Cancer Patients
Conditions
Brief summary
This study investigates the use of digital and standardized documentation by patients of frequently occurring adverse events in oncological therapies.
Detailed description
This research study is structured as a Phase I and II clinical trial. In phase I, the feasibility of using a smartphone application to document adverse events that have occurred during oncological therapies by the patient will be investigated. In phase II we will investigate whether the use of the smartphone app allows an improvement of patient care by reducing occurred adverse events.
Interventions
OTHERDocumentation of cancer treatment side effects
Standardized documentation of occurred side effects
Sponsors
Thomas Seufferlein
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* infusional combination therapy with at least two chemotherapy substances with or without further targeted therapies * combination of at least two immune-checkpoint inhibitors * able to read and understand German
Exclusion criteria
Participants who meet any of the following criteria will be excluded: * severe neurological disorders * severe psychiatric disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase I: Patient acceptance of a new medium of communication | 6 months | Acceptance of documentation of occurring side effects of oncological therapies with new communication media |
| Phase II: Change of occurred adverse events | 6 months | Changes of side effects by at least 1 degree according to CTCAE scoring in comparison to the study start |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase II: Doses of chemotherapy | 6 months | Maintenance of chemotherapy doses through better adverse event management |
| Phase II: Incidence of adverse events | 6 months | Incidence of treatment-emergent adverse events as assessed by the CTCAE scale |
Countries
Germany
Contacts
Primary ContactThomas Seufferlein, Prof. Dr.
Outcome results
None listed