Early Education Programme in Malnourished Cancer Patients

Beauvais Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Nutrition Aspect of Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Rate of acceptance

Evaluation of the rate of screening failures and the explanation of refusals when the program is offered to patients (CONSORT Standards)

Time frame: during the 5-days programme

Rate of patients' skills development during the therapeutic educative programme

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)

Time frame: 8 months

Programme and environment (hosting) satisfaction questionnaire assessment

Patient's motivational level during the therapeutic educative programme

Time frame: during the 5-days programme

Acceptance of treatment assessment

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

Time frame: 8 months

Assessment of the programme's cost

Calculation of "cost-utility" and "cost-effectiveness" based on a group of 6 people by PTE session

Time frame: during the 5-days programme

Real cost estimation

Estimation of avoided costs and calculation of the difference with the actual consolidated cost of the NEHOTEL stay

Time frame: during the 5-days programme

Secondary Outcomes

Quality of Life Questionnaire related to cancer (QLQ C30) to assess the patients' quality of life

Scale from 0 (worse quality of life) to 100 (best quality of life)

Time frame: 8 months

Quality of Life Questionnaire Head and Neck (QLQ H&N35) to assess the patients' quality of life

Scale from 0 (worse quality of life) to 100 (best quality of life)

Time frame: 8 months

Number of therapeutic events completed

Number of therapeutic events completed compared to the initial objective (IDP)

Time frame: 8 months

The count of adverse events related or not to treatment

Time frame: 8 months

Anthropomorphic markers (weight in kilograms)