A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers (UR-GOAL RCT)

University of Rochester

Status: Enrolling

Conditions: Oncology; Myeloid Leukemia, Acute; Cancer

Treatments: Behavioral: UR-GOAL

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06697600

1R01CA288318-01A1 (Other Grant/Funding Number)

UOCPC24064

Details and patient eligibility

About

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.

Full description

This is a multicenter randomized controlled trial with four sites 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. Subjects will be randomized 1:1 to either the intervention arm or the attention control arm. Compared to an attention control, UR-GOAL will improve patient distress, observed and patient-perceived shared decision making (SDM), and patient decisional conflict.

Enrollment: 640 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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640 participants in 2 patient groups

UR-GOAL Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: UR-GOAL

Attention Control Arm

No Intervention group

Description:

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.