Clinical trial NCT05495165: Early Education Programme in Malnourished Cancer Patients
Official title: Feasibility of Early Nutritional Prehabilitation Through a Therapeutic Education Programme for Cancer People With Potential Risk of Malnutrition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nutrition Aspect of Cancer
Keywords: Malnutrition
cancer
prehabilitation
therapeutic education
Lead sponsor: Beauvais Hospital
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 60 patients entered a 5-day educational device and then followed monthly for 8 months remotely by a smart phone application and dietary consultations.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of acceptance
timeFrame: during the 5-days programme
measure: Rate of patients' skills development during the therapeutic educative programme
timeFrame: 8 months
measure: Programme and environment (hosting) satisfaction questionnaire assessment
timeFrame: during the 5-days programme
measure: Acceptance of treatment assessment
timeFrame: 8 months
measure: Assessment of the programme's cost
timeFrame: during the 5-days programme
measure: Real cost estimation
timeFrame: during the 5-days programme
Secondary outcomes:
measure: Quality of Life Questionnaire related to cancer (QLQ C30) to assess the patients' quality of life
timeFrame: 8 months
measure: Quality of Life Questionnaire Head and Neck (QLQ H&N35) to assess the patients' quality of life
timeFrame: 8 months
measure: Number of therapeutic events completed
timeFrame: 8 months
measure: The count of adverse events related or not to treatment
timeFrame: 8 months
measure: Anthropomorphic markers (weight in kilograms)
timeFrame: 8 months
measure: Anthropomorphic markers (height in meters)
timeFrame: 8 months
measure: anthropomorphic markers (weight and height are used to calculate the BMI in kg/m^2)
timeFrame: 8 months
measure: Biological markers (quantity of albumine in blood)
timeFrame: 8 months
measure: Biological markers (quantity of lymphocyte in blood)
timeFrame: 8 months
measure: 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])
timeFrame: 8 months
measure: Food intake quantity and quality estimation with the Visual Analogue Scale (VAS)
timeFrame: 8 months
measure: Consumption of Nutritional Oral Complements (NOC)
timeFrame: 8 months
measure: Borg Rating Scale of Perceived Exertion (Borg) scale after a physical activity to assess the physical activity and the effectiveness of reinforcement tools
timeFrame: 8 months
measure: International Physical Activity Questionnaire (IPAQ) to assess the physical activity and the effectiveness of reinforcement tools
timeFrame: 8 months
measure: World Health Organisation (WHO) scale to evaluate the capacity to move to assess the physical activity and the effectiveness of reinforcement tools
timeFrame: 8 months
measure: Drawing test Questionnaire to assess the socio-aesthetic programme and the patients' self-esteem
timeFrame: 8 months
measure: Rosenberg Self-Esteem Scale (Rosenberg) questionnaire to assess the socio-aesthetic programme and the patients' self-esteem
timeFrame: 8 months
measure: Hospital Anxiety and Depression (HAD) scale to assess the sophrology programme and the patients' anxiety and depression
timeFrame: 8 months
measure: European Quality of Life-5 Dimensions Visual Analogue Scale (EQ-5D-VAS) to assess the sophrology programme and the patients' well-being
timeFrame: 8 months
Other outcomes:
measure: Zarit scale to evaluate the motivation and the effectiveness of the presence of the caregiver
timeFrame: during the 5-days programme
measure: Getting started with the eCRF application (Diétis) by patients
timeFrame: during the 5-days programme
measure: Assessment of the level of adherence to the application tool (Diétis) during the follow-up of 8 months
timeFrame: 8 months
Locations:
Study officials:
affiliation: Beauvais Hospital
name: Sif Dr Bendjaballah, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6.