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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：DRCI Strasbourg
- 電話番号：0388117438
- メール：dpidrci@chru-strasbourg.fr
研究場所
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Strasbourg、フランス、67098
- 募集
- Service de Médecine Interne et Nutrition, Hôpital de Hautepierre, Hôpitaux universitaires de Strasbourg
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主任研究者：
- Alain Pradignac, MD
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コンタクト：
- Alain PRADIGNAC, MD
- 電話番号：33.3.88.12.75.89
- メール：alain.pradignac@chru-strasbourg.fr
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コンタクト：
- Jean-François MUNIER
- 電話番号：33.3.88.12.79.69
- メール：Jeanfrancois.munier@chru-strasbourg.fr
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Variation of the Medical Outcome Study Short Form 36 score
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sarcopenia index measurement
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Alain PARDIGNAC、Strasbourg Universitary hospitals
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 6117
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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