Web-based Platform for Nutrition Management in Patients With Cancer

Официальное название

Web-based Platform for Nutrition Management in Patients With Cancer: A Randomized Clinical Trial

Обзор

It is crucial to promptly identify nutritional issues in these patients within the community and provide them with dietary guidance, nutritional counseling, and support. This study will be conducted in communities in Chengdu, Sichuan. Community management teams will register oncology patients, collecting information such as demographic data, tumor type, stage, specific treatment plan, treatment hospital, regularity of hospital admissions, and frequency of independent smartphone use. Registered patients will be screened based on inclusion and exclusion criteria. For those who meet the criteria, the community management team will contact them and recommend the use of a dedicated app developed by the research team. An initial nutritional assessment will also be conducted. Patients identified with nutritional risks will be directly referred to the research team's clinical nutritionists for face-to-face consultations. After additional tests, such as body composition analysis, necessary nutritional education and stepwise nutritional interventions will be provided. These patients will also use the app for dietary monitoring and nutritional guidance. For patients without nutritional risks, the app will be recommended for daily questionnaire completion and activity tracking.

Вмешательства

• Другое nutrtion care based on app
  Self-Intervention: During the period of staying at home, patients use the app developed by the team for self-intervention, including dietary monitoring and check-ins, nutritional risk assessment, learning of educational knowledge, and online expert consultations. Community Intervention: When nutritional risks are detected, pop-up alerts will notify patients to communicate with the community management team. Patients can seek basic nutritional consultations and receive advice from the community

Первичные конечные точки

• body weight change [Срок оценки: baseline, pre-intervention；every 2 weeks after randomization until 6 moths.]

Вторичные конечные точки (2)

• PG-SGA [Срок оценки: baseline, pre-intervention；every 2 weeks after randomization until 6 moths.]
• NRS2002 [Срок оценки: baseline, pre-intervention；every 2 weeks after randomization until 6 moths.]

Критерии участия

Критерии включения

• Pathologically confirmed malignant tumor;
• PG-SGA score of 4-9 points;
• Age: ≥18 years, with an expected survival time of more than 1 year;
• Possesses adequate cognitive and reading abilities to complete questionnaires and use the APP.

Критерии исключения

• Presence of neurological or psychiatric disorders affecting cognitive function, including central nervous system metastasis of tumors;
• Suffering from conditions severely impacting digestion, metabolism, or food intake;
• Patients in the cachexia stage or refractory cachexia phase.

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

Китай · 1 центр

• West China hospital — Чэнду

Идентификаторы

NCT: NCT07307404 · 2024-2316

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗