Development and Evaluation of the Effectiveness of a Multimedia-based Hormonal Therapy Information Program for Patients With Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Functional Assessment of Cancer Therapy-Prostate (FACT-P)
研究概览
简要总结
This study takes place in the Divisions of Urology. Patients who have only received hormonal therapy will be enrolled. Patients will be randomly sorted into an experimental group and a control group after completing a pretest questionnaire. The experimental group will receive the the multimedia hormone therapy information program once per week for 6 consecutive weeks, while the control group will receive routine care. The follow-up data collections will be completed at 8 and 12 weeks after the pretest. For quantitative measurement, the main variables will be social support, self-efficacy, quality of life, and positive thinking.
详细描述
This study takes place in the Divisions of Urology at Chang Gung Memorial Hospitals. Patients who have only received hormonal therapy will be enrolled. With reference to past research findings, self-efficacy theory, and experts' advice, a multimedia hormone therapy information program was developed. The multimedia hormone therapy information program covered 6 topics, namely the recognition of hormone therapy and multimedia information programs, mindfulness, exercise, stress relief, positive thinking, and prevention or reduction of fatigue. A pilot study will be conducted to check the feasibility of intervention study design and the effectiveness of the program will be tested. Patients will be randomly sorted into an experimental group (multimedia information group, n = 36 to 40) and a control group (routine care group, n = 36 to 40) after completing a pretest questionnaire. The experimental group will receive the multimedia information intervention once per week for 6 consecutive weeks, while the control group will receive routine care. The follow-up data collections will be completed at 8 and 12 weeks after the pretest. For quantitative measurement, the main variables will be social support, self-efficacy, quality of life, positive thinking, and satisfaction with program. Generalized Estimating Equations (GEEs) will be used to o analyze data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patients with prostate cancer who were receiving hormonal therapy
- •patients were at least 20 years old
- •patients were ability to communicate in Chinese or Taiwanese
- •the married partner agrees to study together, or the single patient has a cohabitation partner who agrees to study together.
- •patients or family have a smart phone or tablet and can connect to the Internet.
排除标准
- •having a history of other cancers
- •unknown diagnosis of prostate cancer or unknown disease status
- •patients who received chemotherapy, radiotherapy, radical prostatectomy or other treatments for prostate cancer in the past
- •having history of mental disorder, e.g., phobia, obsessive-compulsive disorder, generalized anxiety, , major depression, mania, manic-depressive psychosis, or dementia
- •the score of Eastern Cooperative Oncology Group performance is ≧ 2
结局指标
主要结局
Functional Assessment of Cancer Therapy-Prostate (FACT-P)
时间窗: 12 weeks after the pretest
A total of 39 items, including five subdimensions, namely, physical well-being, social/family well-being, emotional well-being, functional well-being, and prostate cancer subscales. A 5-point scoring method was adopted. Higher scores indicate higher quality of life
The Positive Thinking Scale
时间窗: 12 weeks after the pretest
A total of 18 items, including two subscales of personal satisfaction and goal pursuit. A five-point (1-5) scoring method was used. Higher scores indicate a higher level of positive thinking
The Hormonal Dimension of The Expanded Prostate Cancer Index Composite
时间窗: 12 weeks after the pretest
11 items were used, the score of each item ranges from 0 to 100 points. Higher scores indicate fewer hormonal symptoms.
次要结局
- The General Self-Efficacy Scale(12 weeks after the pretest)
- The Social Support Scale(12 weeks after the pretest)
研究者
Ching-Hui Chien
RN PhD Associate Professor
National Taipei University of Nursing and Health Sciences