Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer
Status: | Not yet recruiting |
---|---|
Conditions: | Breast Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 25 - Any |
Updated: | 2/9/2019 |
Start Date: | March 29, 2019 |
End Date: | April 30, 2021 |
Contact: | Kevin C Oeffinger, MD |
Email: | kevin.oeffinger@duke.edu |
Phone: | 919-668-2122 |
EMPOWER-II: Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer
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 a 12-month,
3-arm randomized controlled trial using a smartphone intervention with data being collected
at baseline and 12-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.
primary care provider (PCP) activation on breast cancer surveillance rates among women
previously treated with chest radiotherapy (RT) for a childhood cancer. This is a 12-month,
3-arm randomized controlled trial using a smartphone intervention with data being collected
at baseline and 12-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.
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.
We found this trial at
3
sites
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Phone: 901-595-5892
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Phone: 646-888-0042
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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