This clinical trial examines a financial navigation program in helping patients (and their spouses or partner caregivers, if participating) understand and better manage the financial aspects of cancer care. Cancer patients and their spouse/partner caregivers may be at high risk for financial problems because of the cost of cancer treatment. A financial navigator is a person or team who works 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.
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. SECONDARY OBJECTIVES: I. To examine whether proactive financial navigation improves patient quality of life. II. To examine whether proactive financial navigation decreases financial worry among patients relative to usual care and explore the extent to which financial worry correlates with financial hardship. III. 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. ADDITIONAL OBJECTIVES: I. To explore the impact of proactive financial navigation on spouse/partner caregiver financial hardship, quality of life, and caregiver burden and evaluate the concordance between patient and caregiver credit data. II. 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. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive financial literacy training consisting of watching online educational videos over 2-8 minutes. Patients 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 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 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. Spouse/partner caregiver participation is optional. If a spouse/partner caregiver is participating in the trial along with the patient. If participating, the spouse/partner caregiver receives the same intervention as the patient and will complete questionnaires and have credit reports assessed at baseline and 3, 6, and 12 months. SAMPLE SIZE: Study participants include both patients and optional spouse/partner caregivers. Study enrollment targets are based entirely on patients, but the anticipated number of participants includes both groups. We expect to enroll 326 patients and approximately 196 spouse/partner caregivers for a total of 522 anticipated participants, but the study will be closed to accrual when the patient accrual target of 326 is reached, regardless of the number of participating spouse/partner caregivers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
331
Watch online educational videos
Meet with CENTS counselor and PAF case manager
Ancillary studies
Complete questionnaires
Fairbanks Memorial Hospital
Fairbanks, Alaska, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States
Epic Care-Dublin
Dublin, California, United States
Kaiser Permanente Dublin
Dublin, California, United States
Patient financial hardship
Defined as one or more of the following: from the patient'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 = patient financial hardship; independent variable = intervention versus \[vs.\] control), adjusting for demographic, clinical, financial and practice characteristics.
Time frame: Up to 12 months
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.
Time frame: 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 using two sample t tests.
Time frame: Up to 12 months
Treatment adherence: Number of patients
Number of patients by study arm self-reporting that they did or did not skip medication doses or refuse/decline recommended therapy due to cost concerns.
Time frame: Up to 12 months
Treatment adherence: Proportion of patients
Proportion of patients by study arm self-reporting that they did or did not skip medication doses or refuse/decline recommended therapy due to cost concerns.
Time frame: Up to 12 months
Emergency department/hospital use
Will be abstracted from patients' medical records by site staff. Investigators will categorize visits as anticipated (for chemotherapy or planned procedures) versus unanticipated (complication or treatment side-effect). The cumulative incidence of emergency department and unanticipated hospital use will be calculated by arm to account for death as a competing risk and compared using Cox regression, adjusting for covariates.
Time frame: Up to 12 months
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Epic Care Partners in Cancer Care
Emeryville, California, United States
Kaiser Permanente-Fremont
Fremont, California, United States
Kaiser Permanente-Fresno
Fresno, California, United States
Contra Costa Regional Medical Center
Martinez, California, United States
Kaiser Permanente-Modesto
Modesto, California, United States
...and 256 more locations