Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 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: October 24, 2014
Last verified: October 2014

April 3, 2012
October 24, 2014
July 2010
July 2015   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01579552 on ClinicalTrials.gov Archive Site
  • 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

Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Cancer
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.
  • 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).
    Intervention: Behavioral: survey, questionaire
  • 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).
    Intervention: Behavioral: survey, questionaire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
360
July 2015
July 2015   (final data collection date for primary outcome measure)

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)
Female
25 Years to 49 Years
No
Contact: Kevin Oeffinger, MD 646-888-4730
Contact: Chaya Moskowitz, PhD 646-735-8117
United States
 
NCT01579552
10-104
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • St. Jude Children's Research Hospital
  • University of Colorado, Denver
  • Dana-Farber Cancer Institute
  • University of Chicago
Principal Investigator: Kevin C Oeffinger, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP