Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional educative programme | Other | 5 days educative programme before treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic education for patients in nutrition | Other | Stakeholders give preventive therapeutic education recommandations in their specific expertize |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 8 months |
| Quality of Life Questionnaire Head and Neck (QLQ H&N35) to assess the patients' quality of life |
| Measure | Description | Time Frame |
|---|---|---|
| Zarit scale to evaluate the motivation and the effectiveness of the presence of the caregiver | Scale from 0 (taking care is not constraining for the caregiver) to 88 (taking care is a very heavy load for the caregiver) | during the 5-days programme |
| Getting started with the eCRF application (Diétis) by patients |
Inclusion Criteria:
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
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe Dr Pouillart, Doctor | Contact | 6 13 03 02 11 | +33 | philippe.pouillart@unilasalle.fr |
| Mathilde Harleux, Engineer | Contact | 3 44 11 28 86 | +33 | m.harleux@ch-beauvais.fr |
| Name | Affiliation | Role |
|---|---|---|
| Sif Dr Bendjaballah, Doctor | Beauvais Hospital | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27637832 | Background | 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. |
Not provided
Not provided
The PNI will be calculated by the following equation: [(10 × serum albumin (g/dL)) + (0.005 × total lymphocyte count)].
Albumin Pre-albumin CRP Haemoglobin
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009752 | Nutritional Status |
| D011584 | Psychology |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
Not provided
Not provided
60 patients entered a 5-day educational device and then followed monthly for 8 months remotely by a smart phone application and dietary consultations.
Not provided
Not provided
Not provided
Not provided
|
Scale from 0 (worse quality of life) to 100 (best quality of life) |
| 8 months |
| Number of therapeutic events completed | Number of therapeutic events completed compared to the initial objective (IDP) | 8 months |
| The count of adverse events related or not to treatment | The count of adverse events related or not to treatment | 8 months |
| Anthropomorphic markers (weight in kilograms) | Evolution of cancer biomarkers (IDP) to asses the evolution of undernutrition | 8 months |
| Anthropomorphic markers (height in meters) | Evolution of cancer biomarkers (IDP) to asses the evolution of undernutrition | 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 | 8 months |
| Biological markers (quantity of albumine in blood) | Evolution of cancer biomarkers (IDP) to asses the evolution of undernutrition | 8 months |
| Biological markers (quantity of lymphocyte in blood) | Evolution of cancer biomarkers (IDP) to asses the evolution of undernutrition | 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 | 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 | 8 months |
| Consumption of Nutritional Oral Complements (NOC) | Evolution of NOC's consumption to assess the evolution of undernutrition | 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) | 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 | 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) | 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 | 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)) | 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) | 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) | 8 months |
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 |
| during the 5-days programme |
| Assessment of the level of adherence to the application tool (Diétis) during the follow-up of 8 months | Rate of complete questionnaires and responses to the dietétician calls during the follow-up | 8 months |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D001525 | Behavioral Sciences |
| D004191 | Behavioral Disciplines and Activities |