Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Neoplasms, Early Detection of Cancer

Intervention / Treatment
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* Behavioral: Patient activation
* Behavioral: Primary care physician activation
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned, in a ratio of 1:1:1, to one of the three groups: control, patient activation (PA), or patient activation + primary care provider activation (PA+PCP). Participants will remain in the group they are randomized to with no crossover throughout the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control (C)<br>Targeted mailed educational materials (C). | Behavioral: Control<br>* Mailed educational materials.<br>|
| Experimental: Patient activation (PA)<br>C + patient activation (PA) consisting of (1) smartphone app with HIPAA compliant survivorship care plan that can be viewed, printed, or emailed to their primary care provider; and (2) two-way (interactive) tailored text messages with links to video vignettes discussing the primary barriers to breast MRI and mammography. | Behavioral: Patient activation<br>* 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.<br>Behavioral: Control<br>* Mailed educational materials.<br>|
| Active Comparator: Patient activation + primary care provider activation (PA+PCP)<br>C + PA + PCP activation (PA+PCP) with physician materials about breast cancer risk in this population along with national and international guidelines for breast cancer surveillance. | Behavioral: Patient activation<br>* 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.<br>Behavioral: Primary care physician activation<br>* 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.<br>Behavioral: Control<br>* Mailed educational materials.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Women Who Completed a Breast MRI and Mammogram | Self-reported | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Survivors, Smartphone, Mobile Applications