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临床试验/NCT05303675
NCT05303675已完成不适用

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

Gulseren MARAS2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年4月18日最近更新:
适应症

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
2
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

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.

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.

次要结局

未报告次要终点

研究者

发起方
Gulseren MARAS
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gulseren MARAS

Research Assistant

TC Erciyes University

研究点 (2)

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