Completed

BreastCAREBreast Cancer Risk Reduction: A Patient Doctor Intervention

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What is being tested

BreastCARE

Other
Who is being recruted

Breast Diseases+3

+ Neoplasms

+ Neoplasms by Site

From 40 to 74 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: June 2011
See protocol details

Summary

Principal SponsorUniversity of California, San Francisco
Last updated: August 19, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2011

Actual date on which the first participant was enrolled.

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.

NCT01830933NCT01836250
Principal SponsorUniversity of California, San Francisco
Last updated: August 19, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1235 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 74 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesBreast Neoplasms

Criteria

Inclusion Criteria: 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. Physician component: Primary care physicians currently practicing at the GIM clinics at SFGH and UCSF Exclusion Criteria: Patient component: Women whose physicians object to their participation in the study Physician component: No exclusion criteria for physicians

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Intervention Clinic Patients: The RA will welcome the patient upon arrival at the clinic and again explain study procedures and field any questions. The RA will have the patient sign the HIPAA authorization form and then demonstrate how to enter information and answer questions on the tablet-PC and the patient will indicate their consent electronically before beginning the assessment. Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patietns before she meets with her doctor.

Group II

No Intervention
Patients will be randomized into the intervention or comparison groups at the time of recruitment. Block-randomization will be used to assign patients to intervention or comparison groups. Comparison Clinic Patients. Contact and baseline interview procedures will be the same for patients from the comparison clinics, however there will be no computer assessment at the time of their clinic visit. An RA will meet the patient 10 minutes prior to her appointment time to obtain written HIPAA authorization.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

San Francisco General Hospital (SFGH)

San Francisco, United StatesOpen San Francisco General Hospital (SFGH) in Google Maps

University of California, San Francisco Mt. Zion campus

San Francisco, United States
Completed2 Study Centers