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Clinical Trials/NCT04931251
NCT04931251
Completed
Not Applicable

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

UNC Lineberger Comprehensive Cancer Center8 sites in 1 country258 target enrollmentNovember 11, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neoplasms
Sponsor
UNC Lineberger Comprehensive Cancer Center
Enrollment
258
Locations
8
Primary Endpoint
COST (Comprehensive Score for Financial Toxicity) measure
Status
Completed
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 11, 2021
End Date
July 31, 2025
Last Updated
5 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

COST (Comprehensive Score for Financial Toxicity) measure

Time Frame: 4-6 months

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.

Secondary Outcomes

  • Health-Related Quality of Life (HrQoL) Measures(4-6 months)

Study Sites (8)

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