Clinical Trials Education Program for Hispanic Americans

NCT ID: NCT02083770

Last Updated: 2020-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1034 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2018-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Cancer Clinical Trials Education Program

Intervention Type BEHAVIORAL

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.

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.

Group Type PLACEBO_COMPARATOR

Cancer Clinical Trials Education Program

Intervention Type BEHAVIORAL

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.

Interventions

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Cancer Clinical Trials Education 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\-
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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San Diego State University

OTHER

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Georgia Robins Sadler

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georgia R Sadler, PhD

Role: PRINCIPAL_INVESTIGATOR

UC San Diego Moores Cancer Center

Vanessa L Malcarne, PhD

Role: PRINCIPAL_INVESTIGATOR

San Diego State University

Locations

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UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status

Countries

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United States

References

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Merz EL, Malcarne VL, Roesch SC, Riley N, Sadler GR. A multigroup confirmatory factor analysis of the Patient Health Questionnaire-9 among English- and Spanish-speaking Latinas. Cultur Divers Ethnic Minor Psychol. 2011 Jul;17(3):309-316. doi: 10.1037/a0023883.

Reference Type BACKGROUND
PMID: 21787063 (View on PubMed)

Other Identifiers

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NCI R25CA 130869

Identifier Type: OTHER

Identifier Source: secondary_id

CCT2525

Identifier Type: -

Identifier Source: org_study_id

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