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Completed

NCT Number: NCT05319925

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

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.

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Key information

Conditions

Cancer Behavior Behavioral Symptoms Financial Stress Neoplasms Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Center for Tumor Diseases, University Hospital Heidelberg

Heidelberg, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient reported outcome measure

Other

Newly developed patient-reported instrument to measure financial effects of a cancer diagnosis and therapy of cancer patients in Germany

Other names: FIAT questionnaire

Primary outcomes

  1. Validation of FIAT questionnaire (pre-version): Distribution analysis

    Time frame: 4 months

    Distribution analyses (correspondence to the normal distribution; skew and excess with evidence for possible ceiling and floor effects)

  2. Validation of FIAT questionnaire (pre-version): Factorial validity

    Time frame: 4 months

    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).

  3. Validation of FIAT questionnaire (pre-version): Reliability

    Time frame: 4 months

    Preliminary assessment of reliability with Guttmans-Lambda

  4. Validation of FIAT questionnaire (final version): Distribution analysis

    Time frame: 5 months

    Distribution analyses (correspondence to the normal distribution; skew and excess with evidence for possible ceiling and floor effects)

  5. Validation of FIAT questionnaire (final version): Factorial validity

    Time frame: 5 months

    Exploratory Factor Analysis (EFA) and Confirmatory Factor Analysis (CFA) will be used.

  6. Validation of FIAT questionnaire (pre-version and final version): Test-retest-reliability

    Time frame: 5 months

    Correlations between the measurements between the first and second survey will be obtained to evaluate test-retest-reliability.

  7. Validation of FIAT questionnaire (final version): Test-fairness

    Time frame: 5 months

    Test fairness will be evaluated by means of Multi-Group Confirmatory Factor Analysis (MG-CFA).

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Collaborators

  • Chair of Methods in Empirical Social Research, Institute of Sociology, Technische Universität Dresden
  • Health Economics and Health Care Management, Bielefeld University
  • University of Jena

Registry information

Official study title

Financial Effects of a Tumor Disease

Acronym: FIAT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 11, 2022
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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