Factors Associated With Health-related Quality of Life in Patients With Breast Cancer-Related Lymphedema Undergoing Prospective Surveillance
- Conditions
- Breast Cancer Related Lymphedema
- Registration Number
- NCT07165275
- Lead Sponsor
- Samsung Medical Center
- Brief 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 203
- Patients diagnosed with unilateral upper limb lymphedema related to breast cancer
- Patients who have completed the Lymphedema Quality of Life Questionnaire (LYMQOL)
- malignant lymphedema
- history of palliative chemotherapy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Lymphedema Quality of Life Questionnaire (LYMQOL-Arm) 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)
- Secondary Outcome Measures
Name Time Method 1. Age baseline Demographic data
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.2. Sex baseline All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.
3. Body Mass Index (BMI) baseline 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.4. Place of residence baseline Demographic data
(1) Metropolitan area, (2) Non- metropolitan area
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.5. Careers baseline Demographic data Careers: Yes/No
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.6. Marital status baseline Demographic data (0) Unmarried (Single/Widowed/Divorced), (1) Married
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.7. Number of comorbidities baseline Demographic data
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.1. Time since breast cancer surgery baseline 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.2. Breact cancer stage baseline 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.3. Chemotherapy baseline data regarding cancer surgery and treatment 3. Chemotherapy : Yes/No
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.4. Radiotherapy baseline data regarding cancer surgery and treatment 4. Radiotherapy : Yes/No
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.5. Hormone therapy baseline 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.1. Time since lymphedema diagnosis baseline Lymphedema factors (medical records)
1\. Time since lymphedema diagnosis : years
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.2. Lymphedema in dominant hand baseline 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.3. Lymphedema location baseline Lymphedema factors (medical records) 3. Lymphedema location : Localized/Whole-arm
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.4. Complex Decongestive therapy baseline Lymphedema factors (medical records) 4. Complex Decongestive therapy : Yes/No
All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.5. perometer baseline 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.1. Physical activity level baseline 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.2. Lymphedema factors (patient-reported) baseline 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.3. Subjective swelling severity baseline 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.
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Republic of Korea, South Korea
Samsung Medical Center🇰🇷Seoul, Republic of Korea, South Korea