Factors Affecting Rehabilitation Time for Postoperative Complications Among Breast Cancer Patients

• Conditions: Breast Cancer
• Interventions: Procedure: therapies for breast cancer

• Registration Number: NCT05401877
• Lead Sponsor: Taichung Veterans General Hospital

Brief 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.

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:

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.

Study Timeline

• Study Start: 2021-05-01
• Status Verified: 2022-05
• Study First Submitted: 2022-05-29
• Study First Submitted QC: 2022-05-29
• Last Update Submitted: 2022-05-29
• Study First Posted: 2022-06-02
• Last Update Posted: 2022-06-02
• Primary Completion: 2022-11-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
short term rehabilitation	therapies for breast cancer	breast cancer survivors that recieved post-OP rehabilitation for equal or less than 300 minutes totally.
long term rehabilitation	therapies for breast cancer	breast cancer survivors that recieved post-OP rehabilitation for more than 300 minutes totally.

Primary Outcome Measures

Name	Time	Method
the rehabilitation time	since the first session of rehabilitation until one year after the last session	total post-operation rehabilitation time (minute)

Trial Locations

Locations (1)

Department of Physical Medicine and Rehabilitation; 🇨🇳 Taichung City, Taiwan