Addressing Cancer-Related Financial Toxicity in Rural Oncology Care Settings

NCT ID: NCT04931251

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-11

Study Completion Date

2025-07-31

Brief Summary

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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

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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.

Conditions

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Neoplasms Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a multi-site, single arm, financial navigation intervention
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

no masking

Study Groups

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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

Group Type OTHER

Financial Navigation

Intervention Type BEHAVIORAL

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

Interventions

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Financial Navigation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role lead

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephanie Wheeler, PhD

Role: PRINCIPAL_INVESTIGATOR

Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill

Locations

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NC Basnight Cancer Hospital

Chapel Hill, North Carolina, United States

Site Status

Novant Health

Charlotte, North Carolina, United States

Site Status

Vidant Medical Center, Cancer Center

Greenville, North Carolina, United States

Site Status

Pardee UNC Health Care, Pardee Cancer Center

Hendersonville, North Carolina, United States

Site Status

UNC Lenoir Cancer Care Services

Kinston, North Carolina, United States

Site Status

Carteret Health Care Cancer Center

Morehead City, North Carolina, United States

Site Status

The Outer Banks Hospital

Nags Head, North Carolina, United States

Site Status

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 36192802 (View on PubMed)

Planey 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.

Reference Type BACKGROUND
PMID: 39361410 (View on PubMed)

Wheeler 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.

Reference Type BACKGROUND
PMID: 39793544 (View on PubMed)

Wheeler 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.

Reference Type BACKGROUND
PMID: 39413831 (View on PubMed)

Wheeler 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.

Reference Type RESULT
PMID: 36925862 (View on PubMed)

Petermann 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.

Reference Type RESULT
PMID: 37941608 (View on PubMed)

Biddell 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.

Reference Type RESULT
PMID: 35549521 (View on PubMed)

Related Links

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http://unclineberger.org/patientcare/clinical-trials/clinical-trials

UNC Lineberger Comprehensive Cancer Center Clinical Trials

Other Identifiers

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5R01CA240092

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA016086

Identifier Type: NIH

Identifier Source: secondary_id

View Link

LCCC1941

Identifier Type: -

Identifier Source: org_study_id

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