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Behavioral Intervention
Decisional Intervention for Acute Myeloid Leukemia (UR-GOAL RCT Trial)
N/A
Waitlist Available
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be English or Spanish-speaking
Patients must be aged ≥60 years (from date of consent, confirmed on electronic medical records)
Must not have
Patients with a diagnosis of acute promyelocytic leukemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new intervention for elderly cancer patients with Acute Myeloid Leukemia to see if it is more effective than the current standard treatment.
Who is the study for?
This trial is for adults aged 60 or older with Acute Myeloid Leukemia (AML) who haven't started cancer treatment yet. Caregivers, who can be family, friends, or professionals and must speak English or Spanish, are also included. Patients with certain psychiatric conditions or prior AML treatments (except hydroxyurea) are excluded.
What is being tested?
The study tests a decisional aid called UR-GOAL designed to help older AML patients and their caregivers make informed choices about treatment. Participants will either receive this intervention or an attention control in a randomized manner across multiple centers.
What are the potential side effects?
Since the intervention involves decision-making support rather than medical treatment, there may not be direct physical side effects; however, emotional distress from discussing illness and care options could occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I speak English or Spanish.
Select...
I am 60 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with acute promyelocytic leukemia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Distress Thermometer Questionnaire at 1 month
Secondary study objectives
9-item Shared Decision Making Questionnaire at 2 weeks
Decisional Conflict Scale Questionnaire at 2 weeks
Observed shared decision making
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: UR-GOAL InterventionExperimental Treatment1 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.
Group II: Attention Control ArmActive Control1 Intervention
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.
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Who is running the clinical trial?
University of RochesterLead Sponsor
871 Previous Clinical Trials
549,178 Total Patients Enrolled