Breast Cancer Trials Education Program

NCT ID: NCT02808598

Last Updated: 2016-06-22

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

NA

Total Enrollment

1065 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this study is to test a program designed to increase African American and Hispanic American women's scientific literacy, knowledge of clinical trials, and to facilitate breast cancer clinical trial participation.

Detailed Description

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Knowledge and participation in clinical trials is disproportionately low among minorities. The purpose of this study is to test a program designed to increase African American and Hispanic American women's scientific literacy, knowledge of clinical trials, and to facilitate breast cancer clinical trial participation.

A validation study was also conducted to validate several measures for the Hispanic American and African American populations.

The experimental group watched an education program concerning breast cancer clinical trials while the control group watched an education program on neighborhood safety.

To examine willingness to participate in research was assessed by a post-intervention invitation to complete a sleep diary.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Clinical Trials Education Program

Breast Cancer Clinical Trials Education program is offered to women in the experimental arm. This program was designed to promote increased clinical trials literacy among African American and Hispanic American women. Increased clinical trials knowledge and a better understanding of clinical trials is anticipated to create more positive attitudes, and perceptions about clinical trials among these two groups of women who are traditionally underrepresented in breast cancer clinical trials.

Group Type EXPERIMENTAL

Breast Cancer Clinical Trials Education Program

Intervention Type BEHAVIORAL

The purpose of this study is to test a program designed to increase African American and Hispanic American women's scientific literacy, knowledge of clinical trials, and to facilitate breast cancer clinical trial participation.

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 African American and Hispanic Americans. It also provided an opportunity to evaluate the impact of the Neighborhood Watch Program.

Group Type PLACEBO_COMPARATOR

Breast Cancer Clinical Trials Education Program

Intervention Type BEHAVIORAL

The purpose of this study is to test a program designed to increase African American and Hispanic American women's scientific literacy, knowledge of clinical trials, and to facilitate breast cancer clinical trial participation.

Interventions

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Breast Cancer Clinical Trials Education Program

The purpose of this study is to test a program designed to increase African American and Hispanic American women's scientific literacy, knowledge of clinical trials, and to facilitate breast cancer clinical trial participation.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Self-Identified as an African American or a Hispanic American female
* Speak English and/or Spanish
* Mentally and Physically capable of completing the consenting process

Exclusion Criteria

* None
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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San Diego State University

OTHER

Sponsor Role collaborator

Vista Community Clinic

UNKNOWN

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

Vista Community Clinic

Vista, California, United States

Site Status

Countries

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United States

Other Identifiers

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CCT1043

Identifier Type: -

Identifier Source: org_study_id

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