A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials

NCT ID: NCT05655494

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-20
• Study Completion Date: 2027-08-31

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.

Detailed Description

Racial and ethnic minorities represent the fastest growing segment of the United States adult population, yet they remain significantly underrepresented in cancer clinical trials (CCTs). Low trust in clinical research and recruitment approaches that fail to address multilevel barriers to CCT participation are key reasons for minority population underrepresentation. Community health educators (CHEs) improve trust in research among underrepresented populations, yet relying on exclusively on CHE availability can limit intervention reach. Virtual CHEs (vCHEs) improve scalability by extending CHE capabilities and capitalizing on remote recruitment techniques. The purpose of the current project is to increase referral of diverse participants to NCI-supported clinical trials via a culturally responsive, multi-level intervention that utilizes vCHEs to reach diverse populations. The investigators will consolidate existing referral channels within the ALEX Research Portal. ALEX offers a custom experience for clinicians, CHEs, and patients to facilitate CCT referrals. Clinicians can utilize the portal to refer to CCTs; CHEs can use the portal to create an avatar that can provide introductory information to patients and schedule video-conference follow-ups; patients, families, and community members can use the portal to easily navigate to key information and make self-and other-referrals. The ability to streamline information to patients and CCT referrals to study coordinators is expected to improve the overall referral to CCTs. The ALEX Research Portal utilizes the adaptive virtual human technology developed at the University of Florida that provides users with culturally and linguistically tailored CCT information. The ALEX Research Portal will be developed and launched across three distinct geographic areas of Florida (Gainesville, Jacksonville, and Miami). This unique collaborative opportunity will provide access to participants representative of the racial and ethnic diversity of the state as well as cancer centers conducting CCTs associated with national networks [Experimental Therapeutics Clinical Trials Network (ETCTN), National Clinical Trials Network (NCTN)]. Guided by the Interactive Systems Framework for dissemination and implementation, our goal is to increase referrals to CCTs by optimizing the ALEX Research Portal for broad use. The outcome will be an evidence-based intervention that can be widely disseminated to quickly increase the referral of diverse patients to CCTs. This project will be conducted in three phases: (Phase I) establish a baseline of referrals and accrual of diverse participants to CCTs across multiple Florida Center Centers, (Phase 2) adapt and pilot the ALEX Research Portal using a randomized controlled clinical trial, and (Phase 3) scale the intervention by dissemination via the OneFlorida network. The proposed study will result in an empirically-tested vCHE Research Portal for increasing trust in CCTs among diverse populations that can easily be adapted and disseminated across the state to overcome challenges associated with recruiting diverse participants to CCTs.

Conditions

Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Stand-alone Research Portal

Intervention Type: BEHAVIORAL

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.

Portal with Virtual Community Health Educator (vCHE)

Intervention Type: BEHAVIORAL

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

Stand-alone Research 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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janice Krieger, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

University of Florida

Gainesville, Florida, United States

Site Status: NOT_YET_RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status: RECRUITING

University of Miami

Miami, Florida, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Clinical Trials Referral Office

Role: CONTACT

mayocliniccancerstudies@mayo.edu

855-776-0015

Joanna Serat

Role: CONTACT

Serat.Joanna@mayo.edu

904-953-2402

Facility Contacts

Benjamin Lok, PhD

Role: primary

LOK@CISE.UFL.EDU

352-214-9829

Clinical Trials Referral Office

Role: primary

mayocliniccancerstudies@mayo.edu

855-776-0015

Joanna Serat

Role: backup

Serat.Joanna@mayo.edu

904-953-2402

Olveen Carrasquillo, MD

Role: primary

OCarrasquillo@med.miami.edu

305-243-9765

Other Identifiers

U01CA274970

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-003323

Identifier Type: OTHER

Identifier Source: secondary_id

IRB202201399

Identifier Type: -

Identifier Source: org_study_id