Supportive Care Delivery for Acute Myeloid Leukemia
(ACTIVE DEFAULT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to test a way of delivering supportive care to adults 60 years and older who are starting venetoclax-based treatment for newly diagnosed acute myeloid leukemia (AML). Older adults with AML often have aging-related needs, such as problems with mobility, nutrition, mood, memory, or medications, that are not always addressed in a consistent way. In this study, a health questionnaire and short in-person checks (a geriatric assessment) are used to find these needs early, and matching supportive care orders are prepared in the electronic health record and sent to the treating doctor, who decides whether to place each one. This approach is called Active Default. The main questions the study aims to answer are:
* How often are the prepared supportive care orders signed by treating doctors (implementation fidelity)?
* Can each step of the process, from completing the assessment to receiving supportive care services, be carried out as planned?
Participants will:
* Complete questionnaires and short in-person checks of walking, balance, strength, memory, mood, and medications at the start of treatment
* Receive supportive care services (for example physical therapy, nutrition, or social work) if their doctor approves the prepared orders
* Answer phone check-ins over 90 days and repeat two short checks at about two months
* Be invited to one optional interview about their experience
Healthcare providers involved in participants' care will be invited to complete a one-time survey and an optional interview about the approach.
Who Is on the Research Team?
Aditi Sharma, MD
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
This trial is for adults aged 60 or older who have just been diagnosed with acute myeloid leukemia (AML) and are starting venetoclax-based treatment. Participants should be able to complete questionnaires and brief in-person checks related to their health, mobility, memory, mood, and medications.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants start venetoclax-based therapy and undergo geriatric assessments to identify supportive care needs
Follow-up
Participants are monitored for safety and effectiveness after treatment, including repeat checks at about two months
Optional Interview
Participants may be invited to an optional interview about their experience
What Are the Treatments Tested in This Trial?
Interventions
- Active Default
Trial Overview
The study is testing a new way of providing supportive care by using early assessments to identify aging-related needs. Based on these results, suggested supportive services like physical therapy or nutrition help are sent directly to the doctor through the medical record system for approval.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients aged 60 and older with newly diagnosed AML starting venetoclax-based therapy (n=25) receive the Active Default intervention: a geriatric assessment at the start of treatment, with results crossing pre-specified thresholds generating matched supportive care orders that are prepared in the electronic health record and sent to the treating physician to approve or decline. Patients are followed for 90 days, with phone check-ins and repeat physical function and cognition checks at about 60 days. Healthcare providers involved in enrolled patients' care (up to 15) complete a one-time survey and are invited to an optional interview about the approach.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
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