UR-GOAL Communication Tool for Acute Myeloid Leukemia

(UR-GOAL 2 Trial)

Overseen By Kah Poh Loh, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1-4 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this study is to conduct a pilot randomized trial to evaluate the preliminary efficacy of the UR-GOAL tool in improving SDM and communication between 100 older patients with AML and their oncologists.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the UR-GOAL treatment for acute myeloid leukemia?

The UR-GOAL tool is a communication aid designed to help older patients with acute myeloid leukemia (AML) make informed treatment decisions by addressing their specific needs and values. While it does not directly treat AML, it supports better decision-making, which can improve patients' understanding of their condition and treatment options. ^{1 2 3 4 5}

What makes the UR-GOAL treatment unique for acute myeloid leukemia?

The UR-GOAL treatment is unique because it is a patient-centered communication tool designed to help older patients with acute myeloid leukemia (AML) make informed treatment decisions by addressing their specific vulnerabilities, values, and understanding of their prognosis. Unlike traditional treatments that focus solely on medical interventions, this tool emphasizes shared decision-making and personalized care. ^{1 4 5 6 7}

Research Team

Kah Poh Loh, MD

Principal Investigator

University of Rochester

Eligibility Criteria

This trial is for people aged 60 or older who have been newly diagnosed with Acute Myeloid Leukemia (AML) or are being evaluated for it. They must be able to make their own medical decisions and speak English. Caregivers can also join if they support the patient in health matters, are over 21, and speak English. Oncologists treating these patients can participate too.

Inclusion Criteria

I speak English.

I am an English-speaking caregiver.

I have chosen a caregiver or am eligible even without one.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the UR-GOAL tool to improve shared decision making and communication with oncologists

1-4 weeks

Follow-up

Participants are monitored for satisfaction with the medical decision-making process and communication effectiveness

4 weeks

Treatment Details

Interventions

• UR-GOAL

Trial Overview The UR-GOAL tool is being tested against usual care to see if it improves how doctors and older AML patients talk about treatment options together. The study will involve 100 participants to check how well the tool works in real conversations.

Participant Groups

Group I: UR-GOAL Experimental Treatment 1 Intervention

UR-GOAL helps conducts assessments of fitness, elicits patient values via Best-Worst Scaling, and elicits preferences for prognostic information and assesses prognostic awareness. The tool also includes an AML educational video.

Group II: Usual care Active Control 1 Intervention

Usual care

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Findings from Research

The UR-GOAL tool was found to be feasible for use in treatment decision-making for older adults with acute myeloid leukemia (AML), with a retention rate of 73% among participants, which is above the 50% threshold considered feasible.

Patients and caregivers reported improved understanding of AML and enhanced communication with oncologists after using the tool, indicating its potential effectiveness in supporting informed treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-centered communication tool for older patients with acute myeloid leukemia, their caregivers, and oncologists: A single-arm pilot study. LoCastro, M., Sanapala, C., Wang, Y., et al.[2023]

A systematic review of 41 studies on acute myeloid leukemia and high-risk myelodysplastic syndrome highlighted the importance of incorporating patient-reported outcome (PRO) measures to assess quality of life alongside treatment efficacy.

Despite challenges like high dropout rates and varying measurement tools, effective use of PROs can offer valuable insights into patient experiences and inform better clinical care and future research directions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes in acute myeloid leukemia: Where are we now? Buckley, SA., Kirtane, K., Walter, RB., et al.[2019]

The American Society of Hematology (ASH) developed evidence-based guidelines for managing acute myeloid leukemia (AML) in older adults, emphasizing the importance of patient goals and treatment risks in decision-making.

The guidelines recommend pursuing antileukemic treatment over best supportive management and suggest more-intensive therapy when tolerable, highlighting the need for ongoing discussions between clinicians and patients about treatment options and goals of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

American Society of Hematology 2020 guidelines for treating newly diagnosed acute myeloid leukemia in older adults. Sekeres, MA., Guyatt, G., Abel, G., et al.[2021]

Patients with acute myeloid leukemia (AML) who achieve remission report significantly better quality of life and lower distress levels compared to those with secondary or relapsed AML, highlighting the importance of remission for patient well-being.

The study, involving 42 patients and using validated instruments to assess symptom burden, distress, and quality of life, found that those with secondary or relapsed AML experienced a much higher symptom burden and distress, indicating a need for targeted interventions to support these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of remission status on patients' experiences with acute myeloid leukemia (AML): an exploratory analysis of longitudinal patient-reported outcomes data. Kayastha, N., Wolf, SP., Locke, SC., et al.[2020]

A novel decision aid for acute myeloid leukemia (AML) was developed and tested with 20 patients, achieving 100% completion of all study components, indicating its feasibility for use.

After using the decision aid, patients showed a significant increase in AML knowledge (from 11.8 to 15.1 correct answers) and a reduction in decisional conflict, suggesting that the tool effectively enhances understanding and supports better decision-making in treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel decision aid for acute myeloid leukemia: a feasibility and preliminary efficacy trial. Hildenbrand, JD., Davis, DM., El-Jawahri, A., et al.[2021]

Recent advancements in therapies for acute myeloid leukemia (AML) have expanded treatment options beyond traditional cytotoxic chemotherapy, allowing for more personalized approaches based on specific genetic mutations.

The implementation of shared decision making (SDM) in AML treatment helps patients weigh the risks of relapse against their personal preferences and quality of life, promoting a more informed and collaborative approach to their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to approach shared decision making when determining consolidation, maintenance therapy, and transplantation in acute myeloid leukemia. Walker, AR.[2021]

In a study of 31 patients aged 50 and older with newly diagnosed acute myeloid leukemia (AML), most felt adequately informed about their diagnosis and treatment options, indicating a positive communication dynamic with their doctors.

Despite feeling informed, nearly half of the patients were unaware of their estimated 6-month prognosis, with some overestimating their chances of survival, highlighting a gap in understanding critical prognostic information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Information needs of adult patients 50 or older with newly diagnosed acute myeloid leukemia. Yogaparan, T., Panju, A., Minden, M., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Patient-centered communication tool for older patients with acute myeloid leukemia, their caregivers, and oncologists: A single-arm pilot study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes in acute myeloid leukemia: Where are we now? [2019]

3. United States pubmed.ncbi.nlm.nih.gov

American Society of Hematology 2020 guidelines for treating newly diagnosed acute myeloid leukemia in older adults. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

The impact of remission status on patients' experiences with acute myeloid leukemia (AML): an exploratory analysis of longitudinal patient-reported outcomes data. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

A novel decision aid for acute myeloid leukemia: a feasibility and preliminary efficacy trial. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

How to approach shared decision making when determining consolidation, maintenance therapy, and transplantation in acute myeloid leukemia. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Information needs of adult patients 50 or older with newly diagnosed acute myeloid leukemia. [2022]