Financial Navigation for Cancer

(CAFE Trial)

Overseen By Aaron Scrol

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Non-melanoma skin cancer, Hospice, others

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

Compensation: Varies

Number of Visits: 1

Duration: 6 months

371 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help individuals with new cancer diagnoses manage the financial stress often associated with treatment. It tests a new financial navigation service to determine if it can reduce financial worries and improve quality of life. Participants are divided into three groups: one receives usual care with a resource sheet, another receives the sheet plus a short financial guidance session, and the last receives extended guidance. Eligible participants include those recently diagnosed with cancer (excluding non-melanoma skin or benign tumors) who have visited a CAFÉ clinic. As an unphased trial, this study provides a unique opportunity to access innovative support services that could significantly enhance quality of life.

What prior data suggests that this financial navigation intervention is safe?

Research has shown that financial navigation programs are safe for patients. Studies have found that these programs help patients better understand their healthcare costs and insurance coverage while reducing the financial stress related to cancer treatment. No reports indicate negative effects from participating in financial navigation programs, suggesting these programs are well-tolerated and pose no risks to patient safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Financial Navigation for Cancer trial because it aims to address a crucial aspect of cancer care that often gets overlooked: financial burden. Unlike standard care that primarily focuses on medical treatment, this approach incorporates financial navigation, which helps patients manage the costs associated with their care. The trial explores different levels of support, from providing a simple resource sheet to offering personalized financial guidance through multiple cycles of navigation. This method has the potential to reduce stress and improve the overall quality of life for patients by making cancer care more financially manageable.

What evidence suggests that this trial's financial navigation interventions could be effective for reducing financial hardship in cancer patients?

Research has shown that financial guidance can ease money problems for cancer patients. For example, one study found that this support saved patients and hospitals a total of $39 million. Another study found that financial guidance can reduce money worries, especially for patients more likely to face financial difficulties. In this trial, participants in Arm 2 will receive a brief financial navigation intervention, while those in Arm 3 will receive an extended version. Additionally, help with finances and insurance can improve the quality of life for those dealing with cancer-related money issues. These findings suggest that financial guidance effectively supports patients by reducing financial stress and improving overall well-being during cancer treatment. ^{1 6 7 8 9}

Who Is on the Research Team?

Nora B Henrikson, PhD, MPH

Principal Investigator

Kaiser Permanente

Amanda Petrik, PhDC, MS

Principal Investigator

Kaiser Permanente

Matthew Banegas, PhD, MPH, MS

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for members of KPNW and KPWA who are over 18 years old, have been diagnosed with cancer (excluding non-melanoma skin cancer and benign or in situ tumors) within the last 120 days, speak English (or Spanish at KPNW), visited a CAFÉ clinic recently, and haven't been referred to hospice in the past year. They should not be on a do-not-contact list or have participated in related studies.

Inclusion Criteria

KPNW and KPWA members with a new cancer diagnosis (within the past 120 days from identification date)

I have been enrolled in my current health plan for at least 6 months.

Recent visit to CAFÉ clinic/department

Exclusion Criteria

My cancer is non-invasive or hasn't spread.

My cancer diagnosis is for a type of skin cancer that is not melanoma.

Hospice referral in past year

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive financial navigation intervention to address financial hardship during cancer treatment

6 months

At least 1 phone call per cycle with a CAFÉ Financial Navigator

Follow-up

Participants are monitored for financial hardship and health-related quality of life

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced usual care
• Financial navigation

Trial Overview The study tests a 'financial navigation' service against 'enhanced usual care' to see if it helps reduce financial hardship and improves quality of life for new cancer patients. It also looks at how quickly patients start treatment after diagnosis.

How Is the Trial Designed?

Group I: Arm 3: Extended financial navigation intervention Experimental Treatment 1 Intervention

Participants in this arm will receive their usual care, a Financial Resource Sheet and the brief intervention described in Arm 2 (i.e., one (1) cycle of financial navigation). Plus, they will receive two (2) additional cycles of financial navigation (total cycles: 3; total length: 6 months).

Group II: Arm 2: Brief financial navigation intervention Experimental Treatment 1 Intervention

Participants in this arm will receive their usual care, and the Financial Resource Sheet described in Arm 1, plus one (1) cycle of financial navigation (total cycles: 1; total length: 6 months). In each intervention cycle participants will get at least one (1) phone call with a CAFÉ Financial Navigator, the navigator will talk with participants to identify financial questions or concerns. The navigator will create a personalized plan for each participant. Participants can request extra support from the navigator for up to 6 months.

Group III: Arm 1: Enhanced usual care Active Control 1 Intervention

Participants in this arm will receive their usual care plus a Financial Resource Sheet. The financial resource sheet lists and describes existing organization and community resources available to KP members.

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

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. ascopubs.org ascopubs.org/doi/10.1200/JCO.21.02184

Financial Navigation in Cancer Care Delivery: State of the ... In another study, hospital-hired trained oncology financial navigators saved patients and hospital systems $39,000,000 US dollars (USD) for ...

4. 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] ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7370695/

Financial Burdens of Cancer Treatment: A Systematic ... This study systematically reviewed risk factors and outcomes associated with financial burdens related to cancer treatment.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04960787

NCT04960787 | Financial Navigation Program to Improve ... To determine whether a proactive financial navigation program for patients planning to receive anti-cancer treatment decreases the risk of material household ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCT04960787

Financial Navigation Program to Improve Understanding ... This clinical trial examines a financial navigation program in helping patients understand and better manage the financial aspects of cancer care.

8. sirenetwork.ucsf.edu sirenetwork.ucsf.edu/tools-resources/resources/hybrid-technology-enabled-financial-navigation-model-combat-financial?destination=%2Ftools%2Fevidence-library

A hybrid technology-enabled financial navigation model to ... This approach has the potential to improve treatment adherence, reduce disparities, and serve as a scalable model for addressing financial ...

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

Patient Navigation in Cancer Treatment: A Systematic Review This systematic review provides compelling evidence supporting the value of patient navigation programs in cancer treatment.