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

NCT03670199 | Unknown

• 1 other identifier: 6117
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Undernourished; Digestive Cancer

Outcome Measures

Primary Outcomes (1)

• Variation of the Medical Outcome Study Short Form 36 score

  Use of a scale for quality of life

  Change in score at 30 days before surgery and 1 Day before hospital discharge

Secondary Outcomes (8)

• Sarcopenia index measurement

  30 days before surgery

• Satisfaction score of the Nutrimus tool

  6 months postoperative

• Ease of use of the Nutrimus tool

  6 months postoperative

• Measurement of the Medical Outcome Study Short Form 36 score

  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

  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

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Other: Dietary intervention; Other: Intensify physiotherapist intervention

Control group

ACTIVE COMPARATOR

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

Other: Dietary advice; Other: Physiotherapist intervention

Interventions

Dietary advice OTHER

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

Control group

Physiotherapist intervention OTHER

Respiratory capacity Functional capacity

Control group

Dietary intervention 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

Experimental group

Intensify physiotherapist intervention 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

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patient included in another ongoing clinical trial
• Patient with neuro-endocrine cancer
• Patient reoperated for the same pathology

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

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

Strasbourg, 67098, France

RECRUITING

MeSH Terms

Conditions

Malnutrition; Gastrointestinal Neoplasms

Interventions

Nutrition Assessment; Diet Therapy

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Nutrition Therapy; Therapeutics

Study Officials

• Alain PARDIGNAC

  Strasbourg Universitary hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DRCI Strasbourg

CONTACT

0388117438; dpidrci@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: September 13, 2018
• Study Start: January 29, 2019
• Primary Completion: April 28, 2024
• Study Completion: April 28, 2024
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)