Systematic financial navigation for adults with acute myeloid leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial enrolls adults aged 18–64 with a new diagnosis of acute myeloid leukemia who are planning intensive induction chemotherapy. Participants are randomized to receive systematic financial navigation plus standard financial distress interventions or to receive standard financial distress interventions alone. The primary outcome is patient-reported financial toxicity measured by the 12-item COST instrument, with additional assessments of quality of life and healthcare utilization. Enrollment and interventions occur at two North Carolina cancer centers with materials available in English and Spanish.

Why it matters

Who can join: the full rules

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

Where it's running

• Levine Cancer Insitute
  Charlotte, North Carolina, United States Recruiting
• Atrium Health Wake Forest Baptist Comprehensive Cancer Center
  Winston-Salem, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Thomas Knight, MD — Wake Forest University Health Sciences
• Study coordinator: Courtney Schepel
• Email: Courtney.Schepel@advocatehealth.org
• Phone: (980) 442-2327

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.