Back to resultsReal-time Interactive Digital Healthcare System in Post Operation Patients With Breast Cancer; Pilot Study
Primary Purpose
Breast Cancer, Rehabilitation
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Uincare
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility Criteria
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
Sites / Locations
- Seoul St Mary's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Uincare
Arm Description
Exercise using Uincare
Outcomes
Primary Outcome Measures
Range of motion of affected shoulder
Evaluation of change of range of motion of the affected shoulder from baseline to 12 weeks
Secondary Outcome Measures
Numerical rating scale of affected shoulder
Evaluation of pain of the affected shoulder using numerical rating scale (0-10, with score 0 indicating no pain)
Functional outcome
Evaluation of shoulder function using Quick DASH
Quality of life of the patient with breast cancer
Evaluation of quality of life using FACT-B
Quality of life of the patient
Evaluation of quality of life using EQ-5D
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04152590
Brief Title
Real-time Interactive Digital Healthcare System in Post Operation Patients With Breast Cancer; Pilot Study
Official Title
Hospital-home Linkage Short-term Rehabilitation Therapy Using Real-time Interactive Digital Healthcare System in Post Operation Patients With Breast Cancer; Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 21, 2019 (Actual)
Primary Completion Date
April 27, 2020 (Actual)
Study Completion Date
April 27, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
JongIn Lee
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Rehabilitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Uincare
Arm Type
Experimental
Arm Description
Exercise using Uincare
Intervention Type
Device
Intervention Name(s)
Uincare
Intervention Description
Interactive digital healthcare system
Primary Outcome Measure Information:
Title
Range of motion of affected shoulder
Description
Evaluation of change of range of motion of the affected shoulder from baseline to 12 weeks
Time Frame
Enrollment, 4 week, 8 week, 12 week
Secondary Outcome Measure Information:
Title
Numerical rating scale of affected shoulder
Description
Evaluation of pain of the affected shoulder using numerical rating scale (0-10, with score 0 indicating no pain)
Time Frame
Enrollment, 4 week, 8 week, 12 week
Title
Functional outcome
Description
Evaluation of shoulder function using Quick DASH
Time Frame
Enrollment, 4 week, 8 week, 12 week
Title
Quality of life of the patient with breast cancer
Description
Evaluation of quality of life using FACT-B
Time Frame
Enrollment, 4 week, 8 week, 12 week
Title
Quality of life of the patient
Description
Evaluation of quality of life using EQ-5D
Time Frame
Enrollment, 4 week, 8 week, 12 week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong In Lee, MD PhD
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul St Mary's Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Real-time Interactive Digital Healthcare System in Post Operation Patients With Breast Cancer; Pilot Study
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