Decisional Intervention for Acute Myeloid Leukemia

(UR-GOAL RCT Trial)

Recruiting at 3 trial locations

Overseen By Becky Gravenstede

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Acute promyelocytic leukemia, psychiatric conditions, others

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

Compensation: Varies

Number of Visits: 1

640 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assist patients with Acute Myeloid Leukemia (AML), a type of blood cancer, in making treatment decisions. It compares a special decision-making tool (UR-GOAL), which includes educational videos and priority-setting exercises, to a standard information session about nutrition. Patients who have recently been diagnosed with AML and have not yet started cancer treatment might be suitable candidates. The goal is to determine if the decision tool enhances discussions between patients and doctors about care choices. As an unphased trial, this study provides a unique opportunity for patients to contribute to innovative research that could improve decision-making in AML care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that cancer-directed treatment should not have started, except for certain treatments like hydroxyurea. It's best to discuss your specific medications with the trial team.

What prior data suggests that this decisional intervention is safe for patients with Acute Myeloid Leukemia?

Research has shown that the UR-GOAL program helps patients with acute myeloid leukemia (AML) make better treatment choices by reducing stress and confusion. This tool improves communication between patients and doctors.

UR-GOAL does not involve new drugs or physical treatments, eliminating the risk of physical side effects. Instead, it uses videos and reports to assist patients and caregivers in understanding and discussing the patient's goals and health.

Since UR-GOAL focuses on communication and decision-making, it is designed to be safe and easy for participants to use. The program aims to clarify and simplify matters for patients, ensuring no negative effects from its use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Decisional Intervention for Acute Myeloid Leukemia (AML) because it offers a personalized approach to patient care. Unlike traditional treatments that primarily focus on chemotherapy and medication, this intervention emphasizes understanding patient priorities and integrating them into care decisions. By using the UR-GOAL tool, patients and caregivers view informative videos and complete a best-worst scaling to clarify what matters most to them, which is then used to guide discussions with their oncologists. This approach aims to align treatment plans with individual patient values and perceptions, potentially improving overall satisfaction and outcomes.

What evidence suggests that the UR-GOAL intervention is effective for acute myeloid leukemia?

Research has shown that the UR-GOAL tool, which participants in this trial may receive, helps older adults with acute myeloid leukemia (AML) better understand their diagnosis and treatment options. Studies have found that it reduces stress and increases patients' confidence in their treatment choices. The tool also enhances shared decision-making, where patients and doctors collaborate on decisions. Patients report that UR-GOAL facilitates communication with their doctors. Additionally, it evaluates important factors such as patient preferences, overall health, and understanding of future health outlook. These aspects are crucial for tailoring treatment to individual needs, potentially leading to better outcomes. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 60 or older with Acute Myeloid Leukemia (AML) who haven't started cancer treatment yet. Caregivers, who can be family, friends, or professionals and must speak English or Spanish, are also included. Patients with certain psychiatric conditions or prior AML treatments (except hydroxyurea) are excluded.

Inclusion Criteria

The patient's oncologist has been or will be enrolled on the study

I am a caregiver and can enroll before the patient's next oncologist visit after completing certain steps.

Patients without a caregiver will still be eligible to participate in the study

Exclusion Criteria

Patients with psychiatric or cognitive conditions which the treating oncologist believes prohibits informed consent or compliance with study procedures

I have had treatment for AML, but hydroxyurea was okay.

I have been diagnosed with acute promyelocytic leukemia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the UR-GOAL intervention or attention control, involving video viewing and report discussions

4 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for distress and decision-making outcomes

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• UR-GOAL

Trial Overview The study tests a decisional aid called UR-GOAL designed to help older AML patients and their caregivers make informed choices about treatment. Participants will either receive this intervention or an attention control in a randomized manner across multiple centers.

How Is the Trial Designed?

Group I: UR-GOAL Intervention Experimental Treatment 1 Intervention

Patients will view an AML video, complete the best-worst scaling, and be provided with a summary report consisting of their priorities; they will will be asked to review and discuss at upcoming clinical visits. Caregivers, if available, will view the same AML video and be provided with the same summary report. Oncologists will be provided with a summary report consisting of the patient's geriatric assessment, priorities, and perception of prognosis; they will be asked to review and discuss at upcoming clinical visits.

Group II: Attention Control Arm Active Control 1 Intervention

Patients will view a nutritional video, complete a nutrition questionnaire, and will be provided with a nutrition handout and asked to review and discuss at upcoming clinical visits. Caregivers, if available, will view the nutritional video, and will be provided with a nutrition handout and asked to review and discuss at upcoming clinical visits. Oncologists will be provided with the patient's completed nutrition questionnaire and asked to review and discuss at upcoming clinical visits.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39828449/

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

2. 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.

3. 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.

4. 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 assesses aging-related vulnerabilities, patient values, and prognostic awareness among older patients with AML. In this study, ...

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

Patient‐centered communication tool for older ... Patients agreed that the UR-GOAL tool helped them understand their AML diagnosis and treatment options, communicate with their oncologist, and ...

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. researchgate.net researchgate.net/publication/388154584_Protocol_of_a_decisional_intervention_for_older_adults_with_newly_diagnosed_acute_myeloid_leukemia_and_their_caregivers_UR-GOAL_3

Protocol of a decisional intervention for older adults with ... Protocol of a decisional intervention for older adults with newly diagnosed acute myeloid leukemia and their caregivers: UR-GOAL 3 · No full-text available.