Adherence to Enteral Nutrition
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Assess compliance with recommendations for the implementation of enteral nutrition following the improvement measures implemented in Phase 2.
研究概览
简要总结
Malnutrition is a major challenge in cancer nutrition, affecting approximately 40% of cancer patients and having negative consequences on treatment efficacy, quality of life, and prognosis. It must be detected and managed early, based on clinical and laboratory criteria defined by the HAS recommendations.
To address this, several nutritional strategies are available, ranging from fortified oral feeding to artificial nutrition. Enteral nutrition, which is more physiological and carries fewer risks than parenteral nutrition, is recommended as the first-line treatment. Tools such as personalized care plans and guidelines help tailor patient care.
However, enteral nutrition remains underutilized in clinical practice, despite the recommendations. The ADHENUTE study, conducted at the Institut Curie, showed low compliance with recommendations (31%) and a tendency to favor oral nutritional supplements, even in severely malnourished patients. The lack of traceability of decisions makes it difficult to identify barriers, although patient refusal is sometimes mentioned.
To improve this situation, corrective measures have been implemented:
- for patients, through educational workshops to help them better understand and accept enteral nutrition;
- for healthcare providers, through training sessions to address reservations and enhance knowledge.
A third phase of the study aims to evaluate the impact of these actions, with the goal of increasing adherence to recommendations and the use of enteral nutrition.
详细描述
The primary goal in cancer nutrition is to prevent, limit, and treat malnutrition. On average, 40% of cancer patients are malnourished (with this prevalence rising to as high as 90% depending on the cancer's location and the stage of the disease). Studies have shown that malnutrition reduces the effectiveness of cancer treatments, patients' quality of life, and their prognosis for recovery.
Screening for and management of malnutrition must be initiated early and based on the recommendations of the French National Authority for Health (HAS) in its guidelines titled "Diagnosis of Malnutrition in Children and Adults," updated in November 2020 and November 2021. In adults, the diagnosis of malnutrition (and its severity) is based on phenotypic and etiological criteria, including weight loss, Body Mass Index (BMI), albumin levels, and muscle strength measurements.
Dietary measures and interventions-ranging from optimizing oral intake to the use of Oral Nutritional Supplements (ONS) and Artificial Nutrition (AN)-help combat malnutrition. Enteral nutrition, which utilizes the digestive system, is the more physiological and effective solution, carrying a lower risk of infection. It is the preferred first-line treatment over parenteral nutrition.
Healthcare professionals can use the HAS's Personalized Care Plans (PPS) for oncology, which propose strategies based on treatment, age, and tumor location, as well as the phase of treatment (curative, initial palliative, advanced, or terminal). The nutritional care decision tree, which establishes a management strategy based on the patient's nutritional status and the severity of malnutrition-and is not specific to oncology-is a validated tool.
Despite the recommendations, the use of enteral nutrition remains insufficient. Indeed, and more broadly, this issue of non-compliance with recommendations for the implementation of enteral nutrition is commonly observed. This is confirmed by the study conducted by Defteros et al., which demonstrated that adhering to ESPEN (European Society for Clinical Nutrition and Metabolism) recommendations in clinical practice is difficult.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients hospitalized (including those in the day hospital) in a medical oncology unit;
- •Men or women;
- •Patients for whom enteral nutrition is indicated according to SFNCM recommendations;
排除标准
- •Minors (under 18 years of age)
- •Patients receiving end-of-life palliative care
- •Individuals deprived of their liberty or under legal guardianship (including conservatorship);
- •Adults under judicial protection;
- •Inability to participate in the study for geographical, social, or psychological reasons.
- •Persons referred to in Articles L. 1121-5 through L. 1121-8 and L. 1122-1-2 of the Public Health Code (e.g., minors, adults under guardianship, etc.).
- •Patients who do not speak or understand French.
结局指标
主要结局
Assess compliance with recommendations for the implementation of enteral nutrition following the improvement measures implemented in Phase 2.
时间窗: From enrollment to the end of follow-up, which is 6 months
Percentage of patients for whom the recommendations are followed. Compliance with the recommendations will be assessed by comparing the recommended nutritional interventions with those actually implemented.
次要结局
- Assess the traceability of the reasons for not following a recommendation to initiate enteral nutrition in the patient's medical record(From enrollment to the end of follow-up, which is 6 months)
- Assess the role of the dietetics department in screening for malnutrition and in the implementation of enteral nutrition(From enrollment to the end of follow-up, which is 6 months)
- Assess the delay in initiating enteral nutrition(Since the onset of the disease at the start of enteral nutrition)
- Evaluate the implementation of recommendations based on tumor location(From enrollment to the end of follow-up, which is 6 months)
- Identify other nutritional support methods used as alternatives to enteral nutrition.(From enrollment to the end of follow-up, which is 6 months)
- Assess the time required for the patient to tolerate enteral nutrition(From enrollment to the end of follow-up, which is 6 months)
- Assess the duration of compliance(From enrollment to the end of follow-up, which is 6 months)
- Describe the reasons for discontinuing enteral nutrition(From enrollment to the end of follow-up, which is 6 months)
- Assessing the resolution of malnutrition through the implementation of recommendations(From enrollment to the end of follow-up, which is 6 months)
- Assess the benefits of following the recommendations(From enrollment to the end of follow-up, which is 6 months)