Efficacy of an Interactive Web-based Self-management Support Intervention on Health Outcomes in Patients With Colorectal Cancer: A Mixed-methods Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Change of Functional Assessment of Cancer Therapy- Colorectal
研究概览
简要总结
The study aims to test the efficacy of a web-based interactive self-management support intervention on the primary outcome, quality of life, secondary outcomes, symptom distress, emotional distress, physical activity, and the mediation effects of self-efficacy, and supportive care needs in colorectal cancer patients.
详细描述
Colorectal cancer is the most commonly diagnosed cancer in Taiwan. With proper treatments, most patients can be long-term survivors. However, patients often suffered long-term consequences of the disease and its treatment side effects. In addition, unhealthy lifestyles will further impact on patient's prognosis and quality of life. Face-to-face or web-based self-management support interventions can help colorectal cancer patients to achieve a healthy lifestyle and better adjustment. However, they are costly and may not be assessable for a certain population. Therefore, it is necessary to develop the most cost-effective interventions for patients with colorectal cancer.
Aim: The study aims is to test the efficacy of a web-based interactive self-management support intervention on the primary outcome, quality of life, and secondary outcomes, symptom distress, emotional distress, physical activity, nutrition intake, and the mediation effects of self-efficacy, social support, and supportive care needs in colorectal cancer patients.
Design: A multi-center randomized six-month follow-up parallel-group superiority design will be used to test the intervention efficacy. A convenient sample of 160 post-operative colorectal cancer patients (stage I-III) will be recruited and randomized to the control or intervention group. Outcome variables will be assessed on the baseline, 2nd, 4th, and 6th month in both groups.
Instruments: The study instruments include Cancer Behavior Inventory-Brief Version, 34-item Supportive Care Needs Survey, M.D. Anderson Symptom Inventory, The Center for Epidemiologic Studies Depression Scale, International Physical Activity Questionnaire, and FACT-C.
Data analysis: Descriptive analysis will be used to describe patients' demographics, disease variables, and outcome variables. The Chi-square, t-test, and Linear Mixed Model will be used to test the efficacy of the study interventions.
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
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with colorectal cancer (ICD-10 code: C18-C20, C21.8)
- •Received curative surgery with one month
- •Cancer stage I-III
- •Age between 20 to 75
- •Have an access to the internet at home
排除标准
- •Diagnosed with severe psychological diseases or having a poor mental state preventing cooperate with research measures
- •Not able to communicate verbally or with writing
结局指标
主要结局
Change of Functional Assessment of Cancer Therapy- Colorectal
时间窗: Change from Baseline to 2, 4, and 6 months
There are two subscales, 27 items of FACT-General and 9 items of Colorectal Cancer Subscale. Each item is rated on a 5-point Likert scale (0-4). The total score of the 36 items represents the score of the scale. The possible score for the scale ranges from 0 to 136. The higher values represent better quality of life.
次要结局
- M.D. Anderson Symptom Inventory(Baseline, 2, 4, and 6 months)
- Cancer Behavior Inventory-Brief Version(Change from Baseline to 6 months)
- Supportive Care Needs Survey(Baseline, 2, 4, and 6 months)
- International Physical Activity Questionnaire(Baseline, 2, 4, and 6 months)
研究者
Tsae Jyy, Wang
Director, School of Nursing, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan
National Taipei University of Nursing and Health Sciences