Addressing Cancer-Related Financial Toxicity in Rural Oncology Care Settings

Neoplasms Clinical Trial

Official title:

Addressing Cancer-Related Financial Toxicity in Rural Oncology Care Settings

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04931251
• Other study ID #: LCCC1941
• Secondary ID: R01CA240092
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: November 2023
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: Michelle L Manning, MPH
• Phone: 919-843-8506
• Email: mlmannin[@]email.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 780
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Financial Stress
• Neoplasms

Intervention

Behavioral:
• Financial Navigation
providing financial navigation for cancer patients in NC to identify available financial assistance resources to assist patients with the cost of cancer

Locations

Country	Name	City	State
United States	NC Basnight Cancer Hospital	Chapel Hill	North Carolina
United States	Novant Health	Charlotte	North Carolina
United States	Vidant Medical Center, Cancer Center	Greenville	North Carolina
United States	Pardee UNC Health Care, Pardee Cancer Center	Hendersonville	North Carolina
United States	UNC Lenoir Cancer Care Services	Kinston	North Carolina
United States	Carteret Health Care Cancer Center	Morehead City	North Carolina
United States	The Outer Banks Hospital	Nags Head	North Carolina
United States	Nash UNC Health Care	Rocky Mount	North Carolina
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   UNC Lineberger Comprehensive Cancer Center Clinical Trials