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.
研究概览
地位
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：DRCI Strasbourg
- 电话号码：0388117438
- 邮箱：dpidrci@chru-strasbourg.fr
学习地点
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Strasbourg、法国、67098
- 招聘中
- Service de Médecine Interne et Nutrition, Hôpital de Hautepierre, Hôpitaux universitaires de Strasbourg
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首席研究员：
- Alain Pradignac, MD
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接触：
- Alain PRADIGNAC, MD
- 电话号码：33.3.88.12.75.89
- 邮箱：alain.pradignac@chru-strasbourg.fr
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接触：
- Jean-François MUNIER
- 电话号码：33.3.88.12.79.69
- 邮箱：Jeanfrancois.munier@chru-strasbourg.fr
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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
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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
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有源比较器：Control group
usual preoperative advice for patients who undergoing surgical procedure concerning nutritional cares and physical activity
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Nutritional status assessment Explanation of standard nutritional advices with an written explanation sheet
Respiratory capacity Functional capacity
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Variation of the Medical Outcome Study Short Form 36 score
大体时间：Change in score at 30 days before surgery and 1 Day before hospital discharge
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Use of a scale for quality of life
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Change in score at 30 days before surgery and 1 Day before hospital discharge
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Sarcopenia index measurement
大体时间：30 days before surgery
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Measure from routine preoperative Computerized Tomography scan
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30 days before surgery
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Satisfaction score of the Nutrimus tool
大体时间：6 months postoperative
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Use of a questionnaire
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6 months postoperative
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Ease of use of the Nutrimus tool
大体时间：6 months postoperative
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Use of a questionnaire
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6 months postoperative
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Measurement of the Medical Outcome Study Short Form 36 score
大体时间：Change in score at 1 day before surgery, 1 day before the end of hospitalization, 1 Month, 3 Months and 6 Months post hospitalization
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Use of a scale for quality of life
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Change in score at 1 day before surgery, 1 day before the end of hospitalization, 1 Month, 3 Months and 6 Months post hospitalization
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Evaluation of nutritional parameters
大体时间：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
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Use of a notebook
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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
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Evaluation of respiratory and functional capacities
大体时间：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
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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
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Pain assessment
大体时间：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
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Use of a visual analogue scale Measure of score from 0 to 10
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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
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Length hospitalization
大体时间：Duration (in days) of patient's hospitalization
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Length (in days) between hospital admission and discharge
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Duration (in days) of patient's hospitalization
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合作者和调查者
调查人员
- 首席研究员：Alain PARDIGNAC、Strasbourg Universitary hospitals
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 6117
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