Clinical Trials Education Program for Hispanic Americans
3 mars 2020 mis à jour par: Georgia Robins Sadler, University of California, San Diego
Randomized Controlled Clinical Trials Education Program for Hispanic Americans
Hispanic Americans are underrepresented in cancer clinical trials.
The purpose of this study is to develop and test programs designed to reduce barriers and increase facilitators associated with cancer clinical trials participation for Hispanic Americans.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Hispanic Americans are underrepresented in cancer clinical trials. The purpose of this study is to develop and test education programs designed to reduce barriers and Increase facilitators associated with cancer clinical trials participation for Hispanic Americans. Focus groups were conducted with Hispanic American men and women to obtain culturally-linked attitudes related to clinical trials participation. This information was used to create a prototypic educational program anticipated to increase participation in clinical trials. It was then vetted and honed via additional focus groups.
Simultaneously, a validation study was conducted with Hispanic Americans for a packet of psychosocial instruments that could be used for a subsequent randomized controlled trial to evaluate the impact of the clinical trials education program.
The finalized clinical trials education program was tested via a randomized controlled trial. Participants assigned to the experimental group received the clinical trials education program, while participants in the control arm were administered a comparable, but non-relevant education program. Recruitment to this study has been completed.
Type d'étude
Interventionnel
Inscription (Réel)
1034
Phase
- Phase 3
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.
Lieux d'étude
-
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California
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La Jolla, California, États-Unis, 92093-0850
- UC San Diego Moores Cancer Center
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-
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
21 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Self-identified as Hispanic American
- At least 21 years of age
- Sufficiently literate to comprehend written and spoken testing materials in English or Spanish
- Living in southern California
- Mentally competent to complete the informed consenting process
Exclusion Criteria:
-
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
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Cancer Clinical Trials Education Program
Cancer Clinical Trials Education Program is offered to English- and Spanish-speaking Hispanics in the experimental arm.
This program was designed to promote increased clinical trials literacy among Hispanic Americans.
Increased clinical trials knowledge and a better understanding of clinical trials is anticipated to create more positive attitudes, and perceptions about clinical trials among Hispanic Americans.
|
Hispanic Americans are underrepresented in cancer clinical trials.
The purpose of this study is to develop and test programs designed to reduce barriers and increase facilitators associated with cancer clinical trials participation for Hispanic Americans.
|
|
Comparateur placebo: Neighborhood Watch Education Program
The Neighborhood Watch Program created by the Bureau of Justice Assistance and the National Crime Prevention Council was selected for inclusion in the control arm of this study.
It provided participants with a program of equivalent length and format, as well as an equivalent focus on improving the well-being of Hispanic Americans.
It also provided an opportunity to evaluate the impact of the Neighborhood Watch Program.
|
Hispanic Americans are underrepresented in cancer clinical trials.
The purpose of this study is to develop and test programs designed to reduce barriers and increase facilitators associated with cancer clinical trials participation for Hispanic Americans.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to First Follow-up
Délai: Change from baseline to first follow-up (immediately after receiving intervention)
|
To assess the impact of the intervention arm on participants' knowledge, attitudes, and perceptions related to clinical trials, they were asked to complete the same surveys given at baseline during post-intervention immediately after intervention.
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Change from baseline to first follow-up (immediately after receiving intervention)
|
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Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to Second Follow-up
Délai: Change from baseline to second follow-up (three months after receiving intervention)
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At the three-month follow-up, participants were mailed the final packet of survey instruments to complete and return in a stamped, self-addressed envelope.
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Change from baseline to second follow-up (three months after receiving intervention)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Willingness to Participate in Research
Délai: Two weeks after receiving intervention
|
Two weeks after receiving the intervention, participants were mailed an invitation to participate in a different research study by a researcher not previously known to them, to assess whether the intervention influenced behavior related to clinical trials invitations.
|
Two weeks after receiving intervention
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Georgia R Sadler, PhD, UC San Diego Moores Cancer Center
- Chercheur principal: Vanessa L Malcarne, PhD, San Diego State University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
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)
1 mars 2010
Achèvement primaire (Réel)
1 août 2018
Achèvement de l'étude (Réel)
1 août 2018
Dates d'inscription aux études
Première soumission
4 mars 2014
Première soumission répondant aux critères de contrôle qualité
6 mars 2014
Première publication (Estimation)
11 mars 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 mars 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 mars 2020
Dernière vérification
1 mars 2020
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- CCT2525
- NCI R25CA 130869 (Autre identifiant: UCSD)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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 .