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Une approche à plusieurs niveaux pour connecter les populations sous-représentées aux essais cliniques

4 novembre 2026 mis à jour par: University of Florida

Recrutement d'essais cliniques de précision pour promouvoir l'équité en matière de santé contre le cancer dans toute la Floride

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

350

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: ETCH Lab
  • Numéro de téléphone: 904-953-5375
  • E-mail: ETCH@mayo.edu

Lieux d'étude

  • États-Unis
    • Florida
      • Gainesville, Florida, États-Unis, 32611
        • Pas encore de recrutement
        • University of Florida
        • Contact:
          • Benjamin Lok, PhD
          • Numéro de téléphone: 352-214-9829
          • E-mail: LOK@CISE.UFL.EDU
        • Chercheur principal:
          • Benjamin Lok, PhD
      • Jacksonville, Florida, États-Unis, 32224
        • Recrutement
        • Mayo Clinic in Florida
        • Chercheur principal:
          • Janice Krieger, PhD
        • Contact:
        • Contact:
          • ETCH Lab
          • Numéro de téléphone: 904-953-5375
          • E-mail: ETCH@mayo.edu
      • Miami, Florida, États-Unis, 33136
        • Pas encore de recrutement
        • University of Miami
        • Contact:
        • Chercheur principal:
          • Olveen Carrasquillo, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 100 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Black/African American and Latino/Hispanic participants living in Florida.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
Comportemental: 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.
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.
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Proportion of patients who self-refer to cancer clinical trials
Délai: 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.
Within two 2 months of consent

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Virtual Clinical Health Education (vCHE) preferences
Délai: Within two months of consent

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
Délai: Within two months of consent

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.
Within two months of consent

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Florida

Collaborateurs

National Cancer Institute (NCI)

Les enquêteurs

  • Chercheur principal: Janice Krieger, PhD, Mayo Clinic

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

20 mai 2025

Achèvement primaire (Estimé)

31 août 2027

Achèvement de l'étude (Estimé)

31 août 2027

Dates d'inscription aux études

Première soumission

27 octobre 2022

Première soumission répondant aux critères de contrôle qualité

15 décembre 2022

Première publication (Réel)

19 décembre 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IRB202201399
  • U01CA274970 (Subvention/contrat des NIH des États-Unis)
  • 24-003323 (Autre identifiant: Mayo Clinic Institutional Review Board)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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