A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of Rochester
About 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
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."
Trial design
Treatments tested in this trial
- UR-GOAL
Treatment groups
1,020 Participants
are divided into 2 treatment groupsLocations
4University of Alabama at Birmingham, Division of Hematology and Oncology35233, BirminghamAlabama, United States
University of Rochester Medical Center14642, RochesterNew York, United States
University of North Carolina Lineberger Comprehensive Cancer Center27514, Chapel HillNorth Carolina, United States
Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Section of Hematology/Oncology27157, Winston-SalemNorth Carolina, United States
Sponsors and collaborators
University of Rochester
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov