Factors Associated With Health-related Quality of Life in Patients With Breast Cancer-Related Lymphedema Undergoing Prospective Surveillance

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Related Lymphedema

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 Type: Observational
• Enrollment (Actual): 203

Contacts and Locations

Study Locations

• South Korea
  • Republic of Korea
    • Seoul, Republic of Korea, South Korea, 06351
      • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with unilateral upper limb lymphedema related to breast cancer

Description

Inclusion Criteria:

• Patients diagnosed with unilateral upper limb lymphedema related to breast cancer
• Patients who have completed the Lymphedema Quality of Life Questionnaire (LYMQOL)

Exclusion Criteria:

• malignant lymphedema
• history of palliative chemotherapy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Age	Demographic data All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.	baseline
2. Sex	All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.	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.	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.	baseline
5. Careers	Demographic data Careers: Yes/No All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.	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.	baseline
7. Number of comorbidities	Demographic data All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.	baseline
1. Time since breast cancer surgery	data regarding cancer surgery and treatment 1. Time since breast cancer surgery : years All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.	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.	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.	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.	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.	baseline
1. Time since lymphedema diagnosis	Lymphedema factors (medical records) 1. Time since lymphedema diagnosis : years All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.	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.	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.	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.	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.	baseline
1. Physical activity level	Lymphedema factors (patient-reported) 1. 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.	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.	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.	baseline

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2024
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: July 28, 2025
• First Submitted That Met QC Criteria: September 7, 2025
• First Posted (Estimated): September 10, 2025

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 7, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Lymphatic Diseases; Lymphedema; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Breast Cancer Lymphedema
• Other Study ID Numbers: SMC 2024-05-116-001; RS-2023-CC139237 (Other Grant/Funding Number: Ministry of Health & Welfare)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No