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Educational Intervention for Cancer Survivors' Breast Cancer Screening

Phase 3

Waitlist Available

Led By Chaya Moskowitz, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with a childhood cancer prior to 21 years of age

Treated with > 20 Gy of chest radiation (mantle, mediastinal, lung, or chest)

Must not have

Diagnosed with breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare two ways of teaching patients about their health risks and how to stay healthy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves surveys and questionnaires rather than medical treatments, there are no direct physical side effects. However, discussing personal health risks may cause emotional or psychological discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was diagnosed with cancer before I turned 21.

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

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It has been over 8 years since I had chest radiation.

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I am between 25 and 49 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with breast cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

efficacy

Secondary study objectives

Breast MRI completed by 12-month questionnaire

Economic analysis

Mediating factors

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

0 / 5Eligibility criteria met