Effect of a Mobile Application System Using the Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to Improve Patients' Participation in Symptom Management During Cancer Treatment.
试验速览
- 阶段
- 不适用
- 入组人数
- 222
- 试验地点
- 3
- 主要终点
- Patients' participation in symptom management
研究概览
简要总结
This study aims to evaluate the effect of a mobile application system using the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to improve patients' participation in symptom management during cancer treatment. Our hypothesis is that patients who use a mobile application using the PRO-CTCAE will more likely to recognize symptoms due to cancer treatment and report them better to their clinicians than patients who do not use the mobile application.
详细描述
This is a randomized controlled trial to evaluate the effect of a mobile application system using the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to improve patients' participation in symptom management during cancer treatment. Breast, lung, head and neck, esophagus, and gynecologic cancer patients who will begin new lines of chemotherapy or radiation therapy will be randomly assigned into the intervention and control groups (2:1 ratio). The intervention group will have the mobile application installed on their smart phones which they could record symptoms and adverse events due to cancer treatments using the pre-specified PRO-CTCAE questions for different types of cancer. The control group will have usual care. Primary endpoint is patients' participation/engagement of reporting symptoms and it will be evaluated at 8 weeks after the intervention using a questionnaire developed by the research team. Secondary end points are unexpected hospital visits during treatment during 8 weeks after the beginning of the treatment and quality of life at 8 weeks after the intervention.
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
盲法说明
Statistician who will analyze the results of the study will be blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are scheduled to have chemotherapy or radiation therapy.
- •Patients who own a smartphone (Android) and who can use mobile applications.
- •Patients who understand the purpose of this study and agree to participate in the study
- •Patients age over 18 years old (no age limit, but if necessary informed consent of the caregivers will be obtained for the patients whose age are over 70 years old)
排除标准
- •Patients whose life expectancy is less than 6 months (hospice)
- •Patients who would any physical or mental problems that would make them difficult to use the applications
结局指标
主要结局
Patients' participation in symptom management
时间窗: 8 weeks after the intervention
Patients' participation in reporting and managing symptoms due to cancer treatment will be measured using 7 questions developed by study team. Questions will be asked using 4 Likert scale. Minimum value is 0 and maximum value will be 21. Higher score means better outcome.
次要结局
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C-30(8 weeks after the intervention)
- Unexpected visits(8 weeks after the intervention)
研究者
Juhee Cho
Director, Cancer Education Center, Samsung Medical Center
Samsung Medical Center