NCT04316156

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2021

Completed
Last Updated

December 16, 2021

Status Verified

December 1, 2021

Enrollment Period

1.6 years

First QC Date

March 18, 2020

Last Update Submit

December 14, 2021

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Numerical rating scale of affected shoulder

    Enrollment, 4 week, 8 week, 12 week

  • Functional outcome (Quick Disability of Arm, Shoulder, Hand)

    Enrollment, 4 week, 8 week, 12 week

  • Quality of life in the patient with breast cancer (1)

    Enrollment, 4 week, 8 week, 12 week

  • Quality of life in the patient with breast cancer (2)

    Enrollment, 4 week, 8 week, 12 week

Study Arms (2)

Exercise using Uincare Homeplus

EXPERIMENTAL

Uincare Homeplus

Device: Uincare Homeplus

Exercise using brochure

ACTIVE COMPARATOR

brochure

Other: Brochure

Interventions

Uincare HomeplusDEVICE

Interactive digital healthcare system

Also known as: digital healthcare
Exercise using Uincare Homeplus
BrochureOTHER

Brochure

Exercise using brochure

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

Location

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

Seoul, Seocho-gu, 06591, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 36454316DERIVED

  • 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.

    PMID: 34412658DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • JIHYE HWANG, Professor

    Physical & Rehabilitation Medicine Samsung Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Range of motion
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 18, 2020

First Posted

March 20, 2020

Study Start

April 1, 2020

Primary Completion

November 17, 2021

Study Completion

November 17, 2021

Last Updated

December 16, 2021

Record last verified: 2021-12

Locations

KR(2)