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

Financial Effects of a Tumor Disease

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Patient reported outcome measure

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 213

Contacts and Locations

• Study Contact: Name: Eva C. Winkler, Prof. Dr. Dr.; Phone Number: 004962215637216; Email: eva.winkler@med.uni-heidelberg.de

Study Locations

• Germany
  • Heidelberg, Germany
    • National Center for Tumor Diseases, University Hospital Heidelberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with all types of cancer who have undergone at least two months of cancer related therapy with an ECOG Status < 2, who are treated at the day care unit and ambulances of the NCT Heidelberg or conservative day care unit and oncological ward B100, Jena University Hospital.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: 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 Names: FIAT questionnaire
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).	Other: 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 Names: FIAT questionnaire

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg
• Collaborators: Health Economics and Health Care Management, Bielefeld University; Chair of Methods in Empirical Social Research, Institute of Sociology, Technische Universität Dresden; Haematology and Oncology, University of Jena
• Investigators: Principal Investigator: Eva C Winkler, Prof. Dr. Dr., National Center for Tumor Diseases, University Hospital Heidelberg

Publications and helpful links

General Publications

• 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.

Helpful Links

• project description

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Cancer; Financial Toxicity; Financial Effects; Patient-reported Outcome
• Other Study ID Numbers: S-177/2021; 70113978 (Other Grant/Funding Number: German Cancer Aid)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No