Supportive Care Delivery for Acute Myeloid Leukemia

(ACTIVE DEFAULT Trial)

AS
Overseen ByAditi Sharma, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
Must be taking: Venetoclax
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

AS

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

I am 60 years old or older.
I am planning to start venetoclax-based lower-intensity therapy as my first treatment.
Provider participants: Participating leukemia attending physicians and supportive care service leads involved in the care of enrolled participants
See 3 more

Exclusion Criteria

I have acute promyelocytic leukemia.
Patient participants: Life expectancy under 14 days or hospice enrollment at screening
I am scheduled to start intensive or non-venetoclax-based treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants start venetoclax-based therapy and undergo geriatric assessments to identify supportive care needs

90 days
Initial in-person checks, followed by phone check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment, including repeat checks at about two months

4 weeks

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

Group I: Active DefaultExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+