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OpenTrials
Completed

NCT Number: NCT05401877

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.

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Key information

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Physical Medicine and Rehabilitation

Taichung, Taiwan, 40705

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

therapies for breast cancer

Procedure

the type of tumor removal surgery, combined therapy

Primary outcomes

  1. the rehabilitation time

    Time frame: since the first session of rehabilitation until one year after the last session

    total post-operation rehabilitation time (minute)

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 2, 2022
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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