RecruitingInterventional

The Impact of Systematic Financial Navigation in Acute Myeloid Leukemia "SF-NAV"

NCT ID: NCT06945042Sponsor: Wake Forest University Health SciencesLast updated: 2026-05-26

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.

Arms & interventions

OtherArm A
The intervention will consist of systematic financial navigation with consistent screening and intervention on any financial related issues. All patients randomized to the financial navigational group will be contacted by clinical trial staff assigned to the study to screen for financial needs. Based on the results of this assessment, the clinical trials staff will refer to the appropriate services for personalized recommendations and assistance provided by Atrium Health personnel including financial navigators, nurse navigators. All the resources provided to the patient, including counseling, will be free of charge. Assessment will be performed once per month for 6 months.
OtherArm B
All patients randomized to the Standard of Care arm will have access to the financial distress resources (Financial Navigation and Nurse Navigation) as per current clinical policy which is per patient or clinician request. Utilization of these resources will be tracked to assess and describe the per-protocol population. All the resources provided to the patient, including counseling, will be free of charge as per institutional policy.

Outcome measures

Primary

Self-reported financial toxicity as assessed by the total score of the COmprehensive Score Financial Toxicity (COST) assessment tool at 6 months after enrollment.
For each participant, the total score of the COST at the 6-month assessment will be calculated. The total score is informed by 11 questions, each assessed on a 5-point scale of numerical values ranging 0 to 4, and the total score may range from 0 to 44 (where the lower score, the worse the financial well-being of the participant). Data of COST assessments from all randomized participants will inform this intent-to-treat analysis comparing scores between the arms.
Time frame: From the date of randomization up until six months

Secondary

Self-reported financial toxicity as assessed by the total score of the COmprehensive Score Financial Toxicity (COST) assessment tool at 3 months after enrollment.
Time frame: From the date of randomization up until three months
Self-reported financial toxicity as assessed by the total score of the COmprehensive Score Financial Toxicity (COST) assessment tool at 12 months after enrollment.
Time frame: From the date of randomization up until twelve months
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
Time frame: From the date of randomization up until three months
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
Time frame: From the date of randomization up until six months
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
Time frame: From the date of randomization up until twelve months
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
Time frame: From the date of randomization up until three months
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
Time frame: From the date of randomization up until six months
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
Time frame: From the date of randomization up until twelve months
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
Time frame: From the date of randomization up until three months
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
Time frame: From the date of randomization up until six months
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
Time frame: From the date of randomization up until twelve months
Overall survival
Time frame: From the date of randomization up until date of death or last known follow-up, assessed over 3 years.
Comparison of relapse-free survival All randomized participants will inform this analysis.
Time frame: From the date of randomization up until date of relapse, death or last known follow-up, assessed over 3 years.
Annualized count of acute care visits
Time frame: From the date of randomization up until twelve months

Eligibility criteria

Sex: AllAge: 18 Years to 64 YearsHealthy volunteers: No

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

Study locations (2)

Levine Cancer Insitute

Charlotte, North Carolina, 28204

Recruiting

Courtney Schepel · Contact

Courtney.Schepel@advocatehealth.org

Thomas Knight, MD · Principal Investigator

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27103

Recruiting

Madelyn Burkart, MD · Contact

336-716-2841 Madelyn.Burkart@wfusm.edu