Financial Navigation for Acute Myeloid Leukemia

Overseen By Courtney Schepel

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Acute Promyelocytic Leukemia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the financial burden of cancer treatment affects health and quality of life for individuals with Acute Myeloid Leukemia (AML). Participants will receive either systematic financial navigation, offering personalized assistance with financial issues, or standard financial distress support. Both groups will have access to free resources and counseling. The trial seeks individuals diagnosed with AML who plan to undergo intensive chemotherapy. Participants should be able to communicate in English or Spanish. As an unphased study, this trial offers a unique opportunity to contribute to research that could enhance financial support systems for future AML patients.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on financial navigation during cancer treatment, so it's best to discuss your current medications with the trial team.

What prior data suggests that systematic financial navigation is safe for patients with acute myeloid leukemia?

In this clinical trial, the treatment is called Systematic Financial Navigation. It is not a medicine or medical procedure but a support system to manage the financial stress of cancer treatment. As it is not a physical treatment like a drug or surgery, there are no typical side effects or safety risks.

The goal is to help individuals better handle financial issues while dealing with cancer. Participants will receive assistance from financial and nurse navigators. These professionals guide patients through financial challenges, ensuring they receive the necessary support.

There is no specific safety data because this is not a medical treatment. Instead, it is a support service designed to reduce stress and improve quality of life. Therefore, there are no safety concerns as there might be with a new drug. This trial aims to determine if such support can positively impact patients' lives without adding any risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Financial Navigation for Acute Myeloid Leukemia trial because it aims to tackle the often-overlooked financial challenges faced by patients. Unlike standard care, which typically provides financial support only upon request, this new approach involves proactive, systematic financial navigation. This means patients receive consistent screening and targeted interventions for financial issues right from the start, potentially reducing stress and allowing them to focus more on their health. By integrating personalized assistance from financial and nurse navigators, the trial hopes to demonstrate that addressing financial distress comprehensively can improve overall patient well-being.

What evidence suggests that systematic financial navigation is effective for reducing financial toxicity in acute myeloid leukemia patients?

Research has shown that money worries can harm the health and quality of life of people with acute myeloid leukemia (AML). This trial will randomize participants into one of two arms to address these concerns. One arm will receive Systematic Financial Navigation, a system designed to manage money-related issues by offering consistent support and advice. This approach includes regular check-ins and access to financial experts who can help patients find the right resources and support. The other arm will receive the Standard of Care Financial Distress Intervention, which includes nurse navigation and pharmacy resources. Although limited data exists on the effectiveness of these interventions, helping patients handle financial stress might improve their overall well-being during cancer treatment. ^{2 3 6 7 8}

Who Is on the Research Team?

Thomas Knight, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for patients with Acute Myeloid Leukemia or T-Lymphoblastic Leukemia/Lymphoma. It's designed to help understand how financial stress from cancer costs affects their health and quality of life.

Inclusion Criteria

I can read and understand English or Spanish.

I understand and can follow the study's procedures.

I can understand and am willing to sign a consent form.

Exclusion Criteria

I do not want to undergo chemotherapy for AML.

I have had a stem cell transplant from a donor.

I have been diagnosed with Acute Promyelocytic Leukemia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive systematic financial navigation or standard of care financial distress intervention

6 months

Monthly assessments

Follow-up

Participants are monitored for self-reported physical health and financial toxicity

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Systematic Financial Navigation

Trial Overview The study compares two approaches: Arm A receives standard interventions for financial distress, while Arm B gets those plus systematic financial navigation to see if it improves outcomes.

How Is the Trial Designed?

Group I: Systematic Financial Navigation Experimental Treatment 1 Intervention

Participants randomized to Arm A will initiate navigation as soon as feasibly possible after randomization but no later than 4 weeks from enrollment. The intervention will consist of systematic financial navigation with consistent screening and intervention on any financial related issues. The clinical trials staff will refer the participant to the appropriate services for personalized recommendations and assistance provided by Atrium Health personnel including financial navigators, nurse navigators. All the resources provided to the patient, including counseling, will be free of charge. Assessment will be performed once per month for 6 months.

Group II: Standard of Care Financial Distress Intervention Experimental Treatment 1 Intervention

Participants randomized to Arm B will receive standard of care financial distress treatment including nurse navigation and pharmacy resources as soon as feasibly possible after randomization but no later than 4 weeks from enrollment. All patients randomized to the Standard of Care arm will have access to the financial distress resources (Financial Navigation and Nurse Navigation) as per current clinical policy which is per patient or clinician request. All the resources provided to the patient, including counseling, will be free of charge as per institutional policy.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Atrium Health Levine Cancer Institute

Collaborator

Trials

30

Recruited

4,700+

Swim Across America

Collaborator

Trials

11

Recruited

410+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06945042

ONC-LEUK-2406: The Impact of Systematic Financial ... The purpose of this research is to see how personal financial burden (financial toxicity) related to cancer affects the overall health and quality of life ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8446831/

A systematic literature review of disease burden and clinical ... A systematic literature review of disease burden and clinical efficacy for patients with relapsed or refractory acute myeloid leukemia - PMC.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2152265024024479

Clinical Outcomes of Patients With Newly Diagnosed Acute ... The 5-year OS rate in the entire cohort was 30 % (35 % in patients <60 years and 16 % if ≥60 years), with 92 % of deaths attributed to AML-related complications ...

4. jmcp.org jmcp.org/doi/10.18553/jmcp.2020.19220

Economic and Clinical Burden of Acute Myeloid Leukemia ... Outcomes for patients with AML remain unsatisfactory, with a 5-year overall survival of only 28%. While the National Comprehensive Cancer ...

5. ashpublications.org ashpublications.org/hematology/article/2020/1/129/474302/Practice-patterns-and-outcomes-for-adults-with

Practice patterns and outcomes for adults with acute myeloid ... Treatment outcomes for adults with acute myeloid leukemia (AML) are better in higher- vs lower-volume hospitals and academic vs nonacademic centers.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06945042/onc-leuk-2406-the-impact-of-systematic-financial-navigation-in-acute-myeloid-leukemia

ONC-LEUK-2406: The Impact of Systematic Financial ... The purpose of this research is to see how personal financial burden (financial toxicity) related to cancer affects the overall health and ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.7035

Clinical outcomes of patients with newly diagnosed acute ... 7035. Background: Standard induction therapy for acute myeloid leukemia (AML) results in 5-year overall survival (OS) rates of 30-45%.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11898379/

Real-world treatment outcomes from a retrospective cohort ... We performed a retrospective chart review of adult patients with acute myeloid leukemia who were treated at Harbor-UCLA from 2014 to 2022