Clinical trial NCT05655494: A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials
Official title: Precision Clinical Trial Recruitment to Promote Cancer Health Equity Across Florida
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-12-19
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

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.

Primary outcomes:
measure: Proportion of patients who self-refer to cancer clinical trials
timeFrame: Within 2 months of consent
Secondary outcomes:
measure: Virtual Clinical Health Education (vCHE) preferences
timeFrame: Within two months of consent
measure: Change in trust in Cancer Clinical Trials
timeFrame: Within two months of consent
measure: Mediators of intervention effectiveness
timeFrame: Follow-up review 2 months after intervention
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Janice Krieger, PhD
role: PRINCIPAL_INVESTIGATOR
References: