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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: DRCI Strasbourg
- Telefonnummer: 0388117438
- E-post: dpidrci@chru-strasbourg.fr
Studieorter
-
-
-
Strasbourg, Frankrike, 67098
- Rekrytering
- Service de Médecine Interne et Nutrition, Hôpital de Hautepierre, Hôpitaux universitaires de Strasbourg
-
Huvudutredare:
- Alain Pradignac, MD
-
Kontakt:
- Alain PRADIGNAC, MD
- Telefonnummer: 33.3.88.12.75.89
- E-post: alain.pradignac@chru-strasbourg.fr
-
Kontakt:
- Jean-François MUNIER
- Telefonnummer: 33.3.88.12.79.69
- E-post: Jeanfrancois.munier@chru-strasbourg.fr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
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
|
|
Aktiv komparator: Control group
usual preoperative advice for patients who undergoing surgical procedure concerning nutritional cares and physical activity
|
Nutritional status assessment Explanation of standard nutritional advices with an written explanation sheet
Respiratory capacity Functional capacity
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Variation of the Medical Outcome Study Short Form 36 score
Tidsram: Change in score at 30 days before surgery and 1 Day before hospital discharge
|
Use of a scale for quality of life
|
Change in score at 30 days before surgery and 1 Day before hospital discharge
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Sarcopenia index measurement
Tidsram: 30 days before surgery
|
Measure from routine preoperative Computerized Tomography scan
|
30 days before surgery
|
|
Satisfaction score of the Nutrimus tool
Tidsram: 6 months postoperative
|
Use of a questionnaire
|
6 months postoperative
|
|
Ease of use of the Nutrimus tool
Tidsram: 6 months postoperative
|
Use of a questionnaire
|
6 months postoperative
|
|
Measurement of the Medical Outcome Study Short Form 36 score
Tidsram: Change in score at 1 day before surgery, 1 day before the end of hospitalization, 1 Month, 3 Months and 6 Months post hospitalization
|
Use of a scale for quality of life
|
Change in score at 1 day before surgery, 1 day before the end of hospitalization, 1 Month, 3 Months and 6 Months post hospitalization
|
|
Evaluation of nutritional parameters
Tidsram: 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
|
Use of a notebook
|
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
|
|
Evaluation of respiratory and functional capacities
Tidsram: 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
|
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
|
|
|
Pain assessment
Tidsram: 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
|
Use of a visual analogue scale Measure of score from 0 to 10
|
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
|
|
Length hospitalization
Tidsram: Duration (in days) of patient's hospitalization
|
Length (in days) between hospital admission and discharge
|
Duration (in days) of patient's hospitalization
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Alain PARDIGNAC, Strasbourg Universitary hospitals
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 6117
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .