Financial Navigation for Cancer-Related Financial Toxicity

No longer recruiting at 8 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if financial navigation can assist cancer patients in managing treatment costs. It focuses on reducing financial stress and enhancing the quality of life for patients in both rural and non-rural communities in North Carolina. Participants will collaborate with a financial navigator to seek financial assistance and complete surveys to monitor their progress. The trial seeks individuals who have had cancer within the last five years or are living with advanced cancer and experiencing financial strain from their treatment. As an unphased trial, this study provides patients with the opportunity to access potentially beneficial financial resources and support.

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 prior data suggests that financial navigation is safe for patients?

Research has shown that financial navigation programs help cancer patients manage treatment costs. These programs aim to reduce "financial toxicity," the stress and burden of medical bills. Studies have found that more than half of cancer patients face significant financial challenges due to treatment costs.

Financial navigation involves working with a financial navigator who helps find resources and assistance to manage these costs. The program includes surveys to better understand patients' financial situations and typically involves a few meetings with the navigator to ease the financial burden.

Since financial navigation focuses on support and guidance rather than medication or medical procedures, it poses no traditional safety risks like side effects. Instead, the goal is to improve quality of life by reducing financial stress. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Financial Navigation treatment because it directly addresses the financial burden that often accompanies cancer care, an area many standard treatments overlook. Unlike traditional methods that primarily focus on medical interventions, Financial Navigation involves personalized guidance through financial toxicity screening and multiple sessions with a financial navigator. This approach aims to alleviate financial stress by connecting patients with resources and assistance, potentially improving overall well-being and adherence to medical treatments. By targeting the financial challenges head-on, this treatment could significantly enhance the quality of life for cancer patients.

What evidence suggests that financial navigation is effective for reducing cancer-related financial toxicity?

Studies have shown that financial navigation, provided to participants in this trial, can ease the financial burden of cancer care. Research indicates that this approach improves access to financial assistance and simplifies health insurance management. In one study, all patients experienced financial stress, and most reported feeling better after using financial navigation. Early evidence suggests that structured financial navigation is well-received and aids patients in managing cancer treatment costs. Although the full effectiveness is still under study, early results are promising in reducing financial stress for cancer patients. ^{4 5 6 7 8}

Who Is on the Research Team?

Stephanie Wheeler, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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, 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 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]

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, 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 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]

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]

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]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/OP-25-00874

Financial Navigation for People Newly Diagnosed With ... Financial navigation could mitigate or prevent cancer-related financial hardship, but its effectiveness has not been established in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9022465/

Evidence of the Feasibility and Preliminary Efficacy ... Oncology financial navigation (OFN) aims to reduce financial hardship by coordinating processes of accessing financial assistance and health insurance options.

3. jnccn.org jnccn.org/abstract/journals/jnccn/22/8/article-p557.xml

Impact of a Comprehensive Financial Navigation ... Results: All 50 patients assessed for study eligibility screened positive for financial distress. A total of 46 patients completed both the ...

4. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21730

Navigating financial toxicity in patients with cancer: A ... These results provide initial evidence that structured financial navigation demonstrates acceptability, enables high-fidelity provision of ...

5. stacks.cdc.gov stacks.cdc.gov/view/cdc/119647/cdc_119647_DS1.pdf

Financial Navigation Staff Perspectives on Patients' ... Cancer treatment costs contribute to the financial toxicity experienced by cancer patients, especially as insurance co-pays and out of pocket (OOP) costs ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12511694/

A Hybrid Technology-Enabled Financial Navigation Model ... Financial toxicity is an immediate and pervasive issue for cancer patients, with over half experiencing catastrophic health expenditures during ...

7. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06745-4

Lessening the Impact of Financial Toxicity (LIFT): a protocol for ... Almost half of the patients with cancer report cancer-related financial hardship, termed “financial toxicity” (FT), which affects health-related ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04931251

Addressing Cancer-Related Financial Toxicity in Rural ... The financial navigation intervention consists of screening patients using the COST measure for financial toxicity. If the patient scores 23 or lower, they are ...