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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
efficacy
Secondary outcome measures
Breast MRI completed by 12-month questionnaire
Economic analysis
Mediating factors
+1 moreTrial 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
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).
Find a Location
Who is running the clinical trial?
University of ChicagoOTHER
1,001 Previous Clinical Trials
817,370 Total Patients Enrolled
Dana-Farber Cancer InstituteOTHER
1,078 Previous Clinical Trials
340,512 Total Patients Enrolled
University of Colorado, DenverOTHER
1,732 Previous Clinical Trials
2,143,188 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.It has been over 8 years since I had chest radiation.I am between 25 and 49 years old.I have been diagnosed with breast cancer.
Research Study Groups:
This trial has the following groups:- Group 1: attention control group
- Group 2: Intervention Group
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA cleared this survey for use with patients?
"There is some data supporting the efficacy of surveys and questionnaires, and multiple rounds of data have been collected to support their safety, so they received a score of 3."
Answered by AI
Does this experimental treatment plan have an age limit?
"The age bracket for this clinical trial is between 25-49 years old."
Answered by AI
Who is the target demographic for this clinical trial?
"This trial is open to 360 patients aged 25-49 who have malignancies and meet the following criteria: Participant in the CCSS cohort, 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."
Answered by AI
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