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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms

  • Hematopoietic and Lymphoid Cell Neoplasm
  • Metastatic Malignant Solid Neoplasm
  • Neoplasms
  • Recurrent Malignant Solid Neoplasm

NCT number NCT04960787
Study type Interventional
Source SWOG Cancer Research Network
Contact
Status Recruiting
Phase N/A
Start date October 12, 2021
Completion date October 1, 2026

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