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

NCT ID: NCT04152590

Last Updated: 2020-05-28

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-21

Study Completion Date

2020-04-27

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 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.

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 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.

Conditions

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Breast Cancer Rehabilitation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Uincare

Exercise using Uincare

Group Type EXPERIMENTAL

Uincare

Intervention Type DEVICE

Interactive digital healthcare system

Interventions

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Uincare

Interactive digital healthcare system

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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JongIn Lee

OTHER

Sponsor Role lead

Responsible Party

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JongIn Lee

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jong In Lee, MD PhD

Role: STUDY_CHAIR

Seoul St. Mary's Hospital

Locations

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Seoul St Mary's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KC19EESI0325

Identifier Type: -

Identifier Source: org_study_id

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