Evaluating the Impact of Financial Navigation on Financial Catastrophe and Distress for Cancer Care: A Randomized Control Trial- COST-FIN
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Incidence of financial catastrophe (FC)
研究概览
简要总结
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:
- If a financial navigation program can effectively and significantly reduce financial catastrophe and distress for cancer patients in Nigeria?
- If a financial navigation program is financially sustainable and cost-effective for cancer centers in Nigeria?
Participants will be required to:
- Complete surveys about their demographics, clinical history, and socioeconomic status
- Complete questionnaires about their quality of life and psychological wellbeing
- 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.
详细描述
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:
- The incidence of financial catastrophe
- Financial distress
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Unable to provide consent
- •Has initiated definitive cancer treatment at the study site or elsewhere in the past
- •Only receiving best supportive care
结局指标
主要结局
Incidence of financial catastrophe (FC)
时间窗: From enrollment to 12 months
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.
Levels of financial distress (FD)
时间窗: From enrollment to 3, 6 and 12 months
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.
次要结局
- Rate of cost-related non-adherence(From enrollment to 6 months)