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

Completed

• Conditions: Breast Cancer Metastatic
• Interventions: Other: patient-reported-outcomes

• Registration Number: NCT03132506
• Lead Sponsor: University Hospital Tuebingen

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.

Study Timeline

• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-28
• Study Start: 2017-06-01
• Primary Completion: 2024-07-17
• Study Completion: 2024-07-17
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 106

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
paper-based patient-reported-outcomes	patient-reported-outcomes	-
on web-based patient-reported-outcomes	patient-reported-outcomes	-

Primary Outcome Measures

Name	Time	Method
QLQ-C30 questionnaire for baseline	8 weeks	Overall patient completion rate in the paperbacked questionnaire and the web-tool, respectively

Secondary Outcome Measures

Name	Time	Method
Influence factors for the completion rates	8 weeks	patient's satisfaction
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,
Adverse events-1	8 weeks	The date of clinical diagnosis of AE compared with the date of early AE onset
Patient satisfaction	baseline, 4 weeks, 8 weeks	at baseline, after 4 weeks and after 8 weeks
Health related quality of life (HRQL) assessements -1	baseline, 4 weeks, 8 weeks	PHQ-9
Adverse events-2	8 weeks	Consistency of AE documentation ePRO and clinician based
Health related quality of life (HRQL) assessements -2	baseline, 8 weeks	The HRQL assessements PROCTCAE taxane measured at baseline and weekly (8 weeks)

Trial Locations

Locations (1)

Department for Women's Health; 🇩🇪 Tübingen, Germany