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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01879189
First received: June 12, 2013
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: Breast Cancer Screening Decision Aid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: PROSPR/PCIPS Project 3: Communication of Personalized Breast Cancer Risk Using a Web-based Breast Cancer Screening Decision Aid Tool

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Mammography Use Correlated to Personal Risk of Breast Cancer [ Time Frame: One year post-intervention ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Worry, Behavior, Numeracy, Knowledge, Satisfaction [ Time Frame: 6 weeks post-intervention ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1500
Study Start Date: September 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   39 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01879189

Locations
United States, Pennsylvania
Helen O. Dickens Center for Women's Health Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Marilyn Schapira, MD, MPH    215-898-2022    mschap@mail.med.upenn.edu   
Principal Investigator: Marilyn Schapira, MD, MPH         
Family Medicine Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Marilyn Schapira, MD, MPH    215-898-2022    mschap@mail.med.upenn.edu   
Principal Investigator: Marilyn Schapira, MD, MPH         
Family Medicine St. Leonard's Court Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Marilyn Schapira, MD, MPH    215-898-2022    mschap@mail.med.upenn.edu   
Principal Investigator: Marilyn Schapira, MD, MPH         
Penn OB/GYN Associates Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Marilyn Schapira, MD, MPH    215-898-2022    mschap@mail.med.upenn.edu   
Principal Investigator: Marilyn Schapira, MD, MPH         
Penn Center for Primary Care Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Marilyn Schapira, MD, MPH    215-898-2022    mschap@mail.med.upenn.edu   
Principal Investigator: Marilyn Schapira, MD, MPH         
Penn Internal Medicine Associates Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Marilyn Schapira, MD, MPH    215-898-2022    mschap@mail.med.upenn.edu   
Principal Investigator: Marilyn Schapira, MD, MPH         
Edward S. Cooper Internal Medicine Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Marilyn Schapira, MD, MPH    215-898-2022    mschap@mail.med.upenn.edu   
Principal Investigator: Marilyn Schapira, MD, MPH         
Internal Medicine Radnor Not yet recruiting
Radnor, Pennsylvania, United States, 19087
Contact: Marilyn Schapira, MD, MPH    215-898-2022    mschap@mail.med.upenn.edu   
Principal Investigator: Marilyn Schapira, MD, MPH         
Penn Health for Women Not yet recruiting
Radnor, Pennsylvania, United States, 19087
Contact: Marilyn Schapira, MD, MPH    215-898-2022    mschap@mail.med.upenn.edu   
Principal Investigator: Marilyn Schapira, MD, MPH         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Marilyn Schapira, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01879189     History of Changes
Other Study ID Numbers: 81670
Study First Received: June 12, 2013
Last Updated: June 26, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 20, 2014