Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06630962
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Evaluating the Impact of Financial Navigation on Financial Catastrophe and Distress for Cancer Care
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating the Impact of Financial Navigation on Financial Catastrophe and Distress for Cancer Care A Randomized Control Trial- COST-FIN
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COST-FIN
Brief Summary:
The goal of this study is to investigate the effectiveness of a structured financial navigation program in reducing financial catastrophe and financial distress for cancer patients in Nigeria
The main study questions being investigated are
1 If a financial navigation program can effectively and significantly reduce financial catastrophe and distress for cancer patients in Nigeria
2 If a financial navigation program is financially sustainable and cost-effective for cancer centers in Nigeria
Participants will be required to
1 Complete surveys about their demographics clinical history and socioeconomic status
2 Complete questionnaires about their quality of life and psychological wellbeing
3 Report all costs related to their cancer care
Investigators will compare participants in the financial navigation program and those not in the financial navigation program to identify potential differences in catastrophic health expenditure and financial distress
The main study questions being investigated are
1 If a financial navigation program can effectively and significantly reduce financial catastrophe and distress for cancer patients in Nigeria
2 If a financial navigation program is financially sustainable and cost-effective for cancer centers in Nigeria
Participants will be required to
1 Complete surveys about their demographics clinical history and socioeconomic status
2 Complete questionnaires about their quality of life and psychological wellbeing
3 Report all costs related to their cancer care
Investigators will compare participants in the financial navigation program and those not in the financial navigation program to identify potential differences in catastrophic health expenditure and financial distress
Detailed Description:
Over 100000 individuals are diagnosed with cancer annually in Nigeria the highest burden out of all countries in sub-Saharan Africa SSA Treatment options are limited and often delayed due to lack of insurance coverage and high out-of-pocket costs which is devastating for Nigerias 83 million living in poverty 40 of the population Importantly it is estimated that 77-94 of cancer patients in SSA face financial catastrophe FC where health expenses exceed 25 of household expenditure 40 of non-subsistence expenditures or 10 of household income
While Nigeria has recently planned to invest 300 billion USD in the National Cancer Control Plan a comprehensive initiative to centralize and strengthen multidisciplinary cancer care high-quality research on innovative methods to eliminate cost barriers and make treatment affordable is needed
In the United States structured financial navigation programs FNP have been successful in helping patients finance their cancer care and save costs and have been associated with reduced levels of financial distress However there is paucity of data high-quality on the effectiveness of an FNP for cancer care in SSA
The proposed study will investigate the effectiveness of an FNP in reducing financial catastrophe and distress for cancer patients in Nigeria The FNP will hire financial navigators FNs at the cancer centers to educate patients on financial literacy enroll patients in insurance and find alternative funding sources such as charitable solutions The randomized control trial will enroll 200 newly diagnosed breast colorectal or prostate cancer patients at two cancer centers in Lagos Nigeria and investigate the impact of the FNP on
1 The incidence of financial catastrophe
2 Financial distress
3 Budget and financial sustainability analysis of the FNP -- by conducting a cost-effectiveness analysis by comparing the programs cost to the benefits in terms of funding secured and number of participants enrolled in insurance
This study -- the first of its kind in SSA -- will inform the potential for FNPs to reduce the financial burden of cancer treatment in resource-constrained settings If effective programs like this would serve as an invaluable resource to increase access to care and in turn improve cancer outcomes in the region
In light of Nigerian governments recently renewed interest in improving access to cancer care findings from this study will be crucial in health policy reform Further this studys findings will inform and influence cancer care in SSA and will prompt effectiveness in other similar contexts
Finally if found to be effective data from this investigation will lay the foundation to support an R01-level study to comprehensively evaluate the implementation and adoption of FNPs in Nigeria and other parts of SSA
While Nigeria has recently planned to invest 300 billion USD in the National Cancer Control Plan a comprehensive initiative to centralize and strengthen multidisciplinary cancer care high-quality research on innovative methods to eliminate cost barriers and make treatment affordable is needed
In the United States structured financial navigation programs FNP have been successful in helping patients finance their cancer care and save costs and have been associated with reduced levels of financial distress However there is paucity of data high-quality on the effectiveness of an FNP for cancer care in SSA
The proposed study will investigate the effectiveness of an FNP in reducing financial catastrophe and distress for cancer patients in Nigeria The FNP will hire financial navigators FNs at the cancer centers to educate patients on financial literacy enroll patients in insurance and find alternative funding sources such as charitable solutions The randomized control trial will enroll 200 newly diagnosed breast colorectal or prostate cancer patients at two cancer centers in Lagos Nigeria and investigate the impact of the FNP on
1 The incidence of financial catastrophe
2 Financial distress
3 Budget and financial sustainability analysis of the FNP -- by conducting a cost-effectiveness analysis by comparing the programs cost to the benefits in terms of funding secured and number of participants enrolled in insurance
This study -- the first of its kind in SSA -- will inform the potential for FNPs to reduce the financial burden of cancer treatment in resource-constrained settings If effective programs like this would serve as an invaluable resource to increase access to care and in turn improve cancer outcomes in the region
In light of Nigerian governments recently renewed interest in improving access to cancer care findings from this study will be crucial in health policy reform Further this studys findings will inform and influence cancer care in SSA and will prompt effectiveness in other similar contexts
Finally if found to be effective data from this investigation will lay the foundation to support an R01-level study to comprehensively evaluate the implementation and adoption of FNPs in Nigeria and other parts of SSA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None