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This study investigates the use of digital and standardized documentation by patients of frequently occurring adverse events in oncological therapies.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smartphone-users | Cancer patients who use smartphones |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Documentation of cancer treatment side effects | Other | Standardized documentation of occurred side effects |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Patient acceptance of a new medium of communication | Acceptance of documentation of occurring side effects of oncological therapies with new communication media | 6 months |
| Phase II: Change of occurred adverse events | Changes of side effects by at least 1 degree according to CTCAE scoring in comparison to the study start | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Phase II: Doses of chemotherapy | Maintenance of chemotherapy doses through better adverse event management | 6 months |
| Phase II: Incidence of adverse events | Incidence of treatment-emergent adverse events as assessed by the CTCAE scale |
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Inclusion Criteria:
Exclusion Criteria:
Participants who meet any of the following criteria will be excluded:
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Phase I:
- 30 participants in total non-randomly divided into three age groups (< 55 years, 55-75 years, > 75 years) of 10 people each.
Phase II:
- 36 participants randomly assigned a group of 18 persons (smartphone users, non-smartphone users)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Seufferlein, Prof. Dr. | Contact | +4973150044501 | thomas.seufferlein@uniklinik-ulm.de |
| Name | Affiliation | Role |
|---|---|---|
| Seufferlein | University Hospital Ulm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Ulm | Ulm | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34086740 | Derived | Kestler AMR, Kuhlwein SD, Kraus JM, Schwab JD, Szekely R, Thiam P, Huhne R, Jahn N, Furstberger A, Ikonomi N, Balig J, Schuler R, Kuhn P, Steger F, Seufferlein T, Kestler HA. Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol. PLoS One. 2021 Jun 4;16(6):e0252493. doi: 10.1371/journal.pone.0252493. eCollection 2021. |
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| 6 months |