Financial Counseling for Cancer Patients

(CAN-ASSIST Trial)

Not currently recruiting at 5 trial locations

Overseen By Richard J Echeverria

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Indolent cancer, ECOG > 2, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to assist cancer patients facing financial challenges and related issues like food or housing insecurity. It compares three groups: one receives extra financial counseling and navigation (CostCOM), another gains access to educational resources, and the last receives usual care. The trial aims to determine if these approaches help patients adhere to their cancer treatment plans, reduce financial stress, and improve quality of life. This trial may suit individuals diagnosed with cancer within the last four months, currently undergoing treatment, and experiencing financial hardship or related social needs. As an unphased trial, it offers a unique opportunity to explore innovative support methods that could significantly enhance treatment experiences and 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 seems to focus on financial counseling rather than changes to your medical treatment.

What prior data suggests that this financial counseling program is safe for cancer patients?

Research has shown that financial navigation and counseling programs, such as CostCOM, are generally safe for patients. These programs aim to reduce the financial stress of cancer treatment by helping patients manage healthcare costs and improve their financial understanding. Initial findings suggest that patients handle these programs well, with no negative side effects reported.

Similarly, financial education programs, like FinEd, provide patients with resources and information to better understand their finances and access support services. Studies indicate that these programs help ease financial burdens without causing harm to participants. Both types of programs are designed to support patients without introducing health risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Financial Counseling for Cancer Patients trial because it explores innovative ways to reduce financial stress for patients undergoing treatment. Unlike usual care, which may not actively address financial hardships, the CostCOM treatment stands out by providing two personalized sessions with a remote financial counselor to help navigate out-of-pocket costs and offer financial advice. Additionally, the FinEd treatment arm provides patients with a comprehensive list of financial resources and educational materials to boost financial literacy. These approaches aim to empower patients with the tools and knowledge needed to manage the financial burdens of cancer treatment, potentially improving their overall wellbeing and treatment outcomes.

What evidence suggests that this trial's treatments could be effective for cancer patients facing financial hardship?

Research has shown that the CostCOM program, which participants in this trial may receive, includes financial counseling and guidance that can improve cancer care and patient outcomes. One study found that patients who participated in CostCOM followed their care plans more effectively and experienced less financial stress. This program provides personalized advice on managing out-of-pocket costs and connects patients to helpful resources.

Another treatment arm in this trial is the FinEd approach, which offers educational materials and lists of resources. Research on its exact effectiveness remains less clear. However, providing patients with information about financial resources might help them manage their finances better. Overall, both programs in this trial aim to reduce financial worries and improve the quality of life for cancer patients facing financial challenges. ^{1 3 6 7 8}

Who Is on the Research Team?

Gelareh Sadigh

Principal Investigator

University of California, Irvine

Are You a Good Fit for This Trial?

This trial is for newly diagnosed cancer patients who are experiencing financial hardship and social needs, such as concerns about food, housing, transportation, or utilities. Participants must screen positive for these challenges to be eligible.

Inclusion Criteria

I am experiencing financial difficulties or have health-related social needs.

I was diagnosed with cancer in the last 4 months.

Getting treatment in University of California Irvine-affiliated oncology clinics

Exclusion Criteria

Patients participating in other therapeutic clinical trials covering the cost of treatment.

My daily activity is significantly limited due to my health.

My cancer is slow-growing and I am not currently receiving treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either CostCOM, FinEd, or Enhanced Usual Care interventions

6 months

2 remote sessions for CostCOM, self-guided for FinEd, usual care for EUC

Follow-up

Participants are monitored for outcomes such as cost-related cancer care non-adherence, financial worry, and quality of life

6-8 months

What Are the Treatments Tested in This Trial?

Interventions

• CostCOM
• Financial Education
• Provision of local and national resources to address financial and social needs

Trial Overview

The study compares three approaches: a comprehensive financial navigation program (CostCOM), access to financial education materials plus resources list without a navigator (FinEd), and the usual care practices. It aims to see which method best improves adherence to cancer care due to cost issues, reduces financial worry, increases health insurance understanding, enhances quality of life and sleep quality, and decreases missed appointments.

How Is the Trial Designed?

Group I: Arm C: FinEd Experimental Treatment 4 Interventions

Usual care + access to local and national resources including (1) a detailed list of local and national resources for financial navigation, and social needs where patients can self-refer and (2) video and online /printed educational materials to improve financial health literacy

Group II: Arm B: CostCOM Experimental Treatment 3 Interventions

Usual care + two 1-hour phone or video sessions with a remote financial counselor including out-of-pocket cost communication, financial navigation and counseling.

Group III: Arm A: Enhanced Usual Care (EUC) Active Control 2 Interventions

Usual care + pre-screening for financial hardship and social risks

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Chao Family Comprehensive Cancer Center

Collaborator

Trials

4

Recruited

300+

Published Research Related to This Trial

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 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]

The DIScussions of COst (DISCO) App was successfully pilot-tested with 32 cancer patients, showing that it significantly increased patients' self-efficacy in managing treatment costs and interacting with their physicians.

All clinic visits included cost discussions after using the DISCO App, indicating that the app effectively prompted these important conversations, which are often overlooked in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The DISCO App: A pilot test of a multi-level intervention to reduce the financial burden of cancer through improved cost communication. Hamel, LM., Dougherty, DW., Hastert, TA., et al.[2023]

A financial counseling (FC) intervention for chemotherapy patients was found to be feasible and acceptable, with high completion rates for initial phone calls (98%) but lower rates for in-person visits (47%) and the entire intervention (30%).

Despite the intervention's acceptability, there were no significant changes in financial distress (FD) between the FC and standard care groups, indicating that while patients appreciated the cost transparency, it did not directly alleviate their financial burdens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Piloting a Financial Counseling Intervention for Patients With Cancer Receiving Chemotherapy. Kircher, SM., Yarber, J., Rutsohn, J., et al.[2020]

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]

A study involving interviews with 35 financial navigation staff from 29 cancer centers revealed that communication issues significantly affect how patients and staff discuss cancer-related financial burdens, highlighting the need for better expectations and timing in these sensitive conversations.

The financial burden of cancer profoundly impacts patients' overall well-being, leading to increased stress, difficulties in adhering to treatment, and challenges in meeting basic needs, suggesting that regular discussions about costs are essential for supporting cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Financial navigation: Staff perspectives on patients' financial burden of cancer care. Yeager, KA., Zahnd, WE., Eberth, JM., et al.[2023]

A significant portion of caregivers (43%) reported out-of-pocket expenses for medications during the last six months of their loved ones' lives, highlighting the financial burden of cancer care.

Most oncologists (73%) did not inquire about patients' financial ability before suggesting out-of-pocket medications, and many provided insufficient explanations about the benefits and alternatives, indicating a need for improved communication skills regarding treatment costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Out-of-Pocket Spending for Cancer Medication, Financial Burden, and Cost Communication with Oncologists in the Last Six Months of Life in Israel. Tur-Sinai, A., Bentur, N., Urban, D.[2021]

The CostCOM intervention, which provided personalized cost communication and financial navigation for 23 newly diagnosed cancer patients, was highly feasible with an 86.9% completion rate, significantly reducing patients' financial worry as indicated by improved COST scores (from 10.0 to 16.9).

Patients reported high satisfaction with the CostCOM program (average score of 4.1 out of 5), and 75% felt it positively impacted their mental health, suggesting that addressing financial concerns can enhance overall well-being without affecting their treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment out-of-pocket cost communication and remote financial navigation in patients with cancer: a feasibility study. Sadigh, G., Coleman, D., Switchenko, JM., et al.[2023]

A study involving 32 participants, including oncology providers, patients, and caregivers, revealed a consensus that cost communication in oncology should not be led by providers, but rather by social workers or financial advisors who are better equipped to handle these discussions.

Participants emphasized the importance of timely cost conversations, ideally at the time of diagnosis, and suggested that discussions should include various financial metrics beyond just overall treatment costs, such as lost workdays and out-of-pocket expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing routine communication about costs of cancer treatment: perspectives of providers, patients, and caregivers. Haverfield, MC., Singer, AE., Gray, C., et al.[2020]

Patients in the USA often face significant financial burdens from cancer care, and both physicians and patients lack adequate information about these costs, which can lead to misunderstandings and increased stress.

There is a need for improved cost transparency and education for both patients and physicians, as many patients want to discuss costs but rarely have these conversations, highlighting a gap in communication regarding financial aspects of cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The financial burden of cancer care: do patients in the US know what to expect? Peppercorn, J.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06295367

Study Details | NCT06295367 | Cost Communication and ...

This clinical trial evaluates the effect of Cost Communication and Financial Navigation (CostCOM) intervention on adherence to care and financial burden in ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40147544

Study protocol for ECOG-ACRIN EAQ222CD - PubMed - NIH

A successful CostCOM is a scalable and financially sustainable program that can improve cancer care delivery, patients' experience, and health outcomes. Trial ...

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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 ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9834906/

Treatment out-of-pocket cost communication and remote ...

We conducted a pilot study assessing the feasibility of a personalized out-of-pocket cost communication, remote financial navigation, and counseling (CostCOM) ...

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ecog-acrin.org

ecog-acrin.org/clinical-trials/eaq222cd-various-cancer/

EAQ222CD / COSTCOM Home Page

This clinical trial evaluates the effect of Cost Communication and Financial Navigation (CostCOM) intervention on adherence to care and financial burden in ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12128040/

Study Protocol for ECOG-ACRIN EAQ222CD - PMC

A successful CostCOM is a scalable and financially sustainable program that can improve cancer care delivery, patients' experience, and health outcomes.

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carle.org

carle.org/for-providers/research/clinical-trials/864

Cost Communication and Financial Navigation in Cancer ...

This clinical trial evaluates the effect of Cost Communication and Financial Navigation (CostCOM) intervention on adherence to care and financial burden in ...

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oncpracticemanagement.com

oncpracticemanagement.com/issues/2023/june-2023-vol-13-no-6/financial-navigation-can-reduce-the-financial-toxicity-of-cancer-care

Financial Navigation Can Reduce the Financial Toxicity of ...

Results from a new study add to the evidence that programs aimed at reducing the financial burden of cancer treatment can save money and improve the quality ...