Clinical trial NCT03132506: E-Health Portal for Individualized Treatment Monitoring and Patient Engagement in Oncology Research
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Metastatic
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Germany
name: Department of Gynecology and Obstetrics, University Hospital Heidelberg, Germany
name: Department of Gynecology and Obstetrics, University Hospital Erlangen, Germany
First posted: 2017-04-28
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patient population for the paperbased PRO capture is part of the PRAEGNANT study population and shall comprize 100 patients, we aim to collect additional web based ePRO datasets for 200 patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: QLQ-C30 questionnaire for baseline
timeFrame: 8 weeks
Secondary outcomes:
measure: All other questionnaires for baseline and follow up time points.
timeFrame: Baseline, 8 weeks
measure: Influence factors for the completion rates
timeFrame: 8 weeks
measure: Influence factors for the completion rates
timeFrame: 8 weeks
measure: Influence factors for the completion rates
timeFrame: 8 weeks
measure: Influence factors for the completion rates
timeFrame: 8 weeks
measure: Influence factors for the completion rates
timeFrame: 8 weeks
measure: Adverse events-1
timeFrame: 8 weeks
measure: Adverse events-2
timeFrame: 8 weeks
measure: Patient satisfaction
timeFrame: baseline, 4 weeks, 8 weeks
measure: Health related quality of life (HRQL) assessements -1
timeFrame: baseline, 4 weeks, 8 weeks
measure: Health related quality of life (HRQL) assessements -1
timeFrame: baseline, 4 weeks, 8 weeks
measure: Health related quality of life (HRQL) assessements -1
timeFrame: baseline, 4 weeks, 8 weeks
measure: Health related quality of life (HRQL) assessements -1
timeFrame: baseline, 4 weeks, 8 weeks
measure: Health related quality of life (HRQL) assessements -1
timeFrame: baseline, 4 weeks, 8 weeks
measure: Health related quality of life (HRQL) assessements -2
timeFrame: baseline, 8 weeks
measure: Health related quality of life (HRQL) assessements -2
timeFrame: baseline, 8 weeks
measure: Health related quality of life (HRQL) assessements -2
timeFrame: baseline, 8 weeks
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Department for Women's Health
Study officials:
References:
citation: Wallwiener 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.