Interventions to Decrease Financial Toxicity
Purpose
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.
Conditions
- Cancer, Breast
- Cancer Colorectal
- Cancer, Ovarian
- Cervical Cancer
- Uterine Cancer
- Vulvar Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- 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
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Proactive Cost of Care (P-COC) intervention |
One time session with trained educator to review: Cost Information Flyer: Anticipated out of pocket costs flyer by cancer type and stage 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" |
|
|
Active Comparator Usual Care |
Participants receive an existing patient pamphlet "Patient and Family Guide" |
|
Recruiting Locations
Birmingham, Alabama 35294
More Details
- Status
- Recruiting
- Sponsor
- University of Alabama at Birmingham
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.