Addressing Financial and Social Needs Among Patients With Cancer

NCT06430840 | Active Not Recruiting

• 2 other identifiers: 4937UCI-24-28
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 6

Brief Summary

Financial hardship and health-related social needs (e.g., insecurity about food, housing, transportation, utilities) are common among patients with cancer, resulting in health disparities in cancer outcomes. Our study will test the efficacy of a multicomponent financial navigation and counseling program delivered by a financial navigator (CostCOM), vs. direct patient access to financial education materials and comprehensive list of local resources in the absence of a financial navigator (FinEd) vs. practice usual care among newly diagnosed cancer patients who screen positive for financial hardship and social needs. Investigators anticipate that both CostCOM and FinEd compared to enhanced usual care will improve cost-related cancer care nonadherence, financial worry, health insurance literacy, quality of life and sleep quality and decrease number of missed appointments.

Conditions

Cancer; Financial Hardship

Keywords

Sleep; Cancer; Financial Hardship; financial education; financial navigation; cost communication

Outcome Measures

Primary Outcomes (1)

• Patients' Cost-Related Cancer Care Non-Adherence

  Number of patients who report any incidence during the 6 months (measured at 3, and 6 months) when they self-reports a positive response to any of: (1) delay, (2) forego, (3) stop, or (4) change in cancer prescribed medication due to cost, (5) refuse recommended cancer tests, or (6) skip cancer office visits due to cost.

  Within 6-months after randomization

Secondary Outcomes (8)

• Patients' Treatment Completion

  Within 6-months after randomization

• Patients' Missed Appointments

  Within 6-months after randomization

• Patients' Material Financial Hardship

  Within 6-months after randomization

• Patients' Financial Worry

  Within 6-months after randomization

• Patients' Insurance Literacy

  Within 6-months after randomization

Study Arms (3)

Arm A: Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

Usual care + pre-screening for financial hardship and social risks

Other: Usual care; Other: Screening for financial and social needs

Arm B: CostCOM

EXPERIMENTAL

Usual care + two 1-hour phone or video sessions with a remote financial counselor including out-of-pocket cost communication, financial navigation and counseling.

Behavioral: CostCOM (Cost Communication, Financial navigation and counseling); Other: Usual care; Other: Screening for financial and social needs

Arm C: FinEd

EXPERIMENTAL

Usual care + access to local and national resources including (1) a detailed list of local and national resources for financial navigation, and social needs where patients can self-refer and (2) video and online /printed educational materials to improve financial health literacy

Behavioral: Provision of local and national resources to address financial and social needs; Behavioral: Financial Education; Other: Usual care; Other: Screening for financial and social needs

Interventions

CostCOM (Cost Communication, Financial navigation and counseling) BEHAVIORAL

Patients will receive two 1-hour, phone or video sessions with a remote financial counselor, each session will cover each of these 3 components of CostCOM. Out-of-pocket cost communication (OOPC): A review of insurance benefits and education of the patient-specific OOPC for anticipated treatment regimen if any (i.e., medication). The OOPC is provided as a total estimate and will be updated at 3-month session in case of changes in treatment or insurance. Financial navigation: Real-time professional guidance to identify financial assistance programs (e.g., co-pay, living expenses) that alleviate costs of care and discuss information to improve insurance coverage. Financial counseling: To address the range of patients' financial concerns and enroll patients in financial assistance programs.

Arm B: CostCOM

Provision of local and national resources to address financial and social needs BEHAVIORAL

Patients will be provided with a comprehensive list of local resources (in patients' preferred language) in Orange County that can help with food insecurity, ir transportation, as well as contact information for national non-profit organization where patients can self-refer for financial navigation (e.g., Patient Advocate Foundation (PAF)

Arm C: FinEd

Financial Education BEHAVIORAL

Patient will receive online and paper educational materials on topics such as health insurance and health insurance literacy, navigating hospitals' price estimator tool.

Arm C: FinEd

Usual care OTHER

Patients in all arms will receive usual care, which includes routine oncology visits, use of available ancillary staff, and internal or external resources for co-pay assistance or free medication per normal clinic procedures.

Arm A: Enhanced Usual Care (EUC); Arm B: CostCOM; Arm C: FinEd

Screening for financial and social needs OTHER

Patients will be screened for financial hardship and health-related social risks.

Arm A: Enhanced Usual Care (EUC); Arm B: CostCOM; Arm C: FinEd

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Speak English or Spanish
• years or older
• Were diagnosed with any stage of cancer within the last 120 days
• Getting treatment in University of California Irvine-affiliated oncology clinics
• Have already started treatment like radiation, or cancer medication
• Screen positive for financial hardship or health-related social needs

You may not qualify if:

• Patients with indolent cancer undergoing observation alone
• Eastern Cooperative Oncology Group (ECOG) Performance status above 2
• Patients not receiving any cancer-directed therapy
• Patients participating in other therapeutic clinical trials covering the cost of treatment.

Sponsors & Collaborators

• University of California, Irvine: lead
• Chao Family Comprehensive Cancer Center: collaborator

Study Sites (6)

UCI Health Cancer Center - Newport

Costa Mesa, California, 92627, United States

Location

UCI Health Chao Family Comprehensive Cancer Center - Fountain Valley

Fountain Valley, California, 92708, United States

Location

CHAO Family Comprehensive Cancer Center- Irvine

Irvine, California, 92612, United States

Location

UCI Health Chao Family Comprehensive Cancer Center - Laguna Hills

Laguna Hills, California, 92653, United States

Location

UCI Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

UCI Health - Yorba Linda

Yorba Linda, California, 92886, United States

Location

MeSH Terms

Conditions

Neoplasms; Financial Stress

Interventions

Counseling; Mass Screening

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Gelareh Sadigh

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor In Residence

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: May 28, 2024
• Study Start: August 26, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)