C61
Conditions
Interventions
Group 1: Daily survey and app-based recording of vital signs (weight, RR, temperature).
- Real-time chat function
- coordination of therapy via individual patient therapy calendar
- Study-specific q
Sponsors
Universitätsklinikum HeidelbergMedizinische Onkologie
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • male patients over 18 years of age • histologically confirmed prostate cancer • indication for the drug treatment of prostate cancer, e.B. with antihormonal therapy, chemotherapy or targeted therapy • an expected observation period of 16 weeks from the start of therapy • Written inform of consent • the patient must have his own privately used smartphone - Android, iOS or tablet • Readiness and sufficient knowledge to be able to use the app • Sufficient German language skills, if possible native language level
Exclusion criteria
Exclusion criteria: • Inability to give written consent to the participation in the study • ECOG > 2 • Severely impaired vision or hearing • Existence of a clinically relevant psychiatric or neurological disorder • Absent of inform of consent for the collection, documentation and evaluation of personal and disease-related data in the electronic database while ensuring all legal data protection regulations • Current participation in another study for which participation in this study is an exclusion criterion (e.B. therapy study) • Study participation in clinically relevant second malignancy at investigator's discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Verification of the feasibility of the "Physician Assistant" app in clinical practice. • Is the app reliably feasible in everyday clinical practice with the available technical resources? • What is the need for human resources on the part of the treatment team? • Can the app be integrated into the clinical treatment context? • What is the adherence of patients to use the app over a period of 16 weeks? | — |
Secondary
| Measure | Time frame |
|---|---|
| • The secondary objective of the study is to obtain initial data on the expansion rate of the expected effects of the intervention required for the sample planning of the follow-up study. • Recording the rate of adverse events of all degrees or serious adverse events (defined as CTCAE >/ = 3°) • Recording the number of unplanned emergency room contacts and hospitalisation rate. • Recording of therapy discontinuations and therapy interruptions • Survival time • Recording of the required procedures for the prophylaxis or therapy of adverse events. • Calculation of the time to contact by the treatment team after entering a critical parameter by the patient • Qualitative and quantitative evaluation of the chat function (consultation events, time) • Depending on the number of "events", initial development of algorithms for the prediction of side effects may be | — |
Countries
Germany
Contacts
Public ContactDirk Jäger
Universitätsklinikum Heidelberg
Outcome results
None listed