A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Rochester
Study ID
NCT06697600
Status
Recruiting
Apply to this trial

Conditions

  • Cancer
  • Myeloid Leukemia, Acute
  • Oncology

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • UR-GOAL — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jul 11, 2025
Status verified
Mar 2026
Primary completion
Oct 1, 2029
Completion
Jun 1, 2030

Study Design

Enrollment
1,020 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

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

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham, Division of Hematology and OncologyBirminghamAlabama35233
Omer Jamy
[email protected]
205-801-9034
University of Rochester Medical CenterRochesterNew York14642
Kah Poh Loh
[email protected]
585-276-4353
Becky Gravenstede
[email protected]
585-727-4728
University of North Carolina Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27514
Daniel Richardson
[email protected]
919-966-0127
Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Section of Hematology/OncologyWinston-SalemNorth Carolina27157
Heidi Klepin
[email protected]
335-713-5440

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham, Division of Hematology and Oncology· Birmingham, ALUniversity of Rochester Medical Center· Rochester, NYUniversity of North Carolina Lineberger Comprehensive Cancer Center· Chapel Hill, NCAtrium Health Wake Forest Baptist Comprehensive Cancer Center, Section of Hematology/Oncology· Winston-Salem, NC

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