Clinical trial NCT01830933: Breast Cancer Risk Reduction: A Patient Doctor Intervention
Official title: Breast Cancer Risk Reduction: A Patient Doctor Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer concern, breast cancer risk perception, breast cancer risk
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Susan G. Komen Breast Cancer Foundation
name: California Breast Cancer Research Program
First posted: 2013-04-12
Enrollment: 1235
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Knowledge of Breast Cancer Risk Factors
timeFrame: one week post-initial visit (approximately one week)
measure: Percentage of Participants With Correct Perception of Risk
timeFrame: baseline, one week post-initial visit (approximately one week)
measure: Percentage of Participants Who Had a Discussion of Breast Cancer Risk
timeFrame: one week post-initial visit (approximately one week)
measure: Percentage of Participants Who Reported Discussion of Mammography Screening
timeFrame: up to 14 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital (SFGH)
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco Mt. Zion campus
state: California
Study officials:
affiliation: University of California, San Francisco
name: Celia P Kaplan, DrPH, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Livaudais-Toman J, Karliner LS, Tice JA, Kerlikowske K, Gregorich S, Perez-Stable EJ, Pasick RJ, Chen A, Quinn J, Kaplan CP. Impact of a primary care based intervention on breast cancer knowledge, risk perception and concern: A randomized, controlled trial. Breast. 2015 Dec;24(6):758-66. doi: 10.1016/j.breast.2015.09.009. Epub 2015 Oct 21.