Acute Myeloid LeukemiaNCT06945042
ONC-LEUK-2406: The Impact of Systematic Financial Navigation in Acute Myeloid Leukemia
A study testing Arm A and Arm B in people with Acute Myeloid Leukemia, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Arm A and Arm B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jun 2025to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Diagnosis of Acute Promyelocytic Leukemia
- Unwilling to receive induction chemotherapy for AML
- Previous treatment for hematologic malignancy
- Prior allogeneic hematopoietic stem cell transplant
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Levine Cancer Insitute
Charlotte, North Carolina, 28204
Courtney Schepel, Courtney.Schepel@advocatehealth.org
Thomas Knight, MD
- Recruiting
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27103
Madelyn Burkart, MD, 336-716-2841, Madelyn.Burkart@wfusm.edu
About this study
Official title: The Impact of Systematic Financial Navigation in Acute Myeloid Leukemia "SF-NAV"
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.
Read the 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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Arm A, Arm B
- Keywords
- Financial Navigation, Financial Toxicity
- Medical subject headings
- Leukemia, Myeloid, Acute, Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm AOther
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 BOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Arm B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: From the date of randomization up until twelve months
Overall survival
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.
Measured: 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.
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.
Measured: 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
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.
Measured: From the date of randomization up until twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start27 Jun 2025
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute, Swim Across America, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Thomas Knight, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945042
- Sponsor's protocol ID
- IRB00126844
- Other IDs
- ONC-LEUK-2406, P30CA012197
- Status last verified
- Jul 2026
- First submitted
- 27 Mar 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Systematic Financial Navigation in Acute Myeloid Leukemia "SF-NAV"
- ClinicalTrials.gov ID
- NCT06945042
- Acronym / sponsor ID
- IRB00126844
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Financial Navigation, Financial Toxicity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute, Swim Across America, National Cancer Institute (NCI)
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systematic Financial Navigation | Other | Other: Arm AParticipants 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. |
| Standard of Care Financial Distress Intervention | Other | Other: Arm BParticipants 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- Diagnosis of Acute Promyelocytic Leukemia
- Unwilling to receive induction chemotherapy for AML
- Previous treatment for hematologic malignancy
- Prior allogeneic hematopoietic stem cell transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm AThe 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. | Other | Systematic Financial Navigation |
| Arm BAll 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. | Other | Standard of Care Financial Distress Intervention |
Primary outcome
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.
14 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Knight, MD principal investigator
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm A and Arm B in people with Acute Myeloid Leukemia, run by Wake Forest University Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Courtney Schepel ((980) 442-2327, Courtney.Schepel@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.