NCT03435380

Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 314 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Neoplasms
• Early Detection of Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Patient activation	Smartphone-based materials including text messages and supplemental short videos focusing on how to find a primary care doctor, the importance of medical screening, and how to talk to a doctor about medical screening. Guidelines for monitoring and maintaining health, such as a survivorship care plan, will also be included in the smartphone-based materials.
BEHAVIORAL	Primary care physician activation	Mailed educational print materials sent to the participants' primary care doctors about health risks and recommendations for medical screening for adult women who were treated for a childhood cancer with chest radiation.
BEHAVIORAL	Control	Mailed educational materials.

Timeline

• Start date: 2019-05-07
• Primary completion: 2022-08-31
• Completion: 2023-02-27
• First posted: 2018-02-19
• Last updated: 2023-09-08
• Results posted: 2023-09-08

Locations

5 sites across 1 country: United States