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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help caregivers of children in the Neonatal Neurodevelopmental Follow-up Program at SickKids manage financial stress. It will test a Financial Navigator Program designed to support families facing employment difficulties, high living costs, and food insecurity. The goal is to determine if providing financial guidance at the hospital can ease these burdens. Caregivers with a child in this program who attend a 4-month follow-up appointment may be eligible to participate. As an unphased trial, this study offers caregivers the opportunity to receive valuable financial guidance and support.

Will I have to stop taking my current medications?

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

What prior data suggests that the Financial Navigator is safe for caregivers?

Research has shown that financial navigation programs are generally safe for participants. These programs help people manage money worries related to medical situations. Trained helpers usually offer support over the phone or through secure messages.

Previous studies on financial navigation for patients reported no negative effects. Participants often find the support helpful, as it can reduce financial stress. This makes these programs well-tolerated and low-risk for anyone considering joining a trial like this one. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Financial Navigator intervention because it addresses financial hardship in a novel way by providing personalized guidance through financial challenges related to healthcare costs. Unlike traditional financial aid programs that might offer one-size-fits-all solutions or limited financial assistance, the Financial Navigator offers tailored support, helping individuals understand and access various resources specific to their situations. By focusing on personalized navigation, this approach has the potential to reduce stress and improve overall well-being for patients facing financial difficulties due to medical expenses.

What evidence suggests that the Financial Navigator is effective for reducing financial hardship?

Research has shown that financial navigation programs can reduce money-related stress for patients. One study found that people who received financial guidance reported less financial difficulty than those who did not (40% vs 50%). Participants also experienced a better quality of life, with none reporting a decline, compared to 37.5% in the group receiving regular care. Although most findings come from studies on cancer patients, they suggest that financial navigation can assist anyone facing money problems due to medical needs. In this trial, the Financial Navigator Intervention aims to address issues like high living costs and lack of support, common challenges for caregivers. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

Citations

1. 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10894103/

A proactive financial navigation intervention in patients with ... Usual care patients were more likely to experience financial hardship (50% vs 40%) and declines in quality of life (37.5% vs 0%) compared to ...

3. jnccn.org jnccn.org/abstract/journals/jnccn/22/8/article-p557.xml

Impact of a Comprehensive Financial Navigation ... Results: All 50 patients assessed for study eligibility screened positive for financial distress. A total of 46 patients completed both the ...

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06344-3

The Cancer Financial Experience (CAFÉ) study - Trials Journal The CAFÉ study will provide much-needed early trial evidence on the impact of financial navigation in reducing cancer-related financial hardship.

5. 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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10012722/

Core functions of a financial navigation intervention LIFT is an intervention designed to address financial toxicity (FT) and improve cancer care access and outcomes through financial navigation (FN).

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06486272

NCT06486272 | The Financial Navigator Program Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...

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

The development and preliminary evaluation of a financial ... Four participants (30.8%) reported that they did not review the booklet after the navigator introduced educational materials with them during hospitalization.