An interventional study of Proactive Cost of Care (P-COC) intervention and Usual Care in Cancer, Breast, Cancer Colorectal and Cancer, Ovarian, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-05.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Supportive care
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.
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.
210 studies on the registry are indexed under Vulvar Neoplasms; 71 are open to participants now.
This study's enrollment of 60 is close to the median of 55 across 151 interventional studies indexed under Vulvar Neoplasms.
Browse Vulvar Neoplasms studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
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Exclusion Criteria:
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"
Other: Proactive Cost of Care (P-COC) intervention
Participants receive an existing patient pamphlet "Patient and Family Guide"
Other: Usual Care
As in Arm description
As in Arm description
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.
Time frame: 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.
Time frame: 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Health Insurance Literacy
Health insurance literacy measure (HILM) measures the ability for individuals to choose and use private health insurance. Given the goals of our intervention to help patients use rather than choose health insurance, questions included those assessing confidence using insurance (5 questions) and being proactive when using health insurance (4 questions). Each question is assessed on a scale from 1 (not at all confident) to 4 (very confident). Within each domain (confidence using insurance, being proactive when using health insurance), a higher score indicates more confidence or being more proactive, respectively.
Time frame: Baseline
Health Insurance Literacy
Health insurance literacy measure (HILM) measures the ability for individuals to choose and use private health insurance. Given the goals of our intervention to help patients use rather than choose health insurance, questions included those assessing confidence using insurance (5 questions) and being proactive when using health insurance (4 questions). Each question is assessed on a scale from 1 (not at all confident) to 4 (very confident). Within each domain (confidence using insurance, being proactive when using health insurance), a higher score indicates more confidence or being more proactive, respectively.
Time frame: 6 months
Health Insurance Knowledge
Kaiser Health Insurance Knowledge Survey - 10 items - Scores range from 0-10 based on number of correct responses.
Time frame: Baseline
Health Insurance Knowledge
Kaiser Health Insurance Knowledge Survey - 10 items - Scores range from 0-10 based on number of correct responses.
Time frame: 6 months
Plan to share: No
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University of Alabama at Birmingham