Clinical trial NCT06278831: Efficacy of Structured SOcial COnsultation and Support in Reducing the FINancial Burden of Radiotherapy
Official title: Efficacy of Structured SOcial COnsultation and Support in Reducing the FINancial Burden of Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Financial Toxicity
Lead sponsor: University Medical Center Goettingen
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who are about to receive radiotherapy due to a malignancy are eligible. They must meet the inclusion criteria.

Brief summary: Objectives:

* Assess the extent of financial burden of patients undergoing radiotherapy
* Identify clinical and socio-economical factors correlated with the occurrence and extent of financial toxicity
* Design a structured social consultation to reduce financial burden induced by radiotherapy

Inclusion criteria:

1. age ≥ 18 years of age
2. indication for radiation treatment of a malignant disease
3. Karnofsky Performance score (KPS) ≥ 70%
4. Life expectancy ≥ 3 months

Exclusion criteria:

1. Inability to provide informed consent
2. Inability to attend study visits and fulfill data collection requirements
3. Simultaneous participation in other studies which could interfere with this study Primary outcome: Financial burden as expressed by the COST score, measured at baseline and 3 months after completion of radiotherapy

Secondary outcomes:

* Socio-Economic factors at baseline
* Health-related quality of life (EORTC QLQ-C30) at baseline and 3 months
* Depression (PHQ-9) at baseline and 3 months
* Coping mechanisms to address financial burden

Primary Endpoint: Influence of secondary outcomes on changes of the primary outcome (COST-Score) between baseline and 3 months.

Secondary Endpoints:

* Changes in the COST-Score over time
* Changes in PHQ-9 over time
* Changes in EORTC QLQ-C30 over time

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

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* cancer diagnosis with indication for radiation
* Karnofsky index minimum 70%
* able to consent
* minimum 18 years old

Exclusion Criteria:

* Inability to provide informed consent
* Inability to attend study visits and fulfill data collection requirements
* Simultaneous participation in other studies which could interfere with this study

Primary outcomes:
measure: Financial Toxicity
timeFrame: 4 months
Secondary outcomes:
measure: Factors that may influence the occurrence or extent of financial burden
timeFrame: 4 months
measure: Factors that may influence the occurrence or extent of financial burden
timeFrame: 4 months
measure: Factors that may influence the occurrence or extent of financial burden
timeFrame: 4 months
measure: Factors that may influence the occurrence or extent of financial burden
timeFrame: 4 months
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University Medical Center Göttingen
state: Niedersachsen
Study officials:
affiliation: University Medical Center Goettingen
name: Rami El Shafie, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Goettingen
name: Anna L Kreuser
role: STUDY_DIRECTOR
References:
citation: Huntington SF, Weiss BM, Vogl DT, Cohen AD, Garfall AL, Mangan PA, Doshi JA, Stadtmauer EA. Financial toxicity in insured patients with multiple myeloma: a cross-sectional pilot study. Lancet Haematol. 2015 Oct;2(10):e408-16. doi: 10.1016/S2352-3026(15)00151-9. Epub 2015 Sep 17.
citation: Zafar SY, Peppercorn JM, Schrag D, Taylor DH, Goetzinger AM, Zhong X, Abernethy AP. The financial toxicity of cancer treatment: a pilot study assessing out-of-pocket expenses and the insured cancer patient's experience. Oncologist. 2013;18(4):381-90. doi: 10.1634/theoncologist.2012-0279. Epub 2013 Feb 26.
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citation: Ramsey SD, Bansal A, Fedorenko CR, Blough DK, Overstreet KA, Shankaran V, Newcomb P. Financial Insolvency as a Risk Factor for Early Mortality Among Patients With Cancer. J Clin Oncol. 2016 Mar 20;34(9):980-6. doi: 10.1200/JCO.2015.64.6620. Epub 2016 Jan 25.