CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 314 enrolled
Drug / intervention
Patient activation +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03435380
NCT03435380N/ACompleted

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

Duke University·interventional·Posted Feb 19, 2018·Updated Sep 8, 2023

In Brief

A clinical study evaluating Patient activation, Primary care physician activation, and 1 other intervention for Breast Neoplasms and Early Detection of Cancer. Completed, enrolled 314 participants across 5 sites.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedFeb 19, 2018
Enrollment StartMay 7, 2019
Primary CompletionAug 31, 2022
Study CompletionFeb 27, 2023
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 8.4 years ago

Interventions

Patient activationbehavioral

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.

Primary care physician activationbehavioral

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.

Controlbehavioral

Mailed educational materials.