E-Health Portal for Individualized Treatment Monitoring and Patient Engagement in Oncology Research

Study Overview
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Brief Summary
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Evaluation of patient acceptance and characterization of response behaviour for web-based compared with respective paperbacked patient reported outcomes.

Detailed Description
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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.

Official Title
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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

Conditions
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Breast Cancer Metastatic

Intervention / Treatment
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* Other: patient-reported-outcomes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| paper-based patient-reported-outcomes<br> | Other: patient-reported-outcomes<br>* 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<br>|
| on web-based patient-reported-outcomes<br> | Other: patient-reported-outcomes<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QLQ-C30 questionnaire for baseline | Overall patient completion rate in the paperbacked questionnaire and the web-tool, respectively | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All other questionnaires for baseline and follow up time points. | Overall patient completion rate in the paperbacked questionnaire and the web-tool, respectively, | Baseline, 8 weeks | 
| Influence factors for the completion rates | age | 8 weeks | 
| Influence factors for the completion rates | line of treatment | 8 weeks | 
| Influence factors for the completion rates | treatment | 8 weeks | 
| Influence factors for the completion rates | technical skills | 8 weeks | 
| Influence factors for the completion rates | patient's satisfaction | 8 weeks | 
| Adverse events-1 | The date of clinical diagnosis of AE compared with the date of early AE onset | 8 weeks | 
| Adverse events-2 | Consistency of AE documentation ePRO and clinician based | 8 weeks | 
| Patient satisfaction | at baseline, after 4 weeks and after 8 weeks | baseline, 4 weeks, 8 weeks | 
| Health related quality of life (HRQL) assessements -1 | EORTC QLQ C-30 | baseline, 4 weeks, 8 weeks | 
| Health related quality of life (HRQL) assessements -1 | BR23 | baseline, 4 weeks, 8 weeks | 
| Health related quality of life (HRQL) assessements -1 | NCCN distress thermometer, | baseline, 4 weeks, 8 weeks | 
| Health related quality of life (HRQL) assessements -1 | EQ-VAS | baseline, 4 weeks, 8 weeks | 
| Health related quality of life (HRQL) assessements -1 | PHQ-9 | baseline, 4 weeks, 8 weeks | 
| Health related quality of life (HRQL) assessements -2 | The HRQL assessements EQ-5D-5L measured at baseline and weekly (8 weeks) | baseline, 8 weeks | 
| Health related quality of life (HRQL) assessements -2 | The HRQL assessements PROCTCAE Endocrine measured at baseline and weekly (8 weeks) | baseline, 8 weeks | 
| Health related quality of life (HRQL) assessements -2 | The HRQL assessements PROCTCAE taxane measured at baseline and weekly (8 weeks) | baseline, 8 weeks |