Acute Myeloid Leukemia Clinical Trial

DISCOVERY: Evaluating a Decision Support Tool for Adults Seen in Hematology/Oncology Clinics

Summary

The purpose of this study is to evaluate whether a novel decision support tool called PRIME (Preference Reporting to Improve Management and Experience), which combines values-elicitation with tailored feedback to patients and providers, improves patient-reported values-concordance of initial treatment decisions compared to usual care.

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Full Description

In the last decade, remarkable advances in drug development have led to the approval of 52 new therapies for patients with hematologic malignancies. These new approvals are increasingly enabling clinicians to personalize chemotherapy decisions to achieve what matters most to patients. Therefore, accurately assessing patient preferences is critical to personalizing treatment decisions, particularly among older adults, who face high treatment-related morbidity and/or shorter anticipated survival.

Patient preferences have traditionally been inferred from face-to-face conversations. However, numerous studies, including several systematic reviews, have demonstrated that this process alone is inadequate to reliably capture patient preferences. To support standard shared decision making, multiple stakeholders strongly advocate the development of validated patient-reported measures that accurately capture patients' preferences. In recent guidance about the care of older adults with leukemia, the American Society of Hematology explicitly recommends the development of novel decision support tools to address this growing challenge in patient-centered care. Improved shared decision making has been associated with increased patient-reported quality of care and satisfaction, and a reduction in healthcare utilization.

This study will determine the effectiveness of a novel decision support tool called "PRIME" (Preference Reporting to Improve Management and Experience) to improve the values-concordance of initial treatment decisions. Using best-worst scaling, a validated values-elicitation method, PRIME provides a personalized report to providers and patients of their most important treatment priorities.

In this pragmatic trial, participants will be randomized to receive decision support with PRIME or usual care prior to their first visit with their oncologist. The primary outcome will be clinically significant improvement in values-concordance of the initial treatment decision (on CollaboRATE, a validated 12-point measure).

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Eligibility Criteria

Inclusion Criteria In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

Written or verbal informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information.
Subjects are willing and able to comply with study procedures based on the judgment of the investigator.
Age ≥ 60 years at the time of consent.
New patient to either the hematologic malignancies clinic or the bone marrow transplant/cellular therapy clinic.

Exclusion Criteria

All subjects meeting any of the exclusion criteria listed below at baseline will be excluded from study participation:

1. Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent or participation in the intervention.

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

500

Study ID:

NCT06296368

Recruitment Status:

Not yet recruiting

Sponsor:

UNC Lineberger Comprehensive Cancer Center

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There is 1 Location for this study

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Lineberger Comphrehensive Cancer Center at University of North Carolina
Chapel Hill North Carolina, 27516, United States More Info
Mireille L Leone
Contact
919-445-0768
[email protected]
Daniel R Richardson,, MD, MA, MSc
Principal Investigator

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Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

500

Study ID:

NCT06296368

Recruitment Status:

Not yet recruiting

Sponsor:


UNC Lineberger Comprehensive Cancer Center

How clear is this clinincal trial information?

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