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.

Study Overview

• Status: Recruiting
• Conditions: Digestive Cancer; Undernourished
• Intervention / Treatment: Other: Dietary intervention; Other: Intensify physiotherapist intervention; Other: Dietary advice; Other: Physiotherapist intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: DRCI Strasbourg; Phone Number: 0388117438; Email: dpidrci@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67098
    • Recruiting
    • Service de Médecine Interne et Nutrition, Hôpital de Hautepierre, Hôpitaux universitaires de Strasbourg
    • Principal Investigator: Alain Pradignac, MD
    • Contact: Alain PRADIGNAC, MD; Phone Number: 33.3.88.12.75.89; Email: alain.pradignac@chru-strasbourg.fr
    • Contact: Jean-François MUNIER; Phone Number: 33.3.88.12.79.69; Email: Jeanfrancois.munier@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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; 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
Active Comparator: Control group; usual preoperative advice for patients who undergoing surgical procedure concerning nutritional cares and physical activity	Other: Dietary advice; Nutritional status assessment Explanation of standard nutritional advices with an written explanation sheet; Other: Physiotherapist intervention; Respiratory capacity Functional capacity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sarcopenia index measurement	Measure from routine preoperative Computerized Tomography scan	30 days before surgery
Satisfaction score of the Nutrimus tool	Use of a questionnaire	6 months postoperative
Ease of use of the Nutrimus tool	Use of a questionnaire	6 months postoperative
Measurement of the Medical Outcome Study Short Form 36 score	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	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		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	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	Length (in days) between hospital admission and discharge	Duration (in days) of patient's hospitalization

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Alain PARDIGNAC, Strasbourg Universitary hospitals

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2019
• Primary Completion (Anticipated): April 28, 2024
• Study Completion (Anticipated): April 28, 2024

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (Actual): September 13, 2018

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 6117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No