Financial Navigation Program for Cancer

(CREDIT Trial)

Recruiting at 272 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

331 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial examines a financial navigation program in helping patients (and their spouses or partner caregivers, if participating) understand and better manage the financial aspects of cancer care. Cancer patients and their spouse/partner caregivers may be at high risk for financial problems because of the cost of cancer treatment. A financial navigator is a person or team who works with patients and their families to help them reduce stress or hardship related to the cost of cancer treatment. Financial navigators help patients understand their out-of-pocket expenses and what their health insurance plans may cover. Financial navigation may also help patients set up payment plans, find cost-saving methods for treatments, and improve access to healthcare services that the patient needs. Providing financial navigation to patients may help reduce financial worries and improve quality of life.

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 data supports the effectiveness of the Financial Navigation Program treatment for cancer patients?

Research shows that financial navigation helps cancer patients by identifying financial needs, clarifying treatment costs, and developing plans to manage expenses, which can improve their quality of life and reduce financial stress. ^{1 2 3 4 5}

Is the Financial Navigation Program safe for humans?

The Financial Navigation Program is designed to help cancer patients manage financial stress and does not involve any physical treatment, so there are no safety concerns related to its use. ^{2 5 6 7 8}

How is the Financial Navigation Program for Cancer different from other treatments for cancer-related financial burden?

The Financial Navigation Program for Cancer is unique because it specifically targets financial toxicity (the financial hardship caused by cancer treatment) by systematically identifying patients at high risk, assessing their eligibility for resources, and helping them develop a plan to manage cancer costs. Unlike traditional medical treatments, this program focuses on reducing the financial burden associated with cancer care, which can improve patients' quality of life and treatment adherence. ^{1 2 9 10 11}

Research Team

Veena Shankaran

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

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

Financial Assistance Processes and Mechanisms in Rural and Nonrural Oncology Care Settings. [2023]

2. 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]

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

Impact of trained oncology financial navigators on patient out-of-pocket spending. [2019]

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

Patient navigation for breast and colorectal cancer treatment: a randomized trial. [2021]

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

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

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

Cancer-Related Financial Hardship Screening as Part of Practice Transformation. [2023]

7. Brazil pubmed.ncbi.nlm.nih.gov

Clinical outcomes of patient navigation performed by nurses in the oncology setting: an integrative review. [2022]

8. 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]

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

Knowledge, Attitudes, and Resources of Frontline Oncology Support Personnel Regarding Financial Burden in Patients With Cancer. [2023]

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

Evidence of the Feasibility and Preliminary Efficacy of Oncology Financial Navigation: A Scoping Review. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Oncology navigators' perceptions of cancer-related financial burden and financial assistance resources. [2021]