Breast Cancer Trials Education Program

Breast Cancer Clinical Trial

Official title:

Scientific Literacy and Breast Cancer Clinical Trials Education Program for Hispanic American and African American Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02808598
• Other study ID #: CCT1043
• Status: Completed
• Phase: N/A
• First received: June 16, 2014
• Last updated: June 16, 2016
• Start date: May 2007
• Est. completion date: December 2015

Study information

• Verified date: June 2016
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1065
• Est. completion date: December 2015
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	UC San Diego Moores Cancer Center	La Jolla	California
United States	Vista Community Clinic	Vista	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	San Diego State University, Vista Community Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Personal Health Survey.	The study administered standardized psychosocial measure (Personal Health Survey) at baseline. Data were gathered to measure participants' knowledge and attitudes. The overall data from all measures were then used to evaluate the impact of the intervention, as well as what factors may have moderated and mediated that outcome. To measure changes in participations' behavior, they were immediately offered the opportunity to take part in another study that required a new consent document and collection of saliva samples. Regardless of whether the participants agreed to take part in this second study, they were next invited to be a part of the Ambassador for Clinical Trials Program, which meant they would periodically receive flyers about open clinical trials to share with family, friends, and community contacts.	Baseline data using Personal Health Survey were collected immediately prior to participants' randomization to either the experimental or control study arms.	No
Primary	Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Social Status Survey.	The study administered standardized psychosocial measure (Social Status Survey) at baseline. Data were gathered to measure participants' knowledge and attitudes. The overall data from all measures were then used to evaluate the impact of the intervention, as well as what factors may have moderated and mediated that outcome. To measure changes in participations' behavior, they were immediately offered the opportunity to take part in another study that required a new consent document and collection of saliva samples. Regardless of whether the participants agreed to take part in this second study, they were next invited to be a part of the Ambassador for Clinical Trials Program, which meant they would periodically receive flyers about open clinical trials to share with family, friends, and community contacts.	Baseline data using Social Status Survey were collected immediately prior to participants' randomization to either the experimental or control study arms.	No
Primary	Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Reactions to Race Module.	The study administered standardized psychosocial measure (Reactions to Race Module) at baseline. Data were gathered to measure participants' knowledge and attitudes. The overall data from all measures were then used to evaluate the impact of the intervention, as well as what factors may have moderated and mediated that outcome. To measure changes in participations' behavior, they were immediately offered the opportunity to take part in another study that required a new consent document and collection of saliva samples. Regardless of whether the participants agreed to take part in this second study, they were next invited to be a part of the Ambassador for Clinical Trials Program, which meant they would periodically receive flyers about open clinical trials to share with family, friends, and community contacts.	Baseline data using Reactions to Race Module were collected immediately prior to participants' randomization to either the experimental or control study arms.	No
Primary	Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Beliefs & Attitudes Survey.	The study administered standardized psychosocial measure (Beliefs & Attitudes Survey) at baseline. Data were gathered to measure participants' knowledge and attitudes. The overall data from all measures were then used to evaluate the impact of the intervention, as well as what factors may have moderated and mediated that outcome. To measure changes in participations' behavior, they were immediately offered the opportunity to take part in another study that required a new consent document and collection of saliva samples. Regardless of whether the participants agreed to take part in this second study, they were next invited to be a part of the Ambassador for Clinical Trials Program, which meant they would periodically receive flyers about open clinical trials to share with family, friends, and community contacts.	Baseline data using Beliefs & Attitudes Survey were collected immediately prior to participants' randomization to either the experimental or control study arms.	No
Primary	Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Duke University Religion Index.	The study administered standardized psychosocial measure (Duke University Religion Index) at baseline. Data were gathered to measure participants' knowledge and attitudes. The overall data from all measures were then used to evaluate the impact of the intervention, as well as what factors may have moderated and mediated that outcome. To measure changes in participations' behavior, they were immediately offered the opportunity to take part in another study that required a new consent document and collection of saliva samples. Regardless of whether the participants agreed to take part in this second study, they were next invited to be a part of the Ambassador for Clinical Trials Program, which meant they would periodically receive flyers about open clinical trials to share with family, friends, and community contacts.	Baseline data using Duke University Religion Index were collected immediately prior to participants' randomization to either the experimental or control study arms.	No
Primary	Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Health-Related Quality of Life-4.	The study administered standardized psychosocial measure (Health-Related Quality of Life-4) at baseline. Data were gathered to measure participants' knowledge and attitudes. The overall data from all measures were then used to evaluate the impact of the intervention, as well as what factors may have moderated and mediated that outcome. To measure changes in participations' behavior, they were immediately offered the opportunity to take part in another study that required a new consent document and collection of saliva samples. Regardless of whether the participants agreed to take part in this second study, they were next invited to be a part of the Ambassador for Clinical Trials Program, which meant they would periodically receive flyers about open clinical trials to share with family, friends, and community contacts.	Baseline data using Health-Related Quality of Life-4 were collected immediately prior to participants' randomization to either the experimental or control study arms.	No
Primary	Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Patient Health Questionnaire-9.	The study administered standardized psychosocial measure (Patient Health Questionnaire-9) at baseline. Data were gathered to measure participants' knowledge and attitudes. The overall data from all measures were then used to evaluate the impact of the intervention, as well as what factors may have moderated and mediated that outcome. To measure changes in participations' behavior, they were immediately offered the opportunity to take part in another study that required a new consent document and collection of saliva samples. Regardless of whether the participants agreed to take part in this second study, they were next invited to be a part of the Ambassador for Clinical Trials Program, which meant they would periodically receive flyers about open clinical trials to share with family, friends, and community contacts.	Baseline data using Patient Health Questionnaire-9 were collected immediately prior to participants' randomization to either the experimental or control study arms.	No
Primary	Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Cancer Worry Scale.	The study administered standardized psychosocial measure (Cancer Worry Scale) at baseline. Data were gathered to measure participants' knowledge and attitudes. The overall data from all measures were then used to evaluate the impact of the intervention, as well as what factors may have moderated and mediated that outcome. To measure changes in participations' behavior, they were immediately offered the opportunity to take part in another study that required a new consent document and collection of saliva samples. Regardless of whether the participants agreed to take part in this second study, they were next invited to be a part of the Ambassador for Clinical Trials Program, which meant they would periodically receive flyers about open clinical trials to share with family, friends, and community contacts.	Baseline data using Cancer Worry Scale were collected immediately prior to participants' randomization to either the experimental or control study arms.	No
Primary	Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Powe Fatalism Inventory.	The study administered standardized psychosocial measure (Powe Fatalism Inventory) at baseline. Data were gathered to measure participants' knowledge and attitudes. The overall data from all measures were then used to evaluate the impact of the intervention, as well as what factors may have moderated and mediated that outcome. To measure changes in participations' behavior, they were immediately offered the opportunity to take part in another study that required a new consent document and collection of saliva samples. Regardless of whether the participants agreed to take part in this second study, they were next invited to be a part of the Ambassador for Clinical Trials Program, which meant they would periodically receive flyers about open clinical trials to share with family, friends, and community contacts.	Baseline data using Powe Fatalism Inventory were collected immediately prior to participants' randomization to either the experimental or control study arms.	No
Primary	Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Measure (Barriers to Clinical Trials Participation).	The study administered standardized psychosocial measure (Barriers to Clinical Trials Participation) at baseline and immediately post-intervention. Data were gathered to measure changes in participants' knowledge and attitudes. The overall data from all measures were then used to evaluate the impact of the intervention, as well as what factors may have moderated and mediated that outcome. To measure changes in participations' behavior, they were immediately offered the opportunity to take part in another study that required a new consent document and collection of saliva samples. Regardless of whether the participants agreed to take part in this second study, they were next invited to be a part of the Ambassador for Clinical Trials Program, which meant they would periodically receive flyers about open clinical trials to share with family, friends, and community contacts.	Baseline data using Barriers to Clinical Trials Participation were collected immediately prior to participants' randomization to either the experimental or control study arms and also immediately after the completion of the educational intervention.	No
Primary	Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Clinical Trials Knowledge Questionnaire.	The study administered standardized psychosocial measure (Clinical Trials Knowledge Questionnaire) at baseline and immediately post-intervention. Data were gathered to measure changes in participants' knowledge and attitudes. The overall data from all measures were then used to evaluate the impact of the intervention, as well as what factors may have moderated and mediated that outcome. To measure changes in participations' behavior, they were immediately offered the opportunity to take part in another study that required a new consent document and collection of saliva samples. Regardless of whether the participants agreed to take part in this second study, they were next invited to be a part of the Ambassador for Clinical Trials Program, which meant they would periodically receive flyers about open clinical trials to share with family, friends, and community contacts.	Baseline data using Clinical Trials Knowledge Questionnaire were collected immediately prior to participants' randomization to either the experimental or control study arms and also immediately after the completion of the educational intervention.	No
Primary	Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Neighborhood Watch Knowledge Questionnaire.	The study administered standardized psychosocial measure (Neighborhood Watch Knowledge Questionnaire) at baseline and immediately post-intervention. Data were gathered to measure changes in participants' knowledge and attitudes. The overall data from all measures were then used to evaluate the impact of the intervention, as well as what factors may have moderated and mediated that outcome. To measure changes in participations' behavior, they were immediately offered the opportunity to take part in another study that required a new consent document and collection of saliva samples. Regardless of whether the participants agreed to take part in this second study, they were next invited to be a part of the Ambassador for Clinical Trials Program, which meant they would periodically receive flyers about open clinical trials to share with family, friends, and community contacts.	Baseline data using Neighborhood Watch Knowledge Questionnaire were collected immediately prior to participants' randomization to either the experimental or control study arms and also immediately after the completion of the educational intervention.	No