Nutrition Aspect of CancerNEHOTELNCT05495165
Early Education Programme in Malnourished Cancer Patients
A study testing Therapeutic education for patients in nutrition in people with Nutrition Aspect of Cancer, run by Beauvais Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nutrition Aspect of Cancer
- What is being tested?
- Therapeutic education for patients in nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Patient with severe malnutrition corresponding to at least one of the criteria* below:
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Feasibility of Early Nutritional Prehabilitation Through a Therapeutic Education Programme for Cancer People With Potential Risk of Malnutrition
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
- Being tested
- Therapeutic education for patients in nutrition
- Keywords
- Malnutrition, cancer, prehabilitation, therapeutic education
- Medical subject headings
- Malnutrition, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic education for patients in nutritionOther
Also called 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
Stakeholders give preventive therapeutic education recommandations in their specific expertize
| Study group | Role | What they receive |
|---|---|---|
| Nutritional educative programme | Other | 5 days educative programme before treatment Receives: Other: Therapeutic education for patients in nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of acceptance
Evaluation of the rate of screening failures and the explanation of refusals when the program is offered to patients (CONSORT Standards)
Measured: 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)
Measured: 8 months
Programme and environment (hosting) satisfaction questionnaire assessment
Patient's motivational level during the therapeutic educative programme
Measured: 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
Measured: 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
Measured: 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
Measured: during the 5-days programme
Secondary outcomes (19)
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)
Measured: 8 months
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)
Measured: 8 months
Number of therapeutic events completed
Number of therapeutic events completed compared to the initial objective (IDP)
Measured: 8 months
The count of adverse events related or not to treatment
The count of adverse events related or not to treatment
Measured: 8 months
Anthropomorphic markers (weight in kilograms)
Evolution of cancer biomarkers (IDP) to asses the evolution of undernutrition
Measured: 8 months
Anthropomorphic markers (height in meters)
Evolution of cancer biomarkers (IDP) to asses the evolution of undernutrition
Measured: 8 months
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
Measured: 8 months
Biological markers (quantity of albumine in blood)
Evolution of cancer biomarkers (IDP) to asses the evolution of undernutrition
Measured: 8 months
Biological markers (quantity of lymphocyte in blood)
Evolution of cancer biomarkers (IDP) to asses the evolution of undernutrition
Measured: 8 months
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
Measured: 8 months
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
Measured: 8 months
Consumption of Nutritional Oral Complements (NOC)
Evolution of NOC's consumption to assess the evolution of undernutrition
Measured: 8 months
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)
Measured: 8 months
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
Measured: 8 months
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)
Measured: 8 months
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
Measured: 8 months
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))
Measured: 8 months
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)
Measured: 8 months
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)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study startSep 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutrition Aspect of CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beauvais Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sif Dr Bendjaballah, Doctor, Principal investigator, Beauvais Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495165
- Sponsor's protocol ID
- NEHOTEL
- Acronym
- NEHOTEL
- Status last verified
- Aug 2022
- First submitted
- 17 May 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The PNI will be calculated by the following equation: \[(10 × serum albumin (g/dL)) + (0.005 × total lymphocyte count)\]. Albumin Pre-albumin CRP Haemoglobin
Publications
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.
PubMed 27637832
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Early Nutritional Prehabilitation Through a Therapeutic Education Programme for Cancer People With Potential Risk of Malnutrition
- ClinicalTrials.gov ID
- NCT05495165
- Acronym / sponsor ID
- NEHOTEL / NEHOTEL
- Conditions
- Nutrition Aspect of Cancer
- Keywords
- Malnutrition, cancer, prehabilitation, therapeutic education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beauvais HospitalUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nutritional educative programme | Other | Other: Therapeutic education for patients in nutrition5 days educative programme before treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (14 listed)
- Patient with severe malnutrition corresponding to at least one of the criteria* below:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic education for patients in nutritionAlso: 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 psychologyStakeholders give preventive therapeutic education recommandations in their specific expertize | Other | Nutritional educative programme |
Primary outcome
Rate of acceptance
Time frame: 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
Time frame: 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
Time frame: during the 5-days programme
Patient's motivational level during the therapeutic educative programme
Acceptance of treatment assessment
Time frame: 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
Time frame: 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
Time frame: during the 5-days programme
Estimation of avoided costs and calculation of the difference with the actual consolidated cost of the NEHOTEL stay
19 secondary outcomes
Quality of Life Questionnaire related to cancer (QLQ C30) to assess the patients' quality of life
Time frame: 8 months
Quality of Life Questionnaire Head and Neck (QLQ H&N35) to assess the patients' quality of life
Time frame: 8 months
Number of therapeutic events completed
Time frame: 8 months
The count of adverse events related or not to treatment
Time frame: 8 months
Anthropomorphic markers (weight in kilograms)
Time frame: 8 months
Anthropomorphic markers (height in meters)
Time frame: 8 months
anthropomorphic markers (weight and height are used to calculate the BMI in kg/m^2)
Time frame: 8 months
Biological markers (quantity of albumine in blood)
Time frame: 8 months
Biological markers (quantity of lymphocyte in blood)
Time frame: 8 months
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])
Time frame: 8 months
Food intake quantity and quality estimation with the Visual Analogue Scale (VAS)
Time frame: 8 months
Consumption of Nutritional Oral Complements (NOC)
Time frame: 8 months
Borg Rating Scale of Perceived Exertion (Borg) scale after a physical activity to assess the physical activity and the effectiveness of reinforcement tools
Time frame: 8 months
International Physical Activity Questionnaire (IPAQ) to assess the physical activity and the effectiveness of reinforcement tools
Time frame: 8 months
World Health Organisation (WHO) scale to evaluate the capacity to move to assess the physical activity and the effectiveness of reinforcement tools
Time frame: 8 months
Drawing test Questionnaire to assess the socio-aesthetic programme and the patients' self-esteem
Time frame: 8 months
Rosenberg Self-Esteem Scale (Rosenberg) questionnaire to assess the socio-aesthetic programme and the patients' self-esteem
Time frame: 8 months
Hospital Anxiety and Depression (HAD) scale to assess the sophrology programme and the patients' anxiety and depression
Time frame: 8 months
European Quality of Life-5 Dimensions Visual Analogue Scale (EQ-5D-VAS) to assess the sophrology programme and the patients' well-being
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Background: PubMed 27637832Arends 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.
- Individual participant dataSharing planned: No. The PNI will be calculated by the following equation: [(10 × serum albumin (g/dL)) + (0.005 × total lymphocyte count)]. Albumin Pre-albumin CRP Haemoglobin
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sif Dr Bendjaballah, Doctor principal investigator
Beauvais Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic education for patients in nutrition in people with Nutrition Aspect of Cancer, run by Beauvais Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe Dr Pouillart, Doctor (6 13 03 02 11 ext. +33, philippe.pouillart@unilasalle.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of acceptance (time frame: during the 5-days programme). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05495165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.