Financial Navigation for Cancer Patients

Recruiting at 191 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Cost Communication and Financial Navigation (CostCOM) to determine if it helps cancer patients adhere to treatment plans and reduces financial stress. Cancer treatments can be costly, often causing delays in care due to financial hardship, which may affect patients' quality of life. The trial aims to assess whether financial guidance and support can alleviate these burdens. Patients diagnosed with solid cancer who have started systemic therapy (treatment affecting the whole body) might be suitable candidates. As an unphased trial, this study offers patients the chance to contribute to research that could enhance financial support systems for future cancer care.

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 prior data suggests that the Cost Communication and Financial Navigation (CostCOM) intervention is safe for cancer patients?

Research has shown that the Cost Communication and Financial Navigation (CostCOM) program is safe and easy for patients to use. This program helps cancer patients reduce financial stress by managing their healthcare costs. Since CostCOM offers counseling and education instead of medical treatment, it poses no physical risks or side effects.

Studies have found that patients who participated in CostCOM found it helpful and completed their sessions without problems. For example, one study showed that 86.9% of patients finished the program. This suggests that patients generally feel comfortable and satisfied with it. Overall, CostCOM is designed to support patients financially and emotionally without causing any physical harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Financial Navigation for Cancer Patients trial because it aims to tackle the financial stress many cancer patients face, which is often overlooked in standard care. Unlike traditional approaches that might only offer basic information through brochures, the Cost Communication and Financial Navigation (CostCOM) method provides personalized financial counseling sessions. These sessions help patients understand and manage treatment costs more effectively, potentially improving both their financial and mental well-being. Additionally, by including interviews with non-patient participants, the trial seeks to gain a comprehensive understanding of how financial issues impact cancer care, aiming to create a more supportive healthcare environment.

What evidence suggests that CostCOM is effective for reducing financial burden in cancer patients?

Research shows that financial navigation programs like CostCOM, which participants in this trial may receive, can help cancer patients manage treatment costs and enhance their care. Early studies found that personalized cost communication and remote financial counseling work well. These programs aim to reduce financial stress by helping patients understand and plan for out-of-pocket expenses. While researchers continue to study the full effectiveness of CostCOM, initial findings suggest it could help patients adhere to their cancer care by easing financial burdens. ^{1 6 7 8 9}

Who Is on the Research Team?

Gelareh Sadigh

Principal Investigator

ECOG-ACRIN Cancer Research Group

Are You a Good Fit for This Trial?

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)

I am not solely on palliative or hospice care.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06295367

Study Details | NCT06295367 | Cost Communication and ... This clinical trial evaluates the effect of Cost Communication and Financial Navigation (CostCOM) intervention on adherence to care and financial burden in ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40147544

Study protocol for ECOG-ACRIN EAQ222CD - PubMed - NIH A successful CostCOM is a scalable and financially sustainable program that can improve cancer care delivery, patients' experience, and health outcomes. Trial ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9834906/

Treatment out-of-pocket cost communication and remote ... We conducted a pilot study assessing the feasibility of a personalized out-of-pocket cost communication, remote financial navigation, and counseling (CostCOM) ...

4. ascopubs.org ascopubs.org/doi/10.1200/OP-25-00874

Financial Navigation for People Newly Diagnosed With ... Financial navigation could mitigate or prevent cancer-related financial hardship, but its effectiveness has not been established in ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2347562525000162

The development and preliminary evaluation of a financial ... This study aims to develop a financial navigation program among patients with breast cancer in China and assess its feasibility, acceptability, and preliminary ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12128040/

Study Protocol for ECOG-ACRIN EAQ222CD - PubMed Central A successful CostCOM is a scalable and financially sustainable program that can improve cancer care delivery, patients' experience, and health outcomes.

7. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.35367

Interventions to mitigate cancer‐related medical financial ... This study systematically reviewed interventions mitigating financial hardship in patients with cancer and assessed effectiveness using a meta-analytic method.

8. ecog-acrin.org ecog-acrin.org/clinical-trials/eaq222cd-various-cancer/

EAQ222CD / COSTCOM Home Page This clinical trial evaluates the effect of Cost Communication and Financial Navigation (CostCOM) intervention on adherence to care and financial burden in ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35796885/

Treatment out-of-pocket cost communication and remote ... Results: Mean patient age was 61 (78.3% female; 100% white). Of 23 CostCOM patients, 86.9% completed CostCOM, 60% of them completed a financial ...