Real-time Interactive Digital Healthcare System in Patients With Breast Cancer; Randomized Controlled Trial

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 study. 100 breast cancer patients who underwent axillary lymph node diessection or breast reconstruction following 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 have difficulty with 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 Patients With Breast Cancer; Randomized Controlled Trial, Assessor Blinding, Multi-center Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Uincare Homeplus
* Other: Brochure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who underwent breast cancer surgery (axillary lymph node dissection or breast reconstruction following 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 and 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: 20 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise using Uincare Homeplus<br>Uincare Homeplus | Device: Uincare Homeplus<br>* Interactive digital healthcare system<br>* Other names: digital healthcare;|
| Active Comparator: Exercise using brochure<br>brochure | Other: Brochure<br>* Brochure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion in affected shoulder | Evaluation of change in 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 in the affected shoulder using numerical rating scale minimum   maximum value: 0   10, higher scores mean worse outcome. | Enrollment, 4 week, 8 week, 12 week | 
| Functional outcome (Quick Disability of Arm, Shoulder, Hand) | Evaluation of shoulder function using Quick Disability of Arm, Shoulder, Hand (Quick DASH) ranging from 0 (no disability) to 100 (most severe disability). | Enrollment, 4 week, 8 week, 12 week | 
| Quality of life in the patient with breast cancer (1) | Evaluation of quality of life using Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) The total FACT-B score ranges from 0 to 123, and is calculated by adding the scores from each of these subscales. Lower scores indicate better health. | Enrollment, 4 week, 8 week, 12 week | 
| Quality of life in the patient with breast cancer (2) | Evaluation of quality of life using EQ-5D-5L. This scale is numbered from -0.066 to 0.904. lower value means the worst quality of life you can imagine. | Enrollment, 4 week, 8 week, 12 week |