Educational Intervention for Cancer Survivors' Breast Cancer Screening

Recruiting in Palo Alto (17 mi)

Overseen byChaya Moskowitz, PhD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adult women aged 25-49 who survived childhood cancer, were treated with chest radiation before turning 21, and haven't had breast imaging in the last two years. They must have been part of the CCSS cohort and not diagnosed with breast cancer or participated in Project VISION.

Inclusion Criteria

I speak English and can participate in interviews over the phone.

I was diagnosed with cancer before I turned 21.

I have received more than 20 Gy of radiation therapy to my chest area.

+4 more

Exclusion Criteria

I have been diagnosed with breast cancer.

Participated in the Project VISION feasibility study (exposed to part of the intervention)

Participant Groups

The study compares two methods to educate these women about their health risks and promote wellness, focusing on breast and heart health over a twelve-month period. It's designed specifically for those who received significant chest radiation as children.

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention

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).

Group II: attention control groupActive Control1 Intervention