The Effect of Education and Telephone Follow-up on Quality of Life and Symptom Management in Patients Receiving Androgen Deprivation Therapy
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
- EORTC QLQ-PR25 Prostate Module
研究概览
简要总结
This study was planned as an experimental design study with pretest-posttest control group in order to determine the effects of education and telephone follow-up given to patients receiving androgen deprivation therapy (ADT) for prostate cancer on quality of life and symptom management.The main question[s] it aims to answer are:
- Is the quality of life higher in patients receiving androgen deprivation therapy who are trained and followed up over the phone compared to patients who are only given an education booklet?
- Is symptom management higher in patients receiving androgen deprivation therapy who received training and followed-up over the phone compared to patients who were only given an education booklet?
详细描述
The number of samples to be taken in each group was determined as 24 (total 48) with the help of the G-power (version 3.1) package program. Considering the possible losses in the research and in order to increase the power of the study, it was planned to carry out the research with a total of 60 people, 30 people in the experimental and control groups.
While evaluating the findings obtained in the study, SPSS (Statistical Package for the Social Sciences) version 25.0 (IBM Corp., Armonk, NY, USA) program will be used for statistical analysis.
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
- Single (Participant)
盲法说明
The participant does not know which group he is in.
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Volunteer to participate in the research,
- •Literate and open to communication,
- •Knowing the diagnosis,
- •Those aged 45 and over,
- •Receiving short-term or long-term ADT treatment,
- •The patient or his/her relatives have telephone access,
排除标准
- •Having a mental or psychiatric illness that prevents communication,
- •Those with vision-hearing problems
结局指标
主要结局
EORTC QLQ-PR25 Prostate Module
时间窗: Through study completion, an average of 3 months
It is a questionnaire to measure quality of life and consisting of 25 items. Prostate Cancer-specific side effects related to surgery, radiotherapy or hormonal therapy that are not in QLQ-C30; voiding problems, bowel functions, sexual status. It consists of two functional (sexual activity and sexual function) and four symptom scales (urinary, intestinal, hormone therapy-related symptoms and incontinence). The score of each item in the scale is evaluated by converting it into a linear range of 0 to 100 points. For each of the 25 questions in the module, there are four options: none (1 point), a little (2 points), quite (3 points), a lot (4 points). A high score from the functional scale indicates a high functional level, and a high score from the symptom scale indicates that the symptoms are experienced intensely.
EORTC QLQ-C30 (Version 3.0) Quality of Life Scale
时间窗: Through study completion, an average of 3 months
It is a questionnaire to measure quality of life which consists of three parts, namely "General Health Status Scale", "Functional Scale", "Symptom Scale" and a total of 30 questions. The last two questions (29,30); provides an assessment of the global quality of life. Each item in the scale is evaluated between 0 and 100 points. For each of the 28 questions in the functional scale and symptom scale, there are four options as none (1 point), a little (2 points), quite (3 points), a lot (4 points). On the general health scale, there are options ranging from very bad to excellent in the range of 1-7 points. Higher values represent a better situation
次要结局
- Weight(3 months)
- Prostate Spesific Antigen (PSA)(3 months)
- The heart rate measurement(3 months)
- The blood pressure measurements(3 months)
- BMI(3 months)
- Glucose level(3 months)
- Height(3 months)
- Waist/Hip circumference measurement(3 months)
研究者
Tuğba Sınmaz
RESEARCH ASSISTANT MSc
Istanbul University - Cerrahpasa (IUC)