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

Multiple Myeloma Clinical Trial

— DISCOVERY  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06296368
• Other study ID #: LCCC2305
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: April 2029

Study information

• Verified date: May 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: Mireille L Leone
• Phone: 919-445-0768
• Email: mireille_leone[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: April 2029
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

1. Written or verbal informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information.

2. Subjects are willing and able to comply with study procedures based on the judgment of the investigator.

3. Age = 60 years at the time of consent.

4. 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.

Related Conditions & MeSH terms

• Blood Cancers
• Hematologic Malignancies
• Hematologic Neoplasms
• Leukemia
• Lymphoma
• Multiple Myeloma

Intervention

Behavioral:
• Preference Reporting to Improve Management and Experience (PRIME)
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

Locations

Country	Name	City	State
United States	Lineberger Comphrehensive Cancer Center at University of North Carolina	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in COLLABORATE scores between arms	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.	Up to 24 months
Secondary	Difference in COLLABORATE scores between arms in a subgroup of patients	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.	Up to 24 months

External Links

•   University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials