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BAC-Enhanced Information Sharing for Mammogram Screening
N/A
Recruiting
Led By Guy H. Montgomery, Ph.D.
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female
Age ≥ 40 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6
Awards & highlights
Study Summary
This trial is looking at whether or not informing women of their breast arterial calcification (BAC) results could potentially help with breast cancer screenings.
Who is the study for?
This trial is for women over 40 who are scheduled for a mammogram at Mount Sinai's clinics, can read and speak English or Spanish, and are willing to sign consent forms. It excludes those with cognitive/psychiatric conditions affecting study compliance, pregnant women, or those with known heart issues.Check my eligibility
What is being tested?
The study aims to see if adding breast arterial calcification (BAC) information to post-mammography letters affects healthcare choices in women. It will measure BAC rates in a diverse group of participants and assess reactions to receiving BAC data.See study design
What are the potential side effects?
Since this trial involves sharing information rather than medical interventions, there are no direct side effects from drugs or treatments. However, learning about one's BAC status could potentially cause anxiety or lead to further medical consultations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am female.
Select...
I am 40 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Attendance at a cardiovascular appointment
Secondary outcome measures
Detection of coronary artery disease (CAD)
Healthy Heart Score
Revised Illness Perception Questionnaire (IPQ-R)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Waitlist control groupExperimental Treatment2 Interventions
944 participants will receive a post-mammography results letter without BAC information, which is the current standard of care. These patients will receive BAC information following study completion (approximately 6 months after mammography).
Group II: BAC-enhanced groupExperimental Treatment1 Intervention
944 participants will receive a post-mammography results letter which includes information on their BAC results.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Waitlist Control
2021
N/A
~1920
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
854 Previous Clinical Trials
521,118 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,912,472 Total Patients Enrolled
Guy H. Montgomery, Ph.D.Principal InvestigatorIcahn School of Medicine at Mount Sinai
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can understand and follow the study's instructions without any mental health issues affecting me.I have been told I have coronary artery disease.I am female.I have had heart issues like a heart attack, stroke, or angina, or I'm on nitroglycerin.I am 40 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: BAC-enhanced group
- Group 2: Waitlist control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Is there availability for prospective participants in this research trial?
"Affirmative. The details provided by clinicaltrials.gov are indicative of this medical trial currently recruiting participants, which was initially announced on September 29th 2021 and recently revised on July 1st 2022. A total of 14,875 patients will be accepted from one single location."
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