Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

EMPOWER Study: Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

The purpose of this study is to empower women to improve their health in two very important areas: breast and heart health. This twelve-month study will compare two methods of informing participants about potential health risks and ways to stay healthy.

The EMPOWER Study has been designed for adult women who were treated for a childhood cancer with chest radiation.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: survey, questionaire

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
  • Tennessee
    • Memphis, Tennessee, United States
      • St. Jude Children's Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 49 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant in the CCSS cohort
• Diagnosed with a childhood cancer prior to 21 years of age
• Treated with > 20 Gy of chest radiation (mantle, mediastinal, lung, or chest)
• Age 25-49 years at time of enrollment into the study
• Interval from chest radiation to the time of enrollment of > 8 years
• No mammogram or other breast imaging study in the 24 months prior to enrollment
• English-speaking - The University of Colorado AMC Denver and MSKCC group are not capable of or equipped for conducting a brief motivational interviews by telephone in another language.

Exclusion Criteria:

• Diagnosed with breast cancer
• Participated in the Project VISION feasibility study (exposed to part of the intervention)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; The EMPOWER intervention trial is a 12-month study of 360 women from the Childhood Cancer Survivor Study who have previously been treated with chest radiation, are 25 to 49 years of age at the time of enrollment, are 8 years or more since their chest radiation, and have not had a mammogram or other breast imaging study in the preceding two years. Following a baseline questionnaire, participants will be randomized to the attention control group (N=120) or the intervention group (N=240).	Behavioral: survey, questionaire; The intervention components (mailed tailored print materials followed by telephone-delivered Brief MI). Following enrollment into the study and completion of the informed consent form and baseline survey, participants will be randomized to the active intervention group or the attention control group. The data that will be used in the analysis will come from the baseline survey, medical records of breast imaging studies, and a 12-month follow-up questionnaire.
Active Comparator: attention control group; The EMPOWER intervention trial is a 12-month study of 360 women from the Childhood Cancer Survivor Study who have previously been treated with chest radiation, are 25 to 49 years of age at the time of enrollment, are 8 years or more since their chest radiation, and have not had a mammogram or other breast imaging study in the preceding two years. Following a baseline questionnaire, participants will be randomized to the attention control group (N=120) or the intervention group (N=240).	Behavioral: survey, questionaire; The intervention components (mailed tailored print materials followed by telephone-delivered Brief MI). Following enrollment into the study and completion of the informed consent form and baseline survey, participants will be randomized to the active intervention group or the attention control group. The data that will be used in the analysis will come from the baseline survey, medical records of breast imaging studies, and a 12-month follow-up questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy	Determine the efficacy of an intervention, consisting of mailed tailored print materials followed by a telephone-delivered Brief Motivational Interview, on mammogram screening rates compared with an attention control. Mammogram completed by 12-month questionnaire (confirmed by medical record)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderating factors	By including interaction terms in the model, we will assess potential moderating factors such as age, race/ethnicity, health insurance, & other sociodemographic variables. Moderating effects can be adequately addressed through interactions between the intervention & the above mentioned covariates.124 An interaction with the treatment group indicator suggests differential effectiveness, and moderator variables with statistically significant interactions will remain in the model. Interactions will be estimated using crossproduct terms between the intervention indicator & the mediating variable.	12 months
Mediating factors	Based on results from the MPS & breast ca screening intervention trials among women in the general pop or familial risk, we are a priori interested in mediating effect of 5 variable domains: knowledge of screening guidelines, breast ca health beliefs, decisional balance of the pros & cons of mammography, self-efficacy, & psychological factors. For each of these domains, a global or subscale score will be used as appropriate. For ex, from the BSI-18, a global score of psychological symptoms & a subscale score for each group of symptoms can be estimated.	12 months
Economic analysis	Replication costs of intervention: dollar cost; time cost (per person) • Costs resulting from intervention: total cost of screening/diagnostic imaging, diagnostic procedures, breast surgery, non-procedure breast-related physician visits	12 months
Breast MRI completed by 12-month questionnaire	(confirmed by medical record) • Barriers to completing breast MRI: moderating/mediating variables listed above	12 months

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: University of Colorado, Denver; Dana-Farber Cancer Institute; University of Chicago; St. Jude Children's Research Hospital
• Investigators: Principal Investigator: Chaya Moskowitz, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

General Publications

• Oeffinger KC, Ford JS, Moskowitz CS, Chou JF, Henderson TO, Hudson MM, Diller L, McDonald A, Ford J, Mubdi NZ, Rinehart D, Vukadinovich C, Gibson TM, Anderson N, Elkin EB, Garrett K, Rebull M, Leisenring W, Robison LL, Armstrong GT. Promoting Breast Cancer Surveillance: The EMPOWER Study, a Randomized Clinical Trial in the Childhood Cancer Survivor Study. J Clin Oncol. 2019 Aug 20;37(24):2131-2140. doi: 10.1200/JCO.19.00547. Epub 2019 Jul 1.

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: April 3, 2012
• First Submitted That Met QC Criteria: April 17, 2012
• First Posted (Estimated): April 18, 2012

Study Record Updates

• Last Update Posted (Estimated): November 12, 2025
• Last Update Submitted That Met QC Criteria: November 10, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Questionnaires; telephone counseling session; 10-104; Childhood Cancer Survivor Women Post Chest Radiation
• Additional Relevant MeSH Terms: Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 10-104