Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Rare Diseases

Uterine Cervical Neoplasms

Vulvar Neoplasms

Financial Stress

Uterine Neoplasms

Breast Neoplasms

Ovarian Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Vulvar Diseases

Breast Diseases

Skin Diseases

Stress, Psychological

Behavioral Symptoms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Endocrine System Diseases

Gonadal Disorders

Vulvar Cancer

Ovarian Cancer

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"

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

Proactive Cost of Care (P-COC) intervention

Usual Care

Maria Pisu, PhD

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.

Assessors who conduct surveys are blind to study assignment

Interventions to Decrease Financial Toxicity

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

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.

Kaiser Health Insurance Knowledge Survey - 10 items - Scores range from 0-10 based on number of correct responses.

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.

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.

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.

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.

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Interventions to Decrease Financial Toxicity	NCT05939440	Cancer, Breast Cancer Colorect... Cancer, Ovarian Cervical Cancer Uterine Cancer Vulvar Cancer	Proactive Cost ... Usual Care	18 Years -	University of Alabama at Birmingham
Interventions to Decrease Financial Toxicity	NCT05939440	Cancer, Breast Cancer Colorect... Cancer, Ovarian Cervical Cancer Uterine Cancer Vulvar Cancer	Proactive Cost ... Usual Care	18 Years -	University of Alabama at Birmingham

Spots Global Cancer Trial Database for costs of care