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Addressing Cancer-Related Financial Toxicity in Rural Oncology Care Settings

Addressing Cancer-Related Financial Toxicity in Rural North Carolina Oncology Care Settings

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04931251
Enrollment
258
Registered
2021-06-18
Start date
2021-11-11
Completion date
2025-07-31
Last updated
2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Neoplasms

Keywords

Financial Toxicity, Cancer, Financial Navigation, Carcinoma, Neoplasms

Brief summary

The financial burden, or financial toxicity (FT), of cancer is a consequential and growing problem, particularly for rural patients. It is important to improve our understanding of how financial navigation (FN) can reduce the material, psychological, and behavioral burden of costs associated with cancer care in both rural and non-rural community settings. The purpose of this study is to conduct a financial navigation program in 5 rural and 4 non-rural oncology practices in North Carolina and evaluate the effects of financial navigation on patient outcomes, including financial toxicity and health-related quality of life.

Detailed description

This study is designed to evaluate the implementation and effectiveness of a financial navigation intervention within 5 rural and 4 non-rural oncology settings in North Carolina. Financial navigators from each of the 9 sites will recruit and enroll 255 patients total across all sites into a financial navigation program. The financial navigation intervention consists of screening patients using the COST measure for financial toxicity. If the patient scores 23 or lower, they are considered to have moderate to severe financial toxicity and will be enrolled in the study. Patients will then complete a series of baseline questionnaires to measure their health related quality of life and then they will meet with a financial navigator for a comprehensive intake process to determine potential financial assistance resources the patient may be eligible for and continued visits with the financial navigator until all financial assistance resources have been explored and patients have received benefits or referrals to financial assistance programs. At the end of the intervention, the patients will complete the COST measure again, and repeat baseline surveys to measure health-related quality of life and the patient's acceptability and responsiveness of the financial navigation intervention. Patient participation depends on the depth of patient need but ranges from 2 visits to 6 visits with the financial navigator over approximately 4 months but possibly longer depending on the complexity of the patient's financial need.

Interventions

providing financial navigation for cancer patients in NC to identify available financial assistance resources to assist patients with the cost of cancer

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
UNC Lineberger Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Masking description

no masking

Intervention model description

This is a multi-site, single arm, financial navigation intervention

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients 18 years of age and older * Patients with any type of cancer diagnosed within 5 years and/or living with advanced disease * Patients who score 22 or lower on the COST measure indicating high FT * Patients must be able to read and speak English

Exclusion criteria

* Participants without a cancer diagnosis * Patients diagnosed more than 5 years ago without advanced disease * Patients or caregivers under the age of 18 * Patients who do not sign the consent form * Patients who do not complete the baseline COST survey * Patients who cannot read and speak English

Design outcomes

Primary

MeasureTime frameDescription
COST (Comprehensive Score for Financial Toxicity) measure4-6 monthsTo evaluate the change from baseline to follow-up in scores from the Comprehensive Score for Financial Toxicity (COST) measure after participation in the financial navigation program among 780 rural and non-rural NC cancer patients with high baseline financial distress.

Secondary

MeasureTime frameDescription
Health-Related Quality of Life (HrQoL) Measures4-6 monthsTo evaluate the change from baseline to follow-up in scores from HRQoL, care-altering behaviors and patient perspectives on the intervention itself

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026