Real-time Interactive Digital Healthcare System in Post Operation Patients With Breast Cancer; Pilot Study

Study Overview
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Brief Summary
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This study aims to examine the effect of hospital-home linkage short-term rehabilitation therapy using real-time interactive digital healthcare system (Uincare Homeplus) in post-operative patients with breast cancer. This is prospective pilot study. 20 breast cancer patients who underwent wide local excision-axillary lymph node diessection or modified radical mastectomy will be examined, and those with limited range of motion (ROM) of affected shoulder will be enrolled in the study. Shoulder ROM, Quick-DASH, pain evaluation with NRS, quality of life evaluation with FACT-B and EQ-5D will be evaluated on enrollment, 4-week, 8-week, and 12-weeks after enrollment.

Detailed Description
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The limited range of motion (ROM) of the shoulder occur often after receiving breast cancer surgery, which may be due to post-operative pain, stiffness of shoulder girdle muscle, and etc. Due to this limited ROM, the patients may suffer difficulty in activities of daily life and quality of life may be reduced. Uincare Homeplus is software manufactured in Korea, which uses infrared, kinect camera and motion capture technology to track 3D motion of the patients' articulation. Using this technology, the patients can receive feedback of their motion immediately. The objective of the study is to examine the effect of hospital-home linkage short-term rehabilitation therapy using real-time interactive digital healthcare system (Uincare Homeplus) in post-operative patients with breast cancer.

Official Title
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Hospital-home Linkage Short-term Rehabilitation Therapy Using Real-time Interactive Digital Healthcare System in Post Operation Patients With Breast Cancer; Pilot Study

Conditions
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Breast Cancer, Rehabilitation

Intervention / Treatment
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* Device: Uincare


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who underwent breast cancer surgery (wide local excision-axillary lymph node dissection or modified radical mastectomy) Limited active/passive range of motion of the affected shoulder (Flexion <160' or Abduction <160') post-operative day not exceeding 8 week Patients who agreed informed consent Exclusion Criteria: Bilateral breast cancer surgery Patients with shoulder pain of limited ROM before breast cancer surgery Those unable to perform exercise due to general deconditioning Those with communication difficulty

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Uincare<br>Exercise using Uincare | Device: Uincare<br>* Interactive digital healthcare system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion of affected shoulder | Evaluation of change of range of motion of the affected shoulder from baseline to 12 weeks | Enrollment, 4 week, 8 week, 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical rating scale of affected shoulder | Evaluation of pain of the affected shoulder using numerical rating scale (0-10, with score 0 indicating no pain) | Enrollment, 4 week, 8 week, 12 week | 
| Functional outcome | Evaluation of shoulder function using Quick DASH | Enrollment, 4 week, 8 week, 12 week | 
| Quality of life of the patient with breast cancer | Evaluation of quality of life using FACT-B | Enrollment, 4 week, 8 week, 12 week | 
| Quality of life of the patient | Evaluation of quality of life using EQ-5D | Enrollment, 4 week, 8 week, 12 week |