Interventions to Decrease Financial Toxicity

Trial Title: Interventions to Decrease Financial Toxicity

NCT ID: NCT05939440

Condition: Cancer, Breast
Cancer Colorectal
Cancer, Ovarian
Cervical Cancer
Uterine Cancer
Vulvar Cancer

Conditions: Official terms:
Vulvar Neoplasms
Uterine Neoplasms
Breast Neoplasms
Ovarian Neoplasms
Financial Stress

Conditions: Keywords:
financial toxicity
financial distress
costs of care

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Randomized controlled prospective trial

Primary purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Masking description: Assessors who conduct surveys are blind to study assignment

Intervention:

Intervention type: Other
Intervention name: Proactive Cost of Care (P-COC) intervention
Description: As in Arm description
Arm group label: Proactive Cost of Care (P-COC) intervention

Intervention type: Other
Intervention name: Usual Care
Description: As in Arm description
Arm group label: Usual Care

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.

Criteria for 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

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: O'Neal Comprehensive Cancer Center

Address:
City: Birmingham
Zip: 35294
Country: United States

Start date: June 1, 2022

Completion date: May 31, 2025

Lead sponsor:
Agency: University of Alabama at Birmingham
Agency class: Other

Collaborator:
Agency: O'Neal Comprehensive Cancer Center at UAB
Agency class: Other

Source: University of Alabama at Birmingham

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05939440