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

University Hospital Tuebingen

Status

Completed

Conditions

Breast Cancer Metastatic

Treatments

Other: patient-reported-outcomes

Study type

Observational

Funder types

Other

Identifiers

NCT03132506

Pepper

Details and patient eligibility

About

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

Full 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.

Enrollment

106 patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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