Factors Associated With Health-related Quality of Life in Patients With Breast Cancer-Related Lymphedema Undergoing Prospective Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Lymphedema Quality of Life Questionnaire (LYMQOL-Arm)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with unilateral upper limb lymphedema related to breast cancer
- •Patients who have completed the Lymphedema Quality of Life Questionnaire (LYMQOL)
排除标准
- •malignant lymphedema
- •history of palliative chemotherapy
结局指标
主要结局
Lymphedema Quality of Life Questionnaire (LYMQOL-Arm)
时间窗: 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)
次要结局
- 1. Age(baseline)
- 2. Sex(baseline)
- 3. Body Mass Index (BMI)(baseline)
- 4. Place of residence(baseline)
- 5. Careers(baseline)
- 6. Marital status(baseline)
- 7. Number of comorbidities(baseline)
- 1. Time since breast cancer surgery(baseline)
- 2. Breact cancer stage(baseline)
- 3. Chemotherapy(baseline)
- 4. Radiotherapy(baseline)
- 5. Hormone therapy(baseline)
- 1. Time since lymphedema diagnosis(baseline)
- 2. Lymphedema in dominant hand(baseline)
- 3. Lymphedema location(baseline)
- 4. Complex Decongestive therapy(baseline)
- 5. perometer(baseline)
- 1. Physical activity level(baseline)
- 2. Lymphedema factors (patient-reported)(baseline)
- 3. Subjective swelling severity(baseline)
研究者
JiHye Hwang
Professor
Samsung Medical Center