Clinical trial NCT06630962: Evaluating the Impact of Financial Navigation on Financial Catastrophe and Distress for Cancer Care
Official title: Evaluating the Impact of Financial Navigation on Financial Catastrophe and Distress for Cancer Care: A Randomized Control Trial- COST-FIN
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Neoplasm
Prostate Neoplasm
Colon Neoplasm
Rectal Neoplasm
Keywords: Financial Navigation
Financing Cancer Care
Nigeria
Breast Neoplasm
Prostate Neoplasm
Colon Neoplasm
Rectal Neoplasm
Health Insurance
Randomized Control Trial
Healthcare Cost
Health Expenditure
Financial Risk Sharing
Universal Health Insurance
National Health Insurance Scheme
Catastrophic Health Spending
Financial Distress
Sub-Saharan Africa
Health Plan Implementation
Global Health
Healthcare Economics and Organizations
Clinical Oncology
Cancer Care Facilities
Surgical Oncology
Global Burden of Disease
Social Determinants of Health
Health Impact Assessment
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Potential Crossover: An interim analysis will be conducted once 50% of the recruitment target (100 participants total) have completed at least 6-months of follow-up, which is estimated to occur at approximately 1 year from start of the study. If significant differences between the Financial Navigation Program (FNP) and routine care arms are observed, all enrolled participants in the control arm will be given access to the FNP. Endpoint-related data will be collected until study completion (1-year follow-up for all enrolled participants).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Over 100,000 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 Nigeria's 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 program's 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 government's recently renewed interest in improving access to cancer care, findings from this study will be crucial in health policy reform. Further, this study's 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.

Eligibility criteria: Inclusion Criteria:

* Age 18 years and older
* Recently diagnosed with breast, colorectal or prostate cancer within 6 weeks of presentation at the study site
* Have not received definitive chemotherapy, radiotherapy, or undergone major surgery (diagnostic or temporary interventions, such as excisional biopsy or temporary colostomy may still enroll)
* Candidate for definitive cancer treatment

Exclusion Criteria:

* Unable to provide consent
* Has initiated definitive cancer treatment at the study site or elsewhere in the past
* Only receiving best supportive care

Primary outcomes:
measure: Incidence of financial catastrophe (FC)
timeFrame: From enrollment to 12 months
measure: Levels of financial distress (FD)
timeFrame: From enrollment to 3, 6 and 12 months
Secondary outcomes:
measure: Rate of cost-related non-adherence
timeFrame: From enrollment to 6 months
Other outcomes:
Locations:
city: Ile-Ife
country: Nigeria
facility: Obafemi Awolowo University Teaching Hospitals Complex
city: Lagos
country: Nigeria
facility: Lakeshore Cancer Center
Study officials:
affiliation: Northwestern University
name: Juliet Lumati
role: PRINCIPAL_INVESTIGATOR
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