Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01579552
• Other study ID #: 10-104
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 2010
• Est. completion date: July 2025

Study information

• Verified date: August 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 360
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 49 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (5)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Dana-Farber Cancer Institute, St. Jude Children's Research Hospital, University of Chicago, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Breast MRI completed by 12-month questionnaire	(confirmed by medical record); • Barriers to completing breast MRI: moderating/mediating variables listed above	12 months

External Links

•   Memorial Sloan Kettering Cancer Center