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

December 14, 2021 updated by: JiHye Hwang, Samsung Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gangnam-gu
      • Seoul, Gangnam-gu, Korea, Republic of, 06351
        • Samsung Medical Center
    • Seocho-gu
      • Seoul, Seocho-gu, Korea, Republic of, 06591
        • Department of rehabilitation, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 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 (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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise using Uincare Homeplus
Uincare Homeplus
Device: Uincare Homeplus
Interactive digital healthcare system
Other Names:
  • digital healthcare
Active Comparator: Exercise using brochure
brochure
Other: Brochure
Brochure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion in affected shoulder
Time Frame: Enrollment, 4 week, 8 week, 12 week
Evaluation of change in 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
Time Frame: 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.
Enrollment, 4 week, 8 week, 12 week
Functional outcome (Quick Disability of Arm, Shoulder, Hand)
Time Frame: 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).
Enrollment, 4 week, 8 week, 12 week
Quality of life in the patient with breast cancer (1)
Time Frame: 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.
Enrollment, 4 week, 8 week, 12 week
Quality of life in the patient with breast cancer (2)
Time Frame: 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.
Enrollment, 4 week, 8 week, 12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Ministry of Health, Republic of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

November 17, 2021

Study Completion (Actual)

November 17, 2021

Study Registration Dates

First Submitted

March 18, 2020

First Submitted That Met QC Criteria

March 18, 2020

First Posted (Actual)

March 20, 2020

Study Record Updates

Last Update Posted (Actual)

December 16, 2021

Last Update Submitted That Met QC Criteria

December 14, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC-2019-05-021 (2)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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