Clinical trial · Observational
Financial Effects of a Tumor Disease - Development and Validation of a Patient Reported Outcome Measure in Germany
Financial Effects of a Tumor Disease
NCT05319925CI-TRIAL-00072310FIATcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to develop and to validate a standardised German-language instrument for measuring experienced financial effects of a cancer diagnosis and therapy in a cross-sectional bi-centre study. Obtained data will make the patient-related description of financial difficulties more comprehensible, communicable and addressable in the future, e.g. by offering targeted advisory aids or considering financial effects in health technology assessments.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient reported outcome measure | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Study 1
- description
- Initial examination of the developed questionnaire in the first 100 participants to identify problematic questions and to optimise the instrument. To evaluate test-retest reliability, collected data of the first 100 patients will be used as baseline value and re-assessed in Study 2.
- interventionNames
- Other: Patient reported outcome measure
- label
- Study 2
- description
- Second examination in 300 additional participants and re-assessment in participants from Study 1 (n=400) to validate modified questionnaire in its final form. To evaluate test-retest reliability, data of Study 1 is compared against Study 2 of the same participant sample (n=100).
- interventionNames
- Other: Patient reported outcome measure
Primary outcomes (7)
- measure
- Validation of FIAT questionnaire (pre-version): Distribution analysis
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Any type of historically or cytological confirmed solid cancer or haematological malignancy with an ECOG-Status \<2 and at least two month of cancer related therapy * Patients are treated at the day care unit or ambulances of the NCT Heidelberg or oncological ward B100 at Jena University Hospital Exclusion Criteria: * Patients younger than 18 years old * Patients who refuse or withdraw from informed consent * No sufficient level of German language
References
Publications (3)
- BACKGROUNDPauge S, Surmann B, Mehlis K, Zueger A, Richter L, Menold N, Greiner W, Winkler EC. Patient-Reported Financial Distress in Cancer: A Systematic Review of Risk Factors in Universal Healthcare Systems. Cancers (Basel). 2021 Oct 7;13(19):5015. doi: 10.3390/cancers13195015. PMID 34638499
- DERIVEDPauge S, Zuger A, Richter L, Mathies V, Surmann B, Ernst T, Menold N, Greiner W, Winkler EC, Mehlis K. Towards the assessment of financial distress among cancer patients: a conceptual model of the financial effects of a tumour disease. Support Care Cancer. 2026 Feb 12;34(3):190. doi: 10.1007/s00520-026-10395-6. PMID 41677914
- DERIVEDZuger A, Mathies V, Mehlis K, Pauge S, Richter L, Surmann B, Ernst T, Menold N, Greiner W, Winkler E. Self-reported determinants for subjective financial distress: a qualitative interview study with German cancer patients. BMJ Open. 2025 Jan 28;15(1):e081432. doi: 10.1136/bmjopen-2023-081432. PMID 39880449