C15 C16 C17 C18 C19 C20 C21 C22 C23 C24 C25
Conditions
Interventions
Group 1: One cycle of systemic chemotherapy with VR glasses followed by one cycle of systemic chemotherapy without VR glasses
Group 2: One cycle of systemic chemotherapy without VR glasses followed by
Sponsors
Universitätsklinik Essen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Inclusion criteria: ? Patients who are capable of giving consent =18 years ? Signed written consent form ? Oncological disease ? Indication for systemic intravenous chemotherapy ? Mentally and physically capable of participating in the study procedures as assessed by the investigator.
Exclusion criteria
Exclusion criteria: • Exclusion criteria: ? Contraindications against the use of VR glasses as assessed by the investigator, e.g., known seizure disorder, uncontrolled cerebral metastasis ? Participation in another interventional clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint - Feasibility • Number of patients for whom the use of VR glasses for the pre-defined period (30 minutes) is feasible. • The use is considered feasible if the period of 30 minutes could be maintained in 80% of patients. • Co-primary endpoint – Reduction of anxiety/depression • Reduction of the severity of anxious/depressive symptoms through the use of VR glasses during the application of systemic chemotherapy measured by the German version of the HADS-D self-assessment form each time after the administration of therapy • A reduction of 3 points in the validated HADS-D score is considered a significant improvement of anxious/depressive symptoms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint - Recording of therapy-associated side effects • The therapy-associated side effects are recorded using the "patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE®) questionnaire. • Recording before the start of therapy, after completion of therapy, 2 days after the application of therapy and at follow-up presentation. Secondary endpoint - Recording of vital parameters • Recording of blood pressure and heart rate before the start of therapy and after 30 minutes. Secondary endpoint - Recording of patient satisfaction with the use of the VR glasses • Recording by the "Player Experience Inventory - PXI" questionnaire (German version) after the end of the VR glasses use. Secondary endpoint - Recording of further supportive measures • Recording of the ingested antiemetic and analgesic supportive medication by the patient's diary. | — |
Countries
Germany
Contacts
Public ContactStefan Kasper-Virchow
Universitätsklinik Essen
Outcome results
None listed