Interventions to Decrease Financial Toxicity

NCT ID: NCT05939440

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2025-05-31

Brief Summary

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.

Detailed Description

The investigators will recruit 60 patients diagnosed with gynecologic (ovarian, uterine, cervical, or vulvar cancer), breast or colorectal cancer who are starting a new line of treatment at the O'Neal Comprehensive Cancer Center. Participants will be randomized to Proactive CoC intervention versus Usual Care. Usual Care consists of the current care processes at the cancer center where information on CoC and financial assistance are only provided once a financial need is identified. The main goal is to compare the change in financial distress from baseline to 6 months to see if patients who received any of the Proactive CoC intervention have improved financial distress compared to those in Usual Care.

All participants will complete two main surveys at 0 and 6 months that will ask questions to measure the study outcomes, self-efficacy (patient reported confidence managing certain situations, such as dealing with CoC), depression, anxiety, and insurance knowledge. Participants randomized to any of the Proactive CoC intervention groups will complete three additional phone interviews at 2, 4, and 6 months to check how participants utilized the materials, reasons why they have or have not, and what sections were helpful or not. This study is important to determine whether the Proactive CoC intervention can be successfully delivered, whether the intervention is useful to help patients decrease financial distress, and to inform the design of a future larger study that will include different cancer types and health systems.

Conditions

Cancer, Breast; Cancer Colorectal; Cancer, Ovarian; Cervical Cancer; Uterine Cancer; Vulvar Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Proactive Cost of Care (P-COC) 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 Type: EXPERIMENTAL

Proactive Cost of Care (P-COC) intervention

Intervention Type: OTHER

As in Arm description

Usual Care

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

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

As in Arm description

Interventions

Proactive Cost of Care (P-COC) intervention

As in Arm description

Intervention Type: OTHER

Usual Care

As in Arm description

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Newly diagnosed ovarian cancer (i.e., stage II-IV epithelial histology receiving surgery and chemotherapy), or newly diagnosed cervical cancer (i.e., locally advanced stage IB3-IVA receiving chemoradiation), or newly diagnosed uterine cancer (i.e., high-risk histology likely to receive chemotherapy; serous/clear cell), or newly diagnosed stage I-III breast cancer (i.e., high-risk histology), or newly diagnosed stage III-IV Colorectal Cancer
• Receiving systemic therapy or radiation at University of Alabama at Birmingham O'Neal Comprehensive Cancer Center
• With health insurance coverage
• With reliable access to a phone, mobile device, or Internet

Exclusion Criteria

• Unable to read English
• Does not agree to complete surveys

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

O'Neal Comprehensive Cancer Center at UAB

UNKNOWN

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Maria Pisu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Pisu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

O'Neal Comprehensive Cancer Center

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

UAB2198

Identifier Type: -

Identifier Source: org_study_id