Multi-mode Rehabilitation of Abdominal Tumor Patients Undergoing Concurrent Chemoradiotherapy
Research on Multi-mode Rehabilitation of Abdominal Tumor Patients With Simultaneous Radiotherapy and Chemotherapy Based on Mobile Medicine.
연구 개요
상태
개입 / 치료
상세 설명
Research shows that the combination of early nutritional intervention and psychological palliative intervention can improve the quality of life of patients, reduce the probability of depression, improve the prognosis of patients and prolong the overall survival time for up to two months. The research of Peking University Cancer Hospital in China shows that early nutrition and psychological palliative intervention can improve the prognosis of patients with advanced esophageal cancer and prolong the overall survival by nearly three months. The first mock exam (including exercise, nutrition and Psychology) seems to be more effective than a single model of pre rehabilitation. Therefore, the current triple rehabilitation strategy is advocated, namely, high intensity aerobic exercise during the waiting period, nutritional support based on protein supplementation, and psychological support to eliminate anxiety. Tumor multimodal rehabilitation has received more and more attention, but there is no clinical research on the "triple multimodal rehabilitation" of nutrition + Exercise + psychology in patients with abdominal tumor concurrent radiotherapy and chemotherapy. Therefore, the research on the impact of whole process multimodal rehabilitation (nutrition-Exercise-Psychology) on patients with abdominal tumor concurrent radiotherapy and chemotherapy has been carried out, It has important scientific significance and value to promote the rehabilitation and development of tumor patients undergoing concurrent radiotherapy and chemotherapy.
In this study,the investigators carry out a multi center, randomized controlled clinical study to analyze the impact of the whole process multi-mode rehabilitation management (nutrition-Sports- Psychology) on the nutritional status, physical status, psychological status, treatment side effects and the completion rate of radiotherapy and chemotherapy of patients with abdominal tumors; To explore and establish a multi-mode rehabilitation management path for patients with malignant tumors undergoing concurrent radiotherapy and chemotherapy.
연구 유형
등록 (예상)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Fuxiang Zhou, MD,PhD
- 전화번호: +86-027-67813155
- 이메일: fuxiang.zhou@whu.edu.cn
연구 장소
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Hubei
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Wuhan, Hubei, 중국, 430070
- 모병
- Zhongnan Hopital of Wuhan University
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연락하다:
- Fuxiang Zhou, MD
- 전화번호: +86-027-67813155
- 이메일: fuxiang.zhou@whu.edu.cn
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients who are diagnosed as abdominal malignant tumor by pathology and / or cytology and intend to receive concurrent radiotherapy and chemotherapy;
- Estimated survival time ≥ 3 months;
- ECoG score 0-1;
- The physical activity is acceptable, and the human body composition analysis and 6-minute walking test can be carried out;
- Have reading comprehension ability and be able to complete the questionnaire.
Exclusion Criteria:
- Clinically significant cardiovascular diseases, such as heart failure (NYHA grade III-IV), uncontrolled coronary heart disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension or history of myocardial infarction in the past 1 year;
- Neurological or psychiatric abnormalities affecting cognitive ability, including central nervous system metastasis;
- uncontrolled systemic diseases, such as poorly controlled diabetes mellitus;
- Allergic to milk, whey protein, etc.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 대조군
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실험적: Research Group
multi-mode rehabilitation
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Multimodal rehabilitation
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Completion rate of concurrent chemoradiotherapy
기간: up to 12 weeks
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Completion rate of concurrent chemoradiotherapy
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up to 12 weeks
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Changes in grip strength
기간: up to 12 weeks
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Changes in grip strength
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up to 12 weeks
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Improvement of nutritional status
기간: up to 12 weeks
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PG-SGA score
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up to 12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Side effects of concurrent radiotherapy and chemotherapy
기간: up to 12 weeks
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Side effects of concurrent radiotherapy and chemotherapy
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up to 12 weeks
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disease free survival
기간: up to 12 weeks
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disease free survival
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up to 12 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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