Breast Cancer Clinical Trial

Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Eligible participants will include women who:

Were diagnosed with a childhood cancer prior to the age of 21 years;
Were treated with ≥ 10 Gy of chest RT (recent revision with a lower dose threshold);1
Do not have a history of breast cancer;
Have not had both a breast MRI and mammogram in the previous 24 months;
Do not have a contraindication to MRI (i.e., pacemaker);
Are 25 years of age or older at time of enrollment;
Have an interval from their chest RT to the time of enrollment of at least 8 years;
Have a smartphone;
Are English-speaking.

Participants will be selected from women in the Childhood cancer Survivor Study (CCSS) cohort.

Study is for people with:

Breast Cancer

Estimated Enrollment:

320

Study ID:

NCT03435380

Recruitment Status:

Active, not recruiting

Sponsor:

Duke University

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There are 4 Locations for this study

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Columbia University
New York New York, 10032, United States
Hunter College, City of New York
New York New York, 10065, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
St. Jude Children's Research Hospital
Memphis Tennessee, 38105, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

320

Study ID:

NCT03435380

Recruitment Status:

Active, not recruiting

Sponsor:


Duke University

How clear is this clinincal trial information?

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