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Trial Title:
Early Education Programme in Malnourished Cancer Patients
NCT ID:
NCT05495165
Condition:
Nutrition Aspect of Cancer
Conditions: Official terms:
Malnutrition
Conditions: Keywords:
Malnutrition
cancer
prehabilitation
therapeutic education
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
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.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Therapeutic education for patients in nutrition
Description:
Stakeholders give preventive therapeutic education recommandations in their specific
expertize
Arm group label:
Nutritional educative programme
Other name:
Therapeutic education for patients in sophrology
Other name:
Therapeutic education for patients in socio-aesthetic
Other name:
Therapeutic education for patients in adapted physical activity
Other name:
Therapeutic education for patients in psychology
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
September 2022
Completion date:
June 2024
Lead sponsor:
Agency:
Beauvais Hospital
Agency class:
Other
Source:
Beauvais Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05495165