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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:
Participants will be required to:
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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Financial Navigation Arm | Experimental | 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. |
|
| Routine Care Arm | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Financial Navigation Program | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of financial catastrophe (FC) | To compare the incidence of FC between participants in the financial navigation program (FNP) and control arms. FC is defined as treatment-related costs that exceed 10% of household income (HHI), 25% of total household expenditure (HHE), or 40% of non-essential household spending (HSE). All direct and indirect out-of-pocket (OOP) costs of cancer care will be summed for each participant and represented as a proportion of HHI, HHE, and HSE. | From enrollment to 12 months |
| Levels of financial distress (FD) | To compare the levels of FD experienced between participants in the FNP and control arms. Financial Distress (FD) will be measured using the FACIT-COST tool, a validated patient-reported measure with scores ranging from 0-44 (higher scores represent better financial well-being). FACIT-COST scores will be assessed for all participants at 3, 6, and 12 months from enrollment, and mean scores at 6 months will be compared between both study arms. | From enrollment to 3, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of cost-related non-adherence | Exploratory analysis to compare the rates of treatment non-adherence related to treatment costs between the FNP and control arms. Data on adherence and reasons for non-adherence will be collected through structured interviews with participants and their treating medical oncologists 6 months post-enrollment. | From enrollment to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juliet Lumati | Contact | +1 312 926 4230 | juliet.lumati@northwestern.edu | |
| Kristina Diaz | Contact | 2027253279 | kristina.diaz@northwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Juliet Lumati | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obafemi Awolowo University Teaching Hospitals Complex | Recruiting | Ile-Ife | Nigeria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33538338 | Background | Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. | |
| 30264708 | Background | The Lancet. GLOBOCAN 2018: counting the toll of cancer. Lancet. 2018 Sep 22;392(10152):985. doi: 10.1016/S0140-6736(18)32252-9. Epub 2018 Sep 20. No abstract available. |
| Label | URL |
|---|---|
| Partner site listing related materials to our study and patient enrollment | View source |
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Demographic, socioeconomic, clinical, cost, and patient-reported outcome data will be uploaded and shared for each enrolled participant. All data will be de-identified and dates will be excluded from the dataset.
Data will be shared at study conclusion, once all analyses are complete. The data will be available to the wider research community indefinitely.
Data will be accessible to anyone in the wider research community via the clinicaltrials.gov repository. The data will be identifiable through a unique identification code assigned by clinicaltrials.gov.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 6, 2024 | Sep 26, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 6, 2024 | Sep 26, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 14, 2024 | Sep 26, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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).
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|
| Lakeshore Cancer Center | Recruiting | Lagos | Nigeria |
|
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| 41646304 | Derived | Sohail AH, Afolaranmi O, Wuraola FO, Caputo M, Guiterrez G, Oyewole A, Ebekue DO, Adegbite ZO, Awe C, Ogunniyi T, Opeyemi A, Nwankwo C, Uwechue F, Sherman D, Lambert CN, Adedayo J, Diaz K, Christian EN, Abdulkareem F, Akin-Adigun O, Akingbola A, Okeke S, Knapp G, Dare A, Aduloju T, Akinwumi M, Kohli-Lynch CN, Chen R, Nwogu C, Hirschhorn LR, Adin-Cristian A, Iwuji C, Ilegbune O, Jimoh M, Chugani B, Oputa O, Murthy S, French D, Ackermann R, Murphy R, Seddoh A, Kingham P, Alatise OI, Lumati JS. Evaluating the Impact of Financial Navigation on Financial Catastrophe and Distress for Cancer Care: A Randomized Control Trial- COST-FIN. Res Sq [Preprint]. 2026 Jan 21:rs.3.rs-7686399. doi: 10.21203/rs.3.rs-7686399/v1. |
| 41606671 | Derived | Sohail AH, Afolaranmi O, Wuraola FO, Caputo M, Gutierrez G, Oyewole A, Ebekue DO, Adegbite ZO, Awe C, Ogunniyi T, Opeyemi A, Nwankwo C, Uwechue F, Sherman D, Lambert CN, Adedayo J, Diaz K, Christian EN, Abdulkareem F, Akin-Adigun O, Akingbola A, Okeke S, Knapp G, Dare A, Aduloju T, Akinwumi M, Kohli-Lynch CN, Chen R, Nwogu C, Hirschhorn LR, Adin-Cristian A, Iwuji C, Ilegbune O, Jimoh M, Chugani B, Oputa O, Murthy S, French D, Ackermann R, Murphy R, Seddoh A, Kingham P, Alatise OI, Lumati JS. Evaluating the impact of financial navigation on financial catastrophe and distress for cancer care: a randomized control trial-COST-FIN. Trials. 2026 Jan 28;27(1):167. doi: 10.1186/s13063-026-09480-2. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |