Assessment of Health Related Quality of Life in Women Who Underwent Breast Reconstruction After Radical Surgery (RMQOL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Health related quality of life scores assessed by Breast Q questionnaire
研究概览
简要总结
Nowadays, breast reconstruction is an integral care after mastectomy in breast cancer patient.
With the personalized care, choice a breast reconstructive is an important step involving decisions and mutual accord between patients and their physicians in order to anticipate clinical and psychosocial results.
Two main families of breast reconstruction techniques are often performed including advantages and complications impacting health related quality of life.
Routine assessment of health related quality of life in patients underwent breast reconstruction could allow to identify factors of satisfaction o be taken into account in the choice of breast reconstruction technique in order to improve practices and quality of life of patients
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Normal Breast Checkup ( Mammography, echography and breast magnetic resonance imaging)in the previous 6 months
- •French speaking and writing fluency
- •Agree to participate after receive all information
排除标准
- •Patients with an inability to complete HRQOL questionnaires (cognitive disorders, language barrier)
- •Patient with a failed first breast reconstruction
结局指标
主要结局
Health related quality of life scores assessed by Breast Q questionnaire
时间窗: 12 months after breast reconstruction
次要结局
- social support as assessed by Sarason's Social Support Questionnaire 6-item (SSQ6)(12 months after breast reconstruction)
- level of the precariousness and the disparities of health at breast reconstruction patient by the questionnaire Evaluation of the Precariousness and the Disparities of Health for the Centers of Examination of Health (EPICES)(12 months after breast reconstruction)
- Number of anxious and depress participants as assessed by Hospital Anxiety and Depression Scale (HADS)(12 months after breast reconstruction)
- Health related quality of life scores assessed by Breast Q questionnaire(60 months after breast reconstruction)