Factors Affecting Rehabilitation Time for Postoperative Complications Among Breast Cancer Patients

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: therapies for breast cancer

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 Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Taiwan
  • Taiwan
    • Taichung, Taiwan, Taiwan, 40705
      • Department of Physical Medicine and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients that are registered at the case management system of Taichung Vetetans General Hospital

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

Number of groups / cohorts

2

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.	Procedure: therapies for breast cancer; 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.	Procedure: therapies for breast cancer; 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	total post-operation rehabilitation time (minute)	since the first session of rehabilitation until one year after the last session

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital
• Investigators: Study Director: Yuchun Lee, MD, Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: May 29, 2022
• First Submitted That Met QC Criteria: May 29, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: breast cancer; rehabilitation
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Therapeutics
• Other Study ID Numbers: CE21096B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No