Development and Effectiveness Evaluation of a Self-management Program for Prostate Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Cancer related self-efficacy
研究概览
简要总结
Objectives: This project aims to develop a self-management program for survivors with prostate cancer experiencing urinary incontinence following radical prostatectomy and determine its effectiveness.
Methods: The investigators will develop a self-management program and conduct a study on survivors with prostate cancer experiencing urinary incontinence following radical prostatectomy. And the investigators will test the effectiveness of the self-management program. After completing a pretest, participants will be randomly assigned to the experimental or control group. The self-management group will receive the self-management program for 12 weeks, whereas the information group will receive an information package on a healthy diet. Posttests will be administered 12 and 16 weeks after the pretest. The study variables will include physical symptoms and bothers, cancer-related self-efficacy, social participation, demoralization, and resilience.
详细描述
Objectives: This project aims to develop a self-management program for survivors with prostate cancer experiencing urinary incontinence following radical prostatectomy and determine its effectiveness.
Methods: The investigators will develop a self-management program and conduct a study on survivors with prostate cancer experiencing urinary incontinence following radical prostatectomy. And the investigators will test the effectiveness of the self-management program. After completing a pretest, participants will be randomly assigned to the experimental or control group. The self-management group will receive the self-management program for 12 weeks, whereas the information group will receive an information package on a healthy diet. The self-management program is included a self-management application, a self-management manual, and professional support. The information package consists of a manual on a healthy diet and a multimedia film on a healthy diet. Posttests will be administered 12 and 16 weeks after the pretest. The study variables will include physical symptoms and bothers, cancer-related self-efficacy, social participation, demoralization, and resilience. The statistical analyses will consist of independent sample t-tests, Chi-squire, and generalized estimating equation analysis.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate cancer survivors will include if they fit the following:
- •Received radical prostatectomy and suffering from urinary incontinence for at least one week
- •Eastern Cooperative Oncology Group 0-1 point, able to walk entirely independently
- •Have a smartphone or a tablet with a wireless network
- •Their intimate partner or one of the family members willing to learn together
- •Agreed to participate in the study and completed the informed consent form
排除标准
- •Prostate cancer survivors will be excluded if they had one or more of the following:
- •A request, with the consideration of family members, that the medical team not tell the patient about the diagnosis or condition of the disease
- •A history of psychiatric illness, such as dementia, depression; schizophrenia, or bipolar disorder
- •Suffer from other types of cancer and actively undergoing treatment
研究组 & 干预措施
Self-management group
The experimental group will receive the self-management program for 12 weeks.
干预措施: Self-management program (Behavioral)
Information group
The control group will receive an information package on a healthy diet.
干预措施: Information package (Other)
结局指标
主要结局
Cancer related self-efficacy
时间窗: 16 weeks after the pretest
The Mandarin version of the Cancer Survivors' Self-Efficacy Scale (CSSES) will be used to evaluate the cancer-specific self-efficacy of participants.The total score ranges from 11 to 110; the lower the score, the worse the self-efficacy.
Cancer related self-efficacy
时间窗: Pre-test
The Mandarin version of the Cancer Survivors' Self-Efficacy Scale (CSSES) will be used to evaluate the cancer-specific self-efficacy of participants.The total score ranges from 11 to 110; the lower the score, the worse the self-efficacy.
Cancer related self-efficacy
时间窗: 12 weeks after the pretest
The Mandarin version of the Cancer Survivors' Self-Efficacy Scale (CSSES) will be used to evaluate the cancer-specific self-efficacy of participants.The total score ranges from 11 to 110; the lower the score, the worse the self-efficacy.
次要结局
- Urinary symptoms and bothers(16 weeks after the pretest)
- Social participation(16 weeks after the pretest)
- Demoralization(16 weeks after the pretest)
- Resilience(16 weeks after the pretest)
- Urinary symptoms and bothers(Pre-test)
- Urinary symptoms and bothers(12 weeks after the pretest)
- Social participation(Pre-test)
- Social participation(12 weeks after the pretest)
- Demoralization(Pre-test)
- Demoralization(12 weeks after the pretest)
- Resilience(Pre-test)
- Resilience(12 weeks after the pretest)
研究者
Ching-Hui Chien
RN, PhD, Professor
National Taipei University of Nursing and Health Sciences