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Early Education Programme in Malnourished Cancer Patients (NEHOTEL)

Primary Purpose

Nutrition Aspect of Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Therapeutic education for patients in nutrition
Sponsored by
Beauvais Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nutrition Aspect of Cancer focused on measuring Malnutrition, cancer, prehabilitation, therapeutic education

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Nutritional educative programme

    Arm Description

    5 days educative programme before treatment

    Outcomes

    Primary Outcome Measures

    Rate of acceptance
    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
    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
    Patient's motivational level during the therapeutic educative 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
    Assessment of the programme's cost
    Calculation of "cost-utility" and "cost-effectiveness" based on a group of 6 people by PTE session
    Real cost estimation
    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
    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
    Scale from 0 (worse quality of life) to 100 (best quality of life)
    Number of therapeutic events completed
    Number of therapeutic events completed compared to the initial objective (IDP)
    The count of adverse events related or not to treatment
    The count of adverse events related or not to treatment
    Anthropomorphic markers (weight in kilograms)
    Evolution of cancer biomarkers (IDP) to asses the evolution of undernutrition
    Anthropomorphic markers (height in meters)
    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)
    evolution of cancer biomarkers (IDP) to asses the evolution of undernutrition
    Biological markers (quantity of albumine in blood)
    Evolution of cancer biomarkers (IDP) to asses the evolution of undernutrition
    Biological markers (quantity of lymphocyte in blood)
    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])
    Evolution of cancer biomarkers (IDP) to asses the evolution of undernutrition
    Food intake quantity and quality estimation with the Visual Analogue Scale (VAS)
    Scale from 0 (no food intake) to 10 (normal quatity food intake) to assess the evolution of undernutrition
    Consumption of Nutritional Oral Complements (NOC)
    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
    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
    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
    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
    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
    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
    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
    Scale from 0 (worse health) to 100 (best health)

    Full Information

    First Posted
    May 17, 2022
    Last Updated
    August 10, 2022
    Sponsor
    Beauvais Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05495165
    Brief Title
    Early Education Programme in Malnourished Cancer Patients
    Acronym
    NEHOTEL
    Official Title
    Feasibility of Early Nutritional Prehabilitation Through a Therapeutic Education Programme for Cancer People With Potential Risk of Malnutrition
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Beauvais Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nutrition Aspect of Cancer
    Keywords
    Malnutrition, cancer, prehabilitation, therapeutic education

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Nutritional educative programme
    Arm Type
    Other
    Arm Description
    5 days educative programme before treatment
    Intervention Type
    Other
    Intervention Name(s)
    Therapeutic education for patients in nutrition
    Other Intervention Name(s)
    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
    Intervention Description
    Stakeholders give preventive therapeutic education recommandations in their specific expertize
    Primary Outcome Measure Information:
    Title
    Rate of acceptance
    Description
    Evaluation of the rate of screening failures and the explanation of refusals when the program is offered to patients (CONSORT Standards)
    Time Frame
    during the 5-days programme
    Title
    Rate of patients' skills development during the therapeutic educative programme
    Description
    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)
    Time Frame
    8 months
    Title
    Programme and environment (hosting) satisfaction questionnaire assessment
    Description
    Patient's motivational level during the therapeutic educative programme
    Time Frame
    during the 5-days programme
    Title
    Acceptance of treatment assessment
    Description
    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
    Time Frame
    8 months
    Title
    Assessment of the programme's cost
    Description
    Calculation of "cost-utility" and "cost-effectiveness" based on a group of 6 people by PTE session
    Time Frame
    during the 5-days programme
    Title
    Real cost estimation
    Description
    Estimation of avoided costs and calculation of the difference with the actual consolidated cost of the NEHOTEL stay
    Time Frame
    during the 5-days programme
    Secondary Outcome Measure Information:
    Title
    Quality of Life Questionnaire related to cancer (QLQ C30) to assess the patients' quality of life
    Description
    Scale from 0 (worse quality of life) to 100 (best quality of life)
    Time Frame
    8 months
    Title
    Quality of Life Questionnaire Head and Neck (QLQ H&N35) to assess the patients' quality of life
    Description
    Scale from 0 (worse quality of life) to 100 (best quality of life)
    Time Frame
    8 months
    Title
    Number of therapeutic events completed
    Description
    Number of therapeutic events completed compared to the initial objective (IDP)
    Time Frame
    8 months
    Title
    The count of adverse events related or not to treatment
    Description
    The count of adverse events related or not to treatment
    Time Frame
    8 months
    Title
    Anthropomorphic markers (weight in kilograms)
    Description
    Evolution of cancer biomarkers (IDP) to asses the evolution of undernutrition
    Time Frame
    8 months
    Title
    Anthropomorphic markers (height in meters)
    Description
    Evolution of cancer biomarkers (IDP) to asses the evolution of undernutrition
    Time Frame
    8 months
    Title
    anthropomorphic markers (weight and height are used to calculate the BMI in kg/m^2)
    Description
    evolution of cancer biomarkers (IDP) to asses the evolution of undernutrition
    Time Frame
    8 months
    Title
    Biological markers (quantity of albumine in blood)
    Description
    Evolution of cancer biomarkers (IDP) to asses the evolution of undernutrition
    Time Frame
    8 months
    Title
    Biological markers (quantity of lymphocyte in blood)
    Description
    Evolution of cancer biomarkers (IDP) to asses the evolution of undernutrition
    Time Frame
    8 months
    Title
    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])
    Description
    Evolution of cancer biomarkers (IDP) to asses the evolution of undernutrition
    Time Frame
    8 months
    Title
    Food intake quantity and quality estimation with the Visual Analogue Scale (VAS)
    Description
    Scale from 0 (no food intake) to 10 (normal quatity food intake) to assess the evolution of undernutrition
    Time Frame
    8 months
    Title
    Consumption of Nutritional Oral Complements (NOC)
    Description
    Evolution of NOC's consumption to assess the evolution of undernutrition
    Time Frame
    8 months
    Title
    Borg Rating Scale of Perceived Exertion (Borg) scale after a physical activity to assess the physical activity and the effectiveness of reinforcement tools
    Description
    Score between 0 (no perceived effort) and 20 (perceived effort maximal)
    Time Frame
    8 months
    Title
    International Physical Activity Questionnaire (IPAQ) to assess the physical activity and the effectiveness of reinforcement tools
    Description
    Evolution of the time of intense activity, moderate activity, light intensity and sedentary
    Time Frame
    8 months
    Title
    World Health Organisation (WHO) scale to evaluate the capacity to move to assess the physical activity and the effectiveness of reinforcement tools
    Description
    Scale from 0 (same capacity than before the surgery) to 4 (incapacity to move alone)
    Time Frame
    8 months
    Title
    Drawing test Questionnaire to assess the socio-aesthetic programme and the patients' self-esteem
    Description
    Evolution between the first drawing test at the beginning of the week and the second at the end
    Time Frame
    8 months
    Title
    Rosenberg Self-Esteem Scale (Rosenberg) questionnaire to assess the socio-aesthetic programme and the patients' self-esteem
    Description
    Final score between 10 (worse self-esteem and 40 (best self-esteem))
    Time Frame
    8 months
    Title
    Hospital Anxiety and Depression (HAD) scale to assess the sophrology programme and the patients' anxiety and depression
    Description
    Two scales (one for anxiety and one for depression) from 0 (worse well-being) to 21 (best well-being)
    Time Frame
    8 months
    Title
    European Quality of Life-5 Dimensions Visual Analogue Scale (EQ-5D-VAS) to assess the sophrology programme and the patients' well-being
    Description
    Scale from 0 (worse health) to 100 (best health)
    Time Frame
    8 months
    Other Pre-specified Outcome Measures:
    Title
    Zarit scale to evaluate the motivation and the effectiveness of the presence of the caregiver
    Description
    Scale from 0 (taking care is not constraining for the caregiver) to 88 (taking care is a very heavy load for the caregiver)
    Time Frame
    during the 5-days programme
    Title
    Getting started with the eCRF application (Diétis) by patients
    Description
    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
    Time Frame
    during the 5-days programme
    Title
    Assessment of the level of adherence to the application tool (Diétis) during the follow-up of 8 months
    Description
    Rate of complete questionnaires and responses to the dietétician calls during the follow-up
    Time Frame
    8 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Philippe Dr Pouillart, Doctor
    Phone
    6 13 03 02 11
    Ext
    +33
    Email
    philippe.pouillart@unilasalle.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mathilde Harleux, Engineer
    Phone
    3 44 11 28 86
    Ext
    +33
    Email
    m.harleux@ch-beauvais.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sif Dr Bendjaballah, Doctor
    Organizational Affiliation
    Beauvais Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The PNI will be calculated by the following equation: [(10 × serum albumin (g/dL)) + (0.005 × total lymphocyte count)]. Albumin Pre-albumin CRP Haemoglobin
    Citations:
    PubMed Identifier
    27637832
    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.
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