- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05401877
Factors Affecting Rehabilitation Time for Postoperative Complications Among Breast Cancer Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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:
- Patient characteristic: age, unilateral or bilateral cancer.
- Surgery type: total, partial or simple mastectomy.
- Lymphatic surgery: ALND and SLNB
- Other surgical procedure: breast reconstruction, flap surgery.
- Combined therapy: chemotherapy, radiotherapy or hormone therapy.
- Complications: shoulder stiffness, lymphedema, scar contracture (ex., Axillary web syndrome), neurological deficit.
- 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Taiwan
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Taichung, Taiwan, Taiwan, 40705
- Department of Physical Medicine and Rehabilitation
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients who received operation for breast cancer
- attended rehabilitation at least once for breast cancer related complications
Exclusion Criteria:
- patients who received rehabilitation for other reasons rather than surgical complications
- patients who are transfered to other hospital for rehabilitation
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
short term rehabilitation
breast cancer survivors that recieved post-OP rehabilitation for equal or less than 300 minutes totally.
|
the type of tumor removal surgery, combined therapy
|
|
long term rehabilitation
breast cancer survivors that recieved post-OP rehabilitation for more than 300 minutes totally.
|
the type of tumor removal surgery, combined therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the rehabilitation time
Time Frame: since the first session of rehabilitation until one year after the last session
|
total post-operation rehabilitation time (minute)
|
since the first session of rehabilitation until one year after the last session
|
Collaborators and Investigators
Investigators
- Study Director: Yuchun Lee, MD, Taichung Veterans General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE21096B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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