Breast Cancer Trials Education Program

University of California San Diego

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Breast Cancer Clinical Trials Education Program

Study type: Interventional

Funder types: Other

Identifiers

NCT02808598

CCT1043

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,065 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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1,065 participants in 2 patient groups, including a placebo group

Clinical Trials Education Program

Experimental group

Description:

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.

Treatment:

Behavioral: Breast Cancer Clinical Trials Education Program

Neighborhood Watch Education Program

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Breast Cancer Clinical Trials Education Program