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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,302

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline

Completed

Started Sep 2013

Typical duration for not_applicable breast-cancer

Geographic Reach

1 country

9 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.2 years study duration

First Submitted

Initial submission to the registry

June 12, 2013

Completed

5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2013

Completed

3 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed

3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed

Last Updated

November 29, 2018

Status Verified

November 1, 2018

Enrollment Period

3.6 years

First QC Date

June 12, 2013

Last Update Submit

November 28, 2018

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

Knowledge, Worry, Regret, Decisional Conflict, Accuracy of Risk Perception
6 weeks post-intervention

Study Arms (2)

Decision Aid

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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

Interventions

Breast Cancer Screening Decision AidBEHAVIORAL

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.

Decision Aid

Eligibility Criteria

Age39 Years - 48 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

Prior diagnosis of breast cancer
Major comorbidity that substantially affects their 10 year mortality
Non-English speaker

Contact the study team to confirm eligibility.