Financial Navigator for Financial Hardship

Overseen By Meta van den Heuvel, MD, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

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

Compensation: Varies

Number of Visits: 7

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Financial Navigator for Financial Hardship?

Research shows that financial navigation helps patients with cancer by identifying financial needs, assessing resource eligibility, and planning to manage costs, which can improve quality of life and reduce financial stress. ^{1 2 3 4 5}

How is the Financial Navigator treatment different from other treatments for financial hardship in cancer patients?

The Financial Navigator treatment is unique because it systematically identifies patients at high risk of financial hardship, assesses their eligibility for existing resources, and helps them develop a plan to manage cancer costs, which is not typically addressed by standard cancer care treatments. ^{1 2 5 6 7}

What is the purpose of this trial?

Over one third of caregivers with a child admitted to the Hospital for Sick Children (SickKids) reported having difficulty making ends meet. The SickKids Medical-Financial Partnership (MFP) working group conducted in-depth interviews exploring financial needs and supports with selected caregivers in the Neonatal Neurodevelopmental Follow-up Program (NNFU). Results identified financial stress (including difficulties with employment, high cost of living, poverty, food insecurity, inaccessible supports, benefit time lines, costs of therapy) as a major theme. Caregivers generally supported the idea of hospital-based financial services. In this feasibility study we will trial a Financial Navigator Program in the NNFU.

Eligibility Criteria

This trial is for caregivers with a child admitted to the Hospital for Sick Children who are experiencing financial hardship. It aims to help those struggling with employment, high living costs, poverty, food insecurity, and therapy costs.

Inclusion Criteria

Caregivers with a child followed in the NNFU in SickKids will be invited to participate in our study

My caregiver can attend a 4-month follow-up appointment.

Exclusion Criteria

There are no exclusion criteria.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person or virtual)

Intervention

Caregivers meet with the Financial Navigator to receive financial services such as tax filing and applying for benefits

14 months

2-4 visits (in-person or virtual)

Follow-up

Participants are monitored for demand and economic outcomes, including tax benefit uptake and stress levels

14 months

Follow-up at 4, 8, 12, 18, and 36 months

Treatment Details

Interventions

• Financial Navigator

Trial Overview The study is testing a Financial Navigator Program designed to support these caregivers by addressing their financial needs directly within the hospital setting.

Participant Groups

Group I: Financial Navigator Intervention Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Edwin S.H. Leong Centre for Healthy Children

Collaborator

Trials

1

Recruited

40+

Findings from Research

A study involving 83 stakeholders from 10 oncology care sites revealed that financial navigation (FN) is crucial for addressing the financial hardships faced by cancer patients, highlighting the need for systematic implementation of FN processes.

Key barriers to effective financial assistance included insufficient staff resources and challenges in identifying patient needs, while open communication among staff and patients was identified as a significant facilitator in both rural and nonrural settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Financial Assistance Processes and Mechanisms in Rural and Nonrural Oncology Care Settings. Biddell, CB., Spees, LP., Petermann, V., 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]

The use of patient navigators (PNs) significantly reduced healthcare costs for high-risk patients aged 60 and older, with total costs dropping from $7,640 to $5,676 within 180 days post-discharge.

While the PN intervention showed cost savings for older patients, it did not significantly impact costs for those under 60, suggesting that PNs may be particularly beneficial for older adults in transitional care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Impact of a Postdischarge Community Health Worker Intervention on Health Care Costs in a Safety-Net System. Galbraith, AA., Meyers, DJ., Ross-Degnan, D., et al.[2019]

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]

A significant number of cancer patients experience financial hardship, which negatively impacts their quality of life and treatment adherence, highlighting the need for effective oncology financial navigation (OFN) services.

While the implementation of OFN has been shown to be feasible, existing studies have small sample sizes and primarily focus on urban, academic settings, suggesting a need for future research to include underserved and racially diverse populations to better understand and address financial barriers in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence of the Feasibility and Preliminary Efficacy of Oncology Financial Navigation: A Scoping Review. Doherty, MJ., Thom, B., Gany, F.[2022]

References

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

Financial Assistance Processes and Mechanisms in Rural and Nonrural Oncology Care Settings. [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

Financial Burden Among Patients With Lung Cancer in a Publically Funded Health Care System. [2020]

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

Long-Term Impact of a Postdischarge Community Health Worker Intervention on Health Care Costs in a Safety-Net System. [2019]

5. 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]

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

Evidence of the Feasibility and Preliminary Efficacy of Oncology Financial Navigation: A Scoping Review. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Assessment of financial screening and navigation capabilities at National Cancer Institute community oncology clinics. [2023]