finished. The main foci of the mobile application are physical activity, nutrition, and breathing/relaxation. The contents of the mobile application and the mobile application itself were developed in an iterative co-creation process involving software developers and potential users as well as researchers and clinicians from different disciplines (e.g., physical therapy and nutritional therapy).
Вмешательства
- Поведенческое Lifestyle
Participants assigned to the intervention group receive access to a lifestyle mobile application for three months after rehabilitation or treatment has finished. The digital program is target group-specific and includes personalization and interactive elements without face-to-face appointments during the intervention. One virtual appointment at the beginning of the intervention with the study staff ensures that participants familiarize themselves with the mobile application and that they are ass
Первичные конечные точки
- Health-related quality of life (Scale-Global health status) [Срок оценки: Change from baseline to 3 months]
Вторичные конечные точки (11)
- Health-related quality of life (5 functional scales, 9 symptom scales/items) [Срок оценки: Change from baseline to 3 months]
- Lung cancer-specific health-related quality of life (10 symptom scales/items) [Срок оценки: Change from baseline to 3 months]
- Body mass index [kg/m²] [Срок оценки: Change from baseline to 3 months]
- Physical activity (self-reported) [Срок оценки: Change from baseline to 3 months]
- Functional exercise capacity [Срок оценки: Change from baseline to 3 months]
- Risk for low protein intake [Срок оценки: Change from baseline to 3 months]
- Appetite [Срок оценки: Change from baseline to 3 months]
- Psychological distress [Срок оценки: Change from baseline to 3 months]
- Cancer-related fatigue [Срок оценки: Change from baseline to 3 months]
- Enablement [Срок оценки: Change from baseline to 3 months]
- Self-rated health [Срок оценки: Weekly for 3 months]
Критерии участия
Критерии включения
- Age ≥ 18 years
- Diagnosis of non-small cell lung cancer (NSCLC)
- Estimated life expectancy of ≥ six months (judged by local investigators/responsible health professionals)
- Undergoing inpatient or outpatient rehabilitation OR completion of planned surgery, chemotherapy, or radiation therapy for NSCLC within the past 24 weeks
- Knowledge of German to understand study material and assessments
- Access to a cell phone or tablet
- Written informed consent
Критерии исключения
- Inability to provide informed consent
- Inability to participate in the intervention because of physical, cognitive, or safety reasons (judged by local investigators/responsible health professionals)
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
- Простое слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
Швейцария · 4 центра
- Klinik Barmelweid AG — Barmelweid
- Zürcher RehaZentren | Klinik Davos — Davos
- Berner Reha Zentrum AG — Heiligenschwendi
- Zürcher RehaZentren | Klinik Wald — Wald
Публикации
- Weber M, Raab AM, Schmitt KU, Busching G, Marcin T, Spielmanns M, Puhan MA, Frei A. Efficacy of a digital lifestyle intervention on health-related QUAlity of life in non-small cell LUng CAncer survivors following inpatient rehabilitation: protocol of the QUALUCA Swiss multicentre randomised controlled trial. BMJ Open. 2024 Mar 7;14(3):e081397. doi: 10.1136/bmjopen-2023-081397. PMID 38453202
Идентификаторы
NCT: NCT05819346 · 0