跳至主要内容
临床试验/NCT06025604
NCT06025604招募中不适用

Psycho Social Factors Associated to Return to Work After Breast Cancer Care : a Prognostic Study

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 578 人开始时间: 2023年9月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
578
试验地点
1
主要终点
To identify the impact of psycho social factors on delay of return to any modality of work, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)

研究概览

简要总结

Breast cancer is, in term of incidence, the first cancer among women in France and worldwide. This incidence is increasing, particularly among young women during their professional activity.

Those observations raise de question of return to work of those patients, and, broadly, of the post cancer life and former activities recovery.

The objective of the study is to identify any factor influencing time from diagnosis to return to work (type of treatment, side effects, residual symptoms, medical staff support, occupational physician monitoring, individual or group supportive therapy, adapted physical activity, alternative therapeutics ..), and the main modalities of return to work (part or full time, professional redeployment).

To identify those factors, barriers or supports, would enable the implementation of concrete actions and programs, promoting return to work, and to a free disease life for those patients.

The main objective is to identify psycho social factors involved in the time from diagnosis to return to any modality of work, until 24 month after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included) Secondary objectives are to identify psycho social factors involved in the time from diagnosis to return to work, part time, full time, and redeployment, respectively, until 24 month after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)

详细描述

Patients being took care in Grenoble University Hospital, including Voiron site, from 2015 to 2019, for a localized breast cancer, will be identified be Cristal Link software.

A questionary, including every studied variables and potential confounding factors, will be sent, by post or by e mail, to the patients. An information notice and a non opposition formulary will be joined to the questionary.

Patients will be contacted by a paramedical member of the Women Cancer Center of the University Hospital, in order to explain them the objective of the study, and the modality of personal data management.

The questionary will be returned either by mail, or directly brought back to the Hospital along a medical appointment.

Data collection will focus on return to work delay, return to work modality (part or full time, redeployment), studied variables and potential confounding factors (demographic : marital status, number of dependent children, incomes / related to occupational activity : night work, job responsibility, occupational physician follow up / treatment consequences : OMS status, anxiety, depression, lymphoedema, articular pain, neuropathic pain / Support measures : physical activities, psychological support, alternative therapeutics, familial support, medical staff support).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Patient between 18 and 60 years old
  • Histologically proven localized breast cancer, of any subtype
  • Cared in Grenoble University Hospital between 2015 and 2019
  • Working at the time of diagnosis

排除标准

  • Retired at the end of adjuvant therapy
  • Deprived of liberty, under juridical protection, not able to give consent
  • Psychiatric conditions or addictive behavior interfering with questionary filling

结局指标

主要结局

To identify the impact of psycho social factors on delay of return to any modality of work, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)

时间窗: 30 minutes

Assessment of delay of a any occupational activity recovery, from the diagnosis and until 24 months after treatment, and of any influenced factors by self administrated questionnaire, included standardized questionnaire for subjective variables

次要结局

  • To identify the impact of psycho social factors on delay of return to full time work, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)(30 minutes)
  • To identify the impact of psycho social factors on delay of return to occupational reclassification, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)(30 minutes)
  • To identify the impact of psycho social factors on delay of return to part time work, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)(30 minutes)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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