Systematic financial navigation for adults with acute myeloid leukemia
The Impact of Systematic Financial Navigation in Acute Myeloid Leukemia "SF-NAV"
This program will test whether adding systematic financial navigation to usual support helps adults 18–64 with acute myeloid leukemia lower financial stress and improve quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Charlotte, North Carolina and 1 other locations) |
| Trial ID | NCT06945042 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults 18–64 with a new diagnosis of AML who plan to undergo intensive induction chemotherapy, can consent in English or Spanish, and can comply with study procedures are ideal candidates.
Not a fit: Patients with acute promyelocytic leukemia, those who decline induction chemotherapy, people with prior hematologic malignancies or prior allogeneic transplant, non-English/Spanish speakers, or those not treated at the participating centers are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could reduce financial toxicity and improve patients' quality of life during AML treatment.
How similar studies have performed: Several pilot studies in cancer populations have shown financial navigation is feasible and can reduce financial distress, but randomized evidence specifically in newly diagnosed AML is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Charlotte, North Carolina and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.