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NCT07777471
Improving Delivery of Aging-Related Supportive Care for Older Adults With Acute Myeloid Leukemia
Conditions: Acute Myeloid Leukemia (AML)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 40
Sponsor: University of Alabama at Birmingham
Location: University of Alabama at Birmingham Birmingham Alabama
Summary
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.
Eligibility Criteria
Inclusion Criteria:
Patient participants:
* Age 60 years or older
* Newly diagnosed acute myeloid leukemia (AML), including de novo, secondary, or therapy-related AML, per current World Health Organization (WHO) or International Consensus Classification (ICC) classification
* Planned for first-line venetoclax-based lower-intensity therapy
* English-speaking
* Able to provide informed consent personally or through a Legally Authorized Representative (LAR)
Provider participants:
-Participating leukemia attending physicians and supportive care service leads involved in the care of enrolled participants
Exclusion Criteria:
Patient participants:
* Acute promyelocytic leukemia
* Planned intensive induction or non-venetoclax-based therapy
* Life expectancy under 14 days or hospice enrollment at screening
Source: ClinicalTrials.gov (NCT07777471). StuddyBuddy aggregates publicly available trial information.