NEHOTEL: Early Education Programme in Malnourished Cancer Patients

Sponsor

Beauvais Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05495165

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nutrition Aspect of Cancer	Other: Therapeutic education for patients in nutrition	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.60 patients entered a 5-day educational device and then followed monthly for 8 months remotely by a smart phone application and dietary consultations.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Feasibility of Early Nutritional Prehabilitation Through a Therapeutic Education Programme for Cancer People With Potential Risk of Malnutrition

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Nutritional educative programme 5 days educative programme before treatment	Other: Therapeutic education for patients in nutrition Stakeholders give preventive therapeutic education recommandations in their specific expertize Other Names: Therapeutic education for patients in sophrology Therapeutic education for patients in socio-aesthetic Therapeutic education for patients in adapted physical activity Therapeutic education for patients in psychology

Arm

Intervention/Treatment

Other: Nutritional educative programme

5 days educative programme before treatment

Other: Therapeutic education for patients in nutrition

Stakeholders give preventive therapeutic education recommandations in their specific expertize

Other Names:

Therapeutic education for patients in sophrology

Therapeutic education for patients in socio-aesthetic

Therapeutic education for patients in adapted physical activity

Therapeutic education for patients in psychology

Outcome Measures

Primary Outcome Measures

Rate of acceptance [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 [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)
Programme and environment (hosting) satisfaction questionnaire assessment [during the 5-days programme]
Patient's motivational level during the therapeutic educative programme
Acceptance of treatment assessment [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
Assessment of the programme's cost [during the 5-days programme]
Calculation of "cost-utility" and "cost-effectiveness" based on a group of 6 people by PTE session
Real cost estimation [during the 5-days programme]
Estimation of avoided costs and calculation of the difference with the actual consolidated cost of the NEHOTEL stay

Secondary Outcome Measures

Quality of Life Questionnaire related to cancer (QLQ C30) to assess the patients' quality of life [8 months]
Scale from 0 (worse quality of life) to 100 (best quality of life)
Quality of Life Questionnaire Head and Neck (QLQ H&N35) to assess the patients' quality of life [8 months]
Scale from 0 (worse quality of life) to 100 (best quality of life)
Number of therapeutic events completed [8 months]
Number of therapeutic events completed compared to the initial objective (IDP)
The count of adverse events related or not to treatment [8 months]
The count of adverse events related or not to treatment
Anthropomorphic markers (weight in kilograms) [8 months]
Evolution of cancer biomarkers (IDP) to asses the evolution of undernutrition
Anthropomorphic markers (height in meters) [8 months]
Evolution of cancer biomarkers (IDP) to asses the evolution of undernutrition
anthropomorphic markers (weight and height are used to calculate the BMI in kg/m^2) [8 months]
evolution of cancer biomarkers (IDP) to asses the evolution of undernutrition
Biological markers (quantity of albumine in blood) [8 months]
Evolution of cancer biomarkers (IDP) to asses the evolution of undernutrition
Biological markers (quantity of lymphocyte in blood) [8 months]
Evolution of cancer biomarkers (IDP) to asses the evolution of undernutrition
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]
Evolution of cancer biomarkers (IDP) to asses the evolution of undernutrition
Food intake quantity and quality estimation with the Visual Analogue Scale (VAS) [8 months]
Scale from 0 (no food intake) to 10 (normal quatity food intake) to assess the evolution of undernutrition
Consumption of Nutritional Oral Complements (NOC) [8 months]
Evolution of NOC's consumption to assess the evolution of undernutrition
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]
Score between 0 (no perceived effort) and 20 (perceived effort maximal)
International Physical Activity Questionnaire (IPAQ) to assess the physical activity and the effectiveness of reinforcement tools [8 months]
Evolution of the time of intense activity, moderate activity, light intensity and sedentary
World Health Organisation (WHO) scale to evaluate the capacity to move to assess the physical activity and the effectiveness of reinforcement tools [8 months]
Scale from 0 (same capacity than before the surgery) to 4 (incapacity to move alone)
Drawing test Questionnaire to assess the socio-aesthetic programme and the patients' self-esteem [8 months]
Evolution between the first drawing test at the beginning of the week and the second at the end
Rosenberg Self-Esteem Scale (Rosenberg) questionnaire to assess the socio-aesthetic programme and the patients' self-esteem [8 months]
Final score between 10 (worse self-esteem and 40 (best self-esteem))
Hospital Anxiety and Depression (HAD) scale to assess the sophrology programme and the patients' anxiety and depression [8 months]
Two scales (one for anxiety and one for depression) from 0 (worse well-being) to 21 (best well-being)
European Quality of Life-5 Dimensions Visual Analogue Scale (EQ-5D-VAS) to assess the sophrology programme and the patients' well-being [8 months]
Scale from 0 (worse health) to 100 (best health)

Other Outcome Measures

Zarit scale to evaluate the motivation and the effectiveness of the presence of the caregiver [during the 5-days programme]
Scale from 0 (taking care is not constraining for the caregiver) to 88 (taking care is a very heavy load for the caregiver)
Getting started with the eCRF application (Diétis) by patients [during the 5-days programme]
Rate of errors in filling in the Dietis tool by patients during the intervention week. Number of times the Dietis tool questionnaires were completed by patients during the intervention week
Assessment of the level of adherence to the application tool (Diétis) during the follow-up of 8 months [8 months]
Rate of complete questionnaires and responses to the dietétician calls during the follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.