The Effect of Mobile-Based Care and Monitoring on Lymphatic Edema Management and Quality of Life in Patients Undergoing Breast Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Functional Assessment Scale in Cancer Treatment (FACT-B):
研究概览
简要总结
There is a lack of synthesized evidence focusing on the design and development of mobile applications targeting the care of patients with breast cancer. This gap will impede understanding of care through mobile applications and hinder digital health intervention strategies that support these patients. Considering the increasing needs of breast cancer patients, the magnitude of care burden, and the widespread use of mobile applications, increased studies are needed to improve care in this population. For this purpose, the mobile application to be developed in the project will include information that patients will need in the perioperative period, preoperative training, exercises to be done in the postoperative period, symptom management, nutrition and lifestyle content. Thus, it is thought that the mobile application will contribute to consultancy and care on issues such as patients' quality of life and symptom management.
详细描述
Type of study: This study was planned as a randomized controlled intervention study to determine the effect of mobile-based care and monitoring on lymphedema management and quality of life in patients undergoing breast surgery.
Place and time of the research: It will be conducted at SANKO University Hospital General Surgery Service, after obtaining the permission of the ethics committee and the institution.
Research Population and sample of the research: Sample calculation In the doctoral thesis titled "The Effect of Mobile-Based Care Support Application on Symptom Management and Quality of Life of Patients Undergoing Breast Cancer Surgery", taking into account the last measurement quality of life score averages of the patients in the experimental and control groups, alpha = 0.05 and power = 0.80. When the calculation was made, the minimum sample size per group was found to be 18. It is recommended to have a minimum of 30 people per group. Randomization will be done using the minimization method.
Randomization:
- Number of radiotherapy sessions: 25-30
- Area where radiotherapy is applied: breast, lymph nodes, clavicle
- There is / is not lymph node metastasis
- Type of lymph node intervention taken: sentinal, axillary
- Number of lymph nodes removed: 10-20, 21-30, 30 and above
- BMI: 18-30, 30 and above
- Reconstruction plan: yes/no
- Surgery type: breast conservation, lymph node resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
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
- •18 years and over,
- •Able to understand and speak Turkish,
- •It is decided to undergo breast-conserving surgery or lymph node dissection,
- •Using any of the social media applications (facebook, whatsapp, instagram)
排除标准
- •Having another health problem (amputation, visible scar, visible physical disability, etc.) that may affect body image
- •Those with speech, hearing and vision problems
- •Having a psychiatric diagnosis
- •Having a disease that restricts the movement of the upper extremity (rheumatological diseases, fracture, health problem that will cause joint restriction, amputation, etc.).
- •Never used the application
- •Study termination criteria;
- •Discontinuation of communication with the patient before the data collection stages are completed
- •Leaving work voluntarily
研究组 & 干预措施
control
Patients in the control group will receive routine clinical care after surgery.
intervention
Patients in the intervention group will use the mobile-based care support application (M-Breast cancer personal care and monitoring system (M-MEKKBİS)) developed within the scope of the research after the surgery.
干预措施: Patients in the intervention group will use the mobile-based care support application (M-Breast cancer personal care and monitoring system (M-MEKKBİS) (Other)
结局指标
主要结局
Functional Assessment Scale in Cancer Treatment (FACT-B):
时间窗: six month
This scale was developed by the "Center on Outcomes, Research, and Education (CORE)" in the USA to determine the quality of life in cancer patients. The Functional Assessment Scale in Cancer Treatment (FACT) has been translated into 52 different languages and has scales for different types of cancer. Functional Assessment in Cancer Treatment-Breast Cancer (FACT-B) quality of life scale is a scale adapted to Turkish by the center that aims to measure the quality of life in breast cancer. Permission to use the scale was received by this center . All of the questions in the physical state sub-dimension and questions 1, 3, 4, 5 and 6 in the emotional state sub-dimension contain negative expressions. The total score of the scale varies between 0-144. The total score of the scale is evaluated in relation to the high quality of life.
次要结局
- Body Image and Sexual Adjustment Scale(six month)
- Lymph Edema Findings Evaluation Form(six month)
- Wound Site Evaluation Form(two month)
研究者
Ebru Karaaslan
research assistant
Sanko University