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Clinical Trials/NCT01579552
NCT01579552
Active, not recruiting
Phase 3

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

Memorial Sloan Kettering Cancer Center2 sites in 1 country360 target enrollmentJuly 1, 2010
ConditionsCancer

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Cancer
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
360
Locations
2
Primary Endpoint
efficacy
Status
Active, not recruiting
Last Updated
5 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2010
End Date
July 1, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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

  • Moderating factors(12 months)
  • Mediating factors(12 months)
  • Economic analysis(12 months)
  • Breast MRI completed by 12-month questionnaire(12 months)

Study Sites (2)

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