C00-C97
Conditions
Interventions
Group 1: SOFIA + Treatment as usual
Group 2: treatment as usual
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: (1) a diagnosis of bladder, lung carcinoma or renal carcinoma, head and neck tumours, Hodgkin's lymphoma, malignant melanoma or MSI high tumours; (2) ECOG 0-1; (3) predicted life expectancy > 3 months; (4) ownership of an Internet-capable end device on which SOFIA can be processed (e.g., smartphone); (5) speak German as mother tongue or have a very good knowledge of the German language; (6) written informed consent.
Exclusion criteria
Exclusion criteria: Exclusion criteria are: (1) participation in other clinical studies; (2) ECOG >1; (3) limited legal capacity or impairment thereof; (4) cognitive or physical impairments that make it difficult to process the online modules (e.g. impaired vision); (5) serious psychiatric or mental illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HRQoL; assessed with the EORTC QLQ C30, Version 3; three measurement points: T0 (at the beginning of the intervention); T1 (at the end of the three months intervention phase); T2 (6 months after the beginning of the study). | — |
Secondary
| Measure | Time frame |
|---|---|
| PHQ9-D, GAD7; NCCN Distress-Barometer, CBI-B-D, SCNS-SF34-D, FAPI; evaluation of the treatment under using SOFIA-Monitoring by the physicians; three measurement points: T0 (at the beginning of the intervention); T1 (at the end of the three months intervention phase); T2 (6 months after the beginning of the study). | — |
Countries
Germany
Contacts
Public ContactChristina Sauer
NCT Heidelberg
Outcome results
None listed