Breast Cancer Prevention Education

August 17, 2016 updated by: University of Pennsylvania

Disseminating Breast Cancer Prevention to African American Women

We will develop and evaluate a community-based approach for disseminating comparative effective reviews (CERs) about breast cancer prevention to African American women. The specific aims of our research, as shown below, will target this population because of persistent disparities in breast cancer morbidity and mortality among this population. Our primary aims are:

  1. To evaluate uptake of a community-based strategy for disseminating CERs about breast cancer prevention to African American women based on sociodemographic characteristics, beliefs about medical research, and medical history. We predict that participation in a community forum will be higher among women with greater socioeconomic resources, those who have a family history of breast cancer, and women who have more positive beliefs about research.
  2. To evaluate the impact of evidential versus non-evidential content about breast cancer prevention on psychological and behavioral outcomes that include: knowledge of breast cancer risk factors and prevention strategies, communication with individuals in their social and medical network, and distrust of medical research. We predict that women who receive evidential content that is specific for African American women will report greater knowledge about breast cancer risk factors and prevention strategies, will be more likely to discuss breast cancer prevention strategies with individuals in their social and medical network, and will report greater reductions in distrust of medical research compared to those who receive non-evidential content.

Study Overview

Study Type

Interventional

Enrollment (Actual)

366

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Center for Community Based Research and Health Disparities

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • African American women
  • Ages 35-70
  • No personal history of cancer
  • Resident of Philadelphia metropolitan area

Exclusion Criteria:

  • Non-African American
  • Male
  • Under 35 or over 70 years of age
  • Personal history of cancer
  • Not a resident of Philadelphia Metropolitan Area

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Evidential Group
Participants in this group will receive education about breast cancer prevention and specific information about African American women and breast cancer risk.
Participants will be randomized to either the evidential or non-evidential group. Both groups will receive primarily the same information, except one group will receive information that is more tailored to African American women, while participants in the other group will receive general information about breast cancer prevention.
Active Comparator: Non-Evidential Group
Participants in this group will receive general information about breast cancer prevention without anything specific to African American women.
Participants will be randomized to either the evidential or non-evidential group. Both groups will receive primarily the same information, except one group will receive information that is more tailored to African American women, while participants in the other group will receive general information about breast cancer prevention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention uptake
Time Frame: 1 session
Assessment of participants' attendance at a session.
1 session
knowledge about breast cancer prevention
Time Frame: 6 months
Measurement of women's knowledge about breast cancer prevention at three and six months post intervention compared to baseline measurements.
6 months
Communication about breast cancer prevention
Time Frame: 6 months
Assessment of the extent to which women discuss breast cancer prevention with their health care providers at three and six months post intervention compared to at baseline.
6 months
Distrust of medical research
Time Frame: 6 months
Assessment of the extent to which participants harbor distrust for the medical establishment three and six months post intervention compared to at baseline.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Education
Time Frame: baseline
Assessment of the relationship between participants' education and primary outcomes.
baseline
Family history
Time Frame: baseline
Assessment of the relationship between participants' family history and the primary outcomes.
baseline
Beliefs about research
Time Frame: baseline
Assessment of the relationship between participants' beliefs about research and the primary outcomes.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

February 17, 2011

First Submitted That Met QC Criteria

February 17, 2011

First Posted (Estimate)

February 18, 2011

Study Record Updates

Last Update Posted (Estimate)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 1R18HSO19339-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer Prevention

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