Financial Navigation for Cancer-Related Financial Toxicity

Recruiting at 2 trial locations

Overseen By Mindy Gellin, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: No cancer, Advanced disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

255 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial does not specify whether you need to stop taking your current medications, so it's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Financial Navigation for cancer-related financial toxicity?

Research shows that financial navigation helps cancer patients by identifying those at high risk of financial hardship, guiding them to support resources, and assisting with managing treatment costs. This approach has been shown to improve patient outcomes by reducing financial stress and improving quality of life. ^{1 2 3 4 5}

Is financial navigation safe for cancer patients?

Financial navigation is a strategy used to help cancer patients manage the financial burden of their treatment. It involves assessing patients' financial needs and guiding them to available resources. There is no indication from the research that financial navigation poses any safety risks to patients. ^{1 2 4 6 7}

How does financial navigation differ from other treatments for cancer-related financial toxicity?

Financial navigation is unique because it focuses on identifying patients at risk of financial hardship due to cancer, assessing their eligibility for financial support, and developing personalized plans to manage costs. Unlike traditional medical treatments, it involves a multidisciplinary team, including social workers and nurse navigators, to guide patients through financial challenges, improving their quality of life and access to care. ^{1 2 4 8 9}

Research Team

Stephanie Wheeler, PhD

Principal Investigator

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

Eligibility Criteria

This trial is for adults over 18 with any type of cancer diagnosed within the last 5 years or living with advanced disease, who are experiencing high financial burden from their care. They must be able to read and speak English and score low on a specific financial toxicity survey.

Inclusion Criteria

I was diagnosed with cancer within the last 5 years or have advanced cancer.

You have a high level of fear of falling, as measured by a test called COST, with a score of 22 or lower.

Exclusion Criteria

I have not been diagnosed with cancer.

Patients who do not complete the baseline COST survey

I was diagnosed over 5 years ago and my disease has not advanced.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Financial Navigation Intervention

Participants undergo financial toxicity screening and meet with a financial navigator to explore financial assistance resources

4 months

2-6 visits (in-person)

Follow-up

Participants complete follow-up surveys to evaluate changes in financial toxicity and health-related quality of life

4-6 months

Treatment Details

Interventions

• Financial Navigation

Trial Overview The study tests a program called Financial Navigation designed to help reduce the cost-related stress and impact of cancer treatment. It will compare patient outcomes in rural versus non-rural settings across North Carolina.

Participant Groups

Group I: Financial Navigation Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The LIFT study is a multi-site Phase 2 clinical trial involving 780 cancer patients across nine oncology care settings in North Carolina, aimed at addressing financial toxicity (FT) through financial navigation (FN) services.

The trial will evaluate the effectiveness of FN in reducing FT and improving health-related quality of life, using validated measures like the Comprehensive Score of Financial Toxicity (COST) and the PROMIS Global Health Questionnaire.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Wheeler, SB., Biddell, CB., Manning, ML., et al.[2022]

Financial toxicity (FT) is a significant issue for about half of cancer patients, particularly affecting those from socioeconomically vulnerable backgrounds, leading to negative economic and health outcomes.

Financial navigation, led by social workers or nurse navigators, is a key strategy to help patients manage FT by assessing their risk factors and connecting them to resources, while oncologists can play a crucial role in addressing financial concerns during treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Navigating financial toxicity in patients with cancer: A multidisciplinary management approach. Smith, GL., Banegas, MP., Acquati, C., et al.[2023]

A pilot study involving 34 cancer patients showed that a financial navigation program effectively reduced anxiety about treatment costs for 33% of participants, highlighting its potential to support patients in managing financial stress.

While the program provided valuable assistance with budgeting and insurance applications, it did not significantly change self-reported financial burden, indicating that while anxiety can be alleviated, overall financial challenges may persist.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Feasibility Study of an Oncology Financial Navigation Program. Shankaran, V., Leahy, T., Steelquist, J., et al.[2019]

A study involving 35 financial navigation staff from 29 cancer centers highlighted the importance of proactive financial assessments and tailored assistance to help cancer patients, especially in rural areas, manage financial toxicity.

Best practices identified include using screening tools and patient education, along with a call for more financial navigators and policy reforms to improve access to resources and support for patients facing financial challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to address cancer-related financial toxicity: Recommendations from the field. Edward, J., Petermann, VM., Eberth, JM., et al.[2023]

Financial toxicity, which refers to the financial burdens faced by cancer patients due to their diagnosis and treatment, is becoming a significant issue in the U.S. healthcare system as cancer treatments become more expensive.

Oncology providers can play a crucial role in addressing financial toxicity by implementing routine financial screenings, creating financial navigation programs, and advocating for policies that reduce costs and enhance value-based care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining the Role of the Modern Oncology Provider in Mitigating Financial Toxicity. Su, CT., Shankaran, V.[2023]

The oncology financial navigation intervention, CC Links, significantly reduced financial toxicity for both patients with hematologic cancer and their caregivers, with statistical improvements noted in their financial distress and quality of life.

The intervention was highly accepted by participants, with 89% rating it positively, and it successfully secured an average of $2,500 in financial benefits per participant, indicating its practical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coverage and Cost-of-Care Links: Addressing Financial Toxicity Among Patients With Hematologic Cancer and Their Caregivers. Edward, JS., McLouth, LE., Rayens, MK., et al.[2023]

Financial toxicity, or the financial burden of cancer treatment, is a critical issue that is often overlooked in clinical trial designs, despite its significant impact on patients.

Providing patients with comprehensive information about treatment efficacy, side effects, and costs enables them to make more informed decisions regarding their cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporating financial toxicity considerations into clinical trial design to facilitate patient-centered decision-making in oncology. Gharzai, LA., Jagsi, R.[2023]

The LIFT intervention effectively reduces financial toxicity in cancer patients by implementing core functions such as systematic tracking of patient eligibility for financial support and fostering ongoing relationships between financial navigators and patients.

Identifying both intervention and implementation core functions is crucial for adapting LIFT, with key elements including training for navigators and ensuring engaged sites have the necessary resources to support financial navigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Wheeler, SB., Birken, SA., Wagi, CR., et al.[2023]

The CAFÉ study is a randomized controlled trial designed to assess the effectiveness of financial navigation interventions in reducing cancer-related financial hardship among patients, with outcomes measured at a 12-month follow-up.

By comparing patients receiving either brief or extended financial navigation support to a control group receiving standard care, the study aims to provide evidence on how financial navigation can improve quality of life and reduce financial distress in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Cancer Financial Experience (CAFÉ) study: randomized controlled trial of a financial navigation intervention to address cancer-related financial hardship. Henrikson, NB., Anderson, ML., Dickerson, J., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Navigating financial toxicity in patients with cancer: A multidisciplinary management approach. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Pilot Feasibility Study of an Oncology Financial Navigation Program. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Interventions to address cancer-related financial toxicity: Recommendations from the field. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Defining the Role of the Modern Oncology Provider in Mitigating Financial Toxicity. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Coverage and Cost-of-Care Links: Addressing Financial Toxicity Among Patients With Hematologic Cancer and Their Caregivers. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Incorporating financial toxicity considerations into clinical trial design to facilitate patient-centered decision-making in oncology. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

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. [2023]

9. England pubmed.ncbi.nlm.nih.gov

The Cancer Financial Experience (CAFÉ) study: randomized controlled trial of a financial navigation intervention to address cancer-related financial hardship. [2023]