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

NCT07165275 | Completed

• 2 other identifiers: SMC 2024-05-116-001RS-2023-CC139237
• Study Type: observational
• Target: 203
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Related Lymphedema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• 1. Age

  baseline

• 2. Sex

  baseline

• 3. Body Mass Index (BMI)

  baseline

• 4. Place of residence

  baseline

• 5. Careers

  baseline

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with unilateral upper limb lymphedema related to breast cancer

You may qualify if:

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

You may not qualify if:

• malignant lymphedema
• history of palliative chemotherapy

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Republic of Korea, 06351, South Korea

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: September 10, 2025
• Study Start: June 20, 2024
• Primary Completion: August 31, 2024
• Study Completion: May 31, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

KR (1)