Investigation of the Effect of Mobile Lymphedema Self-Care Support Program on Self-Care, Quality of Life and Lymphedema-Related Symptoms in Women With Breast Cancer-related Lymphedema: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Change in Lymphedema Symptom Intensity and Distress Survey Score
研究概览
简要总结
The aim of this randomized controlled study is to evaluate the effect of the mobile lymphedema self-care support program on self-care, quality of life and symptoms related to lymphedema in women with breast cancer-related lymphedema.
H1: There is a difference between the Lymphedema Self-Care Scale mean score in women who develop lymphedema due to breast cancer, according to the use of the mobile lymphedema self-care support program.
H2: There is a difference between the Lymphedema Quality of Life Scale average score in women who develop lymphedema due to breast cancer according to the status of using the mobile lymphedema self-care support program.
H4: There is a difference between lymphedema arm circumference measurements according to the use of the mobile lymphedema self-care support program in women who develop lymphedema due to breast cancer.
H5: In women who develop lymphedema due to breast cancer, there is a difference in the situation of experiencing symptoms related to lymphedema according to the use of the mobile lymphedema self-care support program.
详细描述
The content of the mobile program was developed by the researchers. The mobile lymphedema self-care support program content was reviewed by an expert group consisting of doctors, physiotherapists and nurses working with patients with lymphedema. Patients will be contacted via telephone and will be informed about the study, and the experimental and control groups will be selected through the randomization program among the patients who agree to participate in the study and meet the sampling inclusion criteria. Patients were blinded, and blindness will be achieved in the data analysing stage. All measurements will be made to the experimental and control groups at the same time. The standard lymphedema self-care training will be given to the experimental and the control group. And the experimental group will be educated on how to use the mobile program. When the study is completed, the control group will also be allowed to use the mobile program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The patients were blinded and the person responsible for the data analysis will be masked as to the patient grouping for analysis.
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosed as breast cancer-related lymphedema
- •literate,
- •having a smart phone,
- •completed breast cancer treatment at least six months ago
- •volunteering to participate in the study
排除标准
- •having morbid obesity
- •having metastazis
- •having dementia
- •having other psychiatric conditions
- •another health problem that could prevent to exercise
- •not using smart phone
研究组 & 干预措施
mobile programme users
Patients will receive and use Mobile Lymphedema Self-Care Support Program application and will receive standart lymphedema education.
干预措施: standart lymphedema education (Other)
control group
Patients who will receive standart lymphedema education
干预措施: standart lymphedema education (Other)
mobile programme users
Patients will receive and use Mobile Lymphedema Self-Care Support Program application and will receive standart lymphedema education.
干预措施: Mobile Lymphedema Self-Care Support Program (Other)
结局指标
主要结局
Change in Lymphedema Symptom Intensity and Distress Survey Score
时间窗: baseline, 1 month, 3 month
The Turkish version of Lymphedema Symptom Intensity and Distress Survey is valid and reliable. The highest score of the scale is 30 and the lowest score is zero. A high score means experiencing too many symptoms.
Change in Breast Cancer Related Lymphedema Self-Care Scale Score
时间窗: baseline, 1 month, 3 month
The Breast Related Lymphedema Self-Care Scale is valid and reliable tool. The lowest score is 31, the highest score is 124. Higher scores indicate better self-care.
Change in Quality of Life Measure for Limb Lymphedema-Arm Scale Score
时间窗: baseline, 1 month, 3 month
The Quality of Life Measure for Limb Lymphedema-Arm Scale was translated and cross-culturally adapted to Turkish. The highest score of the scale is 80 and the lowest score is 20. A high score indicates poor quality of life.
次要结局
- Change in Arm circumferences(baseline, 1 month, 3 month)
研究者
Zeynep Deveci
Principal Investigator
Dokuz Eylul University