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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Rehabilitation
• Intervention / Treatment: Device: Uincare

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul St Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Uincare; Exercise using Uincare	Device: Uincare; Interactive digital healthcare system

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: JongIn Lee
• Investigators: Study Chair: Jong In Lee, MD PhD, Seoul St. Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2019
• Primary Completion (Actual): April 27, 2020
• Study Completion (Actual): April 27, 2020

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: KC19EESI0325

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No