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临床试验/NCT04469205
NCT04469205终止不适用

Randomized and Prospective Study to Assess the Impact of Personalized Coaching on the Time Period and Quality of Return to Work After Breast Cancer

Institut Curie2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2020年10月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
69
试验地点
2
主要终点
Impact of coaching sessions on the return to work rate (number of patients returning at work / total number of patients per arm) 6 months after inclusion in the study

研究概览

简要总结

Evaluate the impact of coaching sessions on the return to work rate (number of patients returning at work / total number of patients per arm) 6 months after inclusion in the study for breast cancer in professionnally active patients.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Any patient active at the time of the diagnosis of breast cancer, treated consecutively at the Institut Curie during the study period, and whose first treatment will be surgery, will be offered participation in the study.
  • •Invasive non-metastatic breast cancer, treated first by surgery
  • •Age ≥ 18 and ≤ 60 years
  • •Active woman at the time of diagnosis
  • •Patient with internet access and email address
  • •Patient affiliated with a social security scheme, speaking and reading French
  • •Signature of informed consent

排除标准

  • •In situ breast cancer
  • •History of breast cancer
  • •Metastatic breast cancer
  • •Inflammatory Breast Cancer
  • •Woman with a life expectancy <6 months at the time of diagnosis (in relation to other serious chronic diseases)
  • •Persons deprived of liberty or under guardianship
  • •Impossibility to submit to the medical follow-up of the test for geographical, social or psychological reasons

研究组 & 干预措施

Intervention Group

Experimental

intervention group that will receive return-to-work coaching sessions. The intervention consists of 3 individual coaching sessions with a certified professional coach. This personalized accompaniment will complete the standard accompaniment offered to all patients.

干预措施: Coaching sessions (Other)

Control Group

No Intervention

control group who will receive the current care which consists of a psychosocial care.

This care consists in offering the patient regular information meetings organized with social workers of the Health Insurance, to consult a psychologist and to access patients' homes at the frequency of their choice and according to their need.

结局指标

主要结局

Impact of coaching sessions on the return to work rate (number of patients returning at work / total number of patients per arm) 6 months after inclusion in the study

时间窗: 6 months

The rate of patients returning to work (part-time or full-time) for more than 2 weeks to 6 months of inclusion in the study in each group.

次要结局

  • The production losses related to presenteeism during maintenance or return to work(6 and 12 months)
  • The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)(6 and 12 months)
  • Sustainability of the return to work(6 and 12 months)
  • Quality of the return to work(6 and 12 months)
  • Impact of the return to work / work stoppage on the quality of life(6 and 12 months)
  • The medico-economic impact of returning to work(12 months)
  • The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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