A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials
Precision Clinical Trial Recruitment to Promote Cancer Health Equity Across Florida
3 other identifiers
observational
350
1 country
3
Brief Summary
The purpose of this study is to pilot test and evaluate an existing tailored ALEX (Agent Leveraging Empathy for eXams) Research Portal to navigate Black and Hispanic adult cancer patients and their family members through referral to cancer clinical trials.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2025
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2022
CompletedFirst Posted
Study publicly available on registry
December 19, 2022
CompletedStudy Start
First participant enrolled
May 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
May 8, 2026
August 1, 2025
2.3 years
October 27, 2022
May 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients who self-refer to cancer clinical trials
Patients from underrepresented groups will be recruited in this study and equally randomized into either a) standard-of-care web-based educational portal about clinical trials or a b) a web-based portal that includes a virtual Community Health Educator. Participants in both conditions will have the opportunity to self-refer (operationalized as expressing interest in being contacted) to a cancer clinical trial. The numbers of patients referred to a cancer clinical trial will be collected in both treatment groups and the proportions compared to determine whether adding a virtual Community Health Educator to web-based educational resources about cancer clinical trials will increase referrals of minority patients. Patients are assigned into 2 groups, and the outcome measure is the number of self-referrals after treatment divided by the total number of patients for both groups.
Within two 2 months of consent
Secondary Outcomes (2)
Virtual Clinical Health Education (vCHE) preferences
Within two months of consent
Change in trust in Cancer Clinical Trials
Within two months of consent
Study Arms (2)
Stand-alone Portal
The standard of care condition will include a portal that provides patients with access to existing online cancer clinical trial resources in one location. This includes links to pages with basic information about cancer clinical trials, ongoing studies, enrollment opportunities for existing institutional research registries, and contact information for study coordinators.
Portal with Virtual Community Health Educator (vCHE)
The virtual community health educator condition will provide all information in standard of care with the addition of a virtual community health educator. Patients will have the opportunity to choose which virtual community health educator will provide digital navigation. The choices will include at least four English-speaking and four Spanish-speaking virtual community health educators representing different genders and racial/ethnic backgrounds.
Interventions
The standard of care condition will include a portal that provides patients with access to existing online cancer clinical trial resources in one location. This includes links to pages with basic information about cancer clinical trials, ongoing studies, enrollment opportunities for existing institutional research registries, and contact information for study coordinators.
The virtual community health educator condition will provide all information in standard of care with the addition of a virtual community health educator. Patients will have the opportunity to choose which virtual community health educator will provide digital navigation. The choices will include at least four English-speaking and four Spanish-speaking virtual community health educators representing different genders and racial/ethnic backgrounds.
Eligibility Criteria
Black/African American and Latino/Hispanic participants living in Florida.
You may qualify if:
- An adult 18 to 100 years of age,
- Able to read English or Spanish at least an eighth-grade level,
- From a racial/ethnic background historically underrepresented in cancer clinical trials (e.g. Blacks or African Americans and/or Hispanics or Latinos),
- Have an email account or the ability to receive texts,
- Willingness to be re-contacted,
- Be a resident of the state of Florida.
You may not qualify if:
- Unable to read English or Spanish at least at eighth-grade level
- Does not have an email account or the ability to receive texts
- Unwilling to be re-contacted
- Non resident of the state of Florida.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- National Cancer Institute (NCI)collaborator
Study Sites (3)
University of Florida
Gainesville, Florida, 32611, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
University of Miami
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janice Krieger, PhD
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2022
First Posted
December 19, 2022
Study Start
May 20, 2025
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
May 8, 2026
Record last verified: 2025-08