Early Education Programme in Malnourished Cancer Patients

NCT05495165 | Unknown DMC

• 1 other identifier: NEHOTEL
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Keywords

Malnutrition; cancer; prehabilitation; therapeutic education

Outcome Measures

Primary Outcomes (6)

• Rate of acceptance

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

  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)

  8 months

• Programme and environment (hosting) satisfaction questionnaire assessment

  Patient's motivational level during the therapeutic educative programme

  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

  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

  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

  during the 5-days programme

Secondary Outcomes (19)

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

  8 months

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

  8 months

• 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

Other Outcomes (3)

• Zarit scale to evaluate the motivation and the effectiveness of the presence of the caregiver

  during the 5-days programme

• Getting started with the eCRF application (Diétis) by patients

  during the 5-days programme

• Assessment of the level of adherence to the application tool (Diétis) during the follow-up of 8 months

  8 months

Study Arms (1)

Nutritional educative programme

OTHER

5 days educative programme before treatment

Other: Therapeutic education for patients in nutrition

Interventions

Therapeutic education for patients in nutrition OTHER

Stakeholders give preventive therapeutic education recommandations in their specific expertize

Also known as: 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

Nutritional educative programme

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beauvais Hospital: lead

Related Publications (1)

• 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.

  PMID: 27637832 BACKGROUND

MeSH Terms

Conditions

Malnutrition; Neoplasms

Interventions

Nutritional Status; Psychology

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Behavioral Sciences; Behavioral Disciplines and Activities

Study Officials

• Sif Dr Bendjaballah, Doctor

  Beauvais Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Dr Pouillart, Doctor

CONTACT

6 13 03 02 11; philippe.pouillart@unilasalle.fr

Mathilde Harleux, Engineer

CONTACT

3 44 11 28 86; m.harleux@ch-beauvais.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: August 10, 2022
• Study Start: September 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2024
• Last Updated: August 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share