Financial Navigation for Cancer Patients

Recruiting at 180 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: ECOG-ACRIN Cancer Research Group

Must be taking: Cancer systemic therapy

Disqualifiers: Indolent cancer, Hospice care, ECOG ≥ 3, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

760 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on financial navigation for cancer patients, so it's unlikely to require changes to your medication regimen.

What data supports the effectiveness of the treatment Cost Communication and Financial Navigation (CostCOM) for cancer patients?

Research shows that financial navigation and cost communication can help cancer patients by reducing their out-of-pocket expenses and improving their satisfaction with care. Additionally, patient navigation has been found to improve access to care, reduce time to treatment, and enhance quality of life, which suggests that CostCOM could be beneficial in managing the financial aspects of cancer treatment. ^{1 2 3 4 5}

Is Financial Navigation safe for cancer patients?

The studies on Financial Navigation, including CostCOM, focus on its feasibility and benefits, such as improved patient knowledge and reduced emergency visits, but they do not report any safety concerns for patients. ^{1 2 6 7 8}

How is the CostCOM treatment different from other treatments for cancer patients?

CostCOM is unique because it focuses on helping cancer patients manage the financial burden of their treatment by providing personalized communication about out-of-pocket costs and remote financial navigation, rather than addressing the medical aspects of cancer treatment. ^{1 3 7 8 9}

Research Team

Gelareh Sadigh

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

The COSTCOM trial is for English or Spanish-speaking adults recently diagnosed with any solid cancer who have started or are about to start systemic therapy. It's also for healthcare workers at NCORP sites involved in financial aspects of patient care. Those not fluent in English/Spanish, without a new cancer diagnosis, or not undergoing treatment are excluded.

Inclusion Criteria

I started my cancer treatment before or within 30 days of enrolling in this study.

Patients must have a completed baseline survey in ECOG American College of Radiology Imaging Network Systems for Easy Entry of Patient Reported Outcomes (EASEE-PRO) within 30 days of the date of OPEN registration and consent (step 0)

Patients must not be enrolled in EAQ221CD or S1912CD given financial navigation is offered as part of these two trials

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Patients receive CostCOM financial counseling sessions over 1 hour within 30 days after enrollment and at 3, 6, and 12 months

12 months

4 visits (in-person)

Follow-up

Participants are monitored for adherence to care and financial burden after intervention

12 months

Treatment Details

Interventions

• Cost Communication and Financial Navigation (CostCOM)

Trial Overview This study tests the Cost Communication and Financial Navigation (CostCOM) program designed to help cancer patients manage financial challenges related to their care. It aims to see if providing financial counseling and resources can improve adherence to treatments and reduce the stress of medical expenses.

Participant Groups

Group I: Non-patient participants: (interview) Experimental Treatment 2 Interventions

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.

Group II: ARM B (CostCOM) Experimental Treatment 3 Interventions

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.

Group III: ARM A (Enhanced usual care) Active Control 2 Interventions

Patients receive PAF brochure describing financial navigation services.

Who Is Running the Clinical Trial?

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials

122

Recruited

160,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The CostCOM intervention, which provided personalized cost communication and financial navigation for 23 newly diagnosed cancer patients, was highly feasible with an 86.9% completion rate, significantly reducing patients' financial worry as indicated by improved COST scores (from 10.0 to 16.9).

Patients reported high satisfaction with the CostCOM program (average score of 4.1 out of 5), and 75% felt it positively impacted their mental health, suggesting that addressing financial concerns can enhance overall well-being without affecting their treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment out-of-pocket cost communication and remote financial navigation in patients with cancer: a feasibility study. Sadigh, G., Coleman, D., Switchenko, JM., et al.[2023]

Navigation programs in oncology significantly improve outcomes for cancer patients by reducing the time it takes to receive a diagnosis and treatment, while also enhancing knowledge and adherence to care among patients and caregivers.

These programs not only benefit patients but also healthcare institutions by lowering costs associated with emergency visits and readmissions, indicating a positive impact on overall healthcare efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of the Oncology Nurse Navigator Throughout the Cancer Trajectory. [2019]

A study involving 11,186 new cancer patients across 4 hospitals found that 32% qualified for financial assistance, receiving a total of $39 million, which significantly reduced their out-of-pocket costs.

Training financial navigators helped patients save an average of $33,265 on medications and $12,256 through insurance enrollment, while hospitals also benefited by avoiding $2.1 million in write-offs annually.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of trained oncology financial navigators on patient out-of-pocket spending. Yezefski, T., Steelquist, J., Watabayashi, K., et al.[2019]

Over 50% of cancer patients desire discussions about treatment costs with their physicians, but less than 33% actually engage in these conversations, highlighting a significant gap in cost communication.

While 75% of physicians believe discussing out-of-pocket costs is their responsibility, fewer than 30% feel comfortable doing so, indicating a need for better training and resources to facilitate these important discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of cost communication in oncology: Patient attitude, provider acceptance, and outcome assessment. Shih, YT., Chien, CR.[2019]

Patient navigation significantly improves participation in cancer screening and reduces the time from screening to diagnosis and from diagnosis to treatment initiation, based on a review of 61 systematic reviews and 53 primary studies.

Emerging evidence indicates that patient navigation enhances quality of life and patient satisfaction during survivorship, while also reducing hospital readmissions during active treatment and survivorship phases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation across the cancer care continuum: An overview of systematic reviews and emerging literature. Chan, RJ., Milch, VE., Crawford-Williams, F., et al.[2023]

A novel methodology was developed to assess the costs of patient navigation programs across six hospital systems, aimed at improving timely access to breast cancer care, highlighting the importance of financial sustainability in these interventions.

The tools created through collaboration with breast oncology navigators are designed to be flexible and relevant for various healthcare settings, which can enhance the implementation of patient navigation programs for chronic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using community-engaged methods to develop a study protocol for a cost analysis of a multi-site patient navigation intervention for breast cancer care. Rajabiun, S., Xiao, V., Bak, S., et al.[2023]

A study involving interviews with 35 financial navigation staff from 29 cancer centers revealed that communication issues significantly affect how patients and staff discuss cancer-related financial burdens, highlighting the need for better expectations and timing in these sensitive conversations.

The financial burden of cancer profoundly impacts patients' overall well-being, leading to increased stress, difficulties in adhering to treatment, and challenges in meeting basic needs, suggesting that regular discussions about costs are essential for supporting cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Financial navigation: Staff perspectives on patients' financial burden of cancer care. Yeager, KA., Zahnd, WE., Eberth, JM., et al.[2023]

The Ambulatory Medical Assistance (AMA) program for patients with hematological malignancies demonstrated a significant reduction in severe adverse events (Grade 3/4) compared to a simulated control group, with rates of 10.1% versus 13.4%.

The cost-effectiveness analysis revealed that the AMA program resulted in avoided adverse event costs totaling €81,113, leading to an incremental cost-effectiveness ratio (ICER) of €864, indicating that the program is a financially viable intervention for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Ambulatory Medical Assistance (AMA) programme during active-phase treatment in patients with haematological malignancies: A cost-effectiveness analysis. Michallet, AS., Malartre, S., Vignaud, E., et al.[2022]

A survey of 78 oncology navigators revealed that approximately 75% of their patients experience financial toxicity related to cancer treatment, highlighting a significant emotional and financial burden on patients.

Navigators identified key barriers to financial assistance for patients, including a lack of resources and knowledge about available support, indicating a need for better training and coordination to help patients access financial aid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncology navigators' perceptions of cancer-related financial burden and financial assistance resources. Spencer, JC., Samuel, CA., Rosenstein, DL., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Treatment out-of-pocket cost communication and remote financial navigation in patients with cancer: a feasibility study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Role of the Oncology Nurse Navigator Throughout the Cancer Trajectory. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Impact of trained oncology financial navigators on patient out-of-pocket spending. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

A review of cost communication in oncology: Patient attitude, provider acceptance, and outcome assessment. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Patient navigation across the cancer care continuum: An overview of systematic reviews and emerging literature. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Using community-engaged methods to develop a study protocol for a cost analysis of a multi-site patient navigation intervention for breast cancer care. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Financial navigation: Staff perspectives on patients' financial burden of cancer care. [2023]

8. England pubmed.ncbi.nlm.nih.gov

The Ambulatory Medical Assistance (AMA) programme during active-phase treatment in patients with haematological malignancies: A cost-effectiveness analysis. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Oncology navigators' perceptions of cancer-related financial burden and financial assistance resources. [2021]