Clinical trial · Interventional
Improving Delivery of Aging-Related Supportive Care for Older Adults With Acute Myeloid Leukemia
Active Default Pilot: Implementation of Geriatric Assessment-Driven Supportive Care for Older Adults With Acute Myeloid Leukemia Receiving Venetoclax-Based Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active Default | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Active Default
- description
- 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.
- interventionNames
- Behavioral: Active Default
Primary outcomes (1)
- measure
- Proportion of eligible triggered supportive care orders signed by the treating physician within 7 days (implementation fidelity)
- timeFrame
- Within 7 days of each supportive care order placement; orders are placed after the baseline geriatric assessment and within 7 days before or after Cycle 1 Day 1 of venetoclax-based therapy (each cycle is 28 days)
- description
- Measured as the number of eligible geriatric assessment-triggered supportive care orders signed by the treating physician within 7 days of order placement, divided by the total number of eligible triggered orders, using electronic health record order data. Eligible triggers are those not already engaged in the corresponding service or pre-declined by the patient at the pre-referral screen. Reported as a point estimate with 95% Clopper-Pearson confidence interval.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available