Addressing Cancer-Related Financial Toxicity in Rural Oncology Care Settings

UNC Lineberger Comprehensive Cancer Center (Other)
Overall Status
Recruiting ID
National Cancer Institute (NCI) (NIH)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Financial Navigation

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 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.

Study Design

Study Type:
Anticipated Enrollment :
780 participants
Intervention Model:
Single Group Assignment
Intervention Model Description:
This is a multi-site, single arm, financial navigation interventionThis is a multi-site, single arm, financial navigation intervention
None (Open Label)
Masking Description:
no masking
Primary Purpose:
Health Services Research
Official Title:
Addressing Cancer-Related Financial Toxicity in Rural Oncology Care Settings
Actual Study Start Date :
Nov 11, 2021
Anticipated Primary Completion Date :
Jun 15, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Financial Navigation

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

Outcome Measures

Primary Outcome Measures

  1. COST (Comprehensive Score for Financial Toxicity) measure [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 Outcome Measures

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

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


Site City State Country Postal Code
1 Novant Health Charlotte North Carolina United States 28207
2 Vidant Medical Center, Cancer Center Greenville North Carolina United States 27834
3 Pardee UNC Health Care, Pardee Cancer Center Hendersonville North Carolina United States 28739
4 UNC Lenoir Cancer Care Services Kinston North Carolina United States 28501
5 Carteret Health Care Cancer Center Morehead City North Carolina United States 28557
6 The Outer Banks Hospital Nags Head North Carolina United States 27959
7 CarolinaEast Health System New Bern North Carolina United States 28560
8 Nash UNC Health Care Rocky Mount North Carolina United States 27804
9 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157

Sponsors and Collaborators

  • UNC Lineberger Comprehensive Cancer Center
  • National Cancer Institute (NCI)


  • Principal Investigator: Stephanie Wheeler, PhD, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill

Study Documents (Full-Text)

None provided.

More Information

Additional Information:


None provided.
Responsible Party:
UNC Lineberger Comprehensive Cancer Center Identifier:
Other Study ID Numbers:
  • LCCC1941
  • R01CA240092
First Posted:
Jun 18, 2021
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by UNC Lineberger Comprehensive Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 21, 2022