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Brief Title: Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer
Official Title: EMPOWER-II: Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer
Study ID: NCT03435380
Brief Summary: The primary purpose of this study is to determine the impact of maximizing patient and primary care provider (PCP) activation on breast cancer surveillance rates among women previously treated with chest radiotherapy (RT) for a childhood cancer. This is an 18-month, 3-arm randomized controlled trial using a smartphone intervention with data being collected at baseline and 18-months through patient and provider surveys and medical record review. Eligible women treated for a childhood cancer with chest RT will be randomly sampled from the Childhood Cancer Survivor Study (CCSS) and randomly selected to one of three groups: control, patient activation (PA) using a smartphone-based intervention, or patient activation + primary care provider activation (PA+PCP) which will include physician materials about breast cancer risk in this population along with guidelines for breast cancer surveillance. Participants in all groups will receive mailed targeted print materials as an educational resource about their previous chest radiation and breast cancer screening recommendations. The primary outcome is a medical record confirmed breast MRI and mammogram with the goal of increasing the rate of women completing the national guideline-based recommended combination of breast MRI and mammogram. This study will test the hypothesis that women in the PA and PA+PCP groups will have significantly higher rates of breast cancer surveillance (breast MRI and mammogram) than women in the control group. In addition, the hypothesis that women in the PA+PCP group will have significantly higher rates of breast cancer surveillance than women in the PA group will also be tested.
Detailed Description:
Minimum Age: 25 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Columbia University, New York, New York, United States
Hunter College, City of New York, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
Name: Kevin C Oeffinger, MD
Affiliation: Duke University
Role: PRINCIPAL_INVESTIGATOR
Name: Jennifer S Ford, PhD
Affiliation: City University of New York, School of Public Health
Role: PRINCIPAL_INVESTIGATOR