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

NCT06945042 | Recruiting DMC

• 2 other identifiers: IRB00126844ONC-LEUK-2406
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Myeloid Leukemia

Keywords

Financial Navigation; Financial Toxicity

Outcome Measures

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.

  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.

  From the date of randomization up until six months

Secondary Outcomes (14)

• Self-reported financial toxicity as assessed by the total score of the COmprehensive Score Financial Toxicity (COST) assessment tool at 3 months after enrollment.

  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.

  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

  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

  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

  From the date of randomization up until twelve months

Study Arms (2)

Systematic Financial Navigation

OTHER

Participants randomized to Arm A will initiate navigation as soon as feasibly possible after randomization but no later than 4 weeks from enrollment. The intervention will consist of systematic financial navigation with consistent screening and intervention on any financial related issues. The clinical trials staff will refer the participant 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.

Other: Arm A

Standard of Care Financial Distress Intervention

OTHER

Participants randomized to Arm B will receive standard of care financial distress treatment including nurse navigation and pharmacy resources as soon as feasibly possible after randomization but no later than 4 weeks from enrollment. 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. All the resources provided to the patient, including counseling, will be free of charge as per institutional policy.

Other: Arm B

Interventions

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.

Systematic Financial Navigation

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.

Standard of Care Financial Distress Intervention

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Atrium Health Levine Cancer Institute: collaborator
• Swim Across America: collaborator

Study Sites (2)

Levine Cancer Insitute

Charlotte, North Carolina, 28204, United States

RECRUITING

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27103, United States

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Financial Stress

Condition Hierarchy (Ancestors)

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

Study Officials

• Thomas Knight, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Courtney Schepel

CONTACT

(980) 442-2327; Courtney.Schepel@advocatehealth.org

Thomas Knight, MD

CONTACT

(980) 442-4363; Thomas.Knight@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 25, 2025
• Study Start: June 27, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

US (2)