P-COC Intervention for Financial Toxicity in Cancer Patients

(P-COC Trial)

Overseen By Aquila Brown-Galvan, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Unable to read English, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help cancer patients manage the financial burden of their treatment. Researchers are testing a new approach called the Proactive Cost of Care (P-COC) intervention, which includes a session with a trained educator and tools to track treatment costs. Participants will either receive this new intervention or continue with the usual care. It suits those newly diagnosed with specific types of cancer, who have health insurance, and can access a phone or the internet.

As an unphased trial, this study offers a unique opportunity for patients to contribute to innovative solutions for managing treatment costs.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this intervention is safe for cancer patients?

Research shows that programs like the Proactive Cost of Care (P-COC) help cancer patients manage financial stress. These programs typically teach patients about potential costs and assist them in tracking expenses. Studies have found that patients generally receive these programs well because they focus on providing information and support rather than medical treatment. No reports indicate negative effects from participating in these programs. The main goal is to reduce financial stress without physical risks, making participation in this type of trial safe for health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Proactive Cost of Care (P-COC) intervention because it directly addresses the financial stress that often accompanies cancer treatment. Unlike the usual care, which only includes a patient pamphlet, the P-COC intervention provides a one-time session with a trained educator who helps patients understand their anticipated costs and how to track them. This proactive approach includes tools like a cost information flyer and a workbook to track out-of-pocket expenses, with ongoing reminders via text or email, potentially easing the financial burden and anxiety for patients.

What evidence suggests that the Proactive Cost of Care (P-COC) intervention is effective for reducing financial toxicity in cancer patients?

This trial will compare the Proactive Cost of Care (P-COC) intervention with Usual Care. Research has shown that the P-COC program can help cancer patients manage the financial stress of treatment costs. In a previous study, patients who participated in the P-COC program experienced less financial pressure from their cancer care. The program offers a session with a trained educator, provides cost information, and includes tools to track expenses, aiding patients in planning and managing their costs more effectively. Early results suggest that clear cost information and guidance can significantly reduce the financial burden on patients. ^{1 6 7 8 9}

Who Is on the Research Team?

Maria Pisu, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for patients with new diagnoses of ovarian, cervical, uterine, breast or colorectal cancer who have health insurance and can access a phone or the internet. They must be receiving treatment at the University of Alabama at Birmingham O'Neal Comprehensive Cancer Center and agree to complete surveys. It's not open to those who can't read English.

Inclusion Criteria

I have been recently diagnosed with ovarian, cervical, uterine, breast, or colorectal cancer at a specified stage.

With health insurance coverage

I am getting cancer treatment at the University of Alabama at Birmingham.

Exclusion Criteria

Unable to read English

I do not agree to complete surveys.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a one-time session with a trained educator to review cost information and tracking tools, followed by monthly reminders to track costs.

6 months

1 session (in-person or virtual), monthly reminders (text or email)

Follow-up

Participants are monitored for changes in financial distress, self-efficacy, depression, anxiety, and insurance knowledge.

6 months

2 main surveys (0 and 6 months), 3 additional phone interviews (2, 4, and 6 months) for intervention group

What Are the Treatments Tested in This Trial?

Interventions

• Proactive Cost of Care (P-COC) intervention
• Usual Care

Trial Overview The study tests a Proactive Cost of Care (P-COC) intervention against usual care. P-COC includes discussions on cost management with an educator and using a Cost Tracking tool designed to help patients manage their healthcare expenses more effectively.

How Is the Trial Designed?

Group I: Proactive Cost of Care (P-COC) intervention Experimental Treatment 1 Intervention

One time session with trained educator to review: 1. Cost Information Flyer: Anticipated out of pocket costs flyer by cancer type and stage 2. Cost Tracking workbook: Out-of-pocket cost tracker Participants also review a "Insurance, Employment, and Financial Assistance flyer" Participants will be reminded to track their costs once a month through an automated text message or e-mail based on patient preference. Participants also receive an existing patient pamphlet "Patient and Family Guide"

Group II: Usual Care Active Control 1 Intervention

Participants receive an existing patient pamphlet "Patient and Family Guide"

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

O'Neal Comprehensive Cancer Center at UAB

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

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]

Financial toxicity, which refers to the financial burdens faced by cancer patients due to their diagnosis and treatment, is becoming a significant issue in the U.S. healthcare system as cancer treatments become more expensive.

Oncology providers can play a crucial role in addressing financial toxicity by implementing routine financial screenings, creating financial navigation programs, and advocating for policies that reduce costs and enhance value-based care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining the Role of the Modern Oncology Provider in Mitigating Financial Toxicity. Su, CT., Shankaran, V.[2023]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/OP.2025.21.10_suppl.354

Proactive costs of care (PCOC) intervention for newly ... The primary outcome was 6-month change in FT (Comprehensive Score for financial Toxicity [COST]; score 0-44, lower score worse FT, and FT ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07217262?aggFilters=status%3A

Study Details | NCT07217262 | Proactive Costs of Care Study The main goal of this trial is to evaluate whether the Proactive Costs of Care intervention can be successfully delivered to cancer patients who ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9163204/

Interventions to Address Cancer-related Financial Toxicity In this study, we examined interventions being implemented by financial navigation staff at various cancer centers that help address financial toxicity ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05939440

NCT05939440 | Interventions to Decrease Financial Toxicity Financial distress affects 30-70% of cancer patients and describes the burden that patients experience due to the costs of care (CoC).

5. oncologynurseadvisor.com oncologynurseadvisor.com/features/financial-toxicity-cancer-patients-assistance/

Financial Toxicity in Cancer Patients: Assistance and Impact Further studies have reported financial toxicity rates of approximately 35% to 79% among patients with breast cancer and 20% to 50% in patients ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10894103/

A proactive financial navigation intervention in patients with ... The development of a financial toxicity patient-reported outcome in cancer: the COST measure. Cancer. 2014;120(20):3245–3253. doi: 10.1002 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11033153/

ESMO expert consensus statements on the screening and ... Current evidence implicates financial toxicity in psychosocial, economic and other harms, leading to suboptimal cancer outcomes along the entire trajectory of ...

8. onclive.com onclive.com/view/optimize-interventions-to-get-a-step-ahead-of-financial-toxicity-in-cancer-care

Optimize Interventions to Get a Step Ahead of Financial ... Financial toxicity affects 50% of cancer patients, with interventions being developed to identify and assist those at risk. A study using the ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04960787

NCT04960787 | Financial Navigation Program to Improve ... ... Financial Aspects of Cancer Care for Patients and Their Spouses (CREDIT) ... Will be measured by the Comprehensive Score for Financial Toxicity-Patient Reported ...