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临床试验/NCT03435380
NCT03435380已完成不适用

EMPOWER-II: Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

Duke University7 个研究点 分布在 1 个国家目标入组 314 人开始时间: 2019年5月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
314
试验地点
7
主要终点
Percentage of Women Who Completed a Breast MRI and Mammogram

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
25 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

Percentage of Women Who Completed a Breast MRI and Mammogram

时间窗: 18 months

Self-reported

次要结局

未报告次要终点

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (7)

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