Breast Cancer Metastatic Clinical Trial
Official title:
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
Evaluation of patient acceptance and characterization of response behaviour for web-based compared with respective paperbacked patient reported outcomes.
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.
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