The Effect of a Self-Management Lymphedema Education Program on Lymphedema, Lymphedema-Related Symptoms, Patient Compliance, Daily Living Activities and Patient Activation in Patients With Breast Cancer-Related Lymphedema: A Quasi-Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- The Impact of a Lymphedema Management Education Program on Symptoms in Breast Cancer-Related Lymphedema Patients Using Circumferential Measurements and Bioimpedance Spectroscopy (BIS)
研究概览
简要总结
The aim of this pre-test post-test quasi-experimental study is to evaluate the effects of a self-management lymphedema (SML) education program on patient adherence, daily life activities, and patient activation in individuals with breast cancer-related lymphedema (BCRL). This study involves 44 patients diagnosed with BCRL and is conducted at Hacettepe University Oncology Hospital Lymphedema Diagnosis and Treatment Application and Research Center. Upper extremity lymphedema assessments are performed at the beginning of the study, followed by the implementation of a structured SML education program. Participants are monitored for a total of 12 months. Data collection tools include the Personal Information Form, Upper Extremity Lymphedema Diagnosis Form, Adaptation to Chronic Illness Scale, KATZ Daily Living Activities Index, Disability of Arm, Shoulder, and Hand Questionnaire, and Patient Activation Measure.
详细描述
This study focuses on evaluating the potential benefits of a structured self-management lymphedema education program in patients with breast cancer-related lymphedema. It aims to improve patient adherence, activation, and daily life activity levels through a comprehensive education-based intervention.The study was conducted as a master's thesis and has been completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
In our study, single-blinded research was implemented by blinding the researcher. Bilateral upper extremity circumferences of the patients were measured at 10 different points, spaced 4 cm apart from the wrist to the axilla, by an expert nurse other than the researcher. The measurements were recorded with an accuracy of up to 0.1 cm.
During the initial interview with the patients, the researcher completed the scales and forms and then conducted the Lymphedema Management Education Program using an educational booklet developed by the researchers.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Being female,
- •Aged 18 years or older,
- •Having undergone axillary lymph node dissection,
- •Having undergone breast cancer surgery,
- •Diagnosed with lymphedema (stage 1-2),
- •Individuals with no surgical plans during the study period.
排除标准
- •Not diagnosed with lymphedema,
- •Having a medical condition that prevents exercise,
- •Having advanced-stage heart or kidney failure,
- •Patients who refused to participate in the study.
结局指标
主要结局
The Impact of a Lymphedema Management Education Program on Symptoms in Breast Cancer-Related Lymphedema Patients Using Circumferential Measurements and Bioimpedance Spectroscopy (BIS)
时间窗: By the end of the program (after 12 months).
The impact of the Lymphedema Management Education Program will be evaluated on symptoms in breast cancer-related lymphedema patients using circumferential measurements and bioimpedance spectroscopy (BIS). Measurements will involve taking circumferential readings at 4 cm intervals along the arm with a 1-inch retractable tape, and arm volumes will be calculated using the truncated cone formula. BIS will provide L-Dex ratios to identify subclinical (≥6.5) and clinical (≥7) lymphedema through the L-Dex U400® device. Lymphedema severity will be classified based on the Tracey-Volume and Stilwell systems by comparing volume differences between affected and unaffected limbs. Baseline and endpoint measurements will be conducted under standardized conditions by a specialist nurse to ensure accuracy and consistency.
The Impact of a Lymphedema Management Education Program on Patient Compliance Using the Patient Activation Measure (PAM)
时间窗: By the end of the program (after 12 months)
The impact of the Lymphedema Management Education Program on patient compliance will be evaluated using the Patient Activation Measure (PAM).
The Impact of a Lymphedema Management Education Program on Activity Levels Using the Patient Activation Measure (PAM)
时间窗: By the end of the program (after 12 months).
The impact of the Lymphedema Management Education Program on activity levels will be evaluated using the Patient Activation Measure (PAM)
The Impact of a Lymphedema Management Education Program on Activity Levels Using the Daily Living (Katz ADL) Index
时间窗: By the end of the program (after 12 months).
The impact of the Lymphedema Management Education Program on activity levels will be evaluated using the Katz Activities of Daily Living (Katz ADL) Index.
The Impact of a Lymphedema Management Education Program on Independence in Daily Living Activities Using the Katz Activities of Daily Living (Katz ADL) Index
时间窗: By the end of the program (after 12 months).
The measurement of independence in daily tasks (e.g., bathing, dressing) will be conducted using the Katz Activities of Daily Living (Katz ADL) Index.
次要结局
未报告次要终点
研究者
Gizem Cansiz Ucar
Principal Investigator
Hacettepe University