Investigation and Comparison of Lymphedema Outcome Measurements Validated in Turkish for Assessment of Breast Cancer Related Lymphedema
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Limb volume measurement
研究概览
简要总结
The aim of this study is to investigate and compare responsiveness of current lymphedema assessment scales validated in Turkish.
详细描述
Lymphedema is defined as the excessive and persistent accumulation of fluid, extracellular proteins, and fat in tissue spaces, caused by inefficiency of the lymphatic drainage system. It is a chronic, progressive condition. Several researchers have investigated the influence on health-related quality of life in upper limb lymphedema after breast cancer treatment using patient reported outcome instruments. Responsiveness of only one of the lymphedema assessment scale, ''Lymphedema Quality of Life Inventory'', has been investigated. Responsiveness of lymphedema assessment scales validated in Turkish has not been examined in detail, thereby limiting their use in clinical trials. Therefore, the aim of this study is to investigate and compare responsiveness of current lymphedema assessment scales validated in Turkish. Patients with breast cancer related lymphedema with International Society of Lymphology-ISL lymphedema stage 2,3 will be included in the study and will receive complex decongestive therapy phase I including meticulous skin and nail care, manuel lymphatic drainage, compression bandages, and remedial exercises. All patients will receive manual lymphatic drainage for three times a week (Monday-Wednesday-Friday) during 4 weeks, 50 minutes a day (a total of 12 sessions) by a trained lymphatic massage therapist. Limb volume will be calculated based on truncated cone method from circumference measurements. Patients will complete Lymphedema Life Impact Scale (LLIS), Patient Benefit Index-Lymphedema(PBI), Lymphedema functioning, disability and health questionnaire(Lymph-ICF), European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer (EORTC-QLQ-30) and Short Form 36 (SF-36) before and after treatment. Changes in limb volumes will be compared in changes in scales after treatment. Responsiveness of the subscales will be will be determined by calculating the effect size (change in all patients), standardized mean response (effect size in a group with improvement), and Guyatt's Responsiveness Index.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with unilateral postmastectomy lymphedema with a International Society of Lymphology-ISL) stage 2 and 3
排除标准
- •Bilateral lymphedema
- •The patients who had known systemic edematogenic conditions (e.g., cardiac/hepatic/renal failure, terminal cancer, on chemotherapy), and/or with cancer recurrence
- •Patients with contraindications for application of complex decongestive therapy (active cutaneous infection, deep vein thrombosis, cardiac edema, and peripheral artery disease)
研究组 & 干预措施
Patients with post-mastectomy lymphedema
Patients with breast cancer related lymphedema who will undergo complex decongestive therapy
干预措施: complex decongestive therapy (Other)
结局指标
主要结局
Limb volume measurement
时间窗: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Limb volume will be calculated based on truncated cone method from circumference measurements
次要结局
- Patient Benefit Index-Lymphedema(PBI)(after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1))
- Lymphoedema functioning, disability and health questionnaire(Lymph-ICF)(after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1))
- European Organization for Research and Treatment of Cancer QoL Breast Cancer (EORTC-QLQ-30)(after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1))
- Short Form 36 (SF-36)(after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1))
- Lymphedema Quality of Life Questionnaire-Arm (LYMQOL)(before treatment (T0))
- Lymphedema Quality of Life Questionnaire-Arm(after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1))
- Lymphedema Life Impact Scale (LLIS)(after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1))