Financial Effects of a Tumor Disease - Development and Validation of a Patient Reported Outcome Measure in Germany
NCT ID: NCT05319925
Last Updated: 2023-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
213 participants
OBSERVATIONAL
2022-06-01
2023-07-31
Brief Summary
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Detailed Description
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Phase 1: Construct definition and item generation
Preliminary study:
The preliminary study aims to identify dimensions, topics and risk factors that are relevant for the assessment of financial effects through qualitative interviews with patients, focus group discussions with potential users of a new instrument (social services, HTA-institutions, payers) and a systematic literature review.
Preliminary questionnaire:
In order to derive a pre-final questionnaire, the aim of this part of the study is to define the construct of financial effects and to generate a list of appropriate indicators for measuring financial effects based on the results available from the literature. The pre-final questionnaire will be peer-reviewed by the interdisciplinary project team (oncology/medical ethics, health economics, methods of empirical social research).
Phase 2: Questionnaire Piloting and Validation
Cognitive pre-test:
A cognitive pre-test of the pre-final questionnaire is conducted to examine comprehension of questions and response option and identify any potential problems respondents would have to understand the questions and to respond to them. The results are used in order to further optimize the first draft of the questionnaire.
Quantitative evaluation and validation:
Quantitative evaluation and validation of the developed questionnaire will be performed based on two studies on the target population by determining the distribution parameters of the indicators and their measurement characteristics. In the first study, the pre-final questionnaire will be tested and after adjustment, the final version will be applied in study 2. Participants of the first study (n=100) will be surveyed again within the second study (n=400 participants), while data of the additional participants (n=300) in study 2 will be measured at a single time point.
For validation purposes, additional scales measuring similar and unrelated constructs, as well as criteria (external concepts affected by financial effects) will be included in the questionnaire. Validity will be assessed by subsequent examining of different relationships between the developed instrument and predefined third variables and criteria. Factorial validity will be examined by factor analyses. Furthermore reliability and test-fairness of the instrument will be assessed through further psychometric testing.
Phase 3: Further applicability of the questionnaire To formulate well-founded recommendations for the use of the instrument, a pilot screening program for social services is evaluated through qualitative interviews with representatives of social services and patients regarding practicability of the instrument. A synthesis of all project results will translate into overall recommendations within the clinical and regulatory context.
Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Study 1
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.
Patient reported outcome measure
Newly developed patient-reported instrument to measure financial effects of a cancer diagnosis and therapy of cancer patients in Germany
Study 2
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).
Patient reported outcome measure
Newly developed patient-reported instrument to measure financial effects of a cancer diagnosis and therapy of cancer patients in Germany
Interventions
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Patient reported outcome measure
Newly developed patient-reported instrument to measure financial effects of a cancer diagnosis and therapy of cancer patients in Germany
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 who refuse or withdraw from informed consent
* No sufficient level of German language
18 Years
ALL
No
Sponsors
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Chair of Methods in Empirical Social Research, Institute of Sociology, Technische Universität Dresden
UNKNOWN
Health Economics and Health Care Management, Bielefeld University
UNKNOWN
Haematology and Oncology, University of Jena
UNKNOWN
University Hospital Heidelberg
OTHER
Responsible Party
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Eva Winkler, MD
Prof. Dr. Dr.
Principal Investigators
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Eva C Winkler, Prof. Dr. Dr.
Role: PRINCIPAL_INVESTIGATOR
National Center for Tumor Diseases, University Hospital Heidelberg
Locations
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National Center for Tumor Diseases, University Hospital Heidelberg
Heidelberg, , Germany
Countries
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References
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Pauge 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.
Zuger 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.
Related Links
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Other Identifiers
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70113978
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
S-177/2021
Identifier Type: -
Identifier Source: org_study_id