A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stand-alone Research Portal, Portal with Virtual Community Health Educator (vCHE).
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Precision Clinical Trial Recruitment to Promote Cancer Health Equity Across Florida
Overview
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.
Interventions
- Behavioral 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. - 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.
Primary outcome measures
- Proportion of patients who self-refer to cancer clinical trials [Time frame: Within two 2 months of consent]
Secondary outcome measures (2)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- University of Florida — Gainesville
- Mayo Clinic in Florida — Jacksonville
- University of Miami — Miami
Identifiers
NCT: NCT05655494 · IRB202201399 · U01CA274970 · 24-003323