NCT01299623

Brief 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
366

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

3.8 years

First QC Date

February 17, 2011

Last Update Submit

August 17, 2016

Conditions

Breast Cancer Prevention

Keywords

breast cancerbreast cancer preventionAfrican American women

Outcome Measures

Primary Outcomes (4)

  • Intervention uptake

    Assessment of participants' attendance at a session.

    1 session

  • 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

  • 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

  • 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

Secondary Outcomes (3)

  • Education

    baseline

  • Family history

    baseline

  • Beliefs about research

    baseline

Study Arms (2)

Evidential Group

ACTIVE COMPARATOR

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

Non-Evidential Group

ACTIVE COMPARATOR

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

Interventions

Comparison of evidential versus non-evidential education on women's breast cancer prevention behaviorsBEHAVIORAL

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.

Evidential GroupNon-Evidential Group

Eligibility Criteria

Age35 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Center for Community Based Research and Health Disparities

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Chanita H Halbert, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2011

First Posted

February 18, 2011

Study Start

August 1, 2010

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

August 19, 2016

Record last verified: 2016-08

Locations

US(1)