Overview

This trial is active, not recruiting.

Condition cancer
Treatments survey, questionaire
Phase phase 3
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator St. Jude Children's Research Hospital
Start date July 2010
End date July 2017
Trial size 360 participants
Trial identifier NCT01579552, 10-104

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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).
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)
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).
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.

Primary Outcomes

Measure
efficacy
time frame: 12 months

Secondary Outcomes

Measure
Moderating factors
time frame: 12 months
Mediating factors
time frame: 12 months
Economic analysis
time frame: 12 months
Breast MRI completed by 12-month questionnaire
time frame: 12 months

Eligibility Criteria

Female participants from 25 years up to 49 years old.

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)

Additional Information

Official title EMPOWER Study: Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer
Principal investigator Kevin C Oeffinger, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.