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

Trial Summary

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.

How does the Financial Navigation treatment for acute myeloid leukemia differ from other treatments?

The Financial Navigation treatment for acute myeloid leukemia is unique because it focuses on managing the economic burden of the disease, rather than directly treating the leukemia itself. This approach aims to help patients navigate the financial challenges associated with high treatment costs, which is a novel aspect compared to traditional medical treatments like chemotherapy or stem cell transplantation. ^{1 2 3 4 5}

What is the purpose of this trial?

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 by evaluating the impact of systematic financial navigation in addition to standard financial distress interventions during cancer treatment.

Research Team

Thomas Knight, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Economic burden associated with acute myeloid leukemia treatment. [2015]

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

Healthcare resource utilization and costs in patients with newly diagnosed acute myeloid leukemia. [2019]

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

Treatment patterns, economic burden, and overall survival in US Medicare Advantage beneficiaries newly diagnosed with acute myeloid leukemia (AML) in 2015-2020. [2022]

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

Healthcare Costs and Utilization for Patients Age 50 to 64 Years with Acute Myeloid Leukemia Treated with Chemotherapy or with Chemotherapy and Allogeneic Hematopoietic Cell Transplantation. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Treatment patterns, healthcare resource utilization, and costs in patients with acute myeloid leukemia in commercially insured and Medicare populations. [2018]