Breast Cancer Related LymphedemaNCT06922513
Clinical Feasibility of Mobile App-Based Self-Management for Breast Cancer-Related Lymphedema
A study testing digital health (Application and Smart Measuring Tape) in people with Breast Cancer Related Lymphedema, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The study evaluates a newly developed service that provides personalized self-management guidance based on evidence-based arm circumference measurements and resulting volume changes. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer Related Lymphedema
- What is being tested?
- digital health (Application and Smart Measuring Tape)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Apr 2025to 21 Oct 2025
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 70 years of age
- Diagnosed with breast cancer-related unilateral upper limb lymphedema
- Possessing an Android or iOS smartphone
- Voluntarily deciding to participate and providing written consent after receiving a detailed explanation of this study
Who cannot join
- Diagnosed with malignant lymphedema due to metastasis or recurrence
- Having severe comorbidities (underlying diseases, neuromusculoskeletal disorders, cognitive, mental, or visual impairments, etc.) that make it difficult to use the application and participate in exercise interventions
- Discontinuation Criteria:
- Development of serious complications or cancer metastasis/recurrence during the study period
- Occurrence of a serious illness unrelated to study participation
- Failure to follow the instructions of the study physician
- Voluntary withdrawal from the study or development of circumstances preventing participation
Trial locations and contacts
1 site in 1 country.
About this study
The study evaluates a newly developed service that provides personalized self-management guidance based on evidence-based arm circumference measurements and resulting volume changes. The research aims to determine whether this digital solution is practical and acceptable for patients while identifying any unexpected challenges during implementation, ultimately establishing its potential for clinical integration into lymphedema care.
- Conditions
- Breast Cancer Related Lymphedema
- Being tested
- digital health (Application and Smart Measuring Tape)
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital health (Application and Smart Measuring Tape)Device
For lymphedema management, we use a smart measuring tape to measure arm circumference and provide analysis results along with self-management strategies.
| Study group | Role | What they receive |
|---|---|---|
| digital health | Experimental | Unilateral Upper Limb Lymphedema Associated with Breast Cancer Receives: Device: digital health (Application and Smart Measuring Tape) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability and Acceptability
Self-Developed Questionnaire A. One item on the necessity of a lymphedema self-management app B. 23 items on satisfaction and acceptability C. Scoring scale: 1 (Strongly Disagree) - 6 (Strongly Agree)
Measured: Baseline, Month 3
SUS
Full Title: System Usability Scale A. A 10-item questionnaire to evaluate system usability B. Score range is 0-100, with a benchmark known to be 68 points Self-developed questionnaire
Measured: Baseline, Month 3
Secondary outcomes (9)
TTM (Transtheoretical Model)
Objective: behavior change stage Scoring System A. Assess health behavior change on a 5-step scale B. (1) Before consideration: No intention to change problem behavior or adopt healthy behavior within the next 6 months, (2) Consideration: No specific plan but plan to take action within the next 6 months, (3) Preparation: Plan to take action within the next 30 days, (4) Action: In progress (less than 6 months), (5) Maintenance: In progress (more than 6 months) C. Check whether the change in the stage has occurred in a positive direction
Measured: Baseline, Month 3
LYMQOL
Full Title: Lymphedema quality of life questionnaire A. A questionnaire to measure the quality of life in patients with arm lymphedema B. Composed of subdomains including function, appearance, symptoms, mood, and quality of life C. Function, appearance, symptoms, and mood are rated on a 1-4 scale where lower scores indicate better quality of life, while quality of life is rated on a 0-10 scale where higher scores indicate better quality of life
Measured: Baseline, Month 3
EQ-5D-5L
Full Title: EuroQol 5-Dimension 5-level Objective: quality of life Scoring System: Each item is evaluated on a 5-point scale and weighted according to the country. EQ VAS evaluates data on a scale of 0-100, with a higher score indicating better health.
Measured: Baseline, Month 3
self-efficacy
Full Title: lymphedema-specific exercise barriers self-efficacy A. Composed of 9 general exercise barriers and 5 lymphedema-related barrier items B. Evaluates how confident one feels about exercising in each situation on a scale from 0% (not confident at all) to 100% (extremely confident) with 10% intervals C. Interpreted as '0-20%=not confident at all, 20-40%=slightly confident, 40-60%=moderately confident, 60-80%=very confident, 80-100%=extremely confident'
Measured: Baseline, Month 3
upper arm use
Self-developed questionnaire A. Level of self-awareness of edema, amount of affected arm use, anxiety about using the affected arm B. Level of self-awareness of edema: 2 items, 0 (not at all) - 10 (very much) scale C. Amount of affected arm use: 1 item, change in arm usage on a -5 to 5 scale D. Anxiety about using the affected arm: 1 item, change in anxiety about arm use on a -5 to 5 scale
Measured: Baseline, Month 3
ICF (International Classification of Functioning, Disability, and Health)
Objective: function, activity and participant, environment Scoring System: A. Assess the 8 items of body functions, 8 items of activities and participation, and 8 items of environmental factors of the breast cancer ICF core set brief B. Body functions are assessed as 0 (no problems) - 4 (extreme problems), 9 (not applicable). Activities and participation are assessed as 0 (no difficulties) - 4 (extreme difficulties), 9 (not applicable). Environment is assessed as 0 (no barriers) - 4 (extreme barriers), +0 (no facilitating factors) - +4 (complete facilitating factors), 9 (not applicable).
Measured: Baseline, Month 3
COPM
Full Title: Canadian Occupational Performance Measure A. A client-centered assessment that identifies and prioritizes everyday problems that limit an individual's participation in daily life across all areas, including self-management, productive activities, and leisure B. Performance and satisfaction for activities selected as important issues are evaluated on a 0-10 scale C. Clinically significant change = 2-point change
Measured: Baseline, Month 3
Smart Measuring Tape
Upper Limb Circumference Measurement
Measured: Baseline, Month 3
Perometer
Optoelectronic Limb Volumeter (Perometer) Upper Limb Volume Measurement
Measured: Baseline, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start11 Apr 2025
- Primary completion21 Oct 2025
- Study completion21 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Related LymphedemaStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JiHye Hwang, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922513
- Sponsor's protocol ID
- SMC 2024-04-011
- Other IDs
- HA23C0423
- Status last verified
- Feb 2026
- First submitted
- 19 Mar 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility of Mobile App-Based Self-Management for Breast Cancer-Related Lymphedema
- ClinicalTrials.gov ID
- NCT06922513
- Acronym / sponsor ID
- SMC 2024-04-011
- Conditions
- Breast Cancer Related Lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 21 Oct 2025 (actual)
- Study completion
- 21 Oct 2025 (actual)
- First posted
- 10 Apr 2025 (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.
The study evaluates a newly developed service that provides personalized self-management guidance based on evidence-based arm circumference measurements and resulting volume changes. The research aims to determine whether this digital solution is practical and acceptable for patients while identifying any unexpected challenges during implementation, ultimately establishing its potential for clinical integration into lymphedema care.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| digital health | Experimental | Device: digital health (Application and Smart Measuring Tape)Unilateral Upper Limb Lymphedema Associated with Breast Cancer |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between 18 and 70 years of age
- Diagnosed with breast cancer-related unilateral upper limb lymphedema
- Possessing an Android or iOS smartphone
- Voluntarily deciding to participate and providing written consent after receiving a detailed explanation of this study
Key exclusion criteria (7 listed)
- Diagnosed with malignant lymphedema due to metastasis or recurrence
- Having severe comorbidities (underlying diseases, neuromusculoskeletal disorders, cognitive, mental, or visual impairments, etc.) that make it difficult to use the application and participate in exercise interventions
- Development of serious complications or cancer metastasis/recurrence during the study period
- Occurrence of a serious illness unrelated to study participation
- Failure to follow the instructions of the study physician
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 |
|---|---|---|
| digital health (Application and Smart Measuring Tape)For lymphedema management, we use a smart measuring tape to measure arm circumference and provide analysis results along with self-management strategies. | Device | digital health |
Primary outcome
Usability and Acceptability
Time frame: Baseline, Month 3
Self-Developed Questionnaire A. One item on the necessity of a lymphedema self-management app B. 23 items on satisfaction and acceptability C. Scoring scale: 1 (Strongly Disagree) - 6 (Strongly Agree)
SUS
Time frame: Baseline, Month 3
Full Title: System Usability Scale A. A 10-item questionnaire to evaluate system usability B. Score range is 0-100, with a benchmark known to be 68 points Self-developed questionnaire
9 secondary outcomes
TTM (Transtheoretical Model)
Time frame: Baseline, Month 3
LYMQOL
Time frame: Baseline, Month 3
EQ-5D-5L
Time frame: Baseline, Month 3
self-efficacy
Time frame: Baseline, Month 3
upper arm use
Time frame: Baseline, Month 3
ICF (International Classification of Functioning, Disability, and Health)
Time frame: Baseline, Month 3
COPM
Time frame: Baseline, Month 3
Smart Measuring Tape
Time frame: Baseline, Month 3
Perometer
Time frame: Baseline, Month 3
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 11 Feb 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital health (Application and Smart Measuring Tape) in people with Breast Cancer Related Lymphedema, run by Samsung Medical Center 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 7 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 11 Feb 2026. 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?
Usability and Acceptability (time frame: Baseline, Month 3). The study lists 2 primary outcomes in all. 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 11 Feb 2026.