Real-time Interactive Digital Healthcare System in Post Operation Patients With Breast Cancer; Pilot Study
May 27, 2020 updated by: JongIn Lee
Hospital-home Linkage Short-term Rehabilitation Therapy Using Real-time Interactive Digital Healthcare System in Post Operation Patients With Breast Cancer; Pilot 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 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.
Study Overview
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 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.
Study Type
Interventional
Enrollment (Actual)
20
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
-
-
-
Seoul, Korea, Republic of
- Seoul St Mary's Hospital
-
-
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
30 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 (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
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Uincare
Exercise using Uincare
|
Interactive digital healthcare system
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of motion of affected shoulder
Time Frame: Enrollment, 4 week, 8 week, 12 week
|
Evaluation of change of 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 of the affected shoulder using numerical rating scale (0-10, with score 0 indicating no pain)
|
Enrollment, 4 week, 8 week, 12 week
|
|
Functional outcome
Time Frame: Enrollment, 4 week, 8 week, 12 week
|
Evaluation of shoulder function using Quick DASH
|
Enrollment, 4 week, 8 week, 12 week
|
|
Quality of life of the patient with breast cancer
Time Frame: Enrollment, 4 week, 8 week, 12 week
|
Evaluation of quality of life using FACT-B
|
Enrollment, 4 week, 8 week, 12 week
|
|
Quality of life of the patient
Time Frame: Enrollment, 4 week, 8 week, 12 week
|
Evaluation of quality of life using EQ-5D
|
Enrollment, 4 week, 8 week, 12 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Jong In Lee, MD PhD, Seoul St. Mary's Hospital
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)
October 21, 2019
Primary Completion (Actual)
April 27, 2020
Study Completion (Actual)
April 27, 2020
Study Registration Dates
First Submitted
October 31, 2019
First Submitted That Met QC Criteria
November 4, 2019
First Posted (Actual)
November 5, 2019
Study Record Updates
Last Update Posted (Actual)
May 28, 2020
Last Update Submitted That Met QC Criteria
May 27, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KC19EESI0325
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.