Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 3

Conditions: Cancer

Treatments: Behavioral: survey, questionaire

Study type: Interventional

Funder types: Other

Identifiers

NCT01579552

10-104

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: Female

Ages: 25 to 49 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

360 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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).

Treatment:

Behavioral: survey, questionaire

Behavioral: survey, questionaire

attention control group

Active Comparator group

Description:

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).

Treatment:

Behavioral: survey, questionaire

Behavioral: survey, questionaire