Financial Navigation Program to Improve Understanding and Management of Financial Aspects of Cancer Care for Patients and Their Spouses

Study Overview
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Brief Summary
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This clinical trial examines a financial navigation program in helping patients and their spouses understand and better manage the financial aspects of cancer care. Cancer patients and their spouses may be at high risk for financial problems because of the cost of cancer treatment. A financial navigator is a person or team who work with patients and their families to help them reduce stress or hardship related to the cost of cancer treatment. Financial navigators help patients understand their out-of-pocket expenses and what their health insurance plans may cover. Financial navigation may also help patients set up payment plans, find cost-saving methods for treatments, and improve access to healthcare services that the patient needs. Providing financial navigation to patients may help reduce financial worries and improve quality of life.

Detailed Description
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PRIMARY OBJECTIVE: I. To determine whether a proactive financial navigation program for patients planning to receive anti-cancer treatment decreases the risk of material household financial hardship over 12 months among patients with newly diagnosed or recurrent metastatic solid tumor, or a newly diagnosed hematologic malignancy, and their spouse caregivers. SECONDARY OBJECTIVES: I. To examine whether proactive financial navigation improves patient and/or spouse caregiver quality of life. II. To examine whether proactive financial navigation decreases financial worry among patients and/or spouse caregivers relative to usual care and explore the extent to which financial worry correlates with financial hardship. ADDITIONAL OBJECTIVES: I. To explore the utilization of financial navigation services by younger, financially fragile, and lower income patients and households and evaluate the moderator effect of age, financial fragility, and income on the impact of the proactive financial navigation intervention. II. To explore whether the proactive financial navigation intervention leads to decreased cost-related medication non-adherence and fewer patient emergency department (ED) visits and unplanned hospital admissions. OUTLINE: Patients and spouses are randomized to 1 of 2 groups. GROUP I: Patients and spouse caregivers receive financial literacy training consisting of watching online educational videos over 2-8 minutes. Patients and spouses also complete questionnaires over 30-60 minutes about education, employment, finances (assets, debt), insurance, and quality of life (financial worry) and have credit reports assessed at baseline and 3, 6, and 12 months. GROUP II: Patients and spouse caregivers receive financial literacy training consisting of watching online educational videos over 2-8 minutes. Patients also meet with Consumer Education and Training Services (CENTS) counselor and Patient Advocate Foundation (PAF) case manager over approximately 1 hour every month for 6 months (with each group). Patients and spouses also complete questionnaires over 30-60 minutes about education, employment, finances (assets, debt), insurance, and quality of life (financial worry) and have credit reports assessed at baseline and 3, 6, and 12 months.

Official Title
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A Randomized Trial Addressing Cancer-Related Financial Hardship Through Delivery of a Proactive Financial Navigation Intervention (CREDIT)

Conditions
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Hematopoietic and Lymphoid Cell Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm

Intervention / Treatment
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* Other: Educational Intervention
* Behavioral: Patient Navigation
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have a diagnosis of a metastatic solid tumor or a hematologic malignancy and must receive anti-cancer treatment (i.e. chemotherapy, hormonal therapy, targeted therapy, biologic therapy, immune therapy, bone marrow transplant). Registration must occur within 120 days after diagnosis. Patients with indolent hematologic diseases undergoing observation alone are not eligible Patients with recurrent solid tumors will be allowed as long as 1) this is the first presentation of metastatic disease and 2) the diagnosis of the metastasis is at least 180 days (6 months) after the diagnosis date of the previous earlier stage cancer Patients with a history of secondary malignancy are allowed as long as they were not diagnosed within the previous 24 months, are not on active therapy, and are disease-free. Patients with adequately treated basal cell or squamous cell skin cancer, and in situ cervical cancer at any point prior to enrollment are eligible Patients who have started anti-cancer treatment for the current diagnosis must have started within 60 days prior to registration Patients who are planning to start anti-cancer treatment for the current diagnosis must start within (=<) 30 days after registration Patients are allowed to be co-enrolled on other clinical trials (including non-treatment studies and studies that may or may not include investigational drugs) Patients must be at least 18 years of age Patients must have a Zubrod performance status of 0-2 Patients must complete the baseline patient reported outcomes (PRO) questionnaires prior to registration and must be able to complete questionnaires in English or Spanish Patients must provide their full name, primary address in the United States (U.S.), birth date and social security number at registration for the purposes of accessing credit report data. (This may be obtained directly from the patient, study questionnaires, or the medical record) Patients must provide email and telephone number for the purposes of being contacted by financial navigators Spouse caregiver must be willing to participate in the trial Spouse caregiver must be legally married, or file their tax returns as married filing jointly The study team acknowledges that other types of caregivers may also face financial hardship following a patient's cancer diagnosis and may similarly benefit from financial education and navigation. The decision to focus solely on spouse caregivers was scientific, to facilitate analysis of primary endpoint (household financial hardship) Spouse caregiver must be living in the same household with the eligible patient enrolling in this trial Spouse caregivers must be at least 18 years of age Spouse caregivers must provide their full name, primary address in the U.S., birth date and social security number at registration for the purposes of accessing credit report data Spouse caregivers must provide email and telephone number for the purposes of being contacted by the financial navigators Spouse caregivers must be able to complete questionnaires in English or Spanish and must complete the baseline questionnaires prior to patient registration Participants (patients and spouse caregivers) must sign and give written informed consent in accordance with institutional and federal guidelines. Use of legally-authorized representative is not permissible for this study. Documentation of informed consent via remote consent is permissible As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system Exclusion Criteria: Patients may not be enrolled in hospice care at the time of registration

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I (usual care)<br>Patients and spouse caregivers receive financial literacy training consisting of watching online educational videos over 2-8 minutes. Patients and spouses also complete questionnaires over 30-60 minutes about education, employment, finances (assets, debt), insurance, and quality of life (financial worry) and have credit reports assessed at baseline and 3, 6, and 12 months. | Other: Educational Intervention<br>* Watch online educational videos<br>* Other names: Intervention, Educational;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Complete questionnaires<br>|
| Experimental: Group II (financial navigation intervention)<br>Patients and spouse caregivers receive financial literacy training consisting of watching online educational videos over 2-8 minutes. Patients also meet with CENTS counselor and PAF case manager over approximately 1 hour every month for 6 months (with each group). Patients and spouses also complete questionnaires over 30-60 minutes about education, employment, finances (assets, debt), insurance, and quality of life (financial worry) and have credit reports assessed at baseline and 3, 6, and 12 months. | Other: Educational Intervention<br>* Watch online educational videos<br>* Other names: Intervention, Educational;Behavioral: Patient Navigation<br>* Meet with CENTS counselor and PAF case manager<br>* Other names: Patient Navigator Program;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Complete questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Household financial hardship | Defined as one or more of the following: from the patient's and/or spouse's credit report within 12 months: any new loans (bank or home equity); exhausting lines of credit by reaching limits on credit cards and home equity loans; credit or other payment delinquencies; becoming subject to a lien, judgment, or other collection process; personal bankruptcy filings. Will conduct a multivariable logistic regression (outcome = household financial hardship; independent variable = intervention versus [vs.] control), adjusting for demographic, clinical, financial and practice characteristics. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life: patient | As measured by composite European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L). The proportion of patients in each arm who experience improved, unchanged, or worsened EQ-5D scores from baseline to 3, 6 (and 12) months will be compared using Fisher's exact test. Mean score changes will be compared using two group t tests. A multivariate linear regression model, with worsening score as the dependent variable and study arm as the independent variable will be performed. | Up to 12 months | 
| Quality of life: spouse | As measured by City of Hope Quality of Life Family subscale scores (Physical Well Being (0-50), Psychological Well Being (0-110); higher scores better). We will determine the proportion of spouse caregivers in each arm who experience improved, unchanged, or worsened Quality of Life Family scores (composite scores for physical, psychological, and social well-being subscales) from baseline to 3, 6 (and 12) months and compare using Fisher's exact test. Mean score changes will be compared using two group t tests. A multivariate linear regression model, with worsening score as the dependent variable and study arm as the independent variable will be performed. | Up to 12 months | 
| Spouse caregiver burden | As measured by the social well-being (Social Concerns, range:0-90, higher scores better) subscale of the City of Hope Quality of Life Family questionnaire. Mean score changes will be compared using two group t tests. A multivariate linear regression model, with worsening score as the dependent variable and study arm as the independent variable will be performed. | Up to 12 months | 
| Financial worry | Will be measured by the Comprehensive Score for Financial Toxicity-Patient Reported Outcome Measure (COST-Functional Assessment of Chronic Illness Therapy [FACIT] version 2; Financial Toxicity Scale ranges from 0-44, with higher scores indicating greater financial well-being). Mean scores (and standard deviation [SD]) at 3, 6 and 12 months will be compared between intervention and usual care patients and spouses using two sample t tests. | Up to 12 months |