Back to resultsBreast Cancer Trials Education Program
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breast Cancer Clinical Trials Education Program
Sponsored by
About this trial
This is an interventional health services research trial for Breast Cancer focused on measuring Clinical Trials, Education, Hispanic Americans, African Americans, Health Disparities, Patient Participation, Refusal to Participate
Eligibility Criteria
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
Sites / Locations
- UC San Diego Moores Cancer Center
- Vista Community Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Clinical Trials Education Program
Neighborhood Watch Education Program
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02808598
First Posted
June 16, 2014
Last Updated
June 16, 2016
Sponsor
University of California, San Diego
Collaborators
San Diego State University, Vista Community Clinic
1. Study Identification
Unique Protocol Identification Number
NCT02808598
Brief Title
Breast Cancer Trials Education Program
Official Title
Scientific Literacy and Breast Cancer Clinical Trials Education Program for Hispanic American and African American Women
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
San Diego State University, Vista Community Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Clinical Trials, Education, Hispanic Americans, African Americans, Health Disparities, Patient Participation, Refusal to Participate
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1065 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clinical Trials Education Program
Arm Type
Experimental
Arm 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.
Arm Title
Neighborhood Watch Education Program
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Breast Cancer Clinical Trials Education Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Personal Health Survey.
Description
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.
Time Frame
Baseline data using Personal Health Survey were collected immediately prior to participants' randomization to either the experimental or control study arms.
Title
Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Social Status Survey.
Description
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.
Time Frame
Baseline data using Social Status Survey were collected immediately prior to participants' randomization to either the experimental or control study arms.
Title
Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Reactions to Race Module.
Description
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.
Time Frame
Baseline data using Reactions to Race Module were collected immediately prior to participants' randomization to either the experimental or control study arms.
Title
Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Beliefs & Attitudes Survey.
Description
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.
Time Frame
Baseline data using Beliefs & Attitudes Survey were collected immediately prior to participants' randomization to either the experimental or control study arms.
Title
Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Duke University Religion Index.
Description
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.
Time Frame
Baseline data using Duke University Religion Index were collected immediately prior to participants' randomization to either the experimental or control study arms.
Title
Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Health-Related Quality of Life-4.
Description
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.
Time Frame
Baseline data using Health-Related Quality of Life-4 were collected immediately prior to participants' randomization to either the experimental or control study arms.
Title
Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Patient Health Questionnaire-9.
Description
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.
Time Frame
Baseline data using Patient Health Questionnaire-9 were collected immediately prior to participants' randomization to either the experimental or control study arms.
Title
Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Cancer Worry Scale.
Description
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.
Time Frame
Baseline data using Cancer Worry Scale were collected immediately prior to participants' randomization to either the experimental or control study arms.
Title
Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Powe Fatalism Inventory.
Description
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.
Time Frame
Baseline data using Powe Fatalism Inventory were collected immediately prior to participants' randomization to either the experimental or control study arms.
Title
Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Measure (Barriers to Clinical Trials Participation).
Description
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.
Time Frame
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.
Title
Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Clinical Trials Knowledge Questionnaire.
Description
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.
Time Frame
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.
Title
Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Neighborhood Watch Knowledge Questionnaire.
Description
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.
Time Frame
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgia R Sadler, PhD
Organizational Affiliation
UC San Diego Moores Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vanessa L Malcarne, PhD
Organizational Affiliation
San Diego State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Vista Community Clinic
City
Vista
State/Province
California
ZIP/Postal Code
92084
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Breast Cancer Trials Education Program
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