Active Early Individualized Psychosocial Accompaniment to Facilitate the Return to Employment of Women With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 128
- 试验地点
- 7
- 主要终点
- Comparison of the effect of early individualized psychosocial assets versus a standard support on social inequalities in the rate of return to work
研究概览
简要总结
The purpose of this study is to compare the effect of early individualized psychosocial assets versus a standard support on social inequalities in the rate of return to work
详细描述
For the group "intervention", patients have four interviews with a psychologist (at cure one of chemotherapy treatment, at cure six of chemotherapy treatment, at last radiotherapy session, and three months after the end of radiotherapy).
In the 2 arms, patients receive 4 sets of questionnaires (baseline, month 12, month 18 and month 24)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥ 18 with work at the time of diagnosis
- •Presenting a unilateral breast cancer exclusively local extension
- •Having received surgery
- •Reporting of adjuvant chemotherapy (+ / - trastuzumab)
- •Reporting to radiotherapy or not (If radiotherapy, it will be done on site investigator)
- •In work at the time of diagnosis (employees, traders and professionals)
- •Patient affiliated to a social security scheme
- •Consent signed by the patient before the implementation of any specific procedure to study
排除标准
- •Presence of in situ lesions, cancer recurrence, metastatic disease immediately, location bilateral
- •Inability physical, psychological, psychiatric or cognitive responses to the questionnaires and participate in interviews
- •Recognition previous ALD (due to another disease)
- •Patient under guardianship
研究组 & 干预措施
Standard group
routine monitoring with questionnaires
干预措施: Questionnaires (Behavioral)
Interviews with psychologist
Patients have interviews with a psychologist (at cure one of chemotherapy treatment,at cure six of chemotherapy treatment, at last radiotherapy session, and three months after the end of radiotherapy) and questionnaires
干预措施: interviews with a psychologist (Behavioral)
Interviews with psychologist
Patients have interviews with a psychologist (at cure one of chemotherapy treatment,at cure six of chemotherapy treatment, at last radiotherapy session, and three months after the end of radiotherapy) and questionnaires
干预措施: Questionnaires (Behavioral)
结局指标
主要结局
Comparison of the effect of early individualized psychosocial assets versus a standard support on social inequalities in the rate of return to work
时间窗: At 24 months
次要结局
- Calculating the cost / benefit ratio of the two modes of care(At 24 months)
- Comparison between the two modes of care, of social inequalities:(At 24 months)