The Effect of E-mobile Education on The Quality of Life in Breast Cancer Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- National Comprehensive Cancer Network (NCCN) Distress Thermometer
研究概览
简要总结
Endocrine hormonal therapy (EHT) applied to avoid recurrence and metastasis of the breast cancer has also side effects which do not threaten life; however, it does negatively effects quality of life. The objective of this study was to determine the effects on quality of life of a mobile app-based (e-mobile) education for supportive care of patients with breast cancer receiving adjuvant endocrine hormonal therapy. The data were collected to with face to face and/or telephone interviews at 2 time points: prior to the initiation (T0) and after the completion (T1) of mobile app-based education. Patients were received education via mobile app for 12 weeks during which they were contacted in every 15 days; a mobile app-based (e-mobile) education was provided, including information about breast cancer definition, treatment process, symptoms management, adequate nutrition, regular physical activity and coping with stress. In this process, the control group patients were provided with standard care.
详细描述
Mobile devices have an increasing role for the patient care and its use in the field of oncology creates promising opportunities for supportive cancer care and patient education. Mobile applications were established for the supportive cancer care but their area of use is limited. Although there are many field specific medical mobile applications, there are few training programs for the benefit of patients. However, these are innovative tools and provide accessibility, individual training and consultancy in order for the patients to be able to cope with side effects of the treatment; thus, improving their quality of life, symptom management and distress.
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, Investigator)
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
- •Diagnosed with primary breast cancer,
- •Non-metastatic,
- •Hormone receptor positive (ER positive and/or PR positive)
- •For whom adjuvant EHT was implemented at least for three months
排除标准
- •Diagnosed with secondary breast cancer,
- •Metastatic,
- •Hormone receptor negative (ER negative and/or PR negative)
研究组 & 干预措施
Receiving mobile app-based education
to receive mobile app-based education on quality of life of women diagnosed with breast cancer implementation of adjuvant endocrine hormonal therapy.
干预措施: receive mobile app-based education (Other)
Standart
not to receive mobile app-based education on quality of life of women diagnosed with breast cancer implementation of adjuvant endocrine hormonal therapy.
结局指标
主要结局
National Comprehensive Cancer Network (NCCN) Distress Thermometer
时间窗: Change from Baseline Distress at 12 weeks
Patients may specify the severity of the distress level they experienced related to their problems, with these numbers, within the course of last 7 days. No distress is specified with "0" point, a severe amount of distress is specified with "10" points.
Functional Assessment for the Cancer Treatment - Endocrine Symptoms Quality of Life Scale (FACT-ES QLS)
时间窗: Change from Baseline Quality of Life at 12 weeks
The scale includes five sub dimensions and total of 46 items measuring the well-being of patients within the course of the last 7 days. There are sub dimensions for each of the following: physical well-being (7 items, 0-28 points), social/family well-being (7 items, 0-28 points), emotional well-being (6 items, 0-24 points), functional well-being (7 items, 0-28 points) and endocrine symptoms (19 items, 0-76 points). Endocrine symptoms' subdimension contains symptoms related to the side effects of EHT. The range of total points of the scale is 0-184. It shows that quality of life increases as total points of the scale increase. It shows that quality of life decreases as total points of the scale decrease.
次要结局
未报告次要终点
研究者
Derya ÇINAR
Asistant Professor
Izmir Bakircay University