A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials

Study Overview
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Brief Summary
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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
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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.

Official Title
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Precision Clinical Trial Recruitment to Promote Cancer Health Equity Across Florida

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Stand-alone Research Portal
* Behavioral: Portal with Virtual Community Health Educator (vCHE)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stand-alone Portal<br>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: Stand-alone Research Portal<br>* 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.<br>|
| Experimental: Portal with Virtual Community Health Educator (vCHE)<br>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. | Behavioral: Portal with Virtual Community Health Educator (vCHE)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who self-refer to cancer clinical trials | A total of 350 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. The 350 patients are assigned into 2 groups, and the outcome measure is the count number of self-referrals after treatment divided by the total number of patients for both groups. | Within 2 months of consent | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 is composed of a series of participant self-report Likert-scale items on the participant's understanding and attitudes of CCTs. 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. | Within two months of consent | 
| Mediators of intervention effectiveness | Potential mediators of intervention effectiveness, such as exposure to the intervention (i.e., whether participants clicked to open the application will be tracked by individual links to participants), psychological processing of content (e.g., comprehension, perceived message quality will be included in a post-intervention questionnaire), and self-reported communication with a healthcare provider about participation in clinical research (which will be measured through the two-week post-intervention communication), will be examined to determine whether they play an underlying mechanistic role between virtual community health educator and increased self-referrals. Potential mediators will be evaluated individually, and multiple potential mediators will not be considered simultaneously. | Follow-up review 2 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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