A communication tool for older patients with acute myeloid leukemia and their caregivers
A Pilot Randomized Controlled Trial of a Patient-centered Communication Tool (UR-GOAL) for Older Patients With Acute Myeloid Leukemia, Their Caregivers, and Their Oncologists
NA · University of Rochester · NCT05335369
This study is testing a new communication tool to help older patients with acute myeloid leukemia and their caregivers make better treatment decisions together with their doctors.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University of Rochester (other) |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT05335369 on ClinicalTrials.gov |
What this trial studies
This pilot trial evaluates the UR-GOAL communication tool designed to enhance shared decision-making and communication between older patients with acute myeloid leukemia (AML), their caregivers, and oncologists. The tool assesses patient fitness, elicits values and preferences, and provides educational resources about AML. Developed with input from stakeholders, the study aims to improve the quality of care and patient engagement in treatment decisions. It includes a randomized approach to compare the tool's effectiveness against usual care.
Who should consider this trial
Good fit: Ideal candidates are English-speaking patients aged 60 and older who are newly diagnosed with AML or being evaluated for possible AML.
Not a fit: Patients who are not English-speaking or those who do not have decision-making capacity may not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could significantly improve communication and decision-making for older patients with AML, leading to better patient-centered care.
How similar studies have performed: Other studies have shown promise in using communication tools to enhance patient engagement and decision-making in oncology, suggesting a favorable outlook for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
Patients
1. Age ≥60 years
2. Newly diagnosed AML or being worked up for possible AML
3. Able to provide informed consent
4. Agreement of their oncologist to participate in the study
5. English-speaking
If patients screen positive for cognitive impairment on the Mini-Cog test performed as part of the baseline assessment, they can still enroll if they are able to provide informed consent and have decision making capacity as determined by their treating oncologist
Caregivers
1. Selected by the patient when asked if there is a "family member, partner, friend or caregiver \[age 21 or older\] with whom the patient discuss or who can be helpful in health-related matters;" patients who cannot identify such a person ("caregiver") can be eligible for the study. A caregiver need not be someone who lives with the patient or provides direct hands-on care. A caregiver can be any person who provides support (in any way) to the patient
2. Able to provide informed consent
3. English-speaking
Oncologists
1. A practicing oncologist
2. At least one of their patients are recruited to the study
3. English-speaking
Where this trial is running
Rochester, New York
- University of Rochester — Rochester, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Kah Poh Loh — University of Rochester
- Study coordinator: Kah Poh Loh
- Email: kahpoh_loh@urmc.rochester.edu
- Phone: 585-275-4401
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Myeloid Leukemia, Acute myeloid leukemia, communication, shared decision making, older adults, geriatric hematology