Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05401877 |
| Other study ID # |
CE21096B |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2021 |
| Est. completion date |
May 1, 2023 |
Study information
| Verified date |
May 2022 |
| Source |
Taichung Veterans General Hospital |
| Contact |
Yuchun Lee, MD |
| Phone |
886-4-23592525 |
| Email |
lyczoj[@]vghtc.gov.tw |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
