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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2017-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Decision Aid

Those in the decision aid arm of the study will be given access to the breast cancer screening decision aid.

Group Type EXPERIMENTAL

Breast Cancer Screening Decision Aid

Intervention Type BEHAVIORAL

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.

Standard of Care

Those in the standard of care arm will not be given access to the decision aid.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

39 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marilyn Schapira, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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