NCT04960787

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 331 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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. 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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Educational Intervention	Watch online educational videos
BEHAVIORAL	Patient Navigation	Meet with CENTS counselor and PAF case manager
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Complete questionnaires

Timeline

• Start date: 2021-10-12
• Primary completion: 2026-09-01
• Completion: 2026-10-01
• First posted: 2021-07-14
• Last updated: 2026-03-13

Locations

266 sites across 2 countries: United States, Puerto Rico