Effect of Lymphedema Prevention Program Based on Theory of Knowledge-attitude-practice on Postoperative Breast Cancer Patients: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Changes in breast cancer-related lymphedema at baseline,9 weeks after surgery,and 18 weeks after surgery
研究概览
简要总结
According to the inclusion and exclusion criteria, a total of 108 patients were enrolled and randomly divided into control group (n = 56) and intervention group (n = 52). The control group received routine nursing, while the intervention group received upper limb lymphedema prevention program for breast cancer patients after surgery. Before surgery, at the third chemotherapy (about 2.1 months after surgery) and the sixth chemotherapy (about 4.2 months after surgery), the self-designed general information questionnaire was used to investigate the patient's basic situation, and the corresponding tools were used to measure the volume of the patient's upper arm, the grip strength of the affected arm, and the range of motion of the affected shoulder joint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Female patients were≥18 years old
- •Pathological puncture confirmed breast cancer with unilateral, no recurrence, and no metastasis
- •Patients with clinical TNM stageⅠ~Ⅲ
- •Patients with proposed surgery and 6 or more chemotherapy
- •The patient was conscious and aware of his condition, with no cognitive impairment or communication problems
排除标准
- •Patients who had cancer other than breast cancer
- •Patients who had history of arm or neck trauma, infection or surgery
- •Patients who had serious diseases such as cardiovascular, cerebrovascular, liver, kidney, etc
- •Patients who had upper limb disability or the affected limb has edema before surgery
- •Patients who had thrombus in the blood vessels of the affected limb
结局指标
主要结局
Changes in breast cancer-related lymphedema at baseline,9 weeks after surgery,and 18 weeks after surgery
时间窗: Baseline-9 weeks after surgery-18 weeks after surgery
Use an inelastic, flexible soft ruler to measure the circumference at 5 positions on the flat wrist crease, 0cm, 10cm, 20cm, 30cm, and 40cm on the wrist crease. The upper limb can be divided into 4 truncated cones, and the measured value is accurate to 0.1 cm. The upper arm volume is calculated using the formula , each h is 10 cm, C1 and C2 are the circumferences next to the two measurement points, and then add up the limb volumes at several positions to get the upper arm volume. According to the International Society of Lymphoma, a volume difference of 10% or more is defined as lymphedema, less than 20% is mild lymphedema, 20% - 40% is moderate lymphedema, and greater than 40% is defined as severe lymphedema. Change(Baseline-9 weeks after surgery-18 weeks after surgery)
次要结局
- Changes in grip strength at baseline,9 weeks after surgery,and 18 weeks after surgery(Baseline-9 weeks after surgery-18 weeks after surgery)
- Change in Arm disability at baseline,9 weeks after surgery,and 18 weeks after surgery(Baseline-9 weeks after surgery-18 weeks after surgery)
- Changes in Shoulder range of motion at baseline,9 weeks after surgery,and 18 weeks after surgery(Baseline-9 weeks after surgery-18 weeks after surgery)
- Change in Quality of life at baseline,9 weeks after surgery,and 18 weeks after surgery(Baseline-9 weeks after surgery-18 weeks after surgery)
研究者
Shi Bohui
Nurse in charge
First Affiliated Hospital Xi'an Jiaotong University