Clinical trial NCT06697600: A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers
Official title: A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Oncology
Myeloid Leukemia, Acute
Cancer
Keywords: older adults
geriatric oncology
caregivers
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-11-20
Enrollment: 640
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized 1:1 to either the UR-GOAL arm or the attention control arm. If the patient has a caregiver that agrees and consents to participate in the study, the caregiver will be enrolled onto the same arm as the patient.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: Patients

Inclusion criteria:

* Age ≥60 years (from date of consent, confirmed on electronic medical records)
* A diagnosis of AML

  * Diagnosis can be based on the International Consensus Classification or World Health Organization
  * Myeloid sarcoma is allowed
* Cancer-directed treatment has not started (e.g., hydroxyurea, leukopheresis, or treatment to temporarily decrease white blood cells 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 (hydroxyurea is acceptable)

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 health-related matters."
* Caregiver may be paid/professional or informal caregiver
* Able to provide informed consent
* English or Spanish-speaking
* Caregiver may enroll any time before the patient's next clinical visit with the oncologist, following the completion of procedures in either the UR-GOAL intervention or attention control arms

Oncologists

Inclusion criteria:

* Oncologists caring for patients with AML Exclusion criteria
* None

Primary outcomes:
measure: Distress Thermometer Questionnaire at 1 month
timeFrame: 1 month
Secondary outcomes:
measure: 9-item Shared Decision Making Questionnaire at 2 weeks
timeFrame: 2 weeks
measure: Decisional Conflict Scale Questionnaire at 2 weeks
timeFrame: 2 weeks
measure: Observed shared decision making
timeFrame: Day 0
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham, Division of Hematology and Oncology
state: Alabama
city: Chapel Hill
country: United States
facility: University of North Carolina Lineberger Comprehensive Cancer Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Section of Hematology/Oncology
state: North Carolina
Study officials:
References:
citation: LoCastro M, Sanapala C, Wang Y, Jensen-Battaglia M, Wittink M, Norton S, Klepin HD, Richardson DR, Mendler JH, Liesveld J, Huselton E, O'Dwyer K, Cortes AM, Rodriguez C, Dale W, Loh KP. Patient-centered communication tool for older patients with acute myeloid leukemia, their caregivers, and oncologists: A single-arm pilot study. Cancer Med. 2023 Apr;12(7):8581-8593. doi: 10.1002/cam4.5547. Epub 2022 Dec 19.