Addressing Cancer-Related Financial Toxicity in Rural Oncology Care Settings
3 other identifiers
interventional
258
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2021
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2021
CompletedFirst Posted
Study publicly available on registry
June 18, 2021
CompletedStudy Start
First participant enrolled
November 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedNovember 26, 2025
November 1, 2025
3.7 years
June 11, 2021
November 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Health-Related Quality of Life (HrQoL) Measures
4-6 months
Study Arms (1)
Financial Navigation
OTHERincludes 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
Interventions
providing financial navigation for cancer patients in NC to identify available financial assistance resources to assist patients with the cost of cancer
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
NC Basnight Cancer Hospital
Chapel Hill, North Carolina, 27514, United States
Novant Health
Charlotte, North Carolina, 28207, United States
Vidant Medical Center, Cancer Center
Greenville, North Carolina, 27834, United States
Pardee UNC Health Care, Pardee Cancer Center
Hendersonville, North Carolina, 28739, United States
UNC Lenoir Cancer Care Services
Kinston, North Carolina, 28501, United States
Carteret Health Care Cancer Center
Morehead City, North Carolina, 28557, United States
The Outer Banks Hospital
Nags Head, North Carolina, 27959, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Related Publications (7)
Wheeler SB, Biddell CB, Manning ML, Gellin MS, Padilla NR, Spees LP, Rogers CD, Rodriguez-O'Donnell J, Samuel-Ryals C, Birken SA, Reeder-Hayes KE, Petermann VM, Deal AM, Rosenstein DL. Lessening the Impact of Financial Toxicity (LIFT): a protocol for a multi-site, single-arm trial examining the effect of financial navigation on financial toxicity in adult patients with cancer in rural and non-rural settings. Trials. 2022 Oct 3;23(1):839. doi: 10.1186/s13063-022-06745-4.
PMID: 36192802BACKGROUNDPlaney AM, Spees LP, Biddell CB, Waters A, Jones EP, Hecht HK, Rosenstein D, Wheeler SB. The intersection of travel burdens and financial hardship in cancer care: a scoping review. JNCI Cancer Spectr. 2024 Sep 2;8(5):pkae093. doi: 10.1093/jncics/pkae093.
PMID: 39361410BACKGROUNDWheeler SB, Thom B, Waters AR, Shankaran V. Interventions to Address Cancer-Related Financial Hardship: A Scoping Review and Call to Action. JCO Oncol Pract. 2025 Jan;21(1):29-40. doi: 10.1200/OP.24.00375. Epub 2025 Jan 10.
PMID: 39793544BACKGROUNDWheeler SB, Manning ML, Gellin M, Padilla N, Spees LP, Biddell CB, Petermann V, Deal A, Rogers C, Rodriguez-O'Donnell J, Samuel-Ryals C, Reeder-Hayes K, Rosenstein DL. Impact of a Comprehensive Financial Navigation Intervention to Reduce Cancer-Related Financial Toxicity. J Natl Compr Canc Netw. 2024 Oct;22(8):557-562. doi: 10.6004/jnccn.2024.7030.
PMID: 39413831BACKGROUNDWheeler SB, Birken SA, Wagi CR, Manning ML, Gellin M, Padilla N, Rogers C, Rodriguez J, Biddell CB, Strom C, Bell RA, Rosenstein DL. Core functions of a financial navigation intervention: An in-depth assessment of the Lessening the Impact of Financial Toxicity (LIFT) intervention to inform adaptation and scale-up in diverse oncology care settings. Front Health Serv. 2022 Nov 9;2:958831. doi: 10.3389/frhs.2022.958831. eCollection 2022.
PMID: 36925862RESULTPetermann VM, Biddell CB, Planey AM, Spees LP, Rosenstein DL, Manning M, Gellin M, Padilla N, Samuel-Ryals CA, Birken SA, Reeder-Hayes K, Deal AM, Cabarrus K, Bell RA, Strom C, Young TH, King S, Leutner B, Vestal D, Wheeler SB. Assessing the pre-implementation context for financial navigation in rural and non-rural oncology clinics. Front Health Serv. 2023 Oct 23;3:1148887. doi: 10.3389/frhs.2023.1148887. eCollection 2023.
PMID: 37941608RESULTBiddell CB, Spees LP, Petermann V, Rosenstein DL, Manning M, Gellin M, Padilla N, Samuel-Ryals CA, Birken SA, Reeder-Hayes K, Deal AM, Cabarrus K, Bell RA, Strom C, DeAntonio PA, Young TH, King S, Leutner B, Vestal D, Wheeler SB. Financial Assistance Processes and Mechanisms in Rural and Nonrural Oncology Care Settings. JCO Oncol Pract. 2022 Sep;18(9):e1392-e1406. doi: 10.1200/OP.21.00894. Epub 2022 May 12.
PMID: 35549521RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie Wheeler, PhD
Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- no masking
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2021
First Posted
June 18, 2021
Study Start
November 11, 2021
Primary Completion
July 31, 2025
Study Completion
July 31, 2025
Last Updated
November 26, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The de-identified data will become available after study completion.
- Access Criteria
- The access criteria for accessing our de-identified participant data is still being developed.
We commit to broadly sharing appropriate materials and de-identified data that are developed with support from the NIH, while protecting participant privacy and confidentiality in accordance with best human subjects research practices and Health Insurance Portability and Accountability Act (HIPAA) guidelines. We commit to the collection, cataloging, protecting, and sharing of clinical and other research data and resources that is consistent with NIH policies, using the Research Electronic Data Capture (REDCap) platform as the mechanism for data storage, protection and sharing. We will only share de-identified IPD.