Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
St. Jude Children's Research Hospital
University of Colorado, Denver
Dana-Farber Cancer Institute
University of Chicago
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01579552
First received: April 3, 2012
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Cancer
Behavioral: survey, questionaire
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: EMPOWER Study: Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • efficacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Moderating factors [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Mediating factors [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Economic analysis [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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


  • Breast MRI completed by 12-month questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    (confirmed by medical record)

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



Estimated Enrollment: 360
Study Start Date: July 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   25 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579552

Contacts
Contact: Kevin Oeffinger, MD 646-888-4730
Contact: Chaya Moskowitz, PhD 646-735-8117

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States
Contact: Melissa M Hudson, MD         
Contact: Gregory Armstrong, MD         
Principal Investigator: Melissa M Hudson, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
St. Jude Children's Research Hospital
University of Colorado, Denver
Dana-Farber Cancer Institute
University of Chicago
Investigators
Principal Investigator: Kevin C Oeffinger, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01579552     History of Changes
Other Study ID Numbers: 10-104
Study First Received: April 3, 2012
Last Updated: April 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Questionnaires
telephone counseling session
10-104
Childhood Cancer Survivor Women Post Chest Radiation

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 24, 2014