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

Last updated: July 15, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Acute Myeloid Leukemia

Platelet Disorders

Treatment

Arm A

Arm B

Clinical Study ID

NCT06945042
IRB00126844
ONC-LEUK-2406
  • Ages 18-64
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofinitial diagnosis is the date of the bone marrow biopsy

  4. Planned intensive induction chemotherapy Note: It is acceptable if chemotherapy hasbeen initiated at the time of enrollment as long as it is within 4 weeks ofdiagnosis

  5. Ability to read and understand the English and/or Spanish language(s)

  6. As determined by the enrolling investigator, ability of the participant tounderstand and comply with study procedures for the entire length of the study.

Exclusion

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

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Arm A
Phase:
Study Start date:
June 27, 2025
Estimated Completion Date:
May 31, 2028

Study 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.

Connect with a study center

  • Levine Cancer Insitute

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

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