Financial Navigation Program for Cancer

(CREDIT Trial)

Not currently recruiting at 281 trial locations

Overseen By Charles M. Farber

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Southwest Oncology Group

Disqualifiers: Hospice care, Non-spouse/partner caregivers

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help cancer patients and their spouse or partner caregivers manage the financial challenges of cancer treatment. It tests a new financial navigation program, which includes financial literacy training through short online videos and, for some, monthly meetings with financial counselors. Participants will learn to handle expenses, understand insurance coverage, and find cost-saving methods. Ideal candidates are those recently diagnosed with metastatic cancer and actively receiving treatment, who feel stressed about treatment costs and can complete surveys in English or Spanish. As an unphased trial, this study offers a unique opportunity to gain valuable financial skills and support during a challenging time.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. It focuses on financial navigation for cancer care, so it's best to discuss your medications with your healthcare provider.

What prior data suggests that this financial navigation program is safe for cancer patients and their caregivers?

Research has shown that financial navigation programs are safe and well-received. Studies have found that these programs help cancer patients and their caregivers save money and improve their quality of life. Financial navigation involves working with experts to manage cancer care costs, reducing stress and hardship.

Most healthcare facilities already offer this kind of assistance, making it a common and accepted practice. There is no risk of physical harm, as it focuses on financial advice and support, not medical treatment. The main goal is to help patients understand their expenses and find better ways to manage them. This approach has significantly reduced financial worries for those dealing with cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Financial Navigation Program for cancer patients because it offers a unique support system that goes beyond traditional medical treatments. Unlike other options that might focus solely on medical care, this program addresses financial stress by providing patients with financial literacy tools and monthly counseling sessions with experts. This holistic approach not only educates patients about managing their finances but also actively helps them navigate complex insurance and financial systems, aiming to reduce financial worry and improve overall quality of life. By integrating financial guidance with cancer care, this program has the potential to significantly ease the burden on patients and their families, making it a groundbreaking addition to cancer support services.

What evidence suggests that this financial navigation program is effective for managing the financial aspects of cancer care?

Research has shown that financial navigation programs can help reduce money problems for cancer patients. In this trial, participants in the financial navigation intervention group will receive assistance in understanding their health insurance options and finding financial help, easing their financial stress. One report found that most participants were satisfied with such programs and felt they understood medical costs better. Additionally, a review of several studies has shown that financial navigation reduces money worries for patients likely to face financial issues. Overall, these programs seem to improve quality of life by helping patients manage the cost of cancer treatment. ^{1 5 6 7 8}

Who Is on the Research Team?

Veena Shankaran

Principal Investigator

SWOG Cancer Research Network

Are You a Good Fit for This Trial?

This trial is for adult cancer patients with metastatic solid tumors or blood cancers starting treatment within 60 days of diagnosis, and their spouses who live together and can complete questionnaires in English or Spanish. Excluded are those on hospice care, with indolent diseases under observation only, or diagnosed with a secondary malignancy within the last 24 months unless it's specific non-active skin cancers.

Inclusion Criteria

I can take care of myself and am up and about more than 50% of my waking hours.

I have completed the required questionnaires in English or Spanish before signing up.

My cancer has returned, but it's the first time it has spread, and it was diagnosed 6 months after my initial cancer diagnosis.

Exclusion Criteria

Patients may not be enrolled in hospice care at the time of registration

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Financial Literacy Training

Participants receive financial literacy training consisting of watching online educational videos over 2-8 minutes and complete questionnaires about education, employment, finances, insurance, and quality of life.

6 months

Monthly visits (virtual)

Financial Navigation Intervention

Participants in the intervention group meet with CENTS counselor and PAF case manager over approximately 1 hour every month for 6 months to receive financial navigation services.

6 months

Monthly visits (virtual)

Follow-up

Participants are monitored for financial hardship, quality of life, and other outcomes at 3, 6, and 12 months.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Financial Navigation Program

Trial Overview

The study tests a financial navigation program designed to help cancer patients and their spouses manage treatment costs. It involves education, patient navigation support, quality-of-life assessments, and completing questionnaires to evaluate the program's effectiveness in reducing financial stress.

How Is the Trial Designed?

Group I: Group II (financial navigation intervention) Experimental Treatment 4 Interventions

Patients receive financial literacy training consisting of watching online educational videos over 2-8 minutes. Patients also meet with CENTS counselor and PAF case manager over approximately 1 hour every month for 6 months (with each group). Patients also complete questionnaires over 30-60 minutes about education, employment, finances (assets, debt), insurance, and quality of life (financial worry) and have credit reports assessed at baseline and 3, 6, and 12 months. If participating, spouse/partner caregivers will receive the same intervention, and will complete questionnaires and have credit reports assessed at baseline and 3, 6, and 12 months.

Group II: Group I (usual care) Active Control 3 Interventions

Patients receive financial literacy training consisting of watching online educational videos over 2-8 minutes. Patients also complete questionnaires over 30-60 minutes about education, employment, finances (assets, debt), insurance, and quality of life (financial worry) and have credit reports assessed at baseline and 3, 6, and 12 months. If participating, spouse/partner caregivers will receive the same intervention, and will complete questionnaires and have credit reports assessed at baseline and 3, 6, and 12 months.

Who Is Running the Clinical Trial?

Southwest Oncology Group

Lead Sponsor

Trials

389

Recruited

260,000+

SWOG Cancer Research Network

Lead Sponsor

Trials

403

Recruited

267,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

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]

A pilot study involving 2741 oncology patients showed that financial hardship screening led by lay navigators was highly feasible, with a 90% completion rate, indicating that integrating such screenings into standard care is practical.

The screening revealed significant racial disparities in financial distress, with 49% of BIPOC patients reporting financial distress compared to 30% of White patients, highlighting the need for targeted interventions to address these inequities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer-Related Financial Hardship Screening as Part of Practice Transformation. Williams, CP., Liang, MI., Rocque, GB., et al.[2023]

In a study of 438 cancer patients, patient navigation (PN) did not significantly improve overall treatment completion time, satisfaction with care, or psychological distress compared to usual care.

However, socially disadvantaged patients who received PN reported higher satisfaction with their care, indicating that PN may be beneficial for specific groups, despite no overall benefits observed in the primary analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation for breast and colorectal cancer treatment: a randomized trial. Fiscella, K., Whitley, E., Hendren, S., et al.[2021]

A study involving 83 stakeholders from 10 oncology care sites revealed that financial navigation (FN) is crucial for addressing the financial hardships faced by cancer patients, highlighting the need for systematic implementation of FN processes.

Key barriers to effective financial assistance included insufficient staff resources and challenges in identifying patient needs, while open communication among staff and patients was identified as a significant facilitator in both rural and nonrural settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Financial Assistance Processes and Mechanisms in Rural and Nonrural Oncology Care Settings. Biddell, CB., Spees, LP., Petermann, V., et al.[2023]

A survey of 214 frontline oncology support personnel (FOSPs) revealed that while they are aware of and comfortable discussing the financial burdens faced by cancer patients, only 15% believe that available resources are sufficient to meet patient needs.

FOSPs experience moral distress due to inadequate resources, highlighting the need for interventions that enhance resource availability and streamline processes to support both patients and the FOSP workforce effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge, Attitudes, and Resources of Frontline Oncology Support Personnel Regarding Financial Burden in Patients With Cancer. Reeder-Hayes, KE., Biddell, CB., Manning, ML., et al.[2023]

Navigation programs in oncology significantly improve outcomes for cancer patients by reducing the time it takes to receive a diagnosis and treatment, while also enhancing knowledge and adherence to care among patients and caregivers.

These programs not only benefit patients but also healthcare institutions by lowering costs associated with emergency visits and readmissions, indicating a positive impact on overall healthcare efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of the Oncology Nurse Navigator Throughout the Cancer Trajectory. [2019]

Nurse navigation in cancer care has been associated with significant improvements in clinical outcomes, including reduced distress, anxiety, and depression among patients.

Patients receiving nurse navigation experienced better symptom management, improved physical conditioning, enhanced quality of life, and quicker initiation of treatment, highlighting the effectiveness of this approach in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of patient navigation performed by nurses in the oncology setting: an integrative review. Rodrigues, RL., Schneider, F., Kalinke, LP., et al.[2022]

A study involving 11,186 new cancer patients across 4 hospitals found that 32% qualified for financial assistance, receiving a total of $39 million, which significantly reduced their out-of-pocket costs.

Training financial navigators helped patients save an average of $33,265 on medications and $12,256 through insurance enrollment, while hospitals also benefited by avoiding $2.1 million in write-offs annually.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of trained oncology financial navigators on patient out-of-pocket spending. Yezefski, T., Steelquist, J., Watabayashi, K., et al.[2019]

A significant number of cancer patients experience financial hardship, which negatively impacts their quality of life and treatment adherence, highlighting the need for effective oncology financial navigation (OFN) services.

While the implementation of OFN has been shown to be feasible, existing studies have small sample sizes and primarily focus on urban, academic settings, suggesting a need for future research to include underserved and racially diverse populations to better understand and address financial barriers in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence of the Feasibility and Preliminary Efficacy of Oncology Financial Navigation: A Scoping Review. Doherty, MJ., Thom, B., Gany, F.[2022]

A survey of 78 oncology navigators revealed that approximately 75% of their patients experience financial toxicity related to cancer treatment, highlighting a significant emotional and financial burden on patients.

Navigators identified key barriers to financial assistance for patients, including a lack of resources and knowledge about available support, indicating a need for better training and coordination to help patients access financial aid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncology navigators' perceptions of cancer-related financial burden and financial assistance resources. Spencer, JC., Samuel, CA., Rosenstein, DL., et al.[2021]

Citations

1.

ascopubs.org

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

Financial Navigation for People Newly Diagnosed With ...

This manuscript reports our primary outcomes, comparing self-reported (1) financial hardship and (2) quality of life between patients receiving ...

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.

sciencedirect.com

sciencedirect.com/science/article/pii/S2347562525000162

The development and preliminary evaluation of a financial ...

Most (91.7%) participants were satisfied with the program and perceived benefits. The intervention significantly improved cost-related health literacy, although ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11063100/

Patient Navigation in Cancer Treatment: A Systematic Review

Thirty-seven studies investigated disadvantaged populations, with 76% of them concluded that patient navigators made a positive impact during treatment. This ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S1551714425000837

Study protocol for ECOG-ACRIN EAQ222CD

A recent meta-analysis of cancer patients showed that financial navigation can reduce financial worry among patients at high risk for financial hardship. [12] ...

6.

cancer.gov

cancer.gov/news-events/cancer-currents-blog/2023/cancer-care-financial-navigation-saves-money

Financial Navigators Reduce the Cost of Cancer Care - NCI

Several studies have now shown that financial navigation programs can help people with cancer and their caregivers save money and improve their quality of life.

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37561111/

Assessment of financial screening and navigation capabilities ...

Most sites (96%) reported offering financial navigation for cancer patients. Sites primarily identified patients needing financial assistance through social ...

8.

ajmc.com

ajmc.com/view/financial-navigation-lessons-from-a-program-in-practice

Financial Navigation: Lessons From a Program in Practice

The history of financial navigation in cancer care reflects an ongoing commitment to addressing the economic challenges faced by patients.