Financial Effects of a Tumor Disease - Development and Validation of a Patient Reported Outcome Measure in Germany

Study Overview
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Brief Summary
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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.

Detailed Description
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Methods and analysis: 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.

Official Title
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Financial Effects of a Tumor Disease

Conditions
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Cancer

Intervention / Treatment
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* Other: Patient reported outcome measure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study 1<br>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. | Other: Patient reported outcome measure<br>* Newly developed patient-reported instrument to measure financial effects of a cancer diagnosis and therapy of cancer patients in Germany<br>* Other names: FIAT questionnaire;|
| Study 2<br>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). | Other: Patient reported outcome measure<br>* Newly developed patient-reported instrument to measure financial effects of a cancer diagnosis and therapy of cancer patients in Germany<br>* Other names: FIAT questionnaire;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of FIAT questionnaire (pre-version): Distribution analysis | Distribution analyses (correspondence to the normal distribution; skew and excess with evidence for possible ceiling and floor effects) | 4 months | 
| Validation of FIAT questionnaire (pre-version): Factorial validity | Exploratory Factor Analysis (EFA) will be used to analyse the factorial structure of the instrument to investigate which theoretically defined properties of the construct can adequately covered and differentiated with help of single indicators (items and questions). | 4 months | 
| Validation of FIAT questionnaire (pre-version): Reliability | Preliminary assessment of reliability with Guttmans-Lambda | 4 months | 
| Validation of FIAT questionnaire (final version): Distribution analysis | Distribution analyses (correspondence to the normal distribution; skew and excess with evidence for possible ceiling and floor effects) | 5 months | 
| Validation of FIAT questionnaire (final version): Factorial validity | Exploratory Factor Analysis (EFA) and Confirmatory Factor Analysis (CFA) will be used. | 5 months | 
| Validation of FIAT questionnaire (pre-version and final version): Test-retest-reliability | Correlations between the measurements between the first and second survey will be obtained to evaluate test-retest-reliability. | 5 months | 
| Validation of FIAT questionnaire (final version): Test-fairness | Test fairness will be evaluated by means of Multi-Group Confirmatory Factor Analysis (MG-CFA). | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Financial Toxicity, Financial Effects, Patient-reported Outcome, Cancer