The Effect of Education, Lymphedema Risk Scoring, and Progressive Upper Extremity Exercises on Strengthening the Self-care Skills of Women Who Have Breast Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- self-care
研究概览
简要总结
In order to prevent lymphedema after breast surgery, patients are advised to know the risk factors for lymphedema and to avoid situations that may cause lymphedema, to perform active and passive arm exercises, to evaluate the affected area for lymphedema, to perform self-care and this should be under the self-management of the patients. Investigators think that this study will have a positive effect on the literature since there are no studies on risk scoring, the combined use of training and exercises to strengthen self-care skills in preventing the development of breast cancer-associated lymphedema. From this point of view, the study was planned as a randomized controlled experiment to examine the effects of preoperative lymphedema scoring and postoperative progressive upper extremity exercises on upper extremity function and self-care in women with breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female gender,
- •Between 18-65 years old
- •BMI ≤30 kg/m2
- •Axillary lymph node dissection (removal of at least 2 lymph nodes),
- •No history of cancer other than breast cancer,
- •Does not have any chronic disease (such as diabetes mellitus, hypertension, chronic obstructive pulmonary disease) that prevents exercise
- •No previous diagnosis of lymphedema,
- •Not pregnant or breastfeeding during the study,
- •Individuals who agree to participate in the study will be included in the study.
排除标准
- •Total (simple) mastectomy,
- •History of bilateral lymph node dissection,
- •Lymphedema (difference >2 cm with an intact extremity)
- •Individuals who do not agree to participate in the study will not be included in the study.
研究组 & 干预措施
Intervention Group
Preoperative: An introductory information form will be filled out, and a lymphedema self-care and exercise booklet will be given.
Postoperative: Patients will be applied Progressive Upper Limb Exercises and Muscle Relaxation Training (PULE-MRT), lymphedema upper extremity circumference measurement, and symptom alert model until discharge, and Muscle Relaxation Training will continue until discharge.
Post-Discharge: They will be asked to record a diary at home. PULE-MRT will continue until day 15. The 15-day exercise program will continue for up to 3 months. Follow-up will be made by telephone according to the symptom alert model at the 1st, 2nd, and 3rd months, and at the end of the 3rd month, the breast cancer-related lymphedema self-care scale will be administered.
干预措施: exercise and training (Other)
Control Group
Preoperative: Introductory information form will be filled out. Postoperative: Standard nursing care will be applied to the patients, lymphedema upper extremity circumference measurement and symptom alert model follow-up form will be applied.
Post-Discharge: Lymphedema upper extremity circumference measurement will be explained to the patients before discharge, and they will be asked to record the 1st, 2nd, and 3rd months at home. Patients will be followed up by telephone according to the symptom alert model at the 1st, 2nd, and 3rd months, and at the end of the 3rd month, the breast cancer-related lymphedema self-care scale will be administered.
结局指标
主要结局
self-care
时间窗: 3rd month
The number of participants with a high self-care score according to the 'Breast Cancer-Related Lymphedema Self-Care Scale'. 'Breast Cancer-Related Lymphedema Self-Care Scale': The lowest 31, the highest 124 points are taken from the scale. Higher scores indicate better self-care.
lymphedema symptom
时间窗: 3rd month
Change from baseline in the number of lymphedema symptoms according to the 'Symptom Warning Model For Lymphedema' at 3-month. 'Symptom Warning Model For Lymphedema':The model consists of 17 symptoms and Yes/No response components. Patients with less than 15% of 17 symptoms are defined as low risk, 15-49% at medium risk, and patients with more than 50% symptoms are defined as high risk.
arm circumference measurement
时间窗: 3nd month
Change from baseline in arm circumference at 3 month. Arm circumference measurement: An increase of 1 cm or more in the circumference of the affected arm compared to the healthy side and an increase of 2 cm or more for late detection of lymphedema indicates the presence of lymphedema.
arm circumference measurement
时间窗: 1st month
Change from baseline in arm circumference at 1 month. Arm circumference measurement:An increase of 1 cm or more in the circumference of the affected arm compared to the healthy side and an increase of 2 cm or more for late detection of lymphedema indicates the presence of lymphedema.
arm circumference measurement
时间窗: 2nd month
Change from baseline in arm circumference at 2 month. Arm circumference measurement: An increase of 1 cm or more in the circumference of the affected arm compared to the healthy side and an increase of 2 cm or more for late detection of lymphedema indicates the presence of lymphedema.
lymphedema symptom
时间窗: 1rd month
Change from baseline in the number of lymphedema symptoms according to the 'Symptom Warning Model For Lymphedema' at 1-month. 'Symptom Warning Model For Lymphedema':The model consists of 17 symptoms and Yes/No response components. Patients with less than 15% of 17 symptoms are defined as low risk, 15-49% at medium risk, and patients with more than 50% symptoms are defined as high risk.
lymphedema symptom
时间窗: 2rd month
Change from baseline in the number of lymphedema symptoms according to the 'Symptom Warning Model For Lymphedema' at 2-month. 'Symptom Warning Model For Lymphedema':The model consists of 17 symptoms and Yes/No response components. Patients with less than 15% of 17 symptoms are defined as low risk, 15-49% at medium risk, and patients with more than 50% symptoms are defined as high risk.
次要结局
未报告次要终点
研究者
Gulseren MARAS
Research Assistant
TC Erciyes University