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Completed

NCT Number: NCT01879189

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

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

39 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Edward S. Cooper Internal Medicine, Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breast Cancer Screening Decision Aid

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.

Primary outcomes

  1. Mammography Use Correlated to Personal Risk of Breast Cancer

    Time frame: One year post-intervention

    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 outcomes

  1. Knowledge, Worry, Regret, Decisional Conflict, Accuracy of Risk Perception

    Time frame: 6 weeks post-intervention

    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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jun 17, 2013
Registry last updated
Nov 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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