- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01299623
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:
- 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.
- 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
Status
Completed
Conditions
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
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Center for Community Based Research and Health Disparities
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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
|
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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
|
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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.
Sponsor
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
Additional Relevant MeSH Terms
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.
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