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临床试验/NCT01563588
NCT01563588终止不适用

Post Therapeutic Support and Rehabilitation Protocol in Hydrothermal Centers for Breast Cancer Patients in Complete Remission: a Multicenter Prospective Randomized Trial Testing the Intervention Versus Best Supportive Care

Centre Jean Perrin4 个研究点 分布在 1 个国家目标入组 251 人开始时间: 2008年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
251
试验地点
4
主要终点
Quality of life (SF36)

研究概览

简要总结

Many breast cancer patients (BCP) will gain weight during chemotherapy and about 10% of them are able to find back to their initial weight after all treatments are finished. Other studies have shown that overweight at diagnosis was associated to a twice higher risk of relapse while a weight gain during treatments increased by 30% to 50% the risk of relapse. In western countries, 75% of BCP have insufficient physical activity. Dietary and activity programs seem to be able to significantly reduce the mortality risk after breast cancer.

The investigators performed a prospective randomized trial consisting in dietary counseling, physical training and physiotherapy in hydrothermal centers. Intervention were delivered in small group session lasting 12 days. SPA cares were offered to patients. Patients in the control group also received dietary counseling given by a dietetician inside anticancer hospital, and were asked to perform more physical activities. Main endpoints of the trial addressed quality of life (SF36) one year after inclusion, weight reduction, anxiety/depression (HAD), sleep quality and long term compliance to instructions. An economic study was associated to the protocol, for volunteers only.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • breast cancer
  • treatment including a chemotherapy
  • in complete remission
  • last treatment in the last 9 months before inclusion
  • signed consent

排除标准

  • metastatic disease
  • women enable to have physical activity
  • heart disease or any pathology preventing physical activity

结局指标

主要结局

Quality of life (SF36)

时间窗: one year after inclusion

Quality of life was measured with the SF36 questionnaire before randomization, at 6, 12, 18, 24 and 36 months. The difference at one year was the main endpoint.

次要结局

  • economic figures(during 2 years after inclusion)
  • Anxiety/depression scores (HAD)(inclusion, 6, 12, 18, 24, 36 months)
  • Weight and morphometric measures(inclusion, 6, 12, 18, 24, 36 months)
  • Sleep quality(inclusion, 6, 12, 18, 24, 36 months)

研究者

发起方
Centre Jean Perrin
申办方类型
Other
责任方
Principal Investigator
主要研究者

Philippe Chollet

Professor Yves-Jean Bignon

Centre Jean Perrin

研究点 (4)

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