Evaluating the Impact of Financial Navigation on Financial Catastrophe and Distress for Cancer Care

NCT ID: NCT06630962

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2026-09-30

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.

Conditions

Breast Neoplasm; Prostate Neoplasm; Colon Neoplasm; Rectal Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Financial Navigation Arm

A financial navigator will educate these participants on financial literacy, insurance plans and payment options available through charities and financial assistance programs. In addition to providing financial counseling, the financial navigator will verify participant insurance documents, maintain records of financial agreements, and coordinate payments with insurance companies.

Group Type: EXPERIMENTAL

Financial Navigation Program

Intervention Type: OTHER

A salaried financial navigator will be hired by the study sites. All responsibilities of the navigator will revolve around the structured financial navigation program. There is currently no research indicating that such a role has been incorporated at cancer centers in sub-Saharan Africa.

Through this program, the financial navigator will educate participants on financial literacy, insurance plans and payment options available through charities and financial assistance programs. In addition to providing financial counseling, the financial navigator will verify participant insurance documents, maintain records of financial agreements, and coordinate payments with insurance companies.

Routine Care Arm

Participants will not have access to the services of the financial navigator. Financial counseling and assistance will be limited to what is routinely provided by the cancer center.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Financial Navigation Program

A salaried financial navigator will be hired by the study sites. All responsibilities of the navigator will revolve around the structured financial navigation program. There is currently no research indicating that such a role has been incorporated at cancer centers in sub-Saharan Africa.

Through this program, the financial navigator will educate participants on financial literacy, insurance plans and payment options available through charities and financial assistance programs. In addition to providing financial counseling, the financial navigator will verify participant insurance documents, maintain records of financial agreements, and coordinate payments with insurance companies.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juliet Lumati

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Obafemi Awolowo University Teaching Hospitals Complex

Ile-Ife, , Nigeria

Site Status: RECRUITING

Lakeshore Cancer Center

Lagos, , Nigeria

Site Status: RECRUITING

Countries

Nigeria

Central Contacts

Juliet Lumati

Role: CONTACT

juliet.lumati@northwestern.edu

+1 312 926 4230

Kristina Diaz

Role: CONTACT

kristina.diaz@northwestern.edu

2027253279

Facility Contacts

Isaiah Oyewole

Role: primary

Bindiya Sadarangani

Role: primary

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://www.argo-research.org/cancer-clinical-trial/

Partner site listing related materials to our study and patient enrollment

Other Identifiers

STU00221204

Identifier Type: -

Identifier Source: org_study_id