An observational study in Financial Toxicity, sponsored by University Medical Center Goettingen. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-04.
Sponsored by University Medical Center Goettingen · Observational
Objectives:
Inclusion criteria:
Exclusion criteria:
Secondary outcomes:
Primary Endpoint: Influence of secondary outcomes on changes of the primary outcome (COST-Score) between baseline and 3 months.
Secondary Endpoints:
This is an exploratory pilot study. To assess the compliance and effectiveness of the used methods all patients willing to participate in the given time period will be enrolled.
To be assessed for eligibility: n = 300 To be allocated/randomised (if applicable) to trial: n = 150 To be analysed: n = 120
The study is designed as a multicenter longitudinal exploratory study of 150 patients. Further details regarding study timetable, inclusion and exclusion criteria and intervention schedule are explained in the destined subsections of this form.
Data is recorded digitally using an electronic case report forms (eCRF). All data is stored pseudonymized in a REDCap® database.
Before enrolment in register, patients will be informed that participation is voluntary and that they may withdraw at any time without having to give reasons and without penalty or loss of benefits to which the subject is otherwise entitled.
In addition, the subject will be given a "Subject Information Sheet", which contains all the important information in writing.
Findings obtained in the course of the cohort study will be stored on electronic media and treated in strict confidence. For the protection of these data, organisational measures have been taken to prevent disclosure to unauthorised third parties.
Background:
Treatment-related financial burden has become increasingly relevant for patients undergoing cancer treatment. Financial burden can encompass several layers, including diminished household income due to the loss of individual working capacity for the duration of treatment and recovery, but also more immediate aspects like the cost of medication, transportation and other out-of-pocket expenses. Those expenses are often either not covered by insurance or need to be paid in advance and later reimbursed, resulting in considerable short-term financial strain. The different aspects of financial burden and their effect on treatment delivery and outcome are summarized under the term "financial toxicity".
Several studies have assessed the effects of financial toxicity on the quality of treatment, as well as on outcomes. They describe the development of coping mechanisms by patients, which could negatively affect treatment adherence and compromise outcomes. Furthermore, deleterious effects on quality of life have been observed as an effect of financial toxicity.
Most of the published literature on financial toxicity has assessed patients treated in the USA, where the amount of treatment-related out-of-pocket expenses can be substantial, depending on the patient's insurance plan. In this model, the lack of insurance coverage for many costly modern treatments can also be a limiting factor to the treatment options a patient can receive, having considerable effect on outcomes in the general population. On the other hand, financial insolvency or debt for the patient and his next of kin can be a result.
Very limited literature is available on the occurrence and effects of financial toxicity in European countries, and Germany in particular, where health insurance is more inclusive and high out-of-pocket expenses for cancer treatment are less likely. Additionally, available literature focuses mainly on patients undergoing drug treatments and little is known about the situation of patients undergoing radiotherapy.
The current study therefore specifically assesses the occurrence and extent of financial toxicity for German cancer patients undergoing radiotherapy treatment. It aims furthermore to identify diagnosis-related and socio-economic risk-factors that can lead to increased financial toxicity, examines coping mechanisms and assesses the effects on health-related quality of life (HR-QoL).
93 studies on the registry are indexed under Financial Stress; 32 are open to participants now.
This study's enrollment of 230 is below the median of 613 across 37 observational studies indexed under Financial Stress.
Browse Financial Stress studies →University Medical Center Goettingen is the lead sponsor of 61 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients who are about to receive radiotherapy due to a malignancy are eligible. They must meet the inclusion criteria.
Exclusion Criteria:
Patients will be approached three times throughout the study at the beforementioned interview dates to fill out a questionnaire. They will be contacted via e-mail, telephone and/or mobile app.
Financial Toxicity
Measure instrument: Comprehensive Score for financial Toxicity COST score. COST score ranges from 0 (severe) to 44 points (no effect). Primary endpoint: Changes in COST-Score over time. Assessment before radiation therapy, after and 3 months after.
Time frame: 4 months
Factors that may influence the occurrence or extent of financial burden
Influence of secondary outcomes on changes of the primary outcome (COST-Score) between baseline and 3 months. Measure instruments: - Socio-Economic factors at baseline (highest level of education, salary, type of employment, number of people who contribute to earnings in household, migration background)
Time frame: 4 months
Factors that may influence the occurrence or extent of financial burden
Influence of secondary outcomes on changes of the primary outcome (COST-Score) between baseline and 3 months. Measure instruments: - Health-related quality of life (EORTC QLQ-C30) at baseline and 3 months: Quality of Life Questionnaire as a Patient-Reported Outcome (PRO) instrument containing 30 questions resulting in multidimensional scores for oncological patients in over 10 subscales
Time frame: 4 months
Factors that may influence the occurrence or extent of financial burden
Influence of secondary outcomes on changes of the primary outcome (COST-Score) between baseline and 3 months. Measure instruments: - Depression (PHQ-9) at baseline and 3 months: a depressive symptom scale and diagnostic tool to screen adult patients resulting in a score from 0 to 27
Time frame: 4 months
Factors that may influence the occurrence or extent of financial burden
Influence of secondary outcomes on changes of the primary outcome (COST-Score) between baseline and 3 months. Measure instruments: - Coping mechanisms to address financial burden (economizing, using savings, opening a loan, borrowing money from friends, talking to oncologist about money, not taking medication, non-adherence to therapy, missing appointments, changing therapy regime, applying for financial aid)
Time frame: 4 months
Plan to share: Undecided
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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University Medical Center Goettingen