Lineberger Comphrehensive Cancer Center at University of North Carolina
Chapel Hill, North Carolina, 27516, United States
Location status: Recruiting
Location contact
Daniel R Richardson,, MD, MA, MSc
PRINCIPAL_INVESTIGATOR
Mireille L Leone
CONTACT
NCT Number: NCT06296368
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.
Interested in participating?
Request Info60 year and older
All sexes
Interventional
Not applicable
Chapel Hill, North Carolina, 27516, United States
Location status: Recruiting
Daniel R Richardson,, MD, MA, MSc
PRINCIPAL_INVESTIGATOR
Mireille L Leone
CONTACT
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
Exclusion criteria
All subjects meeting any of the exclusion criteria listed below at baseline will be excluded from study participation:
PRIME is a decision support tool that uses best-worst scaling to provide a personalized report to providers and patients of their most important treatment priorities
Time frame: Up to 24 months
The effectiveness of PRIME to improve the value-concordance of treatment decisions in older subjects presenting to hematologic malignancy clinics will be determined by differences in CollaboRATE scores (Percentage in each arm that report perfect scores 15/15) at the post-treatment decision assessment between control and intervention groups.
COLLABORATE scores is a Likert scale questionnaire that includes 3 questions rated from 1 to 5. Higher scores represent better patient engagement.
Time frame: Up to 24 months
The secondary outcome will be the difference in CollaboRATE scores (percentage in each arm that report perfect scores 15/15) at the post-treatment decision assessment between control and intervention groups in a subgroup of participants: participants with newly-diagnosed Acute myeloid leukemia, Acute Lymphoblastic leukemia, Diffuse Large B-cell Lymphoma, and Multiple myeloma COLLABORATE scores is a Likert scale questionnaire that includes 3 questions rated from 1 to 5. Higher scores represent better patient engagement.
Contact information is provided by the study sponsor or research team.
UNC Lineberger Comprehensive Cancer Center
Other
Acronym: DISCOVERY
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07714044
Blood Cancer, Blood Cancers
Piscataway, New Jersey, United States
View Trial DetailsNCT01300026
Cancer, Chronic Disease
Hackensack, New Jersey, United States
View Trial DetailsNCT00086125
Bone Marrow Diseases, Disease Attributes
Chicago, Illinois, United States
View Trial DetailsNCT00722488
Blood Protein Disorders, Cardiovascular Diseases
Atlanta, Georgia, United States
View Trial Details