Breast Cancer Prevention Education

Breast Cancer Prevention Clinical Trial

Official title:

Disseminating Breast Cancer Prevention to African American Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01299623
• Other study ID #: 1R18HSO19339-01
• Status: Completed
• Phase: N/A
• First received: February 17, 2011
• Last updated: August 17, 2016
• Start date: August 2010
• Est. completion date: May 2014

Study information

• Verified date: August 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Breast Cancer Prevention
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pennsylvania Center for Community Based Research and Health Disparities	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention uptake	Assessment of participants' attendance at a session.	1 session	No
Primary	knowledge about breast cancer prevention	Measurement of women's knowledge about breast cancer prevention at three and six months post intervention compared to baseline measurements.	6 months	No
Primary	Communication about breast cancer prevention	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	No
Primary	Distrust of medical research	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	No
Secondary	Education	Assessment of the relationship between participants' education and primary outcomes.	baseline	No
Secondary	Family history	Assessment of the relationship between participants' family history and the primary outcomes.	baseline	No
Secondary	Beliefs about research	Assessment of the relationship between participants' beliefs about research and the primary outcomes.	baseline	No