NCT06945042NARecruiting

ONC-LEUK-2406: The Impact of Systematic Financial Navigation in Acute Myeloid Leukemia

Wake Forest University Health Sciences

Start Date

6/27/2025

Completion Date

5/1/2028

Summary

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.

Detailed Description

Financial navigation (FN) has been increasingly recognized as an important interventional tool with the potential to significantly mitigate the onset, severity, and duration of financial toxicity (FT). There have been several recent pilot studies in this area demonstrating the feasibility and effectiveness of this approach. With the suddenness of onset and high healthcare utilization of an acute leukemia diagnosis, financial navigation early in the disease course may represent an opportunity to reduce the financial distress burden of this disease and improve outcomes. The investigators have chosen to conduct this as a randomized, controlled trial (RCT) evaluating the effect of financial navigation (FN) on the patient reported objective measurement of financial toxicity (FT) using the Comprehensive Score for Financial Toxicity (COST) measure. This 12-question measure has become the standard for financial toxicity (FT) quantification in the research setting and will allow for direct comparison between the two groups.

Eligibility Criteria

Age Range: 18 years to 64 years

Inclusion Criteria: 1. Ability to understand and willingness to sign an IRB-approved informed consent. 2. Age 18-64 years at the time of consent 3. Initial diagnosis of Acute Myeloid Leukemia (AML) per investigator Note: Date of initial diagnosis is the date of the bone marrow biopsy 4. Planned intensive induction chemotherapy Note: It is acceptable if chemotherapy has been initiated at the time of enrollment as long as it is within 30 days of therapy initiation 5. Ability to read and understand the English and/or Spanish language(s) 6. As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study. Exclusion Criteria: 1. Diagnosis of Acute Promyelocytic Leukemia 2. Unwilling to receive induction chemotherapy for AML 3. Previous treatment for hematologic malignancy 4. Prior allogeneic hematopoietic stem cell transplant

Interventions

OTHER

Arm A

OTHER

Arm B

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Conditions

Acute Myeloid Leukemia

Locations

Levine Cancer Insitute

Charlotte, North Carolina 28204

United States

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina 27103

United States