Interventions to Decrease Financial Toxicity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Proactive Costs of Care Interventions to Decrease Financial Toxicity in Cancer Patients.

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

Intervention / Treatment
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* Other: Proactive Cost of Care (P-COC) intervention
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled prospective trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proactive Cost of Care (P-COC) intervention<br>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 | Other: Proactive Cost of Care (P-COC) intervention<br>* As in Arm description<br>|
| Active Comparator: Usual Care<br>Participants receive an existing patient pamphlet Patient and Family Guide | Other: Usual Care<br>* As in Arm description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Financial Distress | FD measured using the Comprehensive Score for Financial Toxicity (COST) (12 items) The score ranges from 0 to 44 with lower scores indicating worse financial distress. A Score <26 indicates financial distress is present. | Baseline | 
| Financial Distress | FD measured using the Comprehensive Score for Financial Toxicity (COST) (12 items). The score ranges from 0 to 44 with lower scores indicating worse financial distress. A Score <26 indicates financial distress is present. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self Efficacy | Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy Scale (10 items). Questions ask patients to rate their level of confidence managing situations, problems, and events related to dealing with costs of care. Responses are on a scale of 1 I am not at all confident to 5 I am very confident. Self-efficacy is scored by converting raw scores into a T-score resulting in a standardized score with a mean of 50 and a standard deviation of 10.A higher score indicates more self-efficacy. | Baseline | 
| Self Efficacy | Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy Scale (10 items). Questions ask patients to rate their level of confidence managing situations, problems, and events related to dealing with costs of care. Responses are on a scale of 1 I am not at all confident to 5 I am very confident. Self-efficacy is scored by converting raw scores into a T-score resulting in a standardized score with a mean of 50 and a standard deviation of 10. A higher score indicates more self-efficacy. | 6 months | 
| Depression | Patient Health Questionnaire (PHQ-9). Responses range from 0 Not at all to 3 Nearly every day. Cut points of 5, 10, 15, and 20 are used for mild, moderate, moderately severe, and severe depression. Investigators will dichotomize into mild vs. at least moderate depression. | Baseline | 
| Depression | Patient Health Questionnaire (PHQ-9). Responses range from 0 Not at all to 3 Nearly every day. Cut points of 5, 10, 15, and 20 are used for mild, moderate, moderately severe, and severe depression. Investigators will dichotomize into mild vs. at least moderate depression. | 6 months | 
| Anxiety | General Anxiety Disorder (GAD-7). Responses range from 0 Not at all to 3 Nearly every day. Cut points of 5, 10, and 15 are used for mild, moderate, and severe anxiety. Responses will be dichotomized into mild vs. at least moderate anxiety. | Baseline | 
| Anxiety | General Anxiety Disorder (GAD-7). Responses range from 0 Not at all to 3 Nearly every day. Cut points of 5, 10, and 15 are used for mild, moderate, and severe anxiety. Responses will be dichotomized into mild vs. at least moderate anxiety. | 6 months | 
| Stress | Weekly Stress Inventory - Short Form (WSI-SF). 25-item self-report scale that measures the number of minor stressors that occur in one week. Individual items are scored on an 8-point Likert scale. Two scores are obtained, the event score (WSI-SFE), which ranges from 0-25, and the impact score (WSI-SFI), which ranges from 0-175. A higher event score indicates more stressors and a higher impact score indicates a higher impact from these stressors. | Baseline | 
| Stress | Weekly Stress Inventory - Short Form (WSI-SF). 25-item self-report scale that measures the number of minor stressors that occur in one week. Individual items are scored on an 8-point Likert scale. Two scores are obtained, the event score (WSI-SFE), which ranges from 0-25, and the impact score (WSI-SFI), which ranges from 0-175. A higher event score indicates more stressors and a higher impact score indicates a higher impact from these stressors. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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financial toxicity, financial distress, costs of care