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

Официальное название

Evaluating the Impact of Financial Navigation on Financial Catastrophe and Distress for Cancer Care: A Randomized Control Trial- COST-FIN

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Incidence of financial catastrophe (FC) [Срок оценки: From enrollment to 12 months]
• Levels of financial distress (FD) [Срок оценки: From enrollment to 3, 6 and 12 months]

Вторичные конечные точки (1)

• Rate of cost-related non-adherence [Срок оценки: From enrollment to 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

Nigeria · 2 центра

• Obafemi Awolowo University Teaching Hospitals Complex — Ile-Ife
• Lakeshore Cancer Center — Lagos

Публикации

• 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. PMID 33538338
• 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. PMID 30264708
• Awodutire PO, Kolawole OA, Ilori OR. Data on the survival times of breast cancer patients in a Teaching Hospital, Osogbo. Data Brief. 2020 Aug 1;32:106109. doi: 10.1016/j.dib.2020.106109. eCollection 2020 Oct. PMID 32817870
• Ali-Gombe M, Mustapha MI, Folasire A, Ntekim A, Campbell OB. Pattern of survival of breast cancer patients in a tertiary hospital in South West Nigeria. Ecancermedicalscience. 2021 Feb 25;15:1192. doi: 10.3332/ecancer.2021.1192. eCollection 2021. PMID 33889201
• Gullickson C, Goodman M, Joko-Fru YW, Gnangnon FHR, N'Da G, Woldegeorgis MA, Buziba NG, Karugu C, Manraj SS, Lorenzoni CF, Hansen R, Finesse A, Somdyala NIM, Bukirwa P, Chingonzoh T, Chokunonga E, Liu B, Kantelhardt E, Parkin DM, Jemal A. Colorectal cancer survival in sub-Saharan Africa by age, stage at diagnosis and Human Development Index: A population-based registry study. Int J Cancer. 2021 Oc PMID 34164808
• Saluja S, Alatise OI, Adewale A, Misholy J, Chou J, Gonen M, Weiser M, Kingham TP. A comparison of colorectal cancer in Nigerian and North American patients: is the cancer biology different? Surgery. 2014 Aug;156(2):305-10. doi: 10.1016/j.surg.2014.03.036. Epub 2014 Jun 19. PMID 24953266
• Seraphin TP, Joko-Fru WY, Manraj SS, Chokunonga E, Somdyala NIM, Korir A, N'Da G, Finesse A, Wabinga H, Assefa M, Gnangnon F, Hansen R, Buziba NG, Liu B, Kantelhardt EJ, Parkin DM. Prostate cancer survival in sub-Saharan Africa by age, stage at diagnosis, and human development index: a population-based registry study. Cancer Causes Control. 2021 Sep;32(9):1001-1019. doi: 10.1007/s10552-021-01453-x PMID 34244896
• Ekeke O, Amusan O, Eke N. Management of prostate cancer in port harcourt, Nigeria: changing patterns. J West Afr Coll Surg. 2012 Jul;2(3):58-77. PMID 25452994

Идентификаторы

NCT: NCT06630962 · STU00221204

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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