Early Education Programme in Malnourished Cancer Patients

NCT ID: NCT05495165

Last Updated: 2022-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2024-06-30

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.

Conditions

Nutrition Aspect of Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Nutritional educative programme

5 days educative programme before treatment

Group Type: OTHER

Therapeutic education for patients in nutrition

Intervention Type: OTHER

Stakeholders give preventive therapeutic education recommandations in their specific expertize

Interventions

Therapeutic education for patients in nutrition

Stakeholders give preventive therapeutic education recommandations in their specific expertize

Intervention Type: OTHER

Other Intervention 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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beauvais Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sif Dr Bendjaballah, Doctor

Role: PRINCIPAL_INVESTIGATOR

Beauvais Hospital

Central Contacts

Philippe Dr Pouillart, Doctor

Role: CONTACT

philippe.pouillart@unilasalle.fr

6 13 03 02 11 ext. +33

Mathilde Harleux, Engineer

Role: CONTACT

m.harleux@ch-beauvais.fr

3 44 11 28 86 ext. +33

References

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.

Reference Type: BACKGROUND

PMID: 27637832 (View on PubMed)

Other Identifiers

NEHOTEL

Identifier Type: -

Identifier Source: org_study_id