Trial Title:
Addressing Financial and Social Needs Among Patients With Cancer
NCT ID:
NCT06430840
Condition:
Cancer
Financial Hardship
Conditions: Official terms:
Financial Stress
Conditions: Keywords:
Sleep
Cancer
Financial Hardship
financial education
financial navigation
cost communication
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
CostCOM (Cost Communication, Financial navigation and counseling)
Description:
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 group label:
Arm B: CostCOM
Intervention type:
Behavioral
Intervention name:
Provision of local and national resources to address financial and social needs
Description:
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 group label:
Arm C: FinEd
Intervention type:
Behavioral
Intervention name:
Financial Education
Description:
Patient will receive online and paper educational materials on topics such as health
insurance and health insurance literacy, navigating hospitals' price estimator tool.
Arm group label:
Arm C: FinEd
Intervention type:
Other
Intervention name:
Usual care
Description:
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 group label:
Arm A: Enhanced Usual Care (EUC)
Arm group label:
Arm B: CostCOM
Arm group label:
Arm C: FinEd
Intervention type:
Other
Intervention name:
Screening for financial and social needs
Description:
Patients will be screened for financial hardship and health-related social risks.
Arm group label:
Arm A: Enhanced Usual Care (EUC)
Arm group label:
Arm B: CostCOM
Arm group label:
Arm C: FinEd
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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCI Health Cancer Center - Newport
Address:
City:
Costa Mesa
Zip:
92627
Country:
United States
Status:
Recruiting
Contact:
Last name:
Omar Gutierrez
Email:
canassist@hs.uci.edu
Facility:
Name:
UCI Health Chao Family Comprehensive Cancer Center - Fountain Valley
Address:
City:
Fountain Valley
Zip:
92708
Country:
United States
Status:
Recruiting
Contact:
Last name:
Omar Gutierrez
Phone:
949-745-5066
Email:
canassist@hs.uci.edu
Facility:
Name:
CHAO Family Comprehensive Cancer Center- Irvine
Address:
City:
Irvine
Zip:
92612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Omar Guittierez
Phone:
949-745-5066
Email:
canassist@hs.uci.edu
Facility:
Name:
UCI Health Chao Family Comprehensive Cancer Center - Laguna Hills
Address:
City:
Laguna Hills
Zip:
92653
Country:
United States
Status:
Recruiting
Contact:
Last name:
Omar Gutierrez
Phone:
949-745-5066
Email:
canassist@hs.uci.edu
Facility:
Name:
UCI Chao Family Comprehensive Cancer Center
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Contact:
Last name:
Omar Gutierrez
Email:
canassist@hs.uci.edu
Facility:
Name:
UCI Health - Yorba Linda
Address:
City:
Yorba Linda
Zip:
92886
Country:
United States
Status:
Recruiting
Contact:
Last name:
Omar Gutierrez
Email:
canassist@hs.uci.edu
Start date:
August 26, 2024
Completion date:
December 1, 2026
Lead sponsor:
Agency:
University of California, Irvine
Agency class:
Other
Collaborator:
Agency:
Chao Family Comprehensive Cancer Center
Agency class:
Other
Source:
University of California, Irvine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06430840
