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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: Uincare Homeplus; Other: Brochure

• Registration Number: NCT04316156
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study First Submitted: 2020-03-18
• Study First Submitted QC: 2020-03-18
• Study First Posted: 2020-03-20
• Study Start: 2020-04-01
• Primary Completion: 2021-11-17
• Study Completion: 2021-11-17
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-14
• Last Update Posted: 2021-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise using Uincare Homeplus	Uincare Homeplus	Uincare Homeplus
Exercise using brochure	Brochure	brochure

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quality of life in the patient with breast cancer (1)	Enrollment, 4 week, 8 week, 12 week	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.
Quality of life in the patient with breast cancer (2)	Enrollment, 4 week, 8 week, 12 week	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.
Functional outcome (Quick Disability of Arm, Shoulder, Hand)	Enrollment, 4 week, 8 week, 12 week	Evaluation of shoulder function using Quick Disability of Arm, Shoulder, Hand (Quick DASH) ranging from 0 (no disability) to 100 (most severe disability).
Numerical rating scale of affected shoulder	Enrollment, 4 week, 8 week, 12 week	Evaluation of pain in the affected shoulder using numerical rating scale minimum \~ maximum value: 0 \~ 10, higher scores mean worse outcome.

Trial Locations

Locations (2)

Samsung Medical Center; 🇰🇷 Seoul, Gangnam-gu, Korea, Republic of

Department of rehabilitation, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea; 🇰🇷 Seoul, Seocho-gu, Korea, Republic of