Clinical trial NCT01879189: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2013-06-17
Enrollment: 1302
Sex: FEMALE
Minimum age (years): 39
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Mammography Use Correlated to Personal Risk of Breast Cancer
timeFrame: One year post-intervention
Secondary outcomes:
measure: Knowledge, Worry, Regret, Decisional Conflict, Accuracy of Risk Perception
timeFrame: 6 weeks post-intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Edward S. Cooper Internal Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Family Medicine St. Leonard's Court
state: Pennsylvania
city: Philadelphia
country: United States
facility: Family Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Helen O. Dickens Center for Women's Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Center for Primary Care
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Internal Medicine Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn OB/GYN Associates
state: Pennsylvania
city: Radnor
country: United States
facility: Internal Medicine Radnor
state: Pennsylvania
city: Radnor
country: United States
facility: Penn Health for Women
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Marilyn Schapira, MD
role: PRINCIPAL_INVESTIGATOR
References: