Clinical trial · Observational
E-Health Portal for Individualized Treatment Monitoring and Patient Engagement in Oncology Research
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
NCT03132506CI-TRIAL-00084923completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluation of patient acceptance and characterization of response behaviour for web-based compared with respective paperbacked patient reported outcomes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| patient-reported-outcomes | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- paper-based patient-reported-outcomes
- interventionNames
- Other: patient-reported-outcomes
- label
- on web-based patient-reported-outcomes
- interventionNames
- Other: patient-reported-outcomes
Primary outcomes (1)
- measure
- QLQ-C30 questionnaire for baseline
- timeFrame
- 8 weeks
- description
- Overall patient completion rate in the paperbacked questionnaire and the web-tool, respectively
Secondary outcomes (17)
- measure
- All other questionnaires for baseline and follow up time points.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDWallwiener M, Matthies L, Simoes E, Keilmann L, Hartkopf AD, Sokolov AN, Walter CB, Sickenberger N, Wallwiener S, Feisst M, Gass P, Fasching PA, Lux MP, Wallwiener D, Taran FA, Rom J, Schneeweiss A, Graf J, Brucker SY. Reliability of an e-PRO Tool of EORTC QLQ-C30 for Measurement of Health-Related Quality of Life in Patients With Breast Cancer: Prospective Randomized Trial. J Med Internet Res. 2017 Sep 14;19(9):e322. doi: 10.2196/jmir.8210. PMID 28912116