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

NCT ID: NCT07165275

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-20

Study Completion Date

2025-05-31

Brief Summary

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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

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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

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Breast Cancer Related Lymphedema

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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JiHye Hwang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, Republic of Korea, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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RS-2023-CC139237

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SMC 2024-05-116-001

Identifier Type: -

Identifier Source: org_study_id

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