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Идёт набор NCT06531174

Exploring Individual Nutrition Care Elements and Nutritional Evaluation Methods Within Dietetic Practice in Cancer Care

Наблюдательное Cancer Malnutrition

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: Cancer, Malnutrition. 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
Швеция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The purpose of the study is to explore and deepen the understanding of the dietitian's role and work related to individually tailored nutritional treatment in cancer care. The research questions focus on behavior change strategies, goal setting, the possibility of using calf circumference to assess changes in muscle mass, and mapping energy and protein intake, nutritional symptoms, and food-related quality of life during nutritional treatment for cancer patients. In the first part of the project, audio recordings of conversations between dietitians and patients with cancer will be conducted to investigate the dietitian's work with behavior change strategies and goal setting. Data analysis will be performed using two different methods: content analysis and thematic analysis. The research subjects include both dietitians and cancer patients who engage in conversations. The second part of the project will include 100 patients with cancer at risk for or with malnutrition. Data collection will involve measurements of weight, height, calf circumference, muscle mass, energy and protein intake, nutritional symptoms, and food-related quality of life.

Первичные конечные точки

  • Calf Circumference [Срок оценки: Baseline, 1 month and 3 months]
Вторичные конечные точки (6)
  • Fat Free Mass and Fat Mass [Срок оценки: Baseline, 1 month and 3 months]
  • Food-Related Quality of Life [Срок оценки: Baseline, 1 month and 3 months]
  • Energy and Protein Intake [Срок оценки: Baseline, 1 month and 3 months]
  • Nutrition Impact Symptoms [Срок оценки: Baseline, 1 month and 3 months]
  • Quality of Life [Срок оценки: Baseline, 1 month and 3 months]
  • Muscle Function and Strength [Срок оценки: Baseline, 1 month and 3 months]

Критерии участия

Критерии включения

Inclusion criteria for the first part of the project involve encountering dietitians treating patients with cancer who have malnutrition or are at risk of malnutrition. For these patients, the inclusion criteria are as follows:

  • aged ≥18 years with a diagnosed cancer
  • ongoing nutrition therapy by a dietitian
  • malnutrition or risk of malnutrition according to the hospitals criteria where at least one of the following criteria must be met: low BMI, involuntary weight loss, and/or eating difficulties. Patients can also be included if they are referred to a dietitian based on treatment guidelines due to a high risk of malnutrition associated with the cancer diagnosis or its medical therapy.

For the second part of the project, the inclusion criteria are:

  • aged ≥18 years with a diagnosed cancer
  • undergoing or planned treatment, including surgical, oncological, or a combination of these
  • have been referred to a dietitian but have not yet had their initial contact with the dietitian, and
  • malnutrition or risk of malnutrition according to the hospital's criteria, where at least one of the following criteria must be met: low BMI, involuntary weight loss, and/or eating difficulties. Patients can also be included if they are referred to a dietitian based on treatment guidelines due to a high risk of malnutrition associated with the cancer diagnosis or its medical therapy.

Критерии исключения

For the first part of the project, the exclusion criteria regarding patients are:

  • known dementia or impaired cognitive function, and
  • not proficient in spoken and written Swedish.

For the second part of the project, the exclusion criteria are:

  • known dementia or impaired cognitive function,
  • ongoing nutrition therapy by a dietitian at inclusion, and
  • not proficient in spoken and written Swedish.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швеция · 1 центр
  • Uppsala University — Uppsala

Идентификаторы

NCT: NCT06531174 · 240901

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗