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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04316156
• Other study ID #: SMC-2019-05-021 (2)
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: November 17, 2021

Study information

• Verified date: December 2021
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 17, 2021
• Est. primary completion date: November 17, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Uincare Homeplus
Interactive digital healthcare system

Other:
• Brochure
Brochure

Locations

Country	Name	City	State
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	Samsung Medical Center	Seoul	Gangnam-gu

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Ministry of Health, Republic of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of motion in affected shoulder	Evaluation of change in range of motion of the affected shoulder from baseline to 12 weeks	Enrollment, 4 week, 8 week, 12 week
Secondary	Numerical rating scale of affected shoulder	Evaluation of pain in the affected shoulder using numerical rating scale minimum ~ maximum value: 0 ~ 10, higher scores mean worse outcome.	Enrollment, 4 week, 8 week, 12 week
Secondary	Functional outcome (Quick Disability of Arm, Shoulder, Hand)	Evaluation of shoulder function using Quick Disability of Arm, Shoulder, Hand (Quick DASH) ranging from 0 (no disability) to 100 (most severe disability).	Enrollment, 4 week, 8 week, 12 week
Secondary	Quality of life in the patient with breast cancer (1)	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.	Enrollment, 4 week, 8 week, 12 week
Secondary	Quality of life in the patient with breast cancer (2)	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.	Enrollment, 4 week, 8 week, 12 week