Multidisciplinary Care Pathway With Electronic Patient Reported Outcomes (ePRO) Post-operative Follow-up of Breast Cancer Surgery Complications to Optimize Patient Quality of Life
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
- Patient compliance with the program
研究概览
简要总结
This project is a follow-on study of the BEAUTIFY-2 study (NCT04957186). The "BEAUTIFY" (BrEast cAncer qUaliTy of lIfe aFter surgerY) program was built by a committee of experts on the basis of reflections carried out within 2 focus groups. An application was developed to track patient reported outcome measures.
The study investigators now wish to evaluate the feasibility and impact on pain and quality of life of the "BEAUTIFY" care pathway on a larger cohort. The study hypothesis is that multidisciplinary care organization will improve the management and the quality of life post-breast cancer surgery.
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
- 否
入选标准
- •Breast cancer patient scheduled for surgery
- •Patient able to use a connected electronic object and having a tablet or a smartphone with internet access at home.
- •The patient must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan
排除标准
- •The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- •The subject unable to express consent
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
研究组 & 干预措施
BEAUTIFY application
干预措施: BEAUTIFY application (Device)
结局指标
主要结局
Patient compliance with the program
时间窗: End of study (12 months)
Yes/No: study will be considered feasible if at least 80% of patients complete the program
Patient satisfaction with the intervention
时间窗: End of study (12 months)
Yes/No: study will be considered feasible if at least 80% of patients are satisfied.
次要结局
- Compliance with completing the BEAUTIFY application(End of study (12 months))
- Patient quality of life following surgery(6 months)
- Return to work and/or social activities(1 year)
- Satisfaction of patients with their care(6 months)
- Rate of post-operative complications(6 months)
- Type of post-operative complications(6 months)
- Readmission rate for surgical or medical reason(6 months)