CancerFIATNCT05319925
Financial Effects of a Tumor Disease - Development and Validation of a Patient Reported Outcome Measure in Germany
An observational study of Cancer, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Patient reported outcome measure
- How many people
- 213 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2022to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients younger than 18 years old
- Patients who refuse or withdraw from informed consent
- No sufficient level of German language
Trial locations and contacts
1 site in 1 country.
Germany1 site
National Center for Tumor Diseases, University Hospital Heidelberg
Heidelberg
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Patient reported outcome measure
- Keywords
- Financial Toxicity, Financial Effects, Patient-reported Outcome, Cancer
- Medical subject headings
- Neoplasms, Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient reported outcome measureOther
Also called FIAT questionnaire
Newly developed patient-reported instrument to measure financial effects of a cancer diagnosis and therapy of cancer patients in Germany
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Patient reported outcome measure | |
| 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). Receives: Other: Patient reported outcome measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 4 months
Validation of FIAT questionnaire (pre-version): Reliability
Preliminary assessment of reliability with Guttmans-Lambda
Measured: 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)
Measured: 5 months
Validation of FIAT questionnaire (final version): Factorial validity
Exploratory Factor Analysis (EFA) and Confirmatory Factor Analysis (CFA) will be used.
Measured: 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.
Measured: 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).
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start1 Jun 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or 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
- Responsible party
- Principal investigator, Eva Winkler, MD, University Hospital Heidelberg
- Investigators
- Eva C Winkler, Prof. Dr. Dr., Principal investigator, National Center for Tumor Diseases, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319925
- Sponsor's protocol ID
- S-177/2021
- Other IDs
- 70113978
- Acronym
- FIAT
- Status last verified
- Dec 2023
- First submitted
- 8 Feb 2022
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34638499Pauge 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.
PubMed 41677914Zuger 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.
PubMed 39880449
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial Effects of a Tumor Disease
- ClinicalTrials.gov ID
- NCT05319925
- Acronym / sponsor ID
- FIAT / S-177/2021
- Conditions
- Cancer
- Keywords
- Financial Toxicity, Financial Effects, Patient-reported Outcome, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or 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
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study 1 | – | Other: Patient reported outcome measureInitial 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. |
| Study 2 | – | Other: Patient reported outcome measureSecond 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Patients younger than 18 years old
- Patients who refuse or withdraw from informed consent
- No sufficient level of German language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient reported outcome measureAlso: FIAT questionnaireNewly developed patient-reported instrument to measure financial effects of a cancer diagnosis and therapy of cancer patients in Germany | Other | Study 1, Study 2 |
Primary outcome
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)
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).
Validation of FIAT questionnaire (pre-version): Reliability
Time frame: 4 months
Preliminary assessment of reliability with Guttmans-Lambda
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)
Validation of FIAT questionnaire (final version): Factorial validity
Time frame: 5 months
Exploratory Factor Analysis (EFA) and Confirmatory Factor Analysis (CFA) will be used.
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Background: PubMed 34638499Pauge 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.
- Derived from this study: PubMed 41677914Pauge 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.
- Derived from this study: PubMed 39880449Zuger 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.
- project descriptionLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva C Winkler, Prof. Dr. Dr. principal investigator
National Center for Tumor Diseases, University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of FIAT questionnaire (pre-version): Distribution analysis (time frame: 4 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05319925, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.