C22.0 C43.9 C18.9 C34.0
Conditions
Interventions
Group 1: Multimodal personalized supportive-program. The intervention/s will be delivered before, during and/or after immunetherapy.
Group 2: Standard care with additional monitoring
Sponsors
Chirurgische Klinik Universitätsmedizin Mannheim Medizinische Fakultät Mannheim Universität Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Patients at age =18 years • Patients scheduled for immunotherapy with checkpoint inhibition for the treatment of solid neoplasm. • Assigned to receive an immunotherapeutic regimen (anti-PD-1/anti PD-L1/anti-CTLA-4 therapy) • Sufficient German language skills • Willing to follow a personalized intervention plan and to take part in the scheduled testing • Written informed consent
Exclusion criteria
Exclusion criteria: • Engaging in systematic intense exercise training (at least 1h twice per week) • Patients unable to give informed consent • Expected lack of compliance • Any physical or mental conditions that would hamper the performance of the training programs or the completion of the study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim is to assess the feasibility of a trimodal prehabilitation program for patients undergoing immune checkpoint inhibitor (ICI) treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Further objectives of the BIRDIE trial include assessment of additional physical performance, oncological and immunological outcomes as well as quality of life (QoL). | — |
Countries
Germany
Contacts
Public ContactSteffen Seyfried
Chirurgische Klinik Universitätsmedizin Mannheim Medizinische Fakultät Mannheim Universität Heidelberg
Outcome results
None listed