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NCT05655494 | NOT YET RECRUITING | Cancer


A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials
Sponsor:

Mayo Clinic

Brief Summary:

The purpose of this study is to pilot test and evaluate an existing tailored ALEX Research Portal to navigate Black and Hispanic adult cancer patients and their family members through referral to cancer clinical trials.

Condition or disease

Cancer

Intervention/treatment

Stand-alone Research Portal

Portal with Virtual Community Health Educator (vCHE)

Phase

NA

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. We 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 (ETCTN, 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 Type : INTERVENTIONAL
Estimated Enrollment : 350 participants
Masking : SINGLE
Masking Description : Study Team will recruit an ethnically diverse sample of eligible patients N = 350 (approximately 88 White/non-Hispanic participants, 88 White/Hispanic participants, 88 Black/non-Hispanic participants, and 88 Black/Hispanic participants), evenly distributed across Black/African-American, Hispanic/Latino, and white to complete the intervention.
Primary Purpose : OTHER
Official Title : Precision Clinical Trial Recruitment to Promote Cancer Health Equity Across Florida
Actual Study Start Date : 2025-01-01
Estimated Primary Completion Date : 2027-08-31
Estimated Study Completion Date : 2027-08-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 100 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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.

A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials

Location Details

NCT05655494


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Locations


Not yet recruiting

United States, Florida

University of Florida

Gainesville, florida, United States, 32611

Not yet recruiting

United States, Florida

Mayo Clinic in Florida

Jacksonville, florida, United States, 32224

Not yet recruiting

United States, Florida

University of Miami

Miami, florida, United States, 33136

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