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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new communication tool called UR-GOAL, designed to improve discussions between older patients with acute myeloid leukemia (AML) and their oncologists. The study aims to determine if this tool helps patients better understand their treatment options and make informed decisions. Participants will either use the UR-GOAL tool or continue with their usual care. The trial seeks English-speaking patients aged 60 or older who have recently been diagnosed with AML or are being evaluated for it. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance patient-oncologist communication for future AML patients.

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 prior data suggests that the UR-GOAL tool is safe for improving communication in AML patients?

Research shows that the UR-GOAL communication tool helps older patients with Acute Myeloid Leukemia (AML) and their doctors have better conversations about treatment options. In earlier studies, UR-GOAL helped patients understand their diagnosis and the treatments they could choose. It also made it easier for them to talk with their doctor and make decisions they felt good about.

The safety of this tool for patients appears promising. As a communication tool, not a medication or medical device, UR-GOAL has no reports of physical side effects like those seen with drugs. The focus is on improving conversations and decision-making, not on changing the body. So far, studies show it helps reduce stress and makes patients feel more confident in their decisions, without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the UR-GOAL Communication Tool for Acute Myeloid Leukemia (AML) because it offers a unique way to enhance patient care by focusing on communication and understanding. Unlike traditional treatments that primarily focus on attacking cancer cells with chemotherapy, UR-GOAL helps assess a patient's fitness and brings their personal values and preferences to the forefront, which can be crucial for making informed decisions. It introduces a novel method called Best-Worst Scaling to understand what patients care about most, and it provides educational resources to increase awareness and understanding of their prognosis. This approach could lead to more personalized and satisfying care experiences for patients with AML.

What evidence suggests that the UR-GOAL tool is effective for improving communication in acute myeloid leukemia?

Research has shown that the UR-GOAL tool, which participants in this trial may receive, can help older patients with acute myeloid leukemia (AML) communicate more effectively with their doctors. Studies have found that this tool enhances patients' understanding of their condition, boosting their confidence in discussions with their doctors. Doctors also find it useful for assessing patients' health and discussing AML in a way that aligns with patients' preferences and values. The tool includes a video about AML and assists patients in expressing their priorities in care decisions. Overall, it aims to reduce stress and improve decision-making between patients and doctors. ^{1 5 6 7 8}

Who Is on the Research Team?

Kah Poh Loh, MD

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

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 am an English-speaking caregiver.

Caregivers able to provide informed consent

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. ashpublications.org ashpublications.org/blood/article/140/Supplement%201/324/488158/A-Patient-Centered-Communication-Tool-for-Older

A Patient-Centered Communication Tool for Older Patients ... The UR-GOAL tool may improve patient and caregiver knowledge of AML and perceived efficacy in interacting with the oncologist. A pilot ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879406825000037

Protocol of a decisional intervention for older adults with ... This study will address significant knowledge gaps related to reducing distress and decisional conflict and improving SDM in older adults with AML.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/cam4.5547

Patient‐centered communication tool for older ... Oncologists found the UR-GOAL tool to be useful and helped to understand the patient's fitness level (100.0%), discuss acute myeloid leukemia ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9618777/

Adapting a patient-centered communication tool for older ... The purpose of this single-arm pilot study was to adapt the UR-GOAL communication tool, with an ultimate goal of improving SDM between older adults with AML and ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04625413

A Patient-centered Communication Tool (UR-GOAL) for ... The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awareness. Official Title. A ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05335369

A Patient-Centered Communication Tool (UR-GOAL ... 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 ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36533397/

Patient-centered communication tool for older ... - PubMed The UR-GOAL tool helped them understand their AML diagnosis and treatment options, communicate with their oncologist, and make more informed decisions.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879406824000146

Patient-oncologist discussion of treatment decisions ... In this study, we analyzed clinical encounters informed by the UR-GOAL tool to qualitatively describe how treatment options were discussed between older adults, ...