Financial ToxicitySOCOFIN-1NCT06278831
Efficacy of Structured SOcial COnsultation and Support in Reducing the FINancial Burden of Radiotherapy
An observational study of Financial Toxicity, run by University Medical Center Goettingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Financial Toxicity
- What is being tested?
- Questionnaire
- How many people
- 230 participants
- Where
- 1 siteGermany
- Study dates
- 8 Jul 2023to 15 Oct 2024
- 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: All patients who are about to receive radiotherapy due to a malignancy are eligible. They must meet the inclusion criteria.
Who may be able to join
- cancer diagnosis with indication for radiation
- Karnofsky index minimum 70%
- able to consent
- minimum 18 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Göttingen
Göttingen, Lower Saxony, 37075
About this study
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
Read more
Inclusion criteria:
- age ≥ 18 years of age
- indication for radiation treatment of a malignant disease
- Karnofsky Performance score (KPS) ≥ 70%
- Life expectancy ≥ 3 months
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 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
Read the 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).
- Conditions
- Financial Toxicity
- Being tested
- Questionnaire
- Medical subject headings
- Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (4)
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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start8 Jul 2023
- Primary completion3 Jun 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Financial ToxicityStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Goettingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Rami El Shafie, University Medical Center Goettingen
- Investigators
- Rami El Shafie, Prof. Dr., Principal investigator, University Medical Center GoettingenAnna L Kreuser, Study director, University Medical Center Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278831
- Sponsor's protocol ID
- 2023-02645
- Other IDs
- 2023
- Acronym
- SOCOFIN-1
- Status last verified
- Apr 2025
- First submitted
- 23 Jan 2024
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26686042Zafar 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.
PubMed 23442307Bestvina CM, Zullig LL, Rushing C, Chino F, Samsa GP, Altomare I, Tulsky J, Ubel P, Schrag D, Nicolla J, Abernethy AP, Peppercorn J, Zafar SY. Patient-oncologist cost communication, financial distress, and medication adherence. J Oncol Pract. 2014 May;10(3):162-7. doi: 10.1200/JOP.2014.001406.
PubMed 24839274Fenn KM, Evans SB, McCorkle R, DiGiovanna MP, Pusztai L, Sanft T, Hofstatter EW, Killelea BK, Knobf MT, Lannin DR, Abu-Khalaf M, Horowitz NR, Chagpar AB. Impact of financial burden of cancer on survivors' quality of life. J Oncol Pract. 2014 Sep;10(5):332-8. doi: 10.1200/JOP.2013.001322. Epub 2014 May 27.
PubMed 24865220Ramsey 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.
PubMed 26811521
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Structured SOcial COnsultation and Support in Reducing the FINancial Burden of Radiotherapy
- ClinicalTrials.gov ID
- NCT06278831
- Acronym / sponsor ID
- SOCOFIN-1 / 2023-02645
- Conditions
- Financial Toxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University Medical Center GoettingenUniversity, hospital or other
- Study start
- 8 Jul 2023 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 26 Feb 2024 (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.
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:
- age ≥ 18 years of age
- indication for radiation treatment of a malignant disease
- Karnofsky Performance score (KPS) ≥ 70%
- Life expectancy ≥ 3 months
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 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who are about to receive radiotherapy due to a malignancy are eligible. They must meet the inclusion criteria.
Key inclusion criteria (4 listed)
- cancer diagnosis with indication for radiation
- Karnofsky index minimum 70%
- able to consent
- minimum 18 years old
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| QuestionnairePatients 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. | Other | – |
Primary outcome
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 secondary outcomes
Factors that may influence the occurrence or extent of financial burden
Time frame: 4 months
Factors that may influence the occurrence or extent of financial burden
Time frame: 4 months
Factors that may influence the occurrence or extent of financial burden
Time frame: 4 months
Factors that may influence the occurrence or extent of financial burden
Time frame: 4 months
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 4 May 2025.
- Background: PubMed 26686042Huntington 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.
- Background: PubMed 23442307Zafar 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.
- Background: PubMed 24839274Bestvina CM, Zullig LL, Rushing C, Chino F, Samsa GP, Altomare I, Tulsky J, Ubel P, Schrag D, Nicolla J, Abernethy AP, Peppercorn J, Zafar SY. Patient-oncologist cost communication, financial distress, and medication adherence. J Oncol Pract. 2014 May;10(3):162-7. doi: 10.1200/JOP.2014.001406.
- Background: PubMed 24865220Fenn KM, Evans SB, McCorkle R, DiGiovanna MP, Pusztai L, Sanft T, Hofstatter EW, Killelea BK, Knobf MT, Lannin DR, Abu-Khalaf M, Horowitz NR, Chagpar AB. Impact of financial burden of cancer on survivors' quality of life. J Oncol Pract. 2014 Sep;10(5):332-8. doi: 10.1200/JOP.2013.001322. Epub 2014 May 27.
- Background: PubMed 26811521Ramsey 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.
- Individual participant dataSharing planned: Undecided
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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.
Rami El Shafie, Prof. Dr. principal investigator
University Medical Center Goettingen
Anna L Kreuser study director
University Medical Center Goettingen
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 Financial Toxicity, run by University Medical Center Goettingen 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 4 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 4 May 2025. 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?
Financial Toxicity (time frame: 4 months). 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 NCT06278831, which also lists 5 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 4 May 2025.