A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers
NCT ID: NCT06697600
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
640 participants
INTERVENTIONAL
2025-07-11
2030-06-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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UR-GOAL Intervention
Patients will view an AML video, complete the best-worst scaling, and be provided with a summary report consisting of their priorities; they will will be asked to review and discuss at upcoming clinical visits. Caregivers, if available, will view the same AML video and be provided with the same summary report. Oncologists will be provided with a summary report consisting of the patient's geriatric assessment, priorities, and perception of prognosis; they will be asked to review and discuss at upcoming clinical visits.
UR-GOAL
Patients will view an AML video, complete the best/worst scaling, will be provided with a summary report, and will be asked to review and discuss at upcoming clinical visits. Caregivers, if available, will view an AML video, will be provided with a summary report, and will be asked to review. Oncologists will be provided with a summary report and will be asked to review and discuss at upcoming clinical visits.
Attention Control Arm
Patients will view a nutritional video, complete a nutrition questionnaire, and will be provided with a nutrition handout and asked to review and discuss at upcoming clinical visits. Caregivers, if available, will view the nutritional video, and will be provided with a nutrition handout and asked to review and discuss at upcoming clinical visits. Oncologists will be provided with the patient's completed nutrition questionnaire and asked to review and discuss at upcoming clinical visits.
No interventions assigned to this group
Interventions
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UR-GOAL
Patients will view an AML video, complete the best/worst scaling, will be provided with a summary report, and will be asked to review and discuss at upcoming clinical visits. Caregivers, if available, will view an AML video, will be provided with a summary report, and will be asked to review. Oncologists will be provided with a summary report and will be asked to review and discuss at upcoming clinical visits.
Eligibility Criteria
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Inclusion Criteria
* A new diagnosis of AML
* Diagnosis can be based on the International Consensus Classification or World Health Organization
* Myeloid sarcoma is allowed
* AML with central nervous system involvement is allowed
* Cancer-directed treatment has not started
* Treatment to temporarily decrease white blood cells is acceptable; these may include hydroxyurea, leukapheresis, or cytarabine
* Intrathecal chemotherapy is acceptable
* The patient's oncologist has been or will be enrolled on the study
* English or Spanish-speaking
* Selected by the patient when asked if there is a "family member, partner, friend or caregiver \[age 18 or older\] with whom you discuss or who can be helpful in healthrelated matters."
* Caregiver may be paid/professional or informal caregiver
* Able to provide informed consent
* English or Spanish-speaking
Oncologists
Exclusion Criteria
* Patients with psychiatric or cognitive conditions which the treating oncologist believes prohibits informed consent or compliance with study procedures
* Prior cancer-directed treatment for AML
Caregivers
60 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Rochester
OTHER
Responsible Party
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Kah Poh Loh
Associate Professor, Division of Hematology/Oncology, Department of Medicine
Locations
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University of Alabama at Birmingham, Division of Hematology and Oncology
Birmingham, Alabama, United States
University of Rochester Medical Center
Rochester, New York, United States
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Section of Hematology/Oncology
Winston-Salem, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Omer Jamy
Role: primary
Kah Poh Loh
Role: primary
Becky Gravenstede
Role: backup
Daniel Richardson
Role: primary
Heidi Klepin
Role: primary
References
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LoCastro M, Sanapala C, Wang Y, Jensen-Battaglia M, Wittink M, Norton S, Klepin HD, Richardson DR, Mendler JH, Liesveld J, Huselton E, O'Dwyer K, Cortes AM, Rodriguez C, Dale W, Loh KP. Patient-centered communication tool for older patients with acute myeloid leukemia, their caregivers, and oncologists: A single-arm pilot study. Cancer Med. 2023 Apr;12(7):8581-8593. doi: 10.1002/cam4.5547. Epub 2022 Dec 19.
Other Identifiers
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UOCPC24064
Identifier Type: -
Identifier Source: org_study_id