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NCT Number: NCT06945042

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

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.

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Key information

Conditions

Acute Myeloid Leukemia Behavior Behavioral Symptoms Financial Stress Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type Stress, Psychological

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Levine Cancer Insitute, Charlotte, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to understand and willingness to sign an IRB-approved informed consent.
  • Age 18-64 years at the time of consent
  • Initial diagnosis of Acute Myeloid Leukemia (AML) per investigator Note: Date of initial diagnosis is the date of the bone marrow biopsy
  • 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
  • Ability to read and understand the English and/or Spanish language(s)
  • 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

  • Diagnosis of Acute Promyelocytic Leukemia
  • Unwilling to receive induction chemotherapy for AML
  • Previous treatment for hematologic malignancy
  • Prior allogeneic hematopoietic stem cell transplant

Treatment and study plan

Arm A

Other

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.

Arm B

Other

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.

Primary outcomes

  1. Self-reported financial toxicity as assessed by the total score of the COmprehensive Score Financial Toxicity (COST) assessment tool at 6 months after enrollment.

    Time frame: From the date of randomization up until six months

    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.

Secondary outcomes

  1. 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

    For each participant, the total score of the COST at the 3-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.

  2. 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

    For each participant, the total score of the COST at the 12-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.

  3. 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

    For each participant, the total score of the GPH measure at the 3-month assessment will be calculated. The total raw score is informed by four items and the total raw score may range from 4 to 20 (where the higher score represents more physical health). The total raw score will be standardized to the general population using the scale's published T-scores. The transformed T scores will be used in analyses and range from 16.2 to 67.7.

    Data of GPH assessments from all randomized participants will inform this intent-to-treat analysis comparing scores between the arms.

  4. 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

    For each participant, the total score of the GPH measure at the 6-month assessment will be calculated. The total raw score is informed by four items and the total raw score may range from 4 to 20 (where the higher score represents more physical health). The total raw score will be standardized to the general population using the scale's published T-scores. The transformed T scores will be used in analyses and range from 16.2 to 67.7.

    Data of GPH assessments from all randomized participants will inform this intent-to-treat analysis comparing scores between the arms.

  5. 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

    For each participant, the total score of the GPH measure at the 12-month assessment will be calculated. The total raw score is informed by four items and the total raw score may range from 4 to 20 (where the higher score represents more physical health). The total raw score will be standardized to the general population using the scale's published T-scores. The transformed T scores will be used in analyses and range from 16.2 to 67.7.

    Data of GPH assessments from all randomized participants will inform this intent-to-treat analysis comparing scores between the arms.

  6. 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

    For each participant, the total score of the GMH measure at the 3-month assessment will be calculated. The total raw score is informed by four items and the total raw score may range from 4 to 20 (where the higher score represents more physical health). The total raw score will be standardized to the general population using the scale's published T-scores. The transformed T scores will be used in analyses and range from 21.2 to 67.6.

    Data of GPH assessments from all randomized participants will inform this intent-to-treat analysis comparing scores between the arms.

  7. 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

    For each participant, the total score of the GMH measure at the 6-month assessment will be calculated. The total raw score is informed by four items and the total raw score may range from 4 to 20 (where the higher score represents more physical health). The total raw score will be standardized to the general population using the scale's published T-scores. The transformed T scores will be used in analyses and range from 21.2 to 67.6.

    Data of GPH assessments from all randomized participants will inform this intent-to-treat analysis comparing scores between the arms.

  8. 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

    For each participant, the total score of the GMH measure at the 12-month assessment will be calculated. The total raw score is informed by four items and the total raw score may range from 4 to 20 (where the higher score represents more physical health). The total raw score will be standardized to the general population using the scale's published T-scores. The transformed T scores will be used in analyses and range from 21.2 to 67.6.

    Data of GPH assessments from all randomized participants will inform this intent-to-treat analysis comparing scores between the arms.

  9. 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

    For each participant, the total number of gaps of care reported in the Financial Navigation Intervention Compliance/Coping Survey at the 3-month assessment will be calculated. The total score is informed by 9 questions, each assessed as a binary response "Yes/No", where each response of "Yes" will be mapped to a numerical value of 1 and each "No" will be mapped to a numerical value of 0. The total sum will be calculated as the total score and the total score may range from 0 to 9 (where the higher score represents the most severe gaps in care assessed by the survey).

    Data from the Financial Navigation Intervention Compliance/Coping Survey from all randomized participants will inform this intent-to-treat analysis comparing scores between the arms.

  10. 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

    For each participant, the total number of gaps of care reported in the Financial Navigation Intervention Compliance/Coping Survey at the 6-month assessment will be calculated. The total score is informed by 9 questions, each assessed as a binary response "Yes/No", where each response of "Yes" will be mapped to a numerical value of 1 and each "No" will be mapped to a numerical value of 0. The total sum will be calculated as the total score and the total score may range from 0 to 9 (where the higher score represents the most severe gaps in care assessed by the survey).

    Data from the Financial Navigation Intervention Compliance/Coping Survey from all randomized participants will inform this intent-to-treat analysis comparing scores between the arms.

  11. 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

    For each participant, the total number of gaps of care reported in the Financial Navigation Intervention Compliance/Coping Survey at the 12-month assessment will be calculated. The total score is informed by 9 questions, each assessed as a binary response "Yes/No", where each response of "Yes" will be mapped to a numerical value of 1 and each "No" will be mapped to a numerical value of 0. The total sum will be calculated as the total score and the total score may range from 0 to 9 (where the higher score represents the most severe gaps in care assessed by the survey).

    Data from the Financial Navigation Intervention Compliance/Coping Survey from all randomized participants will inform this intent-to-treat analysis comparing scores between the arms.

  12. Overall survival

    Time frame: From the date of randomization up until date of death or last known follow-up, assessed over 3 years.

    Overall survival is defined as the time interval from the date of diagnosis to the date of death from any cause, or the date of last known follow-up while on study.

    All randomized participants will inform this analysis.

  13. 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.

    Relapse-free survival is defined as the time interval from the completion of initial treatment (which may include induction and consolidation therapy) to the date of the first documented relapse of AML or death from any cause, whichever occurs first. A relapse is characterized by the re-emergence of leukemia cells in the bone marrow or peripheral blood; in absence of disease relapse, participants will be censored at the last follow-up visit where they were confirmed to be in complete remission without evidence of relapse. Relapse-free survival will be calculated for participants achieving complete response after initial treatment only.

  14. Annualized count of acute care visits

    Time frame: From the date of randomization up until twelve months

    The annualized count of acute care visits, where acute care visits include all unplanned hospital admissions and unplanned emergency department visits was calculated for each participant as the total number of acute care visits normalized to an annual basis. Data of randomized will inform this intent-to-treat analysis comparing counts between the arms.

    All randomized participants will inform this analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Courtney Schepel

CONTACT

[email protected]

(980) 442-2327

Thomas Knight, MD

CONTACT

[email protected]

(980) 442-4363

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Atrium Health Levine Cancer Institute
  • National Cancer Institute (NCI)
  • Swim Across America

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 25, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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