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临床试验/NCT02740491
NCT02740491已完成不适用

Evaluation of the Implementation of a "Remission" Consultation in the Management of Patients Treated for Localized Breast Cancer

Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年9月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
The EORTC QLQ-C30 questionnaire

研究概览

简要总结

The main objective of this study is to describe the evolution in quality of life (QLQ-C30) for patients receiving breast cancer care at 3, 6 and 12 months after a "remission" consultation.

详细描述

The secondary objectives of this study are:

A. to describe changes in body image (Image Body Scale Version F) at 3, 6 and 12 months after a "remission" consultation.

B. to describe changes in psychological distress (visual analog scale) at 3, 6 and 12 months after a "remission" consultation.

C. to assess the time of resumption of work (date of last chemotherapy - date of the actual resumption of work) after a "remission" consultation.

D. to evaluate the acceptance rate for the "remission" consultation.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • The patient is receiving care for localized breast cancer and finished her adjuvant treatment (chemotherapy, radiotherapy)
  • The patient has completed his/her adjuvant therapy in the last 6 months (chemotherapy, radiotherapy).

排除标准

  • The patient is participating in another study
  • The patient is under judicial protection
  • It is impossible to correctly inform the patient
  • The patient has a metastatic form of the disease at diagnosis

研究组 & 干预措施

The study population

The study population consists of adult patients diagnosed with localized breast cancer who have completed adjuvant treatment (chemotherapy, radiotherapy) and who are cared for in the Medical Oncology department of the Nîmes University Hospital.

干预措施: Remission Consultation (Other)

结局指标

主要结局

The EORTC QLQ-C30 questionnaire

时间窗: Month 12

The EORTC QLQ-C30 questionnaire

时间窗: Day 0

The EORTC QLQ-C30 questionnaire

时间窗: Month 3

The EORTC QLQ-C30 questionnaire

时间窗: Month 6

次要结局

  • Psychological distress (visual analog scale)(Month 12)
  • Work recovery time (date of last chemotherapy - date of the actual resumption of work)(Month 12)
  • Body Image Scale(Month 12)
  • Acceptance of remission consultation (yes/no)(Day 0)
  • Body Image Scale(Day 0)
  • Body Image Scale(Month 3)
  • Body Image Scale(Month 6)
  • Psychological distress (visual analog scale)(Day 0)
  • Psychological distress (visual analog scale)(Month 3)
  • Psychological distress (visual analog scale)(Month 6)
  • Work recovery time (date of last chemotherapy - date of the actual resumption of work)(Month 3)
  • Work recovery time (date of last chemotherapy - date of the actual resumption of work)(Month 6)

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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