Improving the Quality of Life of Cancer Patients Through a Perioperative and Coordinated Nutrition and Physical Care Program. (PENDICOQ)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03670199|
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : June 3, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Undernourished Digestive Cancer||Other: Dietary advice Other: Physiotherapist intervention Other: Dietary intervention Other: Intensify physiotherapist intervention||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Improving the Quality of Life of Cancer Patients Through a Perioperative and Coordinated Nutrition and Physical Care Program.|
|Actual Study Start Date :||January 29, 2019|
|Estimated Primary Completion Date :||April 28, 2024|
|Estimated Study Completion Date :||April 28, 2024|
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
- Variation of the Medical Outcome Study Short Form 36 score [ Time Frame: Change in score at 30 days before surgery and 1 Day before hospital discharge ]Use of a scale for quality of life
- Sarcopenia index measurement [ Time Frame: 30 days before surgery ]Measure from routine preoperative Computerized Tomography scan
- Satisfaction score of the Nutrimus tool [ Time Frame: 6 months postoperative ]Use of a questionnaire
- Ease of use of the Nutrimus tool [ Time Frame: 6 months postoperative ]Use of a questionnaire
- Measurement of the Medical Outcome Study Short Form 36 score [ Time Frame: 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
- Evaluation of nutritional parameters [ Time Frame: 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
- Evaluation of respiratory and functional capacities [ Time Frame: 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 [ Time Frame: 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
- Length hospitalization [ Time Frame: Duration (in days) of patient's hospitalization ]Length (in days) between hospital admission and discharge
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670199
|Contact: DRCI Strasbourgemail@example.com|
|Service de Médecine Interne et Nutrition, Hôpital de Hautepierre, Hôpitaux universitaires de Strasbourg||Recruiting|
|Strasbourg, France, 67098|
|Contact: Alain PRADIGNAC, MD 18.104.22.168.75.89 firstname.lastname@example.org|
|Contact: Jean-François MUNIER 22.214.171.124.79.69 Jeanfrancois.email@example.com|
|Principal Investigator: Alain PRADIGNAC, MD|
|Sub-Investigator: Serge ROHR, MD|
|Principal Investigator:||Alain PARDIGNAC||Strasbourg Universitary hospitals|