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Trial record 14 of 184 for:    (hispanic OR latina) AND (woman OR women OR female)

Breast Cancer Trials Education Program

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ClinicalTrials.gov Identifier: NCT02808598
Recruitment Status : Completed
First Posted : June 22, 2016
Last Update Posted : June 22, 2016
Sponsor:
Collaborators:
San Diego State University
Vista Community Clinic
Information provided by (Responsible Party):
Georgia Robins Sadler, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Breast Cancer Clinical Trials Education Program Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1065 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Scientific Literacy and Breast Cancer Clinical Trials Education Program for Hispanic American and African American Women
Study Start Date : May 2007
Actual Primary Completion Date : January 2012
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

Placebo Comparator: 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.
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.




Primary Outcome Measures :
  1. Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Personal Health Survey. [ Time Frame: Baseline data using Personal Health Survey were collected immediately prior to participants' randomization to either the experimental or control study arms. ]
    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.

  2. Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Social Status Survey. [ Time Frame: Baseline data using Social Status Survey were collected immediately prior to participants' randomization to either the experimental or control study arms. ]
    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.

  3. Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Reactions to Race Module. [ Time Frame: Baseline data using Reactions to Race Module were collected immediately prior to participants' randomization to either the experimental or control study arms. ]
    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.

  4. Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Beliefs & Attitudes Survey. [ Time Frame: Baseline data using Beliefs & Attitudes Survey were collected immediately prior to participants' randomization to either the experimental or control study arms. ]
    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.

  5. Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Duke University Religion Index. [ Time Frame: Baseline data using Duke University Religion Index were collected immediately prior to participants' randomization to either the experimental or control study arms. ]
    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.

  6. Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Health-Related Quality of Life-4. [ 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. ]
    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.

  7. Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Patient Health Questionnaire-9. [ Time Frame: Baseline data using Patient Health Questionnaire-9 were collected immediately prior to participants' randomization to either the experimental or control study arms. ]
    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.

  8. Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Cancer Worry Scale. [ Time Frame: Baseline data using Cancer Worry Scale were collected immediately prior to participants' randomization to either the experimental or control study arms. ]
    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.

  9. Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Powe Fatalism Inventory. [ Time Frame: Baseline data using Powe Fatalism Inventory were collected immediately prior to participants' randomization to either the experimental or control study arms. ]
    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.

  10. Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Measure (Barriers to Clinical Trials Participation). [ 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. ]
    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.

  11. Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Clinical Trials Knowledge Questionnaire. [ 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. ]
    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.

  12. Educational Post-Intervention Changes in Participants' Breast Cancer Clinical Trials-Using Standardized Neighborhood Watch Knowledge Questionnaire. [ 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. ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808598


Locations
United States, California
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Vista Community Clinic
Vista, California, United States, 92084
Sponsors and Collaborators
University of California, San Diego
San Diego State University
Vista Community Clinic
Investigators
Principal Investigator: Georgia R Sadler, PhD UC San Diego Moores Cancer Center
Principal Investigator: Vanessa L Malcarne, PhD San Diego State University

Responsible Party: Georgia Robins Sadler, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02808598     History of Changes
Other Study ID Numbers: CCT1043
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: June 22, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Georgia Robins Sadler, University of California, San Diego:
Clinical Trials
Education
Hispanic Americans
African Americans
Health Disparities
Patient Participation
Refusal to Participate

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases