Recruiting

UR-GOAL

Sponsor:

University of Rochester

Code:

NCT06697600

Conditions

Oncology

Myeloid Leukemia, Acute

Cancer

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

UR-GOAL

Study Details

Brief 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.

Conditions

Oncology

Myeloid Leukemia, Acute

Cancer

Study ID

NCT06697600

Start date

Jul 11, 2025

Status verified date

Jul, 2026

Completion date

Jun 1, 2030

Anticipated

Primary completion date

Oct 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1020 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: UR-GOAL 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.

no intervention: Attention Control Arm

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.

Interventions

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 measure

  • Distress Thermometer Questionnaire at 1 month [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Kah Poh Loh

585-276-4353Kahpoh_Loh@URMC.Rochester.edu

Becky Gravenstede

585-727-4728becky_gravenstede@urmc.rochester.edu

Locations

University of Alabama at Birmingham, Division of Hematology and Oncology

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Omer Jamy

205-801-9034omerjamy@uabmc.edu

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Kah Poh Loh

585-276-4353kahpoh_loh@urmc.rochester.edu

Becky Gravenstede

585-727-4728becky_gravenstede@urmc.rochester.edu

University of North Carolina Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Daniel Richardson

919-966-0127daniel_richardson@med.unc.edu

Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Section of Hematology/Oncology

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Heidi Klepin

335-713-5440hklepin@wakehealth.edu

More Information

Sponsor

University of Rochester

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • older adults
  • geriatric oncology
  • caregivers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-07-06.