Improving the Quality of Life of Cancer Patients Through a Perioperative and Coordinated Nutrition and Physical Care Program.

NCT ID: NCT03670199

Last Updated: 2021-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-29
• Study Completion Date: 2024-04-28

Brief Summary

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.

Detailed Description

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.

Conditions

Undernourished; Digestive Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Dietary intervention

Intervention Type: OTHER

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

Intensify physiotherapist intervention

Intervention Type: OTHER

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

Control group

usual preoperative advice for patients who undergoing surgical procedure concerning nutritional cares and physical activity

Group Type: ACTIVE_COMPARATOR

Dietary advice

Intervention Type: OTHER

Nutritional status assessment Explanation of standard nutritional advices with an written explanation sheet

Physiotherapist intervention

Intervention Type: OTHER

Respiratory capacity Functional capacity

Interventions

Dietary advice

Nutritional status assessment Explanation of standard nutritional advices with an written explanation sheet

Intervention Type: OTHER

Physiotherapist intervention

Respiratory capacity Functional capacity

Intervention Type: OTHER

Dietary intervention

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

Intervention Type: OTHER

Intensify physiotherapist intervention

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alain PARDIGNAC

Role: PRINCIPAL_INVESTIGATOR

Strasbourg Universitary hospitals

Locations

Service de Médecine Interne et Nutrition, Hôpital de Hautepierre, Hôpitaux universitaires de Strasbourg

Strasbourg, , France

Site Status: RECRUITING

Countries

France

Central Contacts

DRCI Strasbourg

Role: CONTACT

dpidrci@chru-strasbourg.fr

0388117438

Facility Contacts

Alain PRADIGNAC, MD

Role: primary

alain.pradignac@chru-strasbourg.fr

33.3.88.12.75.89

Jean-François MUNIER

Role: backup

Jeanfrancois.munier@chru-strasbourg.fr

33.3.88.12.79.69

Other Identifiers

6117

Identifier Type: -

Identifier Source: org_study_id