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临床试验/NCT05401877
NCT05401877已完成不适用

Factors Affecting Rehabilitation Time for Postoperative Complications Among Breast Cancer Patients

Taichung Veterans General Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
the rehabilitation time

研究概览

简要总结

Breast cancer patients who had undergone surgery, chemotherapy and radiotherapy suffered from complications, including shoulder stiffness, lymphedema and scar contracture. These symptoms impaired one's ADL function. Rehabilitation may relieved symptoms. However, it is difficult to estimate how long one should receive rehabilitation. The study is trying to establish a machine-learning based model in order to predict the period of rehabilitation.

详细描述

Breast cancer survivors suffered from complications after surgery, chemotherapy and radiotherapy. These complications include shoulder stiffness, upper limb lymphedema and scar contracture, which altogether impaired one's ADL function. Rehabilitation had been approved to relieved these symptoms effectively. However, many factor may interfere the patient's participation of rehabilitation, making it difficult to estimate how long one should receive rehabilitation. In Taiwan, National Health Insurance provides affordable, accessible and unlimited health care and medical service for all citizens, eliminating many social-economic barriers. Thus we are trying to establish a machine-learning based model in order to predict the period of rehabilitation.

Our study is a retrospective case-control study. The objectives are breast cancer survivors who attended post-surgery rehabilitation at least once for complications. The following data are collected from e-HIS system:

  1. Patient characteristic: age, unilateral or bilateral cancer.
  2. Surgery type: total, partial or simple mastectomy.
  3. Lymphatic surgery: ALND and SLNB
  4. Other surgical procedure: breast reconstruction, flap surgery.
  5. Combined therapy: chemotherapy, radiotherapy or hormone therapy.
  6. Complications: shoulder stiffness, lymphedema, scar contracture (ex., Axillary web syndrome), neurological deficit.
  7. The first between operation and first time of rehabilitation.

The primary outcome is the total rehabilitation time, which will be divided as short term (less than 360 min) and long time (more than 360 min).

The data will be processed using WEKA and machine learning algorithms, including Logistic regression, supportive vector machine, K-nearest neighbors, decision tree and random forest.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • patients who received operation for breast cancer
  • attended rehabilitation at least once for breast cancer related complications

排除标准

  • patients who received rehabilitation for other reasons rather than surgical complications
  • patients who are transfered to other hospital for rehabilitation

结局指标

主要结局

the rehabilitation time

时间窗: since the first session of rehabilitation until one year after the last session

total post-operation rehabilitation time (minute)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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