Clinical trial NCT04931251: Addressing Cancer-Related Financial Toxicity in Rural Oncology Care Settings
Official title: Addressing Cancer-Related Financial Toxicity in Rural North Carolina Oncology Care Settings
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasms
Carcinoma
Keywords: Financial Toxicity
Cancer
Financial Navigation
Carcinoma
Neoplasms
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-06-18
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a multi-site, single arm, financial navigation intervention
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: COST (Comprehensive Score for Financial Toxicity) measure
timeFrame: 4-6 months
Secondary outcomes:
measure: Health-Related Quality of Life (HrQoL) Measures
timeFrame: 4-6 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: NC Basnight Cancer Hospital
state: North Carolina
city: Charlotte
country: United States
facility: Novant Health
state: North Carolina
city: Greenville
country: United States
facility: Vidant Medical Center, Cancer Center
state: North Carolina
city: Hendersonville
country: United States
facility: Pardee UNC Health Care, Pardee Cancer Center
state: North Carolina
city: Kinston
country: United States
facility: UNC Lenoir Cancer Care Services
state: North Carolina
city: Morehead City
country: United States
facility: Carteret Health Care Cancer Center
state: North Carolina
city: Nags Head
country: United States
facility: The Outer Banks Hospital
state: North Carolina
city: Rocky Mount
country: United States
facility: Nash UNC Health Care
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill
name: Stephanie Wheeler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.