Recruiting

Observational Study

Sponsor:

University of Florida

Code:

NCT05655494

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Stand-alone Research Portal

Portal with Virtual Community Health Educator (vCHE)

Study Details

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.

Conditions

Cancer

Study ID

NCT05655494

Start date

May 20, 2025

Status verified date

Aug, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

350 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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.

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.

Primary outcome measure

  • Proportion of patients who self-refer to cancer clinical trials [ Time Frame: Within two 2 months of consent ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

ETCH Lab

904-953-5375ETCH@mayo.edu

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

ETCH Lab

904-953-5375ETCH@mayo.edu

Principal Investigator:

Janice Krieger, PhD

More Information

Sponsor

University of Florida

Last update posted

May 8, 2026

Last verified

Aug, 2025

Keywords

  • cancer clinical trial
  • community health educator
  • colorectal cancer
  • breast cancer
  • lung cancer
  • prostate cancer
  • skin cancer
  • virtual health
  • mHealth
  • virtual intervention
  • gastrointestinal diseases
  • fibrocystic breast disease
  • online questionnaire
  • Spanish-language version
  • Español
  • colon cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-05-08.