- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03670199
Improving the Quality of Life of Cancer Patients Through a Perioperative and Coordinated Nutrition and Physical Care Program. (PENDICOQ)
Hospitalization, for cancer patients, exposes to a risk of undernutrition which has the effect of significantly increasing infections, pressure ulcers, muscle wasting, loss of autonomy, impaired function and delayed healing.
All of these factors contribute to increase the length of stay in hospital, thus lengthening the spiral of undernutrition, which has serious consequences for the patient welbeing, health establishments and public health.
Undernutrition has been the subject of many studies over the last twenty years, that outline that an adequate nutritional management exerts a direct effect on the reduction of comorbidities and duration of hospitalization.
However, there are periods, in the preoperative course of care, where nutritional and phisical care are not realized in the current clinical practice whereas they could be done, for example, between the diagnosis and the consultation of anesthesia, between the anesthesia consultation and the surgical procedure and the end of hospitalization of the patient.
Current management is usually limited to the period of hospitalization which tends to be reduced. This situation is reinforced by the absence of relays at home, dietary consultations being not reimbursed by French health insurance.
Moreover, a preliminary survey, conducted in 2012 during the pre-operative outpatient anesthesia consultation, shows that 26% of patients are already clinically malnourished, with 16.5 % of them who have lost more than 10% of their weight.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Then, the investigators hypothesize that the combination of perioperative nutrition and mobilization program coordinated andrealized by dieticians and physiotherapists, with the Nutrimus follow-up booklet, would improve the post-operative evolution of patients and reduce their postoperative comorbidities.
This management, initiated at the consultation of anesthesia, would include an accurate nutritional diagnosis, nutritional and physical support therapy to improve their nutritional and muscular status.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: DRCI Strasbourg
- Numero di telefono: 0388117438
- Email: dpidrci@chru-strasbourg.fr
Luoghi di studio
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Strasbourg, Francia, 67098
- Reclutamento
- Service de Médecine Interne et Nutrition, Hôpital de Hautepierre, Hôpitaux universitaires de Strasbourg
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Investigatore principale:
- Alain Pradignac, MD
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Contatto:
- Alain PRADIGNAC, MD
- Numero di telefono: 33.3.88.12.75.89
- Email: alain.pradignac@chru-strasbourg.fr
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Contatto:
- Jean-François MUNIER
- Numero di telefono: 33.3.88.12.79.69
- Email: Jeanfrancois.munier@chru-strasbourg.fr
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patient ≥ 18 years old
- Patient with Karnofsky index superior or equal to 60%.
- Patient with cancer of the following digestive tract: peritoneal carcinoma, sarcoma, pancreas, rectum, esophagus, stomach diagnosed or under diagnosis
- Patient admitted for a scheduled surgery at least 10 days after a preoperative consultation
- Patient affiliated to a social health insurance scheme
- Patient having dated and signed an informed consent
- Patient having been informed of the results of the prior medical examination
Exclusion Criteria:
- Inhospital patients
- Patient admitted in emergency
- Impossibility of giving the patient information (alteration of patient's cognitive function)
- Illiteracy or dyscalculia
- Patients protected (guardianship, curatorship, safeguard of justice)
- Pregnancy, breastfeeding
- Subject in exclusion period (determined by a previous or ongoing study),
- Patient included in another ongoing clinical trial
- Patient with neuro-endocrine cancer
- Patient reoperated for the same pathology
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Experimental group
nutritional and functional management coordinated by dieticians and physiotherapists, with adapted nutritional and physical advice and support, realized with the use of Nutrimus booklet in order to facilitate coordination and delivration of cares proposed to the patients
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Nutritional status assessment Presentation of the Nutrimus booklet by the coordinating dietitian Establishment or adaptation of a nutritional support (prescription of nutritional supplements if necessary).
Delivery and explanation of the preoperative nutritional counseling support
Respiratory capacity Functional capacity Tips adapted for physical activity and strengthening or maintenance of muscle mass Presentation of respiratory physiotherapy exercises to prevent postoperative bronchial congestion Nutrition and physical mobilization tips with the Nutrimus booklet
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Comparatore attivo: Control group
usual preoperative advice for patients who undergoing surgical procedure concerning nutritional cares and physical activity
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Nutritional status assessment Explanation of standard nutritional advices with an written explanation sheet
Respiratory capacity Functional capacity
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Variation of the Medical Outcome Study Short Form 36 score
Lasso di tempo: Change in score at 30 days before surgery and 1 Day before hospital discharge
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Use of a scale for quality of life
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Change in score at 30 days before surgery and 1 Day before hospital discharge
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Sarcopenia index measurement
Lasso di tempo: 30 days before surgery
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Measure from routine preoperative Computerized Tomography scan
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30 days before surgery
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Satisfaction score of the Nutrimus tool
Lasso di tempo: 6 months postoperative
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Use of a questionnaire
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6 months postoperative
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Ease of use of the Nutrimus tool
Lasso di tempo: 6 months postoperative
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Use of a questionnaire
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6 months postoperative
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Measurement of the Medical Outcome Study Short Form 36 score
Lasso di tempo: Change in score at 1 day before surgery, 1 day before the end of hospitalization, 1 Month, 3 Months and 6 Months post hospitalization
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Use of a scale for quality of life
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Change in score at 1 day before surgery, 1 day before the end of hospitalization, 1 Month, 3 Months and 6 Months post hospitalization
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Evaluation of nutritional parameters
Lasso di tempo: Change in values measures at 30 days to 10 days, 1 day before surgery, 1 day before the end of hospitalization, 1 Month, 3 Months and 6 Months post hospitalization
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Use of a notebook
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Change in values measures at 30 days to 10 days, 1 day before surgery, 1 day before the end of hospitalization, 1 Month, 3 Months and 6 Months post hospitalization
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Evaluation of respiratory and functional capacities
Lasso di tempo: Change in measures at 30 days to 10 days, 1 day before surgery, 1 day before the end of hospitalization, 1 Month, 3 Months and 6 Months post hospitalization
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Change in measures at 30 days to 10 days, 1 day before surgery, 1 day before the end of hospitalization, 1 Month, 3 Months and 6 Months post hospitalization
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Pain assessment
Lasso di tempo: Change in score at 30 days to 10 days, 1 day before surgery, 1 day before the end of hospitalization, 1 Month, 3 Months and 6 Months post hospitalization
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Use of a visual analogue scale Measure of score from 0 to 10
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Change in score at 30 days to 10 days, 1 day before surgery, 1 day before the end of hospitalization, 1 Month, 3 Months and 6 Months post hospitalization
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Length hospitalization
Lasso di tempo: Duration (in days) of patient's hospitalization
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Length (in days) between hospital admission and discharge
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Duration (in days) of patient's hospitalization
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Alain PARDIGNAC, Strasbourg Universitary hospitals
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 6117
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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