Breast Cancer Risk Reduction: A Patient Doctor Intervention

NCT01830933 | Completed Results DMC

• 1 other identifier: 150B-0158
• Study Type: interventional
• Target: 1,235
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

Breast cancer concern, breast cancer risk perception, breast cancer risk

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• Percentage of Participants Who Reported Discussion of Mammography Screening

  Self reported discussion of mammography with physician.

  up to 14 months

Study Arms (2)

BreastCARE Intervention

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.

Other: BreastCARE

BreastCARE Comparison

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.

Interventions

BreastCARE OTHER

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.

BreastCARE Intervention

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Susan G. Komen Breast Cancer Foundation: collaborator
• California Breast Cancer Research Program: collaborator

Study Sites (2)

San Francisco General Hospital (SFGH)

San Francisco, California, 94110, United States

Location

University of California, San Francisco Mt. Zion campus

San Francisco, California, 94143, United States

Location

Related Publications (1)

• 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.

  PMID: 26476466 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Celia P. Kaplan, Professor
• Organization: University of California, San Francisco

celia.kaplan@ucsf.edu

415-502-5601

Study Officials

• Celia P Kaplan, DrPH, MA

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2013
• First Posted: April 12, 2013
• Study Start: June 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 19, 2014
• Results First Posted: May 16, 2013

Record last verified: 2014-08

Locations

US (2)