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Completed

NCT Number: NCT04931251

Addressing Cancer-Related Financial Toxicity in Rural Oncology Care Settings

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.

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Key information

Conditions

Neoplasms Behavior Behavioral Symptoms Carcinoma Financial Stress Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NC Basnight Cancer Hospital, Chapel Hill, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Financial navigation

Behavioral

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

Primary outcomes

  1. 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

  1. Health-Related Quality of Life (HrQoL) Measures

    Time frame: 4-6 months

    To evaluate the change from baseline to follow-up in scores from HRQoL, care-altering behaviors and patient perspectives on the intervention itself

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2021
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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