PROSPR/PCIPS Project 3: Communication of Personalized Breast Cancer Risk

PROSPR/PCIPS Project 3: Communication of Personalized Breast Cancer Risk Using a Web-based Breast Cancer Screening Decision Aid Tool

In order to better communicate personal risk of breast cancer to women who have not yet initiated breast cancer screening (mammography), The Annenberg School of Communication at the University of Pennsylvania has created a personal breast cancer screening decision aid tool. This tool will be pilot tested, and then implemented and tested in nine primary care and OB/GYN practices within the University of Pennsylvania Health System.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Breast Cancer Screening Decision Aid

Detailed Description

In order to better communicate personal risk of breast cancer to women who have not yet initiated breast cancer screening (mammography), The Annenberg School of Communication at the University of Pennsylvania has created a personal breast cancer screening decision aid tool. This tool incorporates questions about a women's personal history of breast cancer and compares her to the average women her age in terms of breast cancer risk. The tool helps the women to understand the benefits and risks of breast cancer screening. This tool will be pilot tested using SSI to help develop the final version of the decision aid tool. The decision aid tool will then be implemented and tested in nine general internal medicine, family medicine, and OB/GYN practices within the University of Pennsylvania Health System.

• Study Type: Interventional
• Enrollment (Actual): 1302
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Edward S. Cooper Internal Medicine
    • Philadelphia, Pennsylvania, United States, 19104
      • Family Medicine St. Leonard's Court
    • Philadelphia, Pennsylvania, United States, 19104
      • Family Medicine
    • Philadelphia, Pennsylvania, United States, 19104
      • Helen O. Dickens Center for Women's Health
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Center for Primary Care
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Internal Medicine Associates
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn OB/GYN Associates
    • Radnor, Pennsylvania, United States, 19087
      • Internal Medicine Radnor
    • Radnor, Pennsylvania, United States, 19087
      • Penn Health for Women

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 39 years to 48 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women ages 39-48
• Patient of one of the nine primary care or OB/GYN practices that are participating in the study
• Must have had an appointment at one of these locations in the past 24 months
• Must have an appointment during the study period
• Woman has not yet initiated breast cancer screening (no prior mammogram)
• No history of breast cancer

Exclusion Criteria:

• Prior diagnosis of breast cancer
• Major comorbidity that substantially affects their 10 year mortality
• Non-English speaker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Decision Aid; Those in the decision aid arm of the study will be given access to the breast cancer screening decision aid.	Behavioral: Breast Cancer Screening Decision Aid; The intervention will include access to the personal decision aid tool for patients in the intervention arm of the study, determined by the randomized physician schedule and the patient's appointment time.
NO_INTERVENTION: Standard of Care; Those in the standard of care arm will not be given access to the decision aid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mammography Use Correlated to Personal Risk of Breast Cancer	Medical charts of women in both the intervention and control groups of the study will be analyzed to determine if these women initiated breast cancer screening (mammography) correlated to their personal risk of breast cancer as displayed by the decision aid.	One year post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge, Worry, Regret, Decisional Conflict, Accuracy of Risk Perception	Six weeks after a women's appointment with their primary care or OB/GYN provider, they will receive a post-intervention survey which will assess knowledge, worry, satisfaction, numeracy, behavior, etc.	6 weeks post-intervention

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Marilyn Schapira, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2013
• Primary Completion (ACTUAL): April 1, 2017
• Study Completion (ACTUAL): November 1, 2017

Study Registration Dates

• First Submitted: June 12, 2013
• First Submitted That Met QC Criteria: June 12, 2013
• First Posted (ESTIMATE): June 17, 2013

Study Record Updates

• Last Update Posted (ACTUAL): November 29, 2018
• Last Update Submitted That Met QC Criteria: November 28, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 81670