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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01879189
• Other study ID #: 81670
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: November 2017

Study information

• Verified date: November 2018
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1302
• Est. completion date: November 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 39 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Edward S. Cooper Internal Medicine	Philadelphia	Pennsylvania
United States	Family Medicine	Philadelphia	Pennsylvania
United States	Family Medicine St. Leonard's Court	Philadelphia	Pennsylvania
United States	Helen O. Dickens Center for Women's Health	Philadelphia	Pennsylvania
United States	Penn Center for Primary Care	Philadelphia	Pennsylvania
United States	Penn Internal Medicine Associates	Philadelphia	Pennsylvania
United States	Penn OB/GYN Associates	Philadelphia	Pennsylvania
United States	Internal Medicine Radnor	Radnor	Pennsylvania
United States	Penn Health for Women	Radnor	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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