A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: UR-GOAL.
- Who it may be relevant to
- Registry conditions: Oncology, Myeloid Leukemia, Acute, Cancer. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed 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.
Interventions
- Behavioral 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.
Primary outcome measures
- Distress Thermometer Questionnaire at 1 month [Time frame: 1 month]
Secondary outcome measures (3)
- 9-item Shared Decision Making Questionnaire at 2 weeks [Time frame: 2 weeks]
- Decisional Conflict Scale Questionnaire at 2 weeks [Time frame: 2 weeks]
- Observed shared decision making [Time frame: Day 0]
Eligibility criteria
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 enrolled on the study
- English or Spanish-speaking
- Patients without a caregiver will still be eligible to participate in the study Exclusion criteria
- A diagnosis of acute promyelocytic leukemia
- 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
Inclusion criteria
- 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
Inclusion criteria
- Oncologists caring for patients with AML Exclusion criteria
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 4 centers
- University of Alabama at Birmingham, Division of Hematology and Oncology — Birmingham
- University of Rochester Medical Center — Rochester
- University of North Carolina Lineberger Comprehensive Cancer Center — Chapel Hill
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Section of Hematology/Oncol — Winston-Salem
Publications
- 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 20 PMID 36533397
Identifiers
NCT: NCT06697600 · UOCPC24064 · 1R01CA288318-01A1