Efficacy of Home-based Treatment for Breast Cancer-related Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- the volum of affected arm
研究概览
简要总结
The goal of this clinical trials is to explore the effectiveness of home-based iymphedema treatment and the differences between the home-based and outpatient treatment. The main question is to verify that home-based treatment is as effective as outpatient treatment. We set two groups in this study, comparing the volume of affected upper limb to see if home-based iymphedema treatment is valuable method.
详细描述
Secondary outcome measures:
- Core Quality of Life Questionnaire (EORTC QLQ-C30), It included five functional measures (somatic function, role function, cognitive function, emotional function, social function), three symptom measures (fatigue, pain, nausea and vomiting), six individual measures (dysphagia, loss of appetite, sleep disturbance, constipation, diarrhea, financial hardship), and one patient self-assessment item (total health status).
- Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lymphedema appeared in the upper limb after breast cancer-related treatment, and compared with the healthy side, the edema dimension was more than 2cm.
- •Age 18-75 years old;
- •Edema stage Ⅰ to Ⅱ;
排除标准
- •People with severe cognitive impairment;
- •Bilateral lymphedema;
- •Patients undergoing radiotherapy；
- •Patients with uncontrolled tumors;
- •Congestive heart failure and other comprehensive detumescence treatment contraindicated patients.
研究组 & 干预措施
home-based group
In this group of patients, the therapist conducted standardized comprehensive detumescence treatment at the first treatment which including four steps of skin care, manual lymphatic drainage, low-elastic bandage dressing and functional exercise. After the treatment, videos of manual lymphatic drainage and pressure dressing of family members were provided. Patients or family members were required to perform this treatment at home every day. Video recordings were necessary during treatment at home which were required be sent to the therapist, making sure the session is done every day. They returned to the edema clinic one month later for another evaluation. If patients encounter problems that cannot be solved during home treatment, they should consult online on wechat, or return to the edema clinic in time.
干预措施: Comprehensive detumescence treatment with education video (Other)
outpatient group
Patients were required to go to the lymphedema clinic for comprehensive detumescence treatment, including skin care, manual lymphatic drainage, low-elastic bandaging and functional exercise, 3 to 5 times a week for 1 hour each time. They were re-evaluated after one month of treatment.
干预措施: Comprehensive detumescence treatment (Other)
结局指标
主要结局
the volum of affected arm
时间窗: at the first day and after one month
A soft ruler was used to measure the patient's wrist stripes and 10cm, 20cm, 30cm and 40cm above the wrist stripes, respectively, to obtain the circumference value. The five measurement points can divide the limb into four truncated cones, and then the formula can be used to calculate the volume of each limb segment, in which C1 and C2 are the arm circumference of the upper and lower two points of the measurement segment. h is the length of the measuring section, that is, 10 cm, and the whole limb volume is the sum of the volumes of each section.
次要结局
- Quality of life Core questionnaire scale -- EORTC QLQ-C30(at the first day and after one month)
- Breast Cancer and Lymphedema Symptom Experience Index， BCLE-SEI(at the first day and after one month)