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

Not Applicable

Completed

• Conditions: Breast Cancer; Rehabilitation
• Interventions: Device: Uincare

• Registration Number: NCT04152590
• Lead Sponsor: JongIn Lee

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 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

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.

Study Timeline

• Study Start: 2019-10-21
• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-11-04
• Study First Posted: 2019-11-05
• Primary Completion: 2020-04-27
• Study Completion: 2020-04-27
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-27
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Uincare	Uincare	Exercise using Uincare

Primary Outcome Measures

Name	Time	Method
Range of motion of affected shoulder	Enrollment, 4 week, 8 week, 12 week	Evaluation of change of range of motion of the affected shoulder from baseline to 12 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul St Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of