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

Samsung Medical Center

Status: Completed

Conditions: Breast Cancer

Treatments: Other: Brochure; Device: Uincare Homeplus

Study type: Interventional

Funder types: Other

Identifiers

NCT04316156

SMC-2019-05-021 (2)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Exercise using Uincare Homeplus

Experimental group

Description:

Uincare Homeplus

Treatment:

Device: Uincare Homeplus

Exercise using brochure

Active Comparator group

Description:

brochure

Treatment:

Other: Brochure