A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers
University of Rochester
Summary
This is a multicenter randomized controlled trial that assesses the efficacy of a decisional intervention \[University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia (UR-GOAL)\] compared to an attention control.
Description
This is a multicenter randomized controlled trial with four sites that assesses the efficacy of a decisional intervention \[University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia (UR-GOAL)\] compared to an attention control. Subjects will be randomized 1:1 to either the intervention arm or the attention control arm. Compared to an attention control, UR-GOAL will improve patient distress, observed and patient-perceived shared decision making (SDM), and patient decisional conflict.
Eligibility
- Age range
- 60+ years
- Sex
- All
- Healthy volunteers
- No
Patients Inclusion criteria: * Age ≥60 years (from date of consent, confirmed on electronic medical records) * 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 enrol…
Interventions
- BehavioralUR-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.
Locations (4)
- University of Alabama at Birmingham, Division of Hematology and OncologyBirmingham, Alabama
- University of Rochester Medical CenterRochester, New York
- University of North Carolina Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Section of Hematology/OncologyWinston-Salem, North Carolina