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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests a way to help adults age 60 and older get care for aging-related needs as they start treatment for newly diagnosed acute myeloid leukemia (AML), a blood cancer. Health checks help find needs, such as trouble walking, eating, or remembering things, and care orders are prepared for the doctor to approve. The study checks whether doctors approve these orders and whether each step of care happens as planned.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Patients must be age 60 or older.
- Patients must have newly diagnosed AML, including AML linked to an earlier illness or cancer treatment.
- Patients must plan to start a less intense first treatment that includes venetoclax.
- Patients must speak English.
- Patients must be able to agree to join the study, either on their own or through someone legally allowed to decide for them.
- Providers may join if they are participating leukemia doctors or supportive care team leaders caring for patients in the study.
Who can't join
- Patients with acute promyelocytic leukemia, a specific type of AML.
- Patients who plan to get intensive starting treatment or treatment that does not include venetoclax.
- Patients expected to live less than 14 days or who are enrolled in hospice care when checked for the study.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
AL
- University of Alabama at Birmingham · Birmingham, AL 35233Aditi Sharma, MD · Study contact · 205-975-0412 · adshar@uabmc.eduAditi Sharma, MD · Principal investigatorGabrielle Rocque, MD, MSPH · Sub-investigatorSmita Bhatia, MD, MPH · Sub-investigatorMore trials in Birmingham