Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06278831
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-01-23
Brief Title:
Efficacy of Structured SOcial COnsultation and Support in Reducing the FINancial Burden of Radiotherapy
Sponsor:
University Medical Center Goettingen
Organization:
University Medical Center Goettingen
Study Overview
Official Title:
Efficacy of Structured SOcial COnsultation and Support in Reducing the FINancial Burden of Radiotherapy
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOCOFIN-1
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 allocatedrandomised if applicable to trial n 150 To be analysed n 120
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 allocatedrandomised 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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None