Evaluating the Impact of Financial Navigation on Financial Catastrophe and Distress for Cancer Care (COST-FIN)

October 4, 2024 updated by: Northwestern University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Nigeria
      • Ile-Ife, Nigeria
        • Recruiting
        • Obafemi Awolowo University Teaching Hospitals Complex
        • Contact:
          • Isaiah Oyewole
        • Sub-Investigator:
          • Funmilola Wuraola
      • Lagos, Nigeria
        • Recruiting
        • Lakeshore Cancer Center
        • Contact:
          • Bindiya Sadarangani
        • Sub-Investigator:
          • Chinenye Iwuji

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of financial catastrophe (FC)
Time Frame: 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.
From enrollment to 12 months
Levels of financial distress (FD)
Time Frame: 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.
From enrollment to 3, 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of cost-related non-adherence
Time Frame: From enrollment to 6 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Juliet Lumati, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

September 18, 2024

First Submitted That Met QC Criteria

October 4, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 4, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00221204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be shared at study conclusion, once all analyses are complete. The data will be available to the wider research community indefinitely.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Neoplasm

Clinical Trials on Financial Navigation Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe