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

NCT ID: NCT04316156

Last Updated: 2021-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2021-11-17

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Range of motion

Study Groups

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Exercise using Uincare Homeplus

Uincare Homeplus

Group Type EXPERIMENTAL

Uincare Homeplus

Intervention Type DEVICE

Interactive digital healthcare system

Exercise using brochure

brochure

Group Type ACTIVE_COMPARATOR

Brochure

Intervention Type OTHER

Brochure

Interventions

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Uincare Homeplus

Interactive digital healthcare system

Intervention Type DEVICE

Brochure

Brochure

Intervention Type OTHER

Other Intervention Names

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digital healthcare

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Republic of Korea

OTHER_GOV

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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JiHye Hwang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JIHYE HWANG, Professor

Role: STUDY_CHAIR

Physical & Rehabilitation Medicine Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, Gangnam-gu, South Korea

Site Status

Department of rehabilitation, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea

Seoul, Seocho-gu, South Korea

Site Status

Countries

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South Korea

References

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Park HY, Nam KE, Lim JY, Yeo SM, Lee JI, Hwang JH. Real-Time Interactive Digital Health Care System for Postoperative Breast Cancer Patients: A Randomized Controlled Trial. Telemed J E Health. 2023 Jul;29(7):1057-1067. doi: 10.1089/tmj.2022.0360. Epub 2022 Nov 29.

Reference Type DERIVED
PMID: 36454316 (View on PubMed)

Park HY, Nam KE, Lim JY, Yeo SM, In Lee J, Hwang JH. Real-time interactive digital healthcare system for post-operative breast cancer patients: study protocol for a randomized controlled trial. Trials. 2021 Aug 19;22(1):549. doi: 10.1186/s13063-021-05535-8.

Reference Type DERIVED
PMID: 34412658 (View on PubMed)

Other Identifiers

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SMC-2019-05-021 (2)

Identifier Type: -

Identifier Source: org_study_id