Идёт набор NCT06367257

App-based Recording and Optimization of the Nutritional Status in Patients With Head and Neck Tumors During and After Radio(Chemo)Therapy

Без фазы С лечением Squamous Cell Carcinoma of Head and Neck

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: App Usage, Standard of Care.
Кому может быть актуально: Состояния в реестре: Squamous Cell Carcinoma of Head and Neck. 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: Германия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Patients with head and neck cancer requiring definitive or adjuvant radio(chemo)therapy can take part in the study. The aim is to record the nutritional status and diet of the patients during the trial and regularly at a period of 8 weeks after irradiation and to reduce the rate of weight loss and malnutrition.

Подробное описание

Patients in the experimental arm receive the daily reminder message via app (Emento) that they should pay attention to adequate caloric intake. In addition, these patients receive 3 screening questions about their current health and nutritional status twice a week.

In case of relevant deterioration (any negative value in the screening questions is explained under study procedure), additional further questions are asked, which are specifically aimed at the side effects of the tumor therapy (mainly dysphagia, pain). The answers will be transmitted to the radiation clinic.

If a question is answered positively, this is reported to the radiotherapy clinic on the one hand and on the other hand, the patient is asked to consult the doctor in the clinic as soon as possible.

Вмешательства

Процедура App Usage
Conducting patient surveys with app
Другое Standard of Care
supportive care during and after radio(chemo)therapy according to hospial standards

Первичные конечные точки

Change in rates of weight loss with additional app-based Patient Care [Срок оценки: during trial, about 24 months]

Вторичные конечные точки (10)

Frequency of deteriorations in health status subjectively reported by patients and recorded via the app. [Срок оценки: during trial, about 24 months]
Frequency of additional app-triggered contacts of the clinic with the patients [Срок оценки: during trial, about 24 months]
Frequency of critical health conditions (physician-verified) detected earlier by the app. [Срок оценки: during trial, about 24 months]
Change in quality of life measured per questionnaires [Срок оценки: during trial, about 24 months]
Change of incidence of malnutrition and sarcopenia before, during and after radio(chemo)therapy. [Срок оценки: during trial, about 24 months]
Change of course of malnutrition and sarcopenia before, during and after radio(chemo)therapy. [Срок оценки: during trial, about 24 months]
Rate of therapy interruptions/discontinuations [Срок оценки: during trial, about 24 months]
Overall survival [Срок оценки: during trial, about 24 months]
Disease-free/progression-free survival [Срок оценки: during trial, about 24 months]
Change of Loco-regional tumor control [Срок оценки: during trial, about 24 months]

Критерии участия

Критерии включения

Patients with squamous cell carcinoma in the head and neck region, who receive a postsurgical or definitive radio(chemo)therapy
Patients who have a smartphone on which the Emento app can be installed
Minimum age 18 years