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Search / Trial NCT06697600

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

Launched by UNIVERSITY OF ROCHESTER · Nov 19, 2024

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

Older Adults Geriatric Oncology Caregivers

ClinConnect Summary

This clinical trial, titled "A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers," is designed to help older adults facing acute myeloid leukemia (AML) and their caregivers make informed decisions about their treatment. The study will compare a special support program called the UR-GOAL assessment with a standard attention control group to see which one better helps patients and their caregivers understand their options and make choices about care. The trial is not yet recruiting participants, but it aims to include individuals aged 60 and older who have been diagnosed with AML and have not yet started cancer treatment. Caregivers are also included, and they can be family members, friends, or professionals who help the patient.

To participate, patients must be able to speak English or Spanish and have a confirmed diagnosis of AML, while caregivers should be 18 years or older and able to provide informed consent. Patients without a caregiver can still join the study. Throughout the trial, participants will receive support and information tailored to their needs, which can help ease the decision-making process during a challenging time. It’s important to note that patients with certain types of leukemia or mental health conditions that affect their ability to participate will not be eligible. This study hopes to improve the way older adults and their caregivers navigate treatment options for AML.

Gender

ALL

Eligibility 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

About University Of Rochester

The University of Rochester is a leading academic institution dedicated to advancing medical research and improving patient care through innovative clinical trials. Renowned for its commitment to excellence in education, research, and clinical practice, the university fosters a collaborative environment that integrates cutting-edge scientific inquiry with practical applications in healthcare. With a focus on diverse therapeutic areas, the University of Rochester aims to enhance treatment options and outcomes for patients while contributing to the broader scientific community through rigorous study design and ethical standards in clinical research.

Locations

Birmingham, Alabama, United States

Chapel Hill, North Carolina, United States

Winston Salem, North Carolina, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported