跳至主要内容
临床试验/NCT05116449
NCT05116449招募中不适用

Comparison of Changes in the Quality of Life of Patients Operated on Breast Cancer at the Drôme Ardèche Breast Institute According to Access to Supportive Oncological Care

Ramsay Générale de Santé2 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2021年2月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
310
试验地点
2
主要终点
Quality of life questionnaire : FACT-B

研究概览

简要总结

The aim of this study is to explore the quality of life of cancer patients, in particular women operated on breast cancer, throughout their care journey, taking into account their access to supportive oncological care within and outside the establishment care.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Woman with histologically confirmed invasive breast cancer for whom surgery is scheduled
  • Age> 18 years old
  • Performance status ECOG <2
  • Patient speaking and understanding French and able to complete questionnaires
  • Patient affiliated or beneficiary of a social security scheme
  • Patient having read the information note and not objecting to the use of the data collected

排除标准

  • Patient with metastatic breast cancer
  • Patient with bilateral breast cancer
  • History of cancer of less than 5 years
  • Active infection or other serious underlying condition that may prevent the patient from receiving treatment
  • History or progressive psychiatric illness
  • Person deprived of liberty or under guardianship
  • Inability to undergo medical monitoring for geographical, social or psychological reasons Indication of emergency amputation
  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
  • Pregnant, breastfeeding or parturient woman
  • Patient hospitalized without consent

结局指标

主要结局

Quality of life questionnaire : FACT-B

时间窗: 12 months

Functional Assessment of Cancer Therapy-breast : 27 items about physical well-being, family well-being, emotional and functional well-being. The quotation is between 0 "not at all" and 4 "verry much". The total score is between 0 and 148. The higher the scores, the higher the QoL and the various well-being.

Quality of life questionnaire : EORTC QLQ-C30

时间窗: 12 months

30 items for all patient suffering from cancer. The answer of each question is between 1 "not at all" and 4 "very much"

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验