DISCOVERY: Evaluating a Decision Support Tool for Adults Seen in Hematology/Oncology Clinics
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUNC Lineberger Comprehensive Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Preference Reporting to Improve Management and Experience (PRIME)
BehavioralPRIME 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
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Usual CareNo intervention 0 interventions
Group B: PRIME interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 24 monthsSecondary outcomes
1
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.
Time frame
Up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
UNC Lineberger Comprehensive Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov