Breast CancerNCT04316156
Real-time Interactive Digital Healthcare System in Patients With Breast Cancer; Randomized Controlled Trial
A study testing Uincare Homeplus and Brochure in people with Breast Cancer, run by Samsung Medical Center at 2 sites 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 study. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Uincare Homeplus and Brochure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Apr 2020to 17 Nov 2021
- 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Samsung Medical Center
Seoul, Gangnam-gu, 06351
Department of rehabilitation, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea
Seoul, Seocho-gu, 06591
About this study
Official title: Hospital-home Linkage Short-term Rehabilitation Therapy Using Real-time Interactive Digital Healthcare System in Patients With Breast Cancer; Randomized Controlled Trial, Assessor Blinding, Multi-center 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 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.
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 have difficulty with 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
- Being tested
- Uincare Homeplus, Brochure
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uincare HomeplusDevice
Also called digital healthcare
Interactive digital healthcare system
BrochureOther
Brochure
| Study group | Role | What they receive |
|---|---|---|
| Exercise using Uincare Homeplus | Experimental | Uincare Homeplus Receives: Device: Uincare Homeplus |
| Exercise using brochure | Active comparator | brochure Receives: Other: Brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion in affected shoulder
Evaluation of change in 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 in the affected shoulder using numerical rating scale minimum ~ maximum value: 0 ~ 10, higher scores mean worse outcome.
Measured: Enrollment, 4 week, 8 week, 12 week
Functional outcome (Quick Disability of Arm, Shoulder, Hand)
Evaluation of shoulder function using Quick Disability of Arm, Shoulder, Hand (Quick DASH) ranging from 0 (no disability) to 100 (most severe disability).
Measured: Enrollment, 4 week, 8 week, 12 week
Quality of life in the patient with breast cancer (1)
Evaluation of quality of life using Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) The total FACT-B score ranges from 0 to 123, and is calculated by adding the scores from each of these subscales. Lower scores indicate better health.
Measured: Enrollment, 4 week, 8 week, 12 week
Quality of life in the patient with breast cancer (2)
Evaluation of quality of life using EQ-5D-5L. This scale is numbered from -0.066 to 0.904. lower value means the worst quality of life you can imagine.
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 posted20 Mar 2020
- Study start1 Apr 2020
- Primary completion17 Nov 2021
- Study completion17 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Republic of Korea
- Responsible party
- Principal investigator, JiHye Hwang, Samsung Medical Center
- Investigators
- JIHYE HWANG, Professor, Study chair, Physical & Rehabilitation Medicine Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316156
- Sponsor's protocol ID
- SMC-2019-05-021 (2)
- Status last verified
- Dec 2021
- First submitted
- 18 Mar 2020
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36454316Park 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.
PubMed 34412658
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. 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 Patients With Breast Cancer; Randomized Controlled Trial, Assessor Blinding, Multi-center Study
- ClinicalTrials.gov ID
- NCT04316156
- Acronym / sponsor ID
- SMC-2019-05-021 (2)
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Ministry of Health, Republic of Korea
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 17 Nov 2021 (actual)
- Study completion
- 17 Nov 2021 (actual)
- First posted
- 20 Mar 2020 (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 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.
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 have difficulty with 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise using Uincare Homeplus | Experimental | Device: Uincare HomeplusUincare Homeplus |
| Exercise using brochure | Active comparator | Other: Brochurebrochure |
Who may qualify
- Ages
- 20 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 (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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Uincare HomeplusAlso: digital healthcareInteractive digital healthcare system | Device | Exercise using Uincare Homeplus |
| BrochureBrochure | Other | Exercise using brochure |
Primary outcome
Range of motion in affected shoulder
Time frame: Enrollment, 4 week, 8 week, 12 week
Evaluation of change in 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 (Quick Disability of Arm, Shoulder, Hand)
Time frame: Enrollment, 4 week, 8 week, 12 week
Quality of life in the patient with breast cancer (1)
Time frame: Enrollment, 4 week, 8 week, 12 week
Quality of life in the patient with breast cancer (2)
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 16 Dec 2021.
- Derived from this study: PubMed 36454316Park 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.
- Derived from this study: PubMed 34412658Park 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.
- Individual participant dataSharing planned: Undecided
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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.
JIHYE HWANG, Professor study chair
Physical & Rehabilitation Medicine Samsung Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uincare Homeplus and Brochure in people with Breast Cancer, run by Samsung Medical Center at 2 sites 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 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 in 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?
On the ClinicalTrials.gov record for NCT04316156, which also lists 2 linked publications.
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 16 Dec 2021.