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Completed

NCT Number: NCT07165275

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.

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Key information

Conditions

Breast Cancer Related Lymphedema Breast Cancer Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Sex eligibility

Female

Study type

Observational

Primary location

Samsung Medical Center

Seoul, Republic of Korea, 06351, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. 1. Age

    Time frame: baseline

    Demographic data

    All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.

  2. 2. Sex

    Time frame: baseline

    All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.

  3. 3. Body Mass Index (BMI)

    Time frame: 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. 4. Place of residence

    Time frame: 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. 5. Careers

    Time frame: baseline

    Demographic data Careers: Yes/No

    All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.

  6. 6. Marital status

    Time frame: 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. 7. Number of comorbidities

    Time frame: baseline

    Demographic data

    All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.

  8. 1. Time since breast cancer surgery

    Time frame: baseline

    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.

  9. 2. Breact cancer stage

    Time frame: 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.

  10. 3. Chemotherapy

    Time frame: 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.

  11. 4. Radiotherapy

    Time frame: 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.

  12. 5. Hormone therapy

    Time frame: 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.

  13. 1. Time since lymphedema diagnosis

    Time frame: baseline

    Lymphedema factors (medical records)

    • Time since lymphedema diagnosis : years

    All anonymized clinical data were extracted from medical records in the Clinical Data Warehouse.

  14. 2. Lymphedema in dominant hand

    Time frame: 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.

  15. 3. Lymphedema location

    Time frame: 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.

  16. 4. Complex Decongestive therapy

    Time frame: 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.

  17. 5. perometer

    Time frame: 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.

  18. 1. Physical activity level

    Time frame: baseline

    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.

  19. 2. Lymphedema factors (patient-reported)

    Time frame: 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.

  20. 3. Subjective swelling severity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Sep 10, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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