Feasibility of Early Nutritional Prehabilitation Through a Therapeutic Education Programme for Cancer People With Potential Risk of Malnutrition
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Assessment of the programme's cost
研究概览
简要总结
The innovation is based on the proposal to integrate the patient, just after the announcement, before or at the beginning of the treatment (before the third session of chemotherapy or radiotherapy), in a 5-day training course in a clinical site that inspires peace of mind involving the family caregiver. The therapeutic education programme is led by a multidisciplinary team whose approach is centred on dietetics, supported by tools for encouragement via socio-aesthetics, physical activity and sophrology.
The educational objective is to promote the autonomy of the patient as well as the family caregiver, to involve them in the care pathway alongside the practitioners, with a view to contain undernutrition and reverse the spiral that increases the risks of morbi-mortality.
The aim of the study is to assess patient adherence to the device, the technical and economic feasibility, and its impact on quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •From 18 to 70 years old
- •Patient with an ORL, pancreatic, oesogastric, duodenal or broncho-pulmonary cancer
- •Patient who have not begun their treatments or patient in the beginning of their treatments, less than or equal to two sessions of chemotherapy or radiotherapy
- •patient living in a private home (personal or family)
- •Prognosis greater than 12 months
- •Decision taken at a multidisciplinary consultation meeting (RCP) for a curative treatment
- •WHO Score Performance Status ≤2
- •Patient undernourished at the advertisement codes E44.1 "Mild protein-energy malnutrition" or E44.0 "Moderate protein-energy malnutrition", according to the latest HAS recommendations
- •Patient not undernourished at the time of the announcement, but going to receive a treatment or combination of treatments for curative purposes, whose therapeutic sequences are known to induce nutritional complications inducing a risk of stopping treatment
- •Per os nutrition
- •With internet access and reachable by phone
- •Patient affiliated to the social security system
- •Patient information and signature of informed consent
- •Patient accompanied by a family member or not
排除标准
- •Patient with severe malnutrition corresponding to at least one of the criteria* below:
- •(i) BMI < 17 kg/m². (ii) weight loss ≥ 10% in 1 month or ≥ 15% in 6 months or ≥ 15% of the usual weight before the onset of the disease (iii) albuminemia ≤ 30 g/L. (*) Annex 15.8: HAS 2019 source : A single criterion of severe undernutrition takes precedence over one or more criteria of moderate undernutrition.
- •Treatment for curative purposes not applicable
- •Comorbidities that do not allow participation in the prehabilitation course (patient presenting at least one of the criteria below):
- •Weight greater than 130kgs (limit of resistance of the beds in the reception centre) Sensory deficits: visual, auditory, olfactory, gustatory (not allowing to follow the educational workshops) Cognitive deficit (reading, writing, counting) Physical (ability to move around and participate in activities) Patient at risk of alcohol withdrawal
- •TNM coupled with a deteriorated general condition of the patient at the time of the announcement; prediction of highly mutilating surgery involving an inability to eat through the mouth; metastatic stage.
- •Patient institutionalized and/or not responsible for his or her diet
- •Patient requiring parenteral or artificial enteral nutrition (feeding tube, nasogastric tube, gastrostomy or feeding jejunostomy)
- •History of organ failure (cirrhosis, moderate or severe renal failure, heart failure (NYHA>2), chronic oxygen-dependent respiratory failure)
- •Anaemic patient (hemoglobin level less than 9g/dL)
- •Person deprived of liberty or under guardianship
- •Inability to undergo the medical monitoring of the trial for geographical, social or psychological reasons.
- •Pregnant woman or Breastfeeding woman
- •A delay before the first treatment does not allow inclusion in the NEHOTEL prehabilitation.
研究组 & 干预措施
Nutritional educative programme
5 days educative programme before treatment
干预措施: Therapeutic education for patients in nutrition (Other)
结局指标
主要结局
Assessment of the programme's cost
时间窗: during the 5-days programme
Calculation of "cost-utility" and "cost-effectiveness" based on a group of 6 people by PTE session
Programme and environment (hosting) satisfaction questionnaire assessment
时间窗: during the 5-days programme
Patient's motivational level during the therapeutic educative programme
Acceptance of treatment assessment
时间窗: 8 months
Alliance to care during the 8 months of follow-up via the IDP. This is measured by the number of PTE sessions the patients enroll and by questions on the application of the nutritional advices given during the intervention week
Real cost estimation
时间窗: during the 5-days programme
Estimation of avoided costs and calculation of the difference with the actual consolidated cost of the NEHOTEL stay
Rate of acceptance
时间窗: during the 5-days programme
Evaluation of the rate of screening failures and the explanation of refusals when the program is offered to patients (CONSORT Standards)
Rate of patients' skills development during the therapeutic educative programme
时间窗: 8 months
Rate of patients completing the stay and demonstrating ongoing or effective acquisition on 18 skills (self-reported questionnaire and confronted with observations of nursing staff) (acquired, in progress of acquisition, not acquired)
次要结局
- Number of therapeutic events completed(8 months)
- The count of adverse events related or not to treatment(8 months)
- Anthropomorphic markers (weight in kilograms)(8 months)
- Quality of Life Questionnaire related to cancer (QLQ C30) to assess the patients' quality of life(8 months)
- Biological markers (quantity of lymphocyte in blood)(8 months)
- Biological markers (quantity of albumine and lymphocyte in blood are used to calculate the PNI with the formula [10 * taux albumine (g/dL)] + [nombre de lymphocytes totaux/µL * 0,05])(8 months)
- Quality of Life Questionnaire Head and Neck (QLQ H&N35) to assess the patients' quality of life(8 months)
- anthropomorphic markers (weight and height are used to calculate the BMI in kg/m^2)(8 months)
- Biological markers (quantity of albumine in blood)(8 months)
- Consumption of Nutritional Oral Complements (NOC)(8 months)
- Hospital Anxiety and Depression (HAD) scale to assess the sophrology programme and the patients' anxiety and depression(8 months)
- Anthropomorphic markers (height in meters)(8 months)
- Food intake quantity and quality estimation with the Visual Analogue Scale (VAS)(8 months)
- World Health Organisation (WHO) scale to evaluate the capacity to move to assess the physical activity and the effectiveness of reinforcement tools(8 months)
- Rosenberg Self-Esteem Scale (Rosenberg) questionnaire to assess the socio-aesthetic programme and the patients' self-esteem(8 months)
- European Quality of Life-5 Dimensions Visual Analogue Scale (EQ-5D-VAS) to assess the sophrology programme and the patients' well-being(8 months)
- Borg Rating Scale of Perceived Exertion (Borg) scale after a physical activity to assess the physical activity and the effectiveness of reinforcement tools(8 months)
- International Physical Activity Questionnaire (IPAQ) to assess the physical activity and the effectiveness of reinforcement tools(8 months)
- Drawing test Questionnaire to assess the socio-aesthetic programme and the patients' self-esteem(8 months)