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临床试验/NCT05270577
NCT05270577Unknown不适用

Pre-operative Prehabilitation in Cancer Surgery - Objective Recovery Assessment

Linkoeping University0 个研究点目标入组 90 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
90
主要终点
6 minute walk test (6mwt)

研究概览

简要总结

To compare prehabilitation with physical exercise, psychological support, nutritional support and smoke/alchol stop to "standard of care" before canceer surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients, aged 18 or older, who have been evaluated as eligible for surgery for malignancy in the esophagus, rectum or liver (only metastases from colorectal cancer) will be evaluated for participation.

排除标准

  • Surgery is scheduled in less than 12 weeks.
  • Paralytic or completely immobilized patient, condition making physical training impractical.
  • Cognitive disability making participation impossible.
  • Not speaking or understanding the Swedish language well enough to read and understand the informed consent form.

结局指标

主要结局

6 minute walk test (6mwt)

时间窗: 12 weeks

6 minute walk test (6mwt)

次要结局

  • Appetite and eating behavior is evaluated with Disease Related Appetite Questionnaire (DRAQ)(12 weeks)
  • Time from surgery until the day of first dose of adjuvant chemotherapy (among liver and rectal cancer patients for whom postoperative chemotherapy is planned)(90 day after surgery)
  • 30 s chair stand test(12 weeks)
  • Test of hand grip strength(12 weeks)
  • Cardiopulmonary exercise test with ventilatory gas analysis(12 weeks)
  • Appetite and eating behavior is evaluated with Eating Symptom Questionnaire (ESQ)(12 weeks)
  • Weekly alcohol consumption(12 weeks)
  • Sum of all complications in each patient (comprehensive complication index, CCI)(90d after surgery)
  • Clinical Frailty Scale(12 weeks)
  • International Physical Activity Questionnaire(12 weeks)
  • Length of hospitalization(90d after surgery)
  • Grade of sarcopenia(12 weeks)
  • Incremental cost-effectiveness ratio(2 years after surgery)
  • The presence of malnutrition evaluated with the Global Leadership Initiative on Malnutrition (GLM) criteria(12 weeks)
  • Overall survival(5 years)
  • 4-week point prevalence of smoking abstinence (among baseline smokers)(12 weeks)
  • Episodes of heavy drinking per month(12 weeks)
  • The most severe complication occurring(90d after surgery)
  • Time to functional recovery of physical status as compared to baseline values(90d after surgery)
  • The frequency of failures to go through the full treatment program as planned at the first MDT (including, but not limited to, the full oncological chemotherapy program, radiation treatment and final surgery)(90 days)
  • Quality of Life (QoL)(2 years after surgery)
  • Proportion of patients not able to receive all treatment despite no dissemination of disease(90 day after surgery)

研究者

发起方
Linkoeping University
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Bergthor Björnsson

Associate Professor

Linkoeping University

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