Decisional Intervention for Acute Myeloid Leukemia
(UR-GOAL RCT Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Rochester

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

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.

Inclusion Criteria

The patient's oncologist has been or will be enrolled on the study

I am a caregiver and can enroll before the patient's next oncologist visit after completing certain steps.

Patients without a caregiver will still be eligible to participate in the study

See 8 more

Exclusion Criteria

Patients with psychiatric or cognitive conditions which the treating oncologist believes prohibits informed consent or compliance with study procedures

I have had treatment for AML, but hydroxyurea was okay.

I have been diagnosed with acute promyelocytic leukemia.

Treatment Details

Interventions

UR-GOAL (Behavioral Intervention)

Trial OverviewThe 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.

Participant Groups

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.