Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

NCT01579552 | Active Not Recruiting Phase 3

• 1 other identifier: 10-104
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer

Keywords

Questionnaires; telephone counseling session; 10-104; Childhood Cancer Survivor Women Post Chest Radiation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Moderating factors

  12 months

• Mediating factors

  12 months

• Economic analysis

  12 months

• Breast MRI completed by 12-month questionnaire

  12 months

Study Arms (2)

Intervention Group

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).

Behavioral: survey, questionaire

attention control group

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).

Behavioral: survey, questionaire

Interventions

survey, questionaire BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 25 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Diagnosed with breast cancer
• Participated in the Project VISION feasibility study (exposed to part of the intervention)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• St. Jude Children's Research Hospital: collaborator
• University of Colorado, Denver: collaborator
• Dana-Farber Cancer Institute: collaborator
• University of Chicago: collaborator

Study Sites (2)

Memorial Sloan Kettering Cancer Center (All protocol activities)

New York, New York, 10021, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Location

Related Publications (1)

• Oeffinger KC, Ford JS, Moskowitz CS, Chou JF, Henderson TO, Hudson MM, Diller L, McDonald A, Ford J, Mubdi NZ, Rinehart D, Vukadinovich C, Gibson TM, Anderson N, Elkin EB, Garrett K, Rebull M, Leisenring W, Robison LL, Armstrong GT. Promoting Breast Cancer Surveillance: The EMPOWER Study, a Randomized Clinical Trial in the Childhood Cancer Survivor Study. J Clin Oncol. 2019 Aug 20;37(24):2131-2140. doi: 10.1200/JCO.19.00547. Epub 2019 Jul 1.

  PMID: 31260642 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Chaya Moskowitz, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 18, 2012
• Study Start: July 1, 2010
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 12, 2025

Record last verified: 2025-11

Locations

US (2)