PROSPR/PCIPS Project 3: Communication of Personalized Breast Cancer Risk
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breast Cancer Screening Decision Aid
Sponsored by
About this trial
This is an interventional screening trial for Breast Cancer
Eligibility 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
Sites / Locations
- Edward S. Cooper Internal Medicine
- Family Medicine St. Leonard's Court
- Family Medicine
- Helen O. Dickens Center for Women's Health
- Penn Center for Primary Care
- Penn Internal Medicine Associates
- Penn OB/GYN Associates
- Internal Medicine Radnor
- Penn Health for Women
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Decision Aid
Standard of Care
Arm Description
Those in the decision aid arm of the study will be given access to the breast cancer screening decision aid.
Those in the standard of care arm will not be given access to the decision aid.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01879189
First Posted
June 12, 2013
Last Updated
November 28, 2018
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT01879189
Brief Title
PROSPR/PCIPS Project 3: Communication of Personalized Breast Cancer Risk
Official Title
PROSPR/PCIPS Project 3: Communication of Personalized Breast Cancer Risk Using a Web-based Breast Cancer Screening Decision Aid Tool
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1302 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Decision Aid
Arm Type
Experimental
Arm Description
Those in the decision aid arm of the study will be given access to the breast cancer screening decision aid.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Those in the standard of care arm will not be given access to the decision aid.
Intervention Type
Behavioral
Intervention Name(s)
Breast Cancer Screening Decision Aid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mammography Use Correlated to Personal Risk of Breast Cancer
Description
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.
Time Frame
One year post-intervention
Secondary Outcome Measure Information:
Title
Knowledge, Worry, Regret, Decisional Conflict, Accuracy of Risk Perception
Description
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.
Time Frame
6 weeks post-intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
39 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marilyn Schapira, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edward S. Cooper Internal Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Family Medicine St. Leonard's Court
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Family Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Helen O. Dickens Center for Women's Health
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Penn Center for Primary Care
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Penn Internal Medicine Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Penn OB/GYN Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Internal Medicine Radnor
City
Radnor
State/Province
Pennsylvania
ZIP/Postal Code
19087
Country
United States
Facility Name
Penn Health for Women
City
Radnor
State/Province
Pennsylvania
ZIP/Postal Code
19087
Country
United States
12. IPD Sharing Statement
Learn more about this trial
PROSPR/PCIPS Project 3: Communication of Personalized Breast Cancer Risk
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