Breast CancerNCT04152590
Real-time Interactive Digital Healthcare System in Post Operation Patients With Breast Cancer; Pilot Study
A study testing Uincare in people with Breast Cancer and Rehabilitation, run by JongIn Lee at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Rehabilitation
- What is being tested?
- Uincare
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Oct 2019to 27 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Conditions
- Breast Cancer, Rehabilitation
- Being tested
- Uincare
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UincareDevice
Interactive digital healthcare system
| Study group | Role | What they receive |
|---|---|---|
| Uincare | Experimental | Exercise using Uincare Receives: Device: Uincare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion of affected shoulder
Evaluation of change of range of motion of the affected shoulder from baseline to 12 weeks
Measured: Enrollment, 4 week, 8 week, 12 week
Secondary outcomes (4)
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)
Measured: Enrollment, 4 week, 8 week, 12 week
Functional outcome
Evaluation of shoulder function using Quick DASH
Measured: Enrollment, 4 week, 8 week, 12 week
Quality of life of the patient with breast cancer
Evaluation of quality of life using FACT-B
Measured: Enrollment, 4 week, 8 week, 12 week
Quality of life of the patient
Evaluation of quality of life using EQ-5D
Measured: Enrollment, 4 week, 8 week, 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start21 Oct 2019
- Primary completion27 Apr 2020
- Study completion27 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- JongIn Lee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, JongIn Lee, Seoul St. Mary's Hospital
- Investigators
- Jong In Lee, MD PhD, Study chair, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152590
- Sponsor's protocol ID
- KC19EESI0325
- Status last verified
- May 2020
- First submitted
- 31 Oct 2019
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04152590
- Acronym / sponsor ID
- KC19EESI0325
- Conditions
- Breast Cancer, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- JongIn LeeUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 27 Apr 2020 (actual)
- Study completion
- 27 Apr 2020 (actual)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uincare | Experimental | Device: UincareExercise using Uincare |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UincareInteractive digital healthcare system | Device | Uincare |
Primary outcome
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
4 secondary outcomes
Numerical rating scale of affected shoulder
Time frame: Enrollment, 4 week, 8 week, 12 week
Functional outcome
Time frame: 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
Quality of life of the patient
Time frame: Enrollment, 4 week, 8 week, 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong In Lee, MD PhD study chair
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uincare in people with Breast Cancer and Rehabilitation, run by JongIn Lee at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion of affected shoulder (time frame: Enrollment, 4 week, 8 week, 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2020.