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Breast Cancer Prevention Education

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01299623
First received: February 17, 2011
Last updated: August 17, 2016
Last verified: August 2016
  Purpose

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.

Condition Intervention
Breast Cancer Prevention
Behavioral: Comparison of evidential versus non-evidential education on women's breast cancer prevention behaviors

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Disseminating Breast Cancer Prevention to African American Women

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Intervention uptake [ Time Frame: 1 session ] [ Designated as safety issue: No ]
    Assessment of participants' attendance at a session.

  • knowledge about breast cancer prevention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measurement of women's knowledge about breast cancer prevention at three and six months post intervention compared to baseline measurements.

  • Communication about breast cancer prevention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Distrust of medical research [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Assessment of the extent to which participants harbor distrust for the medical establishment three and six months post intervention compared to at baseline.


Secondary Outcome Measures:
  • Education [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Assessment of the relationship between participants' education and primary outcomes.

  • Family history [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Assessment of the relationship between participants' family history and the primary outcomes.

  • Beliefs about research [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Assessment of the relationship between participants' beliefs about research and the primary outcomes.


Enrollment: 366
Study Start Date: August 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Comparison of evidential versus non-evidential education on women's breast cancer prevention behaviors
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.
Behavioral: Comparison of evidential versus non-evidential education on women's breast cancer prevention behaviors
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.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299623

Locations
United States, Pennsylvania
University of Pennsylvania Center for Community Based Research and Health Disparities
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Chanita H Halbert, PhD University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01299623     History of Changes
Other Study ID Numbers: 1R18HSO19339-01 
Study First Received: February 17, 2011
Last Updated: August 17, 2016
Health Authority: United States: Federal Government

Keywords provided by University of Pennsylvania:
breast cancer
breast cancer prevention
African American women

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

ClinicalTrials.gov processed this record on December 05, 2016