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NCT Number: NCT01579552

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cancer Neoplasms

Age range

25 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Memorial Sloan Kettering Cancer Center (All protocol activities), New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

survey, questionaire

Behavioral

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.

Primary outcomes

  1. efficacy

    Time frame: 12 months

    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)

Secondary outcomes

  1. Moderating factors

    Time frame: 12 months

    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.

  2. Mediating factors

    Time frame: 12 months

    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.

  3. Economic analysis

    Time frame: 12 months

    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

  4. Breast MRI completed by 12-month questionnaire

    Time frame: 12 months

    (confirmed by medical record)

    • Barriers to completing breast MRI: moderating/mediating variables listed above

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Dana-Farber Cancer Institute
  • St. Jude Children's Research Hospital
  • University of Chicago
  • University of Colorado, Denver

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2026
Study completion
2026
First posted
Apr 18, 2012
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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