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

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT06945042
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jun 27, 2025
Status verified
Feb 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

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

Locations (2)

FacilityCityStateZIPSite coordinators
Levine Cancer InsituteCharlotteNorth Carolina28204
Courtney Schepel
[email protected]
Thomas Knight, MD (PRINCIPAL_INVESTIGATOR)
Atrium Health Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth Carolina27103
Madelyn Burkart, MD
[email protected]
336-716-2841

Find similar trials in Charlotte, NC

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Levine Cancer Insitute· Charlotte, NCAtrium Health Wake Forest Baptist Comprehensive Cancer Center· Winston-Salem, NC

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