Breast Cancer Related LymphedemaNCT07165275
Factors Associated With Health-related Quality of Life in Patients With Breast Cancer-Related Lymphedema Undergoing Prospective Surveillance
An observational study of Breast Cancer Related Lymphedema, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Breast cancer-related lymphedema (BCRL) is a chronic condition that affects more than 1 in 5 breast cancer survivors. It causes swelling, pain, and reduced arm function, which can significantly impact quality of life. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer Related Lymphedema
- How many people
- 203 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jun 2024to 31 May 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with unilateral upper limb lymphedema related to breast cancer
Who may be able to join
- Patients diagnosed with unilateral upper limb lymphedema related to breast cancer
- Patients who have completed the Lymphedema Quality of Life Questionnaire (LYMQOL)
Who cannot join
- malignant lymphedema
- history of palliative chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Breast cancer-related lymphedema (BCRL) is a chronic condition that affects more than 1 in 5 breast cancer survivors. It causes swelling, pain, and reduced arm function, which can significantly impact quality of life. This study aims to evaluate how breast cancer survivors perceive their swelling, and whether this perception aligns with actual physical measurements. The investigation will examine how this perception gap relates to quality of life. The findings may help inform the development of more personalized care strategies to support both the physical and emotional well-being of women living with BCRL.
Read the detailed description
This study focuses on identifying factors that influence health-related quality of life (HRQoL) in women with breast cancer-related lymphedema (BCRL). Prior studies have shown that the subjective burden of swelling and psychological responses may affect HRQoL more than objective clinical severity. However, the role of perception-objective congruence-whether participants' awareness of swelling matches actual physical measurements-has not been well explored. The investigators will analyze the impact of this perception gap on functional and emotional outcomes. Participants will be grouped based on whether their perception of swelling aligns with objective limb volume measurements. HRQoL differences across these subgroups will be assessed using validated instruments. The goal is to provide evidence that will inform strategies to promote accurate symptom awareness, effective self-management, and better quality of life in BCRL survivors.
- Conditions
- Breast Cancer Related Lymphedema
- Medical subject headings
- Breast Cancer Lymphedema
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphedema Quality of Life Questionnaire (LYMQOL-Arm)
Health Related Quality of Life(HRQoL) was assessed using the Lymphedema Quality of Life Questionnaire(LYMQOL), which comprises four domains: function (three items), appearance (five items), symptoms (six items), and mood (six items), scored on a 4-point Likert scale (1-4; higher scores indicate greater impairment). The domain scores were calculated as the average of the scores for all items within each domain. The LYMQOL also includes a single overall QoL item, which is scored on a scale from 0 (poor) to 10 (excellent)
Measured: baseline
Secondary outcomes (20)
1. Age
Demographic data
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.
Measured: baseline
2. Sex
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.
Measured: baseline
3. Body Mass Index (BMI)
Demographic data Weight and height will be combined to report BMI (kg/m2)
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.
Measured: baseline
4. Place of residence
Demographic data
(1) Metropolitan area, (2) Non- metropolitan area
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.
Measured: baseline
5. Careers
Demographic data Careers: Yes/No
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.
Measured: baseline
6. Marital status
Demographic data (0) Unmarried (Single/Widowed/Divorced), (1) Married
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.
Measured: baseline
7. Number of comorbidities
Demographic data
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.
Measured: baseline
1. Time since breast cancer surgery
data regarding cancer surgery and treatment
- Time since breast cancer surgery : years
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.
Measured: baseline
2. Breact cancer stage
data regarding cancer surgery and treatment Breact cancer stage : AJCC stage
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.
Measured: baseline
3. Chemotherapy
data regarding cancer surgery and treatment 3. Chemotherapy : Yes/No
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.
Measured: baseline
4. Radiotherapy
data regarding cancer surgery and treatment 4. Radiotherapy : Yes/No
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.
Measured: baseline
5. Hormone therapy
data regarding cancer surgery and treatment 5. Hormone therapy : Yes/No
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.
Measured: baseline
1. Time since lymphedema diagnosis
Lymphedema factors (medical records)
- Time since lymphedema diagnosis : years
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.
Measured: baseline
2. Lymphedema in dominant hand
Lymphedema factors (medical records) 2. Lymphedema in dominant hand : Yes/No
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.
Measured: baseline
3. Lymphedema location
Lymphedema factors (medical records) 3. Lymphedema location : Localized/Whole-arm
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.
Measured: baseline
4. Complex Decongestive therapy
Lymphedema factors (medical records) 4. Complex Decongestive therapy : Yes/No
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.
Measured: baseline
5. perometer
Lymphedema factors (medical records) 5. Limb volume was measured by perometer (Perometer®, Pero-System, Germany) : A perometer is a medical device used to measure limb volume accurately and non-invasively. It employs infrared light beams or optoelectronic sensors to scan the circumference of an extremity, such as an arm or leg, and calculates the overall volume based on these measurements. This tool is commonly used to assess swelling in conditions like lymphedema and to monitor changes over time.
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.
Measured: baseline
1. Physical activity level
Lymphedema factors (patient-reported)
- Physical activity level : Patient self-reported physical activity level categorized as limited in activities of daily living, not limited in activities of daily living, or able to participate in sports.
Data collected through questions asked during clinical visits. All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.
Measured: baseline
2. Lymphedema factors (patient-reported)
Lymphedema factors (patient-reported) 2. Self-care adherence : Patient self-reported adherence to wearing compression stockings categorized as not wearing, wearing occasionally, or wearing regularly (including non-prescribed use).
Data collected through questions asked during clinical visits. All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.
Measured: baseline
3. Subjective swelling severity
Lymphedema factors (patient-reported) 3. Subjective swelling severity : Patient-rated swelling severity of the right/left arm on a numeric rating scale from 0 to 10, where 0 indicates no swelling and 10 indicates extremely severe swelling. Higher scores indicate worse
Data collected via a survey asking, "How much do you think your right/left arm is swollen?".
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start20 Jun 2024
- Primary completion31 Aug 2024
- Study completion31 May 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 203 participants (actual)
- Target duration
- 1 Day
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
- NCT07165275
- Sponsor's protocol ID
- SMC 2024-05-116-001
- Other IDs
- RS-2023-CC139237
- Status last verified
- Sep 2025
- First submitted
- 28 Jul 2025
- Last updated
- 10 Sep 2025
- 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 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Health-related Quality of Life in Patients With Breast Cancer-Related Lymphedema Undergoing Prospective Surveillance
- ClinicalTrials.gov ID
- NCT07165275
- Acronym / sponsor ID
- SMC 2024-05-116-001
- Conditions
- Breast Cancer Related Lymphedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 10 Sep 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.
Breast cancer-related lymphedema (BCRL) is a chronic condition that affects more than 1 in 5 breast cancer survivors. It causes swelling, pain, and reduced arm function, which can significantly impact quality of life. This study aims to evaluate how breast cancer survivors perceive their swelling, and whether this perception aligns with actual physical measurements. The investigation will examine how this perception gap relates to quality of life. The findings may help inform the development of more personalized care strategies to support both the physical and emotional well-being of women living with BCRL.
Detailed description
This study focuses on identifying factors that influence health-related quality of life (HRQoL) in women with breast cancer-related lymphedema (BCRL). Prior studies have shown that the subjective burden of swelling and psychological responses may affect HRQoL more than objective clinical severity. However, the role of perception-objective congruence-whether participants' awareness of swelling matches actual physical measurements-has not been well explored. The investigators will analyze the impact of this perception gap on functional and emotional outcomes. Participants will be grouped based on whether their perception of swelling aligns with objective limb volume measurements. HRQoL differences across these subgroups will be assessed using validated instruments. The goal is to provide evidence that will inform strategies to promote accurate symptom awareness, effective self-management, and better quality of life in BCRL survivors.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with unilateral upper limb lymphedema related to breast cancer
Key inclusion criteria (2 listed)
- Patients diagnosed with unilateral upper limb lymphedema related to breast cancer
- Patients who have completed the Lymphedema Quality of Life Questionnaire (LYMQOL)
Key exclusion criteria (2 listed)
- malignant lymphedema
- history of palliative chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lymphedema Quality of Life Questionnaire (LYMQOL-Arm)
Time frame: baseline
Health Related Quality of Life(HRQoL) was assessed using the Lymphedema Quality of Life Questionnaire(LYMQOL), which comprises four domains: function (three items), appearance (five items), symptoms (six items), and mood (six items), scored on a 4-point Likert scale (1-4; higher scores indicate greater impairment). The domain scores were calculated as the average of the scores for all items within each domain. The LYMQOL also includes a single overall QoL item, which is scored on a scale from 0 (poor) to 10 (excellent)
20 secondary outcomes
1. Age
Time frame: baseline
2. Sex
Time frame: baseline
3. Body Mass Index (BMI)
Time frame: baseline
4. Place of residence
Time frame: baseline
5. Careers
Time frame: baseline
6. Marital status
Time frame: baseline
7. Number of comorbidities
Time frame: baseline
1. Time since breast cancer surgery
Time frame: baseline
2. Breact cancer stage
Time frame: baseline
3. Chemotherapy
Time frame: baseline
4. Radiotherapy
Time frame: baseline
5. Hormone therapy
Time frame: baseline
1. Time since lymphedema diagnosis
Time frame: baseline
2. Lymphedema in dominant hand
Time frame: baseline
3. Lymphedema location
Time frame: baseline
4. Complex Decongestive therapy
Time frame: baseline
5. perometer
Time frame: baseline
1. Physical activity level
Time frame: baseline
2. Lymphedema factors (patient-reported)
Time frame: baseline
3. Subjective swelling severity
Time frame: baseline
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 10 Sep 2025.
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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?
An observational study of 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 2 inclusion and 2 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 10 Sep 2025. 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?
Lymphedema Quality of Life Questionnaire (LYMQOL-Arm) (time frame: baseline). 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 10 Sep 2025.