Breast Cancer Metastatic
Conditions
Brief summary
Evaluation of patient acceptance and characterization of response behaviour for web-based compared with respective paperbacked patient reported outcomes.
Detailed description
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.
Interventions
OTHERpatient-reported-outcomes
Explorative pilot study combining collected data from the PRAEGNANT study on paper-based patient-reported-outcomes with additional collected data on web-based patient-reported-outcomes
Sponsors
National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Germany
Department of Gynecology and Obstetrics, University Hospital Heidelberg, Germany
Department of Gynecology and Obstetrics, University Hospital Erlangen, Germany
University Hospital Tuebingen
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QLQ-C30 questionnaire for baseline | 8 weeks | Overall patient completion rate in the paperbacked questionnaire and the web-tool, respectively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Influence factors for the completion rates | 8 weeks | age |
| Adverse events-1 | 8 weeks | The date of clinical diagnosis of AE compared with the date of early AE onset |
| Adverse events-2 | 8 weeks | Consistency of AE documentation ePRO and clinician based |
| All other questionnaires for baseline and follow up time points. | Baseline, 8 weeks | Overall patient completion rate in the paperbacked questionnaire and the web-tool, respectively, |
| Health related quality of life (HRQL) assessements -1 | baseline, 4 weeks, 8 weeks | EORTC QLQ C-30 |
| Health related quality of life (HRQL) assessements -2 | baseline, 8 weeks | The HRQL assessements EQ-5D-5L measured at baseline and weekly (8 weeks) |
| Patient satisfaction | baseline, 4 weeks, 8 weeks | at baseline, after 4 weeks and after 8 weeks |
Countries
Germany
Outcome results
None listed