Financial Education for Young Adult Cancer Patients

Overseen By Rhea K Khurana, BS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Unable to complete survey, others

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

Compensation: Varies

Number of Visits: Unknown

216 Participants Needed

Trial Summary

What is the purpose of this trial?

The overall aims of this study are to address two important gaps in care for AYA cancer patients: 1) a financial toxicity measurement tool to assess AYA-specific needs, and 2) an intervention for mitigating financial toxicity in this population. Aim 1 involves adapting the COSTA measure and assessing the psychometric properties of the measure for a racial/ethnically diverse group of AYAs. Aim 2 and 3 involve the development and pilot testing of our novel financial education/ navigation (FE/FN) intervention.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Financial education / navigation intervention for young adult cancer patients?

Research shows that financial navigation programs can help reduce financial toxicity (financial hardship due to medical costs) in cancer patients by improving their understanding of treatment costs and managing out-of-pocket expenses. These programs have been shown to improve patient outcomes by providing financial counseling and support, which can help patients cope with the economic burden of cancer care. ^{1 2 3 4 5}

Is financial education for young adult cancer patients safe?

The research on financial education and navigation programs for cancer patients does not report any safety concerns, suggesting that these programs are generally safe for participants. ^{1 2 3 4 6}

How does financial education differ from other treatments for young adult cancer patients?

Financial education for young adult cancer patients is unique because it focuses on reducing 'financial toxicity' (the financial burden of cancer treatment) by improving patients' understanding of treatment costs and providing financial counseling. Unlike traditional medical treatments, this approach aims to enhance financial self-efficacy and support, helping patients manage out-of-pocket expenses and navigate financial challenges associated with cancer care. ^{1 2 3 5 7}

Research Team

Melissa Beauchemin

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for young adults (ages 15-39) diagnosed with cancer within the last 18 months, and their caregivers who handle finances. Participants must speak English or Spanish and not be on hospice care. Those unable to complete financial surveys or with conditions that make participation unsafe are excluded.

Inclusion Criteria

I am an adolescent or young adult participating in this study.

I was diagnosed and treated for cancer within the last 18 months.

Caregiver/financial partner participants:

Exclusion Criteria

Unable to complete financial survey questions or contraindicated (as outlined in Protection of Human Subjects)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Financial Toxicity Assessment

Adaptation of the COST measure and assessment of psychometric properties for a diverse group of AYAs

6 months

Multiple visits for assessment and data collection

Intervention

Pilot test of the financial education/navigation intervention delivered to AYAs

6 months

Regular contact with community partners

Follow-up

Participants are monitored for changes in financial toxicity scores and intervention acceptability

6 months

Treatment Details

Interventions

• Financial education / navigation intervention

Trial Overview The study aims to create a tool for measuring financial stress in young adult cancer patients and test an educational program designed to help manage the financial burden of cancer treatment. It involves adapting a measurement tool and piloting a novel financial education/navigation intervention.

Participant Groups

Group I: Patient Financial Education / Navigation Experimental Treatment 1 Intervention

Individuals who screen positive will all move forward to receive the intervention. This intervention includes partnering with community-based organizations to deliver financial education, connection to resources, and counseling tailored to individual patients and spouses for 6-months.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Patient Advocate Foundation

Collaborator

Trials

1

Recruited

220+

Findings from Research

Financial toxicity (FT) is a significant issue for about half of cancer patients, particularly affecting those from socioeconomically vulnerable backgrounds, leading to negative economic and health outcomes.

Financial navigation, led by social workers or nurse navigators, is a key strategy to help patients manage FT by assessing their risk factors and connecting them to resources, while oncologists can play a crucial role in addressing financial concerns during treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Navigating financial toxicity in patients with cancer: A multidisciplinary management approach. Smith, GL., Banegas, MP., Acquati, C., et al.[2023]

The LIFT study is a multi-site Phase 2 clinical trial involving 780 cancer patients across nine oncology care settings in North Carolina, aimed at addressing financial toxicity (FT) through financial navigation (FN) services.

The trial will evaluate the effectiveness of FN in reducing FT and improving health-related quality of life, using validated measures like the Comprehensive Score of Financial Toxicity (COST) and the PROMIS Global Health Questionnaire.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessening the Impact of Financial Toxicity (LIFT): a protocol for a multi-site, single-arm trial examining the effect of financial navigation on financial toxicity in adult patients with cancer in rural and non-rural settings. Wheeler, SB., Biddell, CB., Manning, ML., et al.[2022]

A pilot study involving 34 cancer patients showed that a financial navigation program effectively reduced anxiety about treatment costs for 33% of participants, highlighting its potential to support patients in managing financial stress.

While the program provided valuable assistance with budgeting and insurance applications, it did not significantly change self-reported financial burden, indicating that while anxiety can be alleviated, overall financial challenges may persist.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Feasibility Study of an Oncology Financial Navigation Program. Shankaran, V., Leahy, T., Steelquist, J., et al.[2019]

A study involving 35 financial navigation staff from 29 cancer centers highlighted the importance of proactive financial assessments and tailored assistance to help cancer patients, especially in rural areas, manage financial toxicity.

Best practices identified include using screening tools and patient education, along with a call for more financial navigators and policy reforms to improve access to resources and support for patients facing financial challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to address cancer-related financial toxicity: Recommendations from the field. Edward, J., Petermann, VM., Eberth, JM., et al.[2023]

The oncology financial navigation intervention, CC Links, significantly reduced financial toxicity for both patients with hematologic cancer and their caregivers, with statistical improvements noted in their financial distress and quality of life.

The intervention was highly accepted by participants, with 89% rating it positively, and it successfully secured an average of $2,500 in financial benefits per participant, indicating its practical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coverage and Cost-of-Care Links: Addressing Financial Toxicity Among Patients With Hematologic Cancer and Their Caregivers. Edward, JS., McLouth, LE., Rayens, MK., et al.[2023]

The CAFÉ study is a randomized controlled trial designed to assess the effectiveness of financial navigation interventions in reducing cancer-related financial hardship among patients, with outcomes measured at a 12-month follow-up.

By comparing patients receiving either brief or extended financial navigation support to a control group receiving standard care, the study aims to provide evidence on how financial navigation can improve quality of life and reduce financial distress in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Cancer Financial Experience (CAFÉ) study: randomized controlled trial of a financial navigation intervention to address cancer-related financial hardship. Henrikson, NB., Anderson, ML., Dickerson, J., et al.[2023]

Adolescents and young adults (AYAs) aged 15-39 face significant financial challenges due to cancer treatment, leading to issues like income loss, debt, and treatment nonadherence.

To effectively address financial toxicity in AYAs, clinical interventions should focus on enhancing financial self-efficacy and providing direct support, using reliable and age-appropriate measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding, measuring, and addressing the financial impact of cancer on adolescents and young adults. Salsman, JM., Bingen, K., Barr, RD., et al.[2020]

References

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

Navigating financial toxicity in patients with cancer: A multidisciplinary management approach. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Lessening the Impact of Financial Toxicity (LIFT): a protocol for a multi-site, single-arm trial examining the effect of financial navigation on financial toxicity in adult patients with cancer in rural and non-rural settings. [2022]

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

Pilot Feasibility Study of an Oncology Financial Navigation Program. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Interventions to address cancer-related financial toxicity: Recommendations from the field. [2023]

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

Coverage and Cost-of-Care Links: Addressing Financial Toxicity Among Patients With Hematologic Cancer and Their Caregivers. [2023]

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

The Cancer Financial Experience (CAFÉ) study: randomized controlled trial of a financial navigation intervention to address cancer-related financial hardship. [2023]

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

Understanding, measuring, and addressing the financial impact of cancer on adolescents and young adults. [2020]