CancerNCT05655494
A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials
An observational study of Cancer, run by University of Florida at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Stand-alone Research Portal and Portal with Virtual Community Health Educator (vCHE)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 350 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 May 2025to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Black/African American and Latino/Hispanic participants living in Florida.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
University of Florida
Gainesville, Florida, 32611
Benjamin Lok, PhD, 352-214-9829, LOK@CISE.UFL.EDU
Benjamin Lok, PhD
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
ETCH Lab, 904-953-5375, ETCH@mayo.edu
- Not yet recruiting
University of Miami
Miami, Florida, 33136
Olveen Carrasquillo, MD, 305-243-9765, OCarrasquillo@med.miami.edu
Olveen Carrasquillo, MD
About this study
Official title: Precision Clinical Trial Recruitment to Promote Cancer Health Equity Across Florida
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.
Read the 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
- Being tested
- Stand-alone Research Portal, Portal with Virtual Community Health Educator (vCHE)
- 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
- Medical subject headings
- Neoplasms, Colorectal Neoplasms, Breast Neoplasms, Lung Neoplasms, Prostatic Neoplasms, Skin Neoplasms, Gastrointestinal Diseases, Fibrocystic Breast Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stand-alone Research PortalBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Stand-alone Research Portal | |
| 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. Receives: Behavioral: Portal with Virtual Community Health Educator (vCHE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within two 2 months of consent
Secondary outcomes (2)
Virtual Clinical Health Education (vCHE) preferences
Participants assigned to the portal with the virtual Community Health Educator (vCHE) will be able to choose a vCHE among a set with different characteristics. Data on participant preferences for particular vCHE characteristics will be collected.
The measure is the count number of the participants that choose the different characteristics of vCHE.
Measured: Within two months of consent
Change in trust in Cancer Clinical Trials
Participants who access the portal will first complete a Clinical Trials Attitudes questionnaire (pre-test) that assesses trust in cancer clinical trials (CCTs). Participants will complete the Clinical Trials Attitudes questionnaire (post-test) after interacting with the vCHE. The Clinical Trials Attitudes questionnaire consists of 14 questions answered on a 5-point scale (strongly agree, agree, neither agree nor disagree, disagree, or strongly disagree)
The change in responses to the Likert-scale items between the pre-intervention questionnaire and the post-intervention questionnaire will be the change in trust in CCTs.
Measured: Within two months of consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start20 May 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Janice Krieger, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655494
- Sponsor's protocol ID
- IRB202201399
- Other IDs
- U01CA274970, 24-003323
- Status last verified
- Nov 2026
- First submitted
- 27 Oct 2022
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Clinical Trial Recruitment to Promote Cancer Health Equity Across Florida
- ClinicalTrials.gov ID
- NCT05655494
- Acronym / sponsor ID
- IRB202201399
- Conditions
- Cancer
- Keywords
- cancer clinical trial, community health educator, colorectal cancer, breast cancer, lung cancer, prostate cancer, skin cancer, virtual health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 May 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stand-alone Portal | – | Behavioral: Stand-alone Research PortalThe 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) | – | 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Black/African American and Latino/Hispanic participants living in Florida.
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stand-alone Research PortalThe 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. | Behavioural | Stand-alone Portal |
| 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. | Behavioural | Portal with Virtual Community Health Educator (vCHE) |
Primary outcome
Proportion of patients who self-refer to cancer clinical trials
Time frame: Within two 2 months of consent
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.
2 secondary outcomes
Virtual Clinical Health Education (vCHE) preferences
Time frame: Within two months of consent
Change in trust in Cancer Clinical Trials
Time frame: Within two months of consent
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janice Krieger, PhD principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University of Florida at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who self-refer to cancer clinical trials (time frame: Within two 2 months of consent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.