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

NCT05319925 | Completed

• 2 other identifiers: S-177/202170113978
• Study Type: observational
• Target: 213
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cancer

Keywords

Financial Toxicity; Financial Effects; Patient-reported Outcome; Cancer

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

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

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

Interventions

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

Also known as: FIAT questionnaire

Study 1; Study 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients younger than 18 years old
• Patients who refuse or withdraw from informed consent
• No sufficient level of German language

Sponsors & Collaborators

• University Hospital Heidelberg: lead
• Chair of Methods in Empirical Social Research, Institute of Sociology, Technische Universität Dresden: collaborator
• Health Economics and Health Care Management, Bielefeld University: collaborator
• Haematology and Oncology, University of Jena: collaborator

Study Sites (1)

National Center for Tumor Diseases, University Hospital Heidelberg

Heidelberg, Germany

Location

Related Publications (2)

• 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.

  PMID: 34638499 BACKGROUND

• 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.

  PMID: 39880449 DERIVED

Related Links

• project description

MeSH Terms

Conditions

Neoplasms; Financial Stress

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Eva C Winkler, Prof. Dr. Dr.

  National Center for Tumor Diseases, University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Dr.

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: April 11, 2022
• Study Start: June 1, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Locations

DE (1)