Neoplasms

Blood and Lymph Conditions

All Conditions

Behaviors and Mental Disorders

Hematologic Neoplasms

Financial Stress

Hematologic Diseases

Stress, Psychological

Behavioral Symptoms

Quality of Life

Patients only participated in financial navigation program.

Patients and their caregivers participated as a dyad in financial navigation program.

The CC Links intervention is built on a platform of interdisciplinary team-based science, which ensured that the financial navigator worked closely with other members of the healthcare team including oncologists, nurses, transplant coordinators, social workers, and case managers, to help enhance financial hardship screening and connect survivors and caregivers with financial assistance services.

CC Links

Jean S Edward, PhD, RN

This trial is a mixed-methods, non-randomized design guided by the Consolidated Framework for Implementation Research (CFIR) to develop, implement, and evaluate Coverage and Cost-of-Care Links (CC Links) -a novel financial navigation intervention for hematologic cancer survivors and their caregivers.

The CC Links intervention included an oncology financial navigator who worked in the Hematology-Oncology Clinic. The navigator's functions included: screening for financial hardship to identify unmet financial needs (using the Comprehensive Score for Financial Toxicity (COST) and National Comprehensive Cancer Network's Distress Thermometer; initiating cost of care conversations; providing cost of care estimates; ensuring adequate health insurance coverage and assisting with applying for additional coverage; assisting with internal financial assistance program applications; connecting survivors/caregivers with disease specific resources and other external assistance programs; coordinating discharge planning; referring survivors to social workers and other staff/resources as needed; and, coordinating financial assistance services as survivors/caregivers transition between outpatient and inpatient settings.

Coverage and Cost-of-Care (CC) Links- Financial Navigation Program

Coverage and Cost-of-Care Links Financial Navigation Program in Hematology and Blood and Bone Marrow Transplantation (BMT)

"Coping behaviors" was measured using a series of 9 yes/no items that first assess whether any recommended cancer care was skipped for any reason (yes/no), and then whether the reason for not receiving the care that they or their doctor believed necessary was due to any of 8 listed reasons (yes/no for each). Typical reasons included 'Couldn't afford care,' 'Insurance company wouldn't approve or pay for care,' and 'Had problems getting to the doctor's office.' The sum of the number of yes responses is the total score, with higher scores indicating greater coping behaviors in response to financial hardship. The items in this scale are from the Medical Expenditure Panel Survey - Experiences with Cancer Survivorship Survey (MEPS-ECSS).

"Material conditions" was measured using 8 items (6 from the Medical Expenditure Panel Survey: Experiences with Cancer Survivorship Supplement (MEPS-ECSS) and 2 from demographic survey) that measure the financial condition of the participant with cancer and their family. Six of the items are yes/no and these include questions on borrowing money or go into debt, filing for bankruptcy, and concerns about having to pay large medical bills because of the cost of cancer treatment. The remaining two items are ordinal and measure the amount of debt related to cancer costs (options range from $0 to $100,00+), and the how they perceive their household's income currently (choices range from 'living comfortably on present income' to 'finding it very difficult on present income'). The latter two items are rescaled to 0-1 variables, so they have the same ranges as the yes/no items and are summed to create the total score. Higher scores indicate greater financial hardship.

Psychological response (i.e. financial toxicity) was measured using the 11-item Comprehensive Score for Financial Toxicity (COST) that measures emotional aspects of financial hardship (financial toxicity) among cancer patients. Each item is scored on a 5-point ordinal scale ranging from 0='Not at all' to 4='Very much.' Sample items include 'My out-of-pocket expense are more than I thought they would be' and 'I am frustrated that I cannot work or contribute as much as I usually do.' Lower values indicate greater financial toxicity.

Health-related QOL was measured using four Patient-Reported Outcomes Measurement Information System (PROMIS) scales.xx Each of these were scored and standardized by submitting the raw values to the HealthMeasures scoring service. We used the standardized values of the total scores throughout the analysis for this study. The four scales include the PROMIS physical health and emotional health subscales (from the 10-item PROMIS Scale v1.2 - Global Health),xx the 4-item PROMIS- Anxiety Short Form, and the 6-item PROMIS-Depression Short Form. The physical (physical health, function, pain, and fatigue items) and emotional health (QOL, mental health, social activities, and emotional problem items) subscales are each based on 4 items, with higher scores indicating a more positive health self-assessment. For the anxiety and depression scales, higher scores indicate a greater manifestation of symptoms.

Distress was measured using the National Comprehensive Cancer Network's (NCCN) Distress Thermometer and its accompanying 40-item problem list. A cutoff score of 4 indicated clinically elevated distress levels

Amount of money saved per patient including grants and financial assistance received, total charges, financial assistance adjustments, insurance payments, and insurance charges.

Jean Edward

Associate Professor

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Participants will receive financial navigation service. During their hospitalization, participants will receive face-to-face information support with material booklets. Following discharge, weekly financial navigation information will be sent via WeChat for 1 month.

The financial navigation encompasses comprehensive information support:

* Strategies on patient-physician costs discussion
* Skills for inquiring and tracking treatment-related costs
* Basic knowledge about health insurance
* Guidance on accessing and applying for financial assistance
* Suggestions for returning to normal life and work
* Strategies for holding a financial-related family meeting

Participants will receive usual care during hospitalization and regular follow-up after discharge. Participants have the freedom to utilize any financial resources, but financial navigators do not offer comprehensive information support. When participants actively inquire about cancer treatment-related costs or financial planning strategies, financial navigators will answer their questions.

One-on-one information support with material booklets during hospitalization. Weekly financial navigation information will be sent via WeChat after discharge for 1 month.

The financial navigation encompasses comprehensive information support:

* Strategies on patient-physician costs discussion
* Skills for inquiring and tracking treatment-related costs
* Basic knowledge about health insurance
* Guidance on accessing and applying for financial assistance
* Suggestions for returning to normal life and work
* Strategies for holding a financial-related family meeting

Financial Navigation

Participants will receive usual oncology care during hospitalization and regular follow-up after discharge. Participants have the freedom to utilize any financial resources, but financial navigators do not offer comprehensive information support.

Usual Care

Xiaoyi Yuan, Master

Weijie Xing, Doctor

The goal of this pilot study is to access the feasibility and impact of a financial navigation program on improving financial toxicity among patients with breast cancer in China.

The main questions it aims to answer are:

* Is the intervention feasible and acceptable among participants?
* Does the intervention enhance participants' cost-related health literacy?
* Does the intervention reduce participants' financial toxicity?

Researchers will compare the financial navigation program with usual oncology care to preliminarily evaluate its effectiveness.

Participants will receive comprehensive information support, including:

* Strategies on patient-physician costs discussion
* Skills for inquiring and tracking treatment-related costs
* Basic knowledge about health insurance
* Guidance on accessing and applying for financial assistance
* Suggestions for returning to normal life and work
* Strategies for holding a financial-related family meeting

Pilot Study of Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China

We do not plan to share individual participant data due to privacy concerns and confidentiality agreements with participants.

The eligibility rate will be calculated as the proportion of participants who meet the eligibility criteria among the total number of participants who will be assessed for eligibility. Reasons for participants' ineligibility will be recorded.

The consent rate will be calculated as the proportion of eligible participants who consent to participate among those who will be approached and eligible for participation. Reasons for participants' refusal to participate will be recorded.

The retention rate will be calculated as the percentage of participants who withdraw from or drop out of the study after enrolment. Reasons for participants' withdrawal or dropout will be recorded.

The adherence rate will be calculated as the proportion of participants completing the entire program. Reasons for participants' nonadherence to the intervention will be recorded.

Participants' satisfaction will be measured with homemade 5 item questionnaire, with higher scores indicating higher satisfaction.

Participants' experiences will be captured through one-on-one, semi-structured qualitative interviews.

The cost-related health literacy will be measured with homemade 10-item questionnaire, with higher scores indicating higher cost-related health literacy.

Financial toxicity will be measured with the Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy Version 2 (COST-FACIT-V2); lower scores (range, 0-44) indicating greater financial toxicity.

Material domain of financial toxicity will be measured with 2 items adapted from the Medical Expenditure Panel Survey (MEPS).

Behavioral domain of financial toxicity will be measured by employment changes and cost-related nonadherence with 6 items adapted from MEPS and previous literature.

Fudan University

Principal Investigator

Participants in this arm will receive their usual care plus a Financial Resource Sheet. The financial resource sheet lists and describes existing organization and community resources available to KP members.

Participants in this arm will receive their usual care, and the Financial Resource Sheet described in Arm 1, plus one (1) cycle of financial navigation (total cycles: 1; total length: 6 months). In each intervention cycle participants will get at least one (1) phone call with a CAFÉ Financial Navigator, the navigator will talk with participants to identify financial questions or concerns. The navigator will create a personalized plan for each participant. Participants can request extra support from the navigator for up to 6 months.

Participants in this arm will receive their usual care, a Financial Resource Sheet and the brief intervention described in Arm 2 (i.e., one (1) cycle of financial navigation). Plus, they will receive two (2) additional cycles of financial navigation (total cycles: 3; total length: 6 months).

The CAFÉ intervention is a financial navigation intervention. During the Intervention, a CAFÉ financial navigator will provide information support and resources to people with cancer after diagnosis. CAFÉ intervention components include: (1) proactive assessment of patient financial questions and concerns (e.g., acute financial need or inability to pay for household expenses; deciding between care options depending on cost; uncertainty around planning for out of pocket costs and/or when patients will need to pay), (2) proactive, personalized support and referrals.

Financial navigation

The financial resource sheet lists and describes existing internal and community resources available to KP members

Enhanced usual care

Nora B Henrikson, PhD, MPH

Matthew Banegas, PhD, MPH, MS

Amanda Petrik, PhDC, MS

This study is a randomized clinical trial designed to test a novel financial navigation intervention. The study assesses the impact of the financial navigation intervention on financial hardship and health-related quality of life, cancer-related material and psychological financial hardship, patient-centered communication, and time to initiation of treatment.

Rationale:

Up to half of people with cancer experience financial hardship. Cancer-related financial hardship is associated with several adverse intermediate and health outcomes, including poor quality of life, treatment non-adherence, and lower survival.

Observational evidence suggests that communication about financial concerns and out-of-pocket (OOP) costs early in the treatment trajectory and in partnership with the care team could help to prevent or lessen financial hardship. This type of communication could be delivered through patient navigation programs and is consistent with both patient and care team preferences.

However, to date there is no evidence from randomized trials showing the impact of financial navigation during the active treatment on financial hardship. Further, no intervention-based studies have provided evidence on the most effective ways to mitigate cancer-related financial hardship.

Background:

As costs of cancer care in U.S. have risen over time, so has the burden of out-of-pocket (OOP) costs and indirect costs such as travel, employment changes, and caregiver costs. These cumulative costs pose increased financial risk for people diagnosed with cancer. Despite a patient's health insurance status, financial hardship from cancer care is prevalent: 47%-49% of cancer survivors report financial hardship and 12%-62% of cancer survivors report debt due to treatment costs. Financial hardship is associated with decreased treatment initiation and adherence, poor symptoms and quality of life, and increased mortality risk, so preventing or mitigating its effects is a clinical imperative.

Integration of cost of cancer care information into conversations between patients and clinicians can optimize medical decision-making and reduce the risk of financial hardship, and is consistent with high-quality cancer care and patient preferences. Patient understanding of OOP costs can assist with planning and budgeting, and can facilitate early connection with financial support services that may help to mitigate the financial burden of cancer care. Yet, less than one in five patients report having cost discussions. Consequently, many patients are uninformed about the costs of their cancer care and face unexpected OOP costs, with important consequences for material (e.g., debt), psychological (e.g., cost-related distress), and behavioral (e.g. treatment adherence) financial hardship.

There is an urgent need for evidence-based interventions on how to prevent or mitigate financial hardship for people with cancer. While the extent of financial hardship as a toxicity of cancer care is increasingly well-documented, there is limited evidence to date as to what types of interventions can mitigate or prevent financial hardship due to cancer care. Policy, societal, and organizational-level interventions, such as those focused on bending the curve of rising health care cost or improving price transparency to ordering providers are all needed, but these may take a long time or show limited effect. In the meantime, patients continue to need assistance navigating, managing and anticipating OOP costs, and patient- and team level-interventions such as the CAFÉ study may hold promise for this purpose.

Cancer Financial Experience

CAFÉ: Clinic Based Intervention to Address Financial Hardship for People With Cancer

Proportion of patients initiating treatment, including radiation, surgery, and systemic therapy.

Defined as the number of days between: 1) date of diagnosis/recurrence and start of first-line treatment. Censoring events will include disenrollment, death, and end of the study, whichever comes first.

Proportion of participants who enrolled in the Kaiser Permanente MFA program within 12 months following baseline

Proportion of participants whose medical billing account is administratively marked as past due within 12 months following baseline

Average OOP expenditures per patient between baseline and 12 months following baseline

16-item instrument intended to assess patient perspective on communication over the course of cancer care. The survey items are conceptually grounded in the 6 functions of patient-centered communication: fostering healing relationships, effectively exchanging information, responding to emotions, making quality decisions, managing uncertainty, and enabling patient self-care.

InCharge Financial Distress/Financial Well-Being Scale. This is a validated, 8-item scale that assesses current ability to meet financial obligations, stress or worry about finances, and satisfaction with present financial situation. It is scored to a 10-point scale, where 1 is "Overwhelming financial distress/lowest financial well-being," and 10 is "No financial distress/highest financial well-being." It has been validated in multiple populations and national norms are provided.

The FACT-G7 is a 7-item version of the Functional Assessment of Cancer Therapy-General (FACT-G), a patient-reported outcome measure used to assess health-related quality of life in patients undergoing cancer therapy. The survey assesses the impacts of cancer therapy in four domains: physical, social/family, emotional, and functional. Higher scores represent higher quality of life.

Items from the Medical Expenditure Panel Survey (Yabroff 2016):

Material financial hardship items:

Have you or has anyone in your family had to borrow money or go into debt because of your cancer, its treatment or the lasting effects of that treatment? (Yes\\No)

Did you or your family ever file for bankruptcy because of your cancer, its treatment, or the lasting effects of that treatment? (Yes\\No)

Have you or your family had to make any other kinds of financial sacrifices because of your cancer, its treatment, or the lasting effects of that treatment? (Yes\\No)

Please think about medical care visits for cancer, its treatment, or the lasting effects of that treatment. Have you ever been unable to cover your share of those visits? (Yes\\No)

Psychological financial hardship item:

Have you ever worried about having to pay large medical bills related to your cancer? (Yes\\No)

Kaiser Permanente

Carcinoma

includes a financial toxicity screening measure (COST), baseline and post-intervention surveys, and approximately 2-6 visits with a financial navigator to identify financial assistance resources

providing financial navigation for cancer patients in NC to identify available financial assistance resources to assist patients with the cost of cancer

Michelle L Manning, MPH

Mindy Gellin, RN

Project Coordinator

Social Worker

Financial Navigator

Stephanie Wheeler, PhD

The financial burden, or financial toxicity (FT), of cancer is a consequential and growing problem, particularly for rural patients. It is important to improve our understanding of how financial navigation (FN) can reduce the material, psychological, and behavioral burden of costs associated with cancer care in both rural and non-rural community settings. The purpose of this study is to conduct a financial navigation program in 5 rural and 4 non-rural oncology practices in North Carolina and evaluate the effects of financial navigation on patient outcomes, including financial toxicity and health-related quality of life.

This study is designed to evaluate the implementation and effectiveness of a financial navigation intervention within 5 rural and 4 non-rural oncology settings in North Carolina. Financial navigators from each of the 9 sites will recruit and enroll 780 patients total across all sites into a financial navigation program. The financial navigation intervention consists of screening patients using the COST measure for financial toxicity. If the patient scores 23 or lower, they are considered to have moderate to severe financial toxicity and will be enrolled in the study. Patients will then complete a series of baseline questionnaires to measure their health related quality of life and then they will meet with a financial navigator for a comprehensive intake process to determine potential financial assistance resources the patient may be eligible for and continued visits with the financial navigator until all financial assistance resources have been explored and patients have received benefits or referrals to financial assistance programs. At the end of the intervention, the patients will complete the COST measure again, and repeat baseline surveys to measure health-related quality of life and the patient's acceptability and responsiveness of the financial navigation intervention. Patient participation depends on the depth of patient need but ranges from 2 visits to 6 visits with the financial navigator over approximately 4 months but possibly longer depending on the complexity of the patient's financial need.

This is a multi-site, single arm, financial navigation intervention

Addressing Cancer-Related Financial Toxicity in Rural Oncology Care Settings

We commit to broadly sharing appropriate materials and de-identified data that are developed with support from the NIH, while protecting participant privacy and confidentiality in accordance with best human subjects research practices and Health Insurance Portability and Accountability Act (HIPAA) guidelines. We commit to the collection, cataloging, protecting, and sharing of clinical and other research data and resources that is consistent with NIH policies, using the Research Electronic Data Capture (REDCap) platform as the mechanism for data storage, protection and sharing. We will only share de-identified IPD.

To evaluate the change from baseline to follow-up in scores from the Comprehensive Score for Financial Toxicity (COST) measure after participation in the financial navigation program among 780 rural and non-rural NC cancer patients with high baseline financial distress.

To evaluate the change from baseline to follow-up in scores from HRQoL, care-altering behaviors and patient perspectives on the intervention itself

National Cancer Institute (NCI)

UNC Lineberger Comprehensive Cancer Center

Patients receive PAF brochure describing financial navigation services.

Patients receive usual financial care per practice standard of care and CostCOM financial counseling sessions over 1 hour within 30 days after enrollment and at 3, 6 and 12 months.

Non-patient participants complete surveys and participant in 1 on 1 in depth semi-structured interview over 20-30 minutes at 15-39 months after first patient enrollment.

Receive PAF brochure describing financial navigation services

Best Practice

Participate in a 1 on 1 in-depth interview

Interview

Survey Administration

Site Public Contact

Jay W. Carlson

Timothy D. Moore

Gelareh Sadigh

This clinical trial evaluates the effect of Cost Communication and Financial Navigation (CostCOM) intervention on adherence to care and financial burden in cancer patients. Many cancer patients experience financial hardship due to high medical out of pocket costs (OOPC), changes in employment, income and insurance. Financial hardship can lead to a delay or a stop in cancer care, and is linked to poor quality of life. Financial navigation programs, such as CostCOM, provide financial counseling, education and connections to appropriate resources to reduce financial barriers to healthcare and minimize financial stress and burden. CostCOM may improve adherence to care and decrease financial burden in patients with cancer.

PRIMARY OBJECTIVE:

I. To compare patient-reported cost-related cancer care non-adherence at 12 months after completion of baseline survey between the enhanced usual care (EUC) and CostCOM study arms.

SECONDARY OBJECTIVES:

I. To compare patient-reported material financial hardship at 12 months after completion of baseline survey between the EUC and CostCOM study arms.

II. To compare patient-reported financial worry at 12 months after completion of baseline survey between the EUC and CostCOM study arms.

III. To compare patient-reported quality of life at 12 months after completion of baseline survey between the EUC and CostCOM study arms.

IV. To compare patient satisfaction with care at 12 months after completion of baseline survey between the EUC and CostCOM study arms.

EXPLORATORY OBJECTIVES:

I. To describe CostCOM (Arm B) patients and their provider experience with various implementation outcomes.

II. To assess accuracy of out-of-pocket estimates communicated with the CostCOM (Arm B) patients at part of the intervention with their reported actual out-of-pocket cost.

III. To compare neighborhood characteristics of patient participants versus (vs.) practice patient population.

IV. To assess patients' satisfaction with CostCOM in patients with Arm B. V. To assess patients' receipt of financial navigation via internal practice or external resources.

VI. To evaluate longitudinal changes in cost-related cancer care non-adherence, material hardship, financial worry, quality of life and satisfaction with care.

OUTLINE:

Non-patient participants: Participants complete surveys and participant in 1 on 1 in depth semi-structured interview over 20-30 minutes at 15-39 months after first patient enrollment.

Patients are randomized to 1 of 2 arms.

ARM A: Patients receive Patient Advocate Foundation (PAF) brochure describing financial navigation services.

ARM B: Patients receive usual financial care per practice standard of care and CostCOM financial counseling sessions over 1 hour within 30 days after enrollment and at 3, 6 and 12 months.

Patients are followed up within 12 months of study intervention completion.

Cost Communication and Financial Navigation in Cancer Patients (COSTCOM)

Effectiveness of Out-of-Pocket Cost COMmunication and Financial Navigation (CostCOM) in Cancer Patients

Mean absolute difference between OOPC estimates for the first cycle of therapy (as estimated by TailorMed Medical Incorporated) and the actual billed out of pocket (OOP) costs (as reported by patients based on their co-pays or medical bills).

Proportion of patients with specific characteristics, including racial, ethnic, payer mix, and neighborhood deprivation indices. Proportions will be compared between study participants and practice patient population.

Qualitative interviews utilizing the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework was used to guide the evaluation questions and examine the effectiveness of the intervention and implementation outcomes.

Participants describe their experience with various components of the CostCOM intervention: price transparency, financial navigation, and financial counseling, barriers and facilitators to participation, and feedback on what they liked and disliked about CostCOM, how it impacted their care, satisfaction with care, and what they would change to make it more helpful or engaging. The outcome measures are the proportion of subjects in the top 10 categories identified (5 for each like and dislike)

Proportion of subjects receiving (at least 1 session) of financial navigation via study intervention, internal practice, or external resources.

Receipt of financial counseling or financial assistance will be documented via treating clinic as extracted from medical records and intervention participants via reports from TailorMed Medical Incorporated

Cost-related cancer care outcomes of non-adherence, material hardship, financial worry, quality of life and satisfaction with care (reported above) are included in a Regression Model (GEE)

The effect of time (unitless Betas (slope)) will be estimated using a regression model (stage-stratified GEE analyses) for the Cost-related Outcomes non-adherence, material hardship, financial worry, quality of life, and satisfaction with care Regression intervention parameter (COSTCOM v EUC) will use EUC as the reference category.

Cost-related cancer care non-adherence is defined as a positive response to any of the following due to costs: Delayed, forewent, stopped, or changed prescribed cancer medication; or delayed, forewent, or refused recommended cancer tests, or cancer office visits

The effect of time (unitless Betas (slope)) will be estimated using a regression model (stage-stratified GEE analyses) for the Cost-related Outcomes non-adherence, material hardship, financial worry, quality of life, and satisfaction with care Regression intervention parameter (COSTCOM v EUC) will use EUC as the reference category.

Material hardship is a binary (yes/no) composite measure defined as a 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 your cancer care, or its treatment (adapted from Medical Expenditure Panel Survey).

The effect of time (unitless Betas (slope)) will be estimated using a regression model (stage-stratified GEE analyses) for the Cost-related Outcomes non-adherence, material hardship, financial worry, quality of life, and satisfaction with care Regression intervention parameter (COSTCOM v EUC) will use EUC as the reference category.

Financial Worry measured by the 12-item Comprehensive Score for Financial Toxicity (de Souza COST measure). Composite Scores range between 0-44 with higher the scores reflecting better the Financial Well-Being. Item 12 , an unscored summary item, will be used separately as a single item measure of financial worry. Mean score and changes in mean scores from baseline at each time point between the arms will be compared using two-sample t-tests.

The effect of time (unitless Betas (slope)) will be estimated using a regression model (stage-stratified GEE analyses) for the Cost-related Outcomes non-adherence, material hardship, financial worry, quality of life, and satisfaction with care Regression intervention parameter (COSTCOM v EUC) will use EUC as the reference category.

Quality of life is measured using the 10-item Patient-Reported Outcomes Measurement Information System (PROMIS-10) ver 1.2 Global Health. A T-score will be calculated for each global mental health and global physical health sections with a higher PROMIS T-score representing more of the concept being measured (mental/physical health). T-scores for the general population have a mean of 50 and a standard deviation (SD) of 10.Thus, a person who has T- scores of 60 for the Global Physical Health or Global Mental Health scales is one standard deviation better (more healthy) than the general population Mean score and changes in mean scores from base

The effect of time (unitless Betas (slope)) will be estimated using a regression model (stage-stratified GEE analyses) for the Cost-related Outcome Satisfaction with care Regression intervention parameter (COSTCOM v EUC) will use EUC as the reference category.

Satisfaction with the care is measured using the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Cancer Care Survey questions. Composite items are rated on a scale of 0 to 10, with 0 being the worst and 10 being the best.

Cost-related cancer care non-adherence is defined as a positive response to any of the following due to costs: Delayed, forewent, stopped, or changed prescribed cancer medication; or delayed, forewent, or refused recommended cancer tests, or cancer office visits. Will be calculated as a report of non-adherence at any point up through the 12mo follow-up survey.

Rate of material hardship at each time point is a binary (yes/no) composite measure defined as a 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 your cancer care, or its treatment (adapted from Medical Expenditure Panel Survey).Material hardship at 12 months is measured as report of material hardship at any of the 3, 6 and 12 follow-ups.

Measured by 12-item Comprehensive Score for Financial Toxicity (de Souza COST measure). Composite Scores range between 0-44 with higher the scores reflecting better the Financial Well-Being. Item 12 , an unscored summary item, will be used separately as a single item measure of financial worry. Mean score and changes in mean scores from baseline at each time point between the arms will be compared using two-sample t-tests.

Measured using the 10-item Patient-Reported Outcomes Measurement Information System (PROMIS-10) version 1.2 Global Health. A T-score will be calculated for each of the global mental health and global physical health sections with a higher PROMIS T-score representing more of the concept being measured (mental/physical health). T-scores for the general population have a mean of 50 and a standard deviation (SD) of 10.Thus, a person who has T- scores of 60 for the Global Physical Health or Global Mental Health scales is one standard deviation better (more healthy) than the general population Mean score and changes in mean scores from baseline at each time point between the arms will be compared using two-sample t-tests.

Satisfaction with the care will be measured using Consumer Assessment of Healthcare Providers and Systems (CAHPS) Cancer Care Survey questions. Composite items are rated on a scale of 0 to 10, with 0 being the worst and 10 being the best. Mean score and changes in mean scores from baseline at each time point between the arms will be compared using two-sample t-tests.

ECOG-ACRIN Cancer Research Group

Herbal and Botanical

All Drugs and Chemicals

Orange

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

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

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

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.

CostCOM (Cost Communication, Financial navigation and counseling)

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)

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

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

Financial Education

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.

Usual care

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

Screening for financial and social needs

Richard J Echeverria

Omar Gutierrez

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.

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.

Addressing Financial and Social Needs Among Patients With Cancer

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.

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.

Number of patients who receive all the prescribed cycle of chemotherapy and/or radiation therapy due within the 6-month study period.

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.

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

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

Patients level of health insurance literacy measured by 21 items Health Insurance Literacy Measure (Score range 21-84). Higher score= higher health insurance literacy

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.

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).

Patients total sleep time, sleep efficiency, nighttime awakening, and sleep latency, measured through a sleep ActiGraph

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Coverage and Cost-of-Care (CC) Links- Financial Navigation Program	NCT05465577	Financial Stres... Hematologic Can... Survivorship	CC Links	18 Years - 100 Years	University of Kentucky
Pilot Study of Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China	NCT06355440	Breast Neoplasm... Financial Toxic... Financial Navig...	Financial Navig... Usual Care	18 Years -	Fudan University
Coverage and Cost-of-Care (CC) Links- Financial Navigation Program	NCT05465577	Financial Stres... Hematologic Can... Survivorship	CC Links	18 Years - 100 Years	University of Kentucky
Cancer Financial Experience	NCT05018000	Cancer	Financial navig... Enhanced usual ...	18 Years -	Kaiser Permanente
Addressing Cancer-Related Financial Toxicity in Rural Oncology Care Settings	NCT04931251	Neoplasms Carcinoma	Financial Navig...	18 Years -	UNC Lineberger Comprehensive Cancer Center
Cost Communication and Financial Navigation in Cancer Patients (COSTCOM)	NCT06295367	Malignant Solid...	Best Practice Financial Navig... Interview Survey Administ...	-	Eastern Cooperative Oncology Group
Pilot Study of Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China	NCT06355440	Breast Neoplasm... Financial Toxic... Financial Navig...	Financial Navig... Usual Care	18 Years -	Fudan University
Addressing Financial and Social Needs Among Patients With Cancer	NCT06430840	Cancer Financial Hards...	CostCOM (Cost C... Provision of lo... Financial Educa... Usual care Screening for f...	18 Years -	University of California, Irvine
Addressing Financial and Social Needs Among Patients With Cancer	NCT06430840	Cancer Financial Hards...	CostCOM (Cost C... Provision of lo... Financial Educa... Usual care Screening for f...	18 Years -	University of California, Irvine
Cost Communication and Financial Navigation in Cancer Patients (COSTCOM)	NCT06295367	Malignant Solid...	Best Practice Financial Navig... Interview Survey Administ...	-	Eastern Cooperative Oncology Group

Spots Global Cancer Trial Database for financial navigation