Efficacy of Structured SOcial COnsultation and Support in Reducing the FINancial Burden of Radiotherapy (SOCOFIN-1)

April 30, 2025 updated by: Prof. Dr. Rami El Shafie, University Medical Center Goettingen

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Niedersachsen
      • Göttingen, Niedersachsen, Germany, 37075
        • University Medical Center Göttingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Financial Toxicity
Time Frame: 4 months
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.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factors that may influence the occurrence or extent of financial burden
Time Frame: 4 months

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)
4 months
Factors that may influence the occurrence or extent of financial burden
Time Frame: 4 months

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
4 months
Factors that may influence the occurrence or extent of financial burden
Time Frame: 4 months

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
4 months
Factors that may influence the occurrence or extent of financial burden
Time Frame: 4 months

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)
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Goettingen

Investigators

  • Principal Investigator: Rami El Shafie, Prof. Dr., University Medical Center Goettingen
  • Study Director: Anna L Kreuser, University Medical Center Goettingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2023

Primary Completion (Actual)

June 3, 2024

Study Completion (Actual)

October 15, 2024

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

February 19, 2024

First Posted (Actual)

February 26, 2024

Study Record Updates

Last Update Posted (Actual)

May 4, 2025

Last Update Submitted That Met QC Criteria

April 30, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-02645

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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