Decisional Intervention for Acute Myeloid Leukemia

(UR-GOAL RCT Trial)

Recruiting at 2 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

Trial Summary

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

The UR-GOAL treatment is unique because it focuses on improving decision-making for patients with acute myeloid leukemia (AML) by using a novel decision aid. This approach helps patients better understand their illness and treatment options, reducing confusion and aiding in making informed choices, which is not typically addressed by standard treatments. ^{1 2 3 4 5}

What is the purpose of this trial?

This is a multicenter randomized controlled trial that assesses the efficacy of a decisional intervention \[University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia (UR-GOAL)\] compared to an attention control.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

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

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

Shared Decision-making in Acute Myeloid Leukemia. [2020]

3. 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]

4. Italy pubmed.ncbi.nlm.nih.gov

Risk factors and decision criteria for intensive chemotherapy in older patients with acute myeloid leukemia. [2013]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Patient, Family Member and Physician Perspectives and Experiences with AML Treatment Decision-Making. [2022]