Clinical trial NCT06945042: ONC-LEUK-2406: The Impact of Systematic Financial Navigation in Acute Myeloid Leukemia
Official title: The Impact of Systematic Financial Navigation in Acute Myeloid Leukemia "SF-NAV"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Myeloid Leukemia
Keywords: Financial Navigation
Financial Toxicity
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Atrium Health Levine Cancer Institute
name: Swim Across America
First posted: 2025-04-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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: 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 4 weeks of diagnosis
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

Primary outcomes:
measure: Self-reported financial toxicity as assessed by the total score of the COmprehensive Score Financial Toxicity (COST) assessment tool at 6 months after enrollment.
timeFrame: From the date of randomization up until six months
Secondary outcomes:
measure: Self-reported financial toxicity as assessed by the total score of the COmprehensive Score Financial Toxicity (COST) assessment tool at 3 months after enrollment.
timeFrame: From the date of randomization up until three months
measure: Self-reported financial toxicity as assessed by the total score of the COmprehensive Score Financial Toxicity (COST) assessment tool at 12 months after enrollment.
timeFrame: From the date of randomization up until twelve months
measure: Self-reported physical health as assessed by the total score of the Global Physical Health (GPH) as part of the Patient-Reported Outcomes Measurement Information System (PROMIS) at 3 months after enrollment
timeFrame: From the date of randomization up until three months
measure: Self-reported physical health as assessed by the total score of the Global Physical Health (GPH) as part of the Patient-Reported Outcomes Measurement Information System (PROMIS) at 6 months after enrollment
timeFrame: From the date of randomization up until six months
measure: Self-reported physical health as assessed by the total score of the Global Physical Health (GPH) as part of the Patient-Reported Outcomes Measurement Information System (PROMIS) at 12 months after enrollment
timeFrame: From the date of randomization up until twelve months
measure: Self-reported physical health as assessed by the total score of the Global Mental Health (GMH) as part of the Patient-Reported Outcomes Measurement Information System (PROMIS) at 3 months after enrollment
timeFrame: From the date of randomization up until three months
measure: Self-reported physical health as assessed by the total score of the Global Mental Health (GMH) as part of the Patient-Reported Outcomes Measurement Information System (PROMIS) at 6 months after enrollment
timeFrame: From the date of randomization up until six months
measure: Self-reported physical health as assessed by the total score of the Global Mental Health (GMH) as part of the Patient-Reported Outcomes Measurement Information System (PROMIS) at 12 months after enrollment
timeFrame: From the date of randomization up until twelve months
measure: Self-reported gaps in care as assessed by the number of gaps of care reported in the Financial Navigation Intervention Compliance/Coping Survey at 3 months after enrollment
timeFrame: From the date of randomization up until three months
measure: Self-reported gaps in care as assessed by the number of gaps of care reported in the Financial Navigation Intervention Compliance/Coping Survey at 6 months after enrollment
timeFrame: From the date of randomization up until six months
measure: Self-reported gaps in care as assessed by the number of gaps of care reported in the Financial Navigation Intervention Compliance/Coping Survey at 12 months after enrollment
timeFrame: From the date of randomization up until twelve months
measure: Overall survival
timeFrame: From the date of randomization up until date of death or last known follow-up, assessed over 3 years.
measure: Comparison of relapse-free survival All randomized participants will inform this analysis.
timeFrame: From the date of randomization up until date of relapse, death or last known follow-up, assessed over 3 years.
measure: Annualized count of acute care visits
timeFrame: From the date of randomization up until twelve months
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Levine Cancer Insitute
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Thomas Knight, MD
role: PRINCIPAL_INVESTIGATOR
References: