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临床试验/NCT05056350
NCT05056350招募中不适用

Professional Life After Breast Cancer: Feasibility of a Coaching Program for an Adapted Return to Work

Institut du Cancer de Montpellier - Val d'Aurelle2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年9月13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
25
试验地点
2
主要终点
Patient adherence of a coaching program for an adapted return to work

研究概览

简要总结

The diagnosis of breast cancer and the treatments implemented have a significant impact on the professional situation.

Maintaining employment and/or reintegration into working life are therefore major issues for cancer patients.

This trial proposes to study the feasibility of a support/coaching program for a return to work in patients after breast cancer.

详细描述

This study involves patients with breast cancer at the end of their adjuvant treatment.

The aim of this study is to evaluate the feasibility of a support program for an adapted return to work of these patients.

This back-to-work support program including an individual interview to identify patient needs and expectations, 7 coaching workshops (every 3 weeks +/- 15 days) and a final individual assessment post workshops.

The evolution of quality of life, psychological distress and perceptions concerning work will also be evaluated through assessments and questionnaires before (inclusion) and after the support program [1 month (+/- 7 days) and 6 months (+/- 1 month) after the final individual assessment].

The study also aims to estimate the recruitment rate in the study and to assess the satisfaction of this support program.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

  • Age ≥18 years
  • Patients cared at the Montpellier Cancer Institute (ICM) for non-metastatic breast cancer who have received adjuvant treatment (radiotherapy and/or chemotherapy)
  • Patient who has completed adjuvant treatment, except for hormonotherapy
  • Patient practicing a profession at the time of diagnosis, looking for a job or in professional retraining at the time of diagnosis
  • Patient expressing spontaneously or on request of the oncologist physical or psychological difficulties in the professional field
  • Patient wishing to be accompanied for an adapted return to her current job or for a return to a new more adapted job
  • Patient who signed the informed consent after informed information by her clinician

排除标准

  • Metastatic breast cancer or any other cancer within the last 5 years
  • Patient who haven't completed herr adjuvant treatment (chemotherapy and/or radiotherapy)
  • Psychological condition requiring therapeutic support (objectified by the Mini International Neuropsychiatric Interview test (MINI) by identifying a Diagnostic and Statistical Manual (DSM)-IV Axis I psychiatric disorder (American Psychiatric Association, 1994) Sheehan et al., 1998) with the patient's refusal of adequate psychiatric treatment (medicated or not) at the time of inclusion in the study
  • Severely impaired global cognitive functioning (objectified by an adjusted score of less than 20 on the Montreal Cognitive Assessment (MoCA) test)
  • Physical inability to answer questionnaires

结局指标

主要结局

Patient adherence of a coaching program for an adapted return to work

时间窗: through study completion, an average of 1 year

Assessment of the feasibility of a support program for an adapted return to work in patients with breast cancer, after their adjuvant treatment. Feasibility is defined by the proportion of patients who have adhered to the support program, with the patient attending at least 5 of the 7 proposed sessions.

次要结局

  • Impact of the support program on the return to work(At 1 month and at 6 months)
  • Estimation of recruitment rate in the study(At inclusion)
  • Evolution of perceptions regarding work importance(AT inclusion, at 1 month and 6 months)
  • Evolution of Work Ability(AT inclusion, at 1 month and 6 months)
  • Evolution of self-efficacy(AT inclusion, at 1 month and 6 months)
  • Satisfaction of the support program Satisfaction of the support program(At 1 month and at 6 months)
  • Quality of life (QoL)(At inclusion, at 1 month and at 6 months)
  • Evolution of the psychological distress of patients(At inclusion, at 1 month and at 6 months)

研究者

发起方
Institut du Cancer de Montpellier - Val d'Aurelle
申办方类型
Other
责任方
Sponsor

研究点 (2)

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