Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06945042

Conditions

Acute Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Arm A

Arm B

Study Details

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

Study ID

NCT06945042

Start date

Jun 27, 2025

Status verified date

Jul, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Systematic Financial Navigation

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: Standard of Care Financial Distress Intervention

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.

Interventions

Arm 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.

Arm 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.

Primary outcome 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. [ Time Frame: From the date of randomization up until six months ]

Central Contacts and Locations

Central contacts

Courtney Schepel

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

Thomas Knight, MD

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

Locations

Levine Cancer Insitute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Courtney Schepel

Courtney.Schepel@advocatehealth.org

Principal Investigator:

Thomas Knight, MD

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Madelyn Burkart, MD

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

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • Financial Navigation
  • Financial Toxicity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-23.