E-Health Portal for Individualized Treatment Monitoring and Patient Engagement in Oncology Research Focused on Capture of Patient Reported Outcomes with Within PRAEGNANT Study Network
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- QLQ-C30 questionnaire for baseline
研究概览
简要总结
Evaluation of patient acceptance and characterization of response behaviour for web-based compared with respective paperbacked patient reported outcomes.
详细描述
Paperbacked pPRO data from up to a total of 100 patients from the cohort of PRAEGNANT are planned to be included in the Pepper I PRO study. Additionally 200 patients will be recruited in the web based ePRO cohort. The study duration per patient is at least 8 weeks. In cases of stable disease the study duration can be extended to up to 6 months with monthly PRO assessments, according to the attached visit matrix, taking approximately 20 minutes per visit.
The documentation at baseline should be performed during clinical routine with trained study personnel followed by remote self-reporting to minimize the patient effort. Pepper I will be conducted as sub-protocol of the PRAEGNANT trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients enrolled in PRAEGNANT
- •Women aged ≥18 years
- •Patients with the diagnosis metastasized breast cancer undergoing any form of systemic therapy
- •Patients who are willing and able to sign the informed consent form
- •Patients with therapy change
排除标准
- •Patients who are not eligible for observation due to severe comorbidities or unavailability according to the treating physician
- •Patients who are not able to handle a tablet computer or are unable to write
- •Patients who are not able to understand the nature and extent of the trial and the procedures require
结局指标
主要结局
QLQ-C30 questionnaire for baseline
时间窗: 8 weeks
Overall patient completion rate in the paperbacked questionnaire and the web-tool, respectively
次要结局
- Adverse events-2(8 weeks)
- All other questionnaires for baseline and follow up time points.(Baseline, 8 weeks)
- Adverse events-1(8 weeks)
- Patient satisfaction(baseline, 4 weeks, 8 weeks)
- Health related quality of life (HRQL) assessements -1(baseline, 4 weeks, 8 weeks)
- Health related quality of life (HRQL) assessements -2(baseline, 8 weeks)
- Influence factors for the completion rates(8 weeks)