Addressing Financial and Social Needs Among Patients With Cancer (CAN-ASSIST)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer; Financial Hardship
• Intervention / Treatment: Other: Usual care; Other: Screening for financial and social needs; Behavioral: CostCOM (Cost Communication, Financial navigation and counseling); Behavioral: Provision of local and national resources to address financial and social needs; Behavioral: Financial Education

Detailed Description

Financial hardship and health-related social needs (HRSNs) (e.g., insecurity about food, housing, transportation, and utilities) are common among patients with cancer, resulting in health disparities in cancer outcomes. Addressing financial hardship and HRSNs can mitigate their damaging health effects, yet screening for them is not the standard clinical practice. There is compelling evidence that out-of-pocket cost (OOPC) communication complemented by financial navigation and counseling delivered by a financial navigator (CostCOM intervention) will decrease financial hardship. However, implementation of this intervention is limited given shortage of financial navigators in many cancer centers. There is also evidence that patients with financial hardship have lower financial health literacy and financial self-efficacy. However, it is not clear whether direct access to local community or national resources and financial education (FinEd intervention) in the absence of financial navigators will meet patient's needs. Investigators propose a 3-arm pilot randomized controlled trial to assess potential efficacy differences in adherence, financial hardship, financial health literacy, quality of life, and sleep between CostCOM vs. FinEd vs. enhanced usual care (EUC) among 90 newly diagnosed cancer patients (1:1 non-metastatic vs. metastatic) who receive systemic or radiation therapy and are screened positive for financial and social needs. Our multidisciplinary team has experience with all facets of the proposed intervention. CostCOM patients will participate in two remote counseling sessions at baseline, and 3 months, and will receive (1) OOPC communication, individualized, patient-specific education of the anticipated medication OOPC; (2) Financial navigation, real-time professional guidance to identify financial assistance programs that will alleviate costs of care and discuss information to improve insurance coverage; and (3) Financial counseling to address the range of patients' financial concerns and enroll patients in financial assistance programs. FinEd patients will receive (1) a comprehensive list of local and national resources where patients can self-refer for financial and social needs; and (2) online and paper financial educational materials on topics such as health insurance and health insurance literacy, and navigating price estimator tools. EUC patients will receive usual care enhanced by screening for financial and social needs. Our goals are to compare the efficacy of CostCOM vs. FinEd vs. EUC at 6 months on (1) patient-reported cost-related cancer care nonadherence (defined as self-reported delay, forgo, stop or change in cancer care due to cost concerns), treatment completion and missed appointments (as obtained via medical record); (2) patient-reported financial worry, material hardship, health insurance literacy, and quality of life; and (3) patient-reported and objectively measured sleep quality using a sleep monitor. The study will support feasibility for a larger trial, and reveal efficacy estimates for potential CostCOM vs. FinEd differences in improving cancer patients' outcomes and approaches for incorporation into routine clinical practice.

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Costa Mesa, California, United States, 92627
      • UCI Health Cancer Center - Newport
    • Fountain Valley, California, United States, 92708
      • UCI Health Chao Family Comprehensive Cancer Center - Fountain Valley
    • Irvine, California, United States, 92612
      • CHAO Family Comprehensive Cancer Center- Irvine
    • Laguna Hills, California, United States, 92653
      • UCI Health Chao Family Comprehensive Cancer Center - Laguna Hills
    • Orange, California, United States, 92868
      • UCI Chao Family Comprehensive Cancer Center
    • Yorba Linda, California, United States, 92886
      • UCI Health - Yorba Linda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Speak English or Spanish
• 18 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm A: Enhanced Usual Care (EUC); Usual care + pre-screening for financial hardship and social risks	Other: Usual care; 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.; Other: Screening for financial and social needs; Patients will be screened for financial hardship and health-related social risks.
Experimental: Arm B: CostCOM; Usual care + two 1-hour phone or video sessions with a remote financial counselor including out-of-pocket cost communication, financial navigation and counseling.	Other: Usual care; 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.; Other: Screening for financial and social needs; Patients will be screened for financial hardship and health-related social risks.; Behavioral: CostCOM (Cost Communication, Financial navigation and counseling); 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.
Experimental: Arm C: FinEd; 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	Other: Usual care; 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.; Other: Screening for financial and social needs; Patients will be screened for financial hardship and health-related social risks.; Behavioral: Provision of local and national resources to address financial and social needs; 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); Behavioral: Financial Education; Patient will receive online and paper educational materials on topics such as health insurance and health insurance literacy, navigating hospitals' price estimator tool.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' Treatment Completion	Number of patients who receive all the prescribed cycle of chemotherapy and/or radiation therapy due within the 6-month study period.	Within 6-months after randomization
Patients' Missed Appointments	Proportion of treatment appointments or office visits that is marked as cancellation or no show in the absence of chart note advising patient not to show up the appointment.	Within 6-months after randomization
Patients' Material Financial Hardship	Number of patients who report any incidence during the 6-months (measured 3, and 6 months) with a self-reported positive response to any of the following: (1) home sale, refinance or move to affordable rental, (2) loans, (3) reaching credit limits, and (4) bankruptcy) because of their cancer care, or its treatment	Within 6-months after randomization
Patients' Financial Worry	Patients level of of financial worry regarding their cancer care will be measured using the Comprehensive Score for Financial Toxicity (COST) 11-item (score 0-44). Higher score= Lower financial worry	Within 6-months after randomization
Patients' Insurance Literacy	Patients level of health insurance literacy measured by 21 items Health Insurance Literacy Measure (Score range 21-84). Higher score= higher health insurance literacy	Within 6-months after randomization
Patients' quality of life	Quality of life will be measured using Patient-Reported Outcomes Measurement Information System (PROMIS)-10. T scores will be calculated ranging between 0-100. Higher score= higher quality of life.	Within 6-months after randomization
Patients' Sleep Quality (Subjective)	Patients quality of sleep will be measured by an Insomnia Severity Index (ISI) that evaluates the severity of patients insomnia symptoms. (score 0-28). The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).	Within 6-months after randomization
Patients Sleep Quality (Objective)	Patients total sleep time, sleep efficiency, nighttime awakening, and sleep latency, measured through a sleep ActiGraph	Within 6-months after randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' experience with intervention	Patients experience and satisfaction with intervention components will be assessed through an interview process from a subset of patients of Arm C: FinEd. Results will be qualitatively measured.	6-8 months after randomization

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: Chao Family Comprehensive Cancer Center
• Investigators: Principal Investigator: Gelareh Sadigh, University of California, Irvine

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 19, 2024
• First Submitted That Met QC Criteria: May 24, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Sleep; financial education; financial navigation; Financial Hardship; cost communication
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Behavior; Financial Stress; Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Preventive Health Services; Behavioral Disciplines and Activities; Mental Health Services; Diagnostic Services; Health Surveys; Surveys and Questionnaires; Public Health Practice; Mass Screening; Counseling
• Other Study ID Numbers: 4937 (University of California Irvine IRB); UCI-24-28 (Other Identifier: University of California Irvine IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No