Breast Cancer Risk Reduction: A Patient Doctor Intervention

Breast Cancer Clinical Trial

— BreastCARE  

Official title:

Breast Cancer Risk Reduction: A Patient Doctor Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01830933
• Other study ID #: 150B-0158
• Status: Completed
• Phase: N/A
• First received: April 10, 2013
• Last updated: August 14, 2014
• Start date: June 2011
• Est. completion date: December 2012

Study information

• Verified date: August 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The proposed research combines the scientific advances in breast cancer research with health information technology (IT) to design a personalized intervention that assesses breast cancer risk for women, disseminates important breast health information, and facilitates discussion of breast cancer risk reduction practices. Our goal is to implement a tablet-PC (personal computer) based breast cancer risk education (BreastCare) intervention in the primary care setting that estimates a woman's individual risk for breast cancer and provides her and her physician with personalized breast cancer risk information and recommendations for action.

Other known NCT identifiers

• NCT01836250

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1235
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 74 Years

Eligibility

Inclusion Criteria:

1. Patient component:

• Women who visit the General Internal Medicine (GIM) practices at SFGH and UCSF during the study period

• Between the ages of 40 and 74

• Self-identify as Asian American, Spanish- and English-speaking Latinas, African American, or White

• Have no history of breast cancer are eligible to participate.

2. Physician component: Primary care physicians currently practicing at the GIM clinics at SFGH and UCSF

Exclusion Criteria:

1. Patient component: Women whose physicians object to their participation in the study

2. Physician component: No exclusion criteria for physicians

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• BreastCARE
Physician Report. At the time of an individual participant's visit to her primary care physician and her completion of the assessment tool, her physician will receive a physician report. The physician report is designed to facilitate communication about breast cancer risk during the primary care visit and to provide tailored risk reduction recommendations.

Locations

Country	Name	City	State
United States	San Francisco General Hospital (SFGH)	San Francisco	California
United States	University of California, San Francisco Mt. Zion campus	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	California Breast Cancer Research Program, Susan G. Komen Breast Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge of Breast Cancer Risk Factors	Risk knowledge was assessed using a post-survey. Participants could have scored 0-100 (with 0 meaning no correct answers, and 100 is all correct answers). This outcome was measured through a survey. Breast cancer risk knowledge was based on a series of eight questions in the survey. O	one week post-initial visit (approximately one week)	No
Primary	Percentage of Participants With Correct Perception of Risk	This outcome was measured through a survey. Women were asked what they thought about their risk of getting breast cancer was compared to other women of the same age.	baseline, one week post-initial visit (approximately one week)	No
Primary	Percentage of Participants Who Had a Discussion of Breast Cancer Risk	Self-reported discussion of breast cancer risk with physicians.	one week post-initial visit (approximately one week)	No
Primary	Percentage of Participants Who Reported Discussion of Mammography Screening	Self reported discussion of mammography with physician.	up to 14 months	No