60 Participants Needed

P-COC Intervention for Financial Toxicity in Cancer Patients

(P-COC Trial)

MP
AB
Overseen ByAquila Brown-Galvan, MPH
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Financial distress affects 30-70% of cancer patients and describes the burden that patients experience due to the costs of care (CoC). One reason may be because patients lack the appropriate information on CoC that would help them better plan for and manage their CoC. Therefore, the investigators plan to test a Proactive CoC intervention which includes a discussion with a trained educator on CoC information and a Cost Tracking tool to help patients deal with their CoC.

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 data supports the effectiveness of the P-COC treatment for financial toxicity in cancer patients?

Research highlights the importance of addressing financial toxicity (the financial burden from cancer treatment) through improved cost communication and financial navigation. Strategies like the DISCO App, which enhances cost discussions, show promise in reducing financial burdens, suggesting that similar interventions like P-COC could be effective.12345

How does the P-COC treatment differ from other treatments for financial toxicity in cancer patients?

The P-COC treatment is unique because it proactively addresses the financial burden of cancer care by integrating financial screening and navigation into the care process, unlike usual care which may not systematically address these financial challenges.12678

Research Team

MP

Maria Pisu, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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.
See 1 more

Exclusion Criteria

Unable to read English
I do not agree to complete surveys.

Timeline

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

Treatment Details

Interventions

  • Proactive Cost of Care (P-COC) intervention
  • Usual Care
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Proactive Cost of Care (P-COC) interventionExperimental Treatment1 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 CareActive Control1 Intervention
Participants receive an existing patient pamphlet "Patient and Family Guide"

Find a Clinic Near You

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+

Findings from Research

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

References

Defining the Role of the Modern Oncology Provider in Mitigating Financial Toxicity. [2023]
Financial toxicity in cancer care: origins, impact, and solutions. [2022]
The DISCO App: A pilot test of a multi-level intervention to reduce the financial burden of cancer through improved cost communication. [2023]
Financial toxicity in cancer patients and subsequent risk of repeat acute care utilization. [2023]
Evaluating meaningful levels of financial toxicity in gynecologic cancers. [2023]
Society of Behavioral Medicine (SBM) position statement: support increased knowledge and efforts to address the financial burden associated with cancer treatment. [2021]
Ask Early and Ask Often: How Discussing Costs Could Save Your Patient's Life. [2018]
Validity of the COmprehensive Score for financial Toxicity (COST) in patients with gynecologic cancer. [2022]