CancerCAN-ASSISTNCT06430840

Addressing Financial and Social Needs Among Patients With Cancer

A study testing CostCOM (Cost Communication, Financial navigation and counseling), Provision of local and national resources to address financial and social needs and Financial Education in people with Cancer and Financial Hardship, run by University of California, Irvine at 6 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer, Financial Hardship
What is being tested?: CostCOM (Cost Communication, Financial navigation and counseling), Provision of local and national resources to address financial and social needs and Financial Education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 6 sitesUnited States
Study dates: 26 Aug 2024to 1 Dec 2026
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

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

Other trials in United States

About this study

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.

Read the 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.

Conditions: Cancer, Financial Hardship
Being tested: CostCOM (Cost Communication, Financial navigation and counseling), Provision of local and national resources to address financial and social needs, Financial Education, Usual care, Screening for financial and social needs
Keywords: Sleep, Cancer, Financial Hardship, financial education, financial navigation, cost communication
Medical subject headings: Neoplasms, Financial Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CostCOM (Cost Communication, Financial navigation and counseling)Behavioural
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.
Provision of local and national resources to address financial and social needsBehavioural
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)
Financial EducationBehavioural
Patient will receive online and paper educational materials on topics such as health insurance and health insurance literacy, navigating hospitals' price estimator tool.
Usual careOther
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.
Screening for financial and social needsOther
Patients will be screened for financial hardship and health-related social risks.

Study groups in NCT06430840
Study group	Role	What they receive
Arm A: Enhanced Usual Care (EUC)	Active comparator	Usual care + pre-screening for financial hardship and social risks Receives: 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. Receives: 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 Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Within 6-months after randomization

Secondary outcomes (8)

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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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
Measured: Within 6-months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Aug 20241 Dec 2026

First posted28 May 2024
Study start26 Aug 2024
Primary completion18 Feb 2026
Study completion1 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06430840
Sponsor's protocol ID: 4937
Other IDs: UCI-24-28
Acronym: CAN-ASSIST
Status last verified: Jun 2026
First submitted: 19 May 2024
Last updated: 22 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Sharifian M, Nguyen V, Madan A, Gutierrez O, Bharucha M, Harris J, Hoyt MA, Milam J, Chen WP, Ziogas A, Sadigh G. Addressing financial and health-related social needs among patients with cancer: Study protocol for CAN-ASSIST pilot clinical trial. Contemp Clin Trials Commun. 2026 Apr 8;51:101637. doi: 10.1016/j.conctc.2026.101637. eCollection 2026 Jun.
PubMed 42016723