Addressing Cancer-Related Financial Toxicity in Rural Oncology Care Settings

Study Overview
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Brief Summary
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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
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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 780 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.

Official Title
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Addressing Cancer-Related Financial Toxicity in Rural Oncology Care Settings

Conditions
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Neoplasms, Carcinoma

Intervention / Treatment
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* Behavioral: Financial Navigation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: This is a multi-site, single arm, financial navigation intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Financial Navigation<br>includes a financial toxicity screening measure (COST), baseline and post-intervention surveys, and approximately 2-6 visits with a financial navigator to identify financial assistance resources | Behavioral: Financial Navigation<br>* providing financial navigation for cancer patients in NC to identify available financial assistance resources to assist patients with the cost of cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COST (Comprehensive Score for Financial Toxicity) measure | To 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. | 4-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-Related Quality of Life (HrQoL) Measures | To evaluate the change from baseline to follow-up in scores from HRQoL, care-altering behaviors and patient perspectives on the intervention itself | 4-6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Financial Toxicity, Cancer, Financial Navigation, Carcinoma, Neoplasms