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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Samsung Medical Center
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Range of motion in affected shoulder
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
JiHye Hwang
Professor
Samsung Medical Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
Range of motion in affected shoulder
Time Frame: Enrollment, 4 week, 8 week, 12 week
Evaluation of change in range of motion of the affected shoulder from baseline to 12 weeks
Secondary Outcomes
- Quality of life in the patient with breast cancer (1)(Enrollment, 4 week, 8 week, 12 week)
- Quality of life in the patient with breast cancer (2)(Enrollment, 4 week, 8 week, 12 week)
- Functional outcome (Quick Disability of Arm, Shoulder, Hand)(Enrollment, 4 week, 8 week, 12 week)
- Numerical rating scale of affected shoulder(Enrollment, 4 week, 8 week, 12 week)