90 Participants Needed

Financial Counseling for Cancer Patients

(CAN-ASSIST Trial)

Recruiting at 5 trial locations
GS
RJ
Overseen ByRichard J Echeverria
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Irvine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Financial hardship and health-related social needs (e.g., insecurity about food, housing, transportation, utilities) are common among patients with cancer, resulting in health disparities in cancer outcomes. Our study will test the efficacy of a multicomponent financial navigation and counseling program delivered by a financial navigator (CostCOM), vs. direct patient access to financial education materials and comprehensive list of local resources in the absence of a financial navigator (FinEd) vs. practice usual care among newly diagnosed cancer patients who screen positive for financial hardship and social needs. Investigators anticipate that both CostCOM and FinEd compared to enhanced usual care will improve cost-related cancer care nonadherence, financial worry, health insurance literacy, quality of life and sleep quality and decrease number of missed appointments.

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.

Is financial counseling for cancer patients safe?

The studies reviewed focus on the feasibility and communication aspects of financial counseling for cancer patients, but they do not report any safety concerns or adverse effects related to the intervention.12345

How is the CostCOM treatment different from other treatments for cancer patients?

CostCOM is unique because it focuses on personalized communication about out-of-pocket costs and provides remote financial navigation and counseling to help cancer patients manage their financial burden, unlike traditional treatments that primarily address medical aspects of cancer care.16789

What data supports the effectiveness of the treatment CostCOM, Cost Communication and Financial Navigation, Financial Education, Financial Counseling, Financial Navigation, Cost Communication, Provision of local and national resources to address financial and social needs for cancer patients?

Research shows that personalized cost communication and financial counseling can help cancer patients manage financial distress. Studies found that interventions like the DISCO App, which improve cost discussions, are feasible and can reduce the financial burden by enhancing communication between patients and healthcare providers.135810

Who Is on the Research Team?

GS

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
See 1 more

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.
See 1 more

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?
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm C: FinEdExperimental Treatment4 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: CostCOMExperimental Treatment3 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 Control2 Interventions
Usual care + pre-screening for financial hardship and social risks

Find a Clinic Near You

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

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

Citations

Treatment out-of-pocket cost communication and remote financial navigation in patients with cancer: a feasibility study. [2023]
Piloting a Financial Counseling Intervention for Patients With Cancer Receiving Chemotherapy. [2020]
The DISCO App: A pilot test of a multi-level intervention to reduce the financial burden of cancer through improved cost communication. [2023]
Out-of-Pocket Spending for Cancer Medication, Financial Burden, and Cost Communication with Oncologists in the Last Six Months of Life in Israel. [2021]
The financial burden of cancer care: do patients in the US know what to expect? [2022]
Cancer-Related Financial Hardship Screening as Part of Practice Transformation. [2023]
Implementing routine communication about costs of cancer treatment: perspectives of providers, patients, and caregivers. [2020]
Financial navigation: Staff perspectives on patients' financial burden of cancer care. [2023]
Impact of trained oncology financial navigators on patient out-of-pocket spending. [2019]
Oncology navigators' perceptions of cancer-related financial burden and financial assistance resources. [2021]
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