BAC-Enhanced Information Sharing for Mammogram Screening

Recruiting at 1 trial location

Overseen By Crystalinda Rapozo

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Nitroglycerin

Disqualifiers: Coronary artery disease, Heart attack, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

14875 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to determine the potential benefits of adding information on patients' breast arterial calcification (BAC) results to the standard results letter women receive after mammography. In addition to looking for potential breast cancer, research shows that mammograms can also detect the presence of calcifications within the breast arteries. Those calcifications can be associated with coronary artery disease. Right now, women are not routinely told whether or not they have BAC; that is, it's not part of standard practice to communicate that information to patients. However, previous research has suggested that patients would like to be informed about their BAC status more often. In this study, the team has two goals. First, the team wants to measure the rates of BAC in a large, diverse group of 14,875 women. Because most of the past research on BAC has largely been focused on White mammography patients, the researchers feel it is important to see if the results are similar or different in a more racially and ethnically diverse sample. Second, the study team wants to understand the effects of giving women information on their BAC results as part of their standard post-mammography letter. Specifically, the study team wants to see how sharing that information might affect women's healthcare choices and lifestyle. The research will include 1,888 women in this second part of the study, which will be the first in the literature to explore women's reactions to BAC information. If research shows that women find the information useful, BAC information may be given to women regularly in the future.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment BAC-Enhanced Information Sharing for Mammogram Screening?

Transcutaneous auricular vagus nerve stimulation (taVNS), a component of the treatment, is a non-invasive method that has shown potential in treating various conditions like epilepsy, depression, and headaches by influencing the nervous system. It is considered safe, inexpensive, and portable, making it a promising tool for enhancing health outcomes. ^{1 2 3 4 5}

Is BAC-Enhanced Information Sharing for Mammogram Screening safe for humans?

Transcutaneous auricular vagus nerve stimulation (taVNS), a related technique, is generally considered safe with only mild and temporary side effects like ear pain, headache, and tingling. There is no evidence of serious adverse effects linked to taVNS. ^{1 2 3 6 7}

How does the BAC-Enhanced Information Sharing treatment for mammogram screening differ from other treatments?

This treatment is unique because it focuses on sharing information about breast arterial calcification (BAC) found during mammograms, which can indicate potential heart disease risk. Unlike standard mammogram reports that primarily focus on breast cancer, this approach aims to inform patients about BAC to encourage follow-up cardiovascular care. ^{8 9 10 11 12}

Research Team

Guy H. Montgomery

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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.

Inclusion Criteria

Read and speak English or Spanish

Ability to understand and the willingness to sign a written informed consent

I am female.

Exclusion 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 have had heart issues like a heart attack, stroke, or angina, or I'm on nitroglycerin.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mammography and Information Sharing

Participants undergo mammography and receive a results letter, with some receiving additional BAC information

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in healthcare choices and lifestyle, including attendance at cardiovascular appointments

6 months

1 visit (virtual)

Waitlist Control Follow-up

Participants in the waitlist control group receive BAC information after study completion

6 months

Treatment Details

Interventions

• BAC-Enhanced Letter
• Waitlist Control

Trial Overview 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.

Participant Groups

Group I: Waitlist control group Experimental Treatment 2 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 group Experimental Treatment 1 Intervention

944 participants will receive a post-mammography results letter which includes information on their BAC results.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Transcutaneous auricular vagus nerve stimulation (taVNS) showed promising results in two patients with structural focal epilepsy, leading to seizure freedom in one patient after 4 weeks and significant reduction in seizures for the other after 20 weeks.

Both patients experienced improved quality of life with no significant adverse events reported, suggesting that taVNS could be a safe and effective treatment option for individuals with focal epilepsy and preserved cognitive function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vagus nerve stimulation therapy in patients with cognitively preserved structural focal epilepsy: A case series report. Shiraishi, H., Egawa, K., Murakami, K., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive and cost-effective method for modulating the vagus nerve, making it a promising alternative to traditional surgical vagus nerve stimulation.

taVNS allows for easy and safe administration, with considerations for proper electrode placement and individual dosing based on perception thresholds, which enhances its potential for treating various central and peripheral diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. Badran, BW., Yu, AB., Adair, D., et al.[2020]

A systematic review of 261 studies revealed significant confusion in the nomenclature for transcutaneous stimulation of the auricular branch of the vagus nerve (ABVN), with 67 full and 27 abbreviated terms identified, highlighting the need for standardization.

The most commonly used terms were 'transcutaneous vagus nerve stimulation' and 'tVNS', but there was no consistent one-to-one relationship between full and abbreviated names, indicating a lack of uniformity in terminology across different research teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward Diverse or Standardized: A Systematic Review Identifying Transcutaneous Stimulation of Auricular Branch of the Vagus Nerve in Nomenclature. Wang, Y., Li, L., Li, S., et al.[2023]

In a study involving 17 healthy adults, transcutaneous auricular vagus nerve stimulation (taVNS) at the left tragus significantly increased brain activity in areas associated with the vagal pathway, indicating its potential efficacy in neuromodulation.

Compared to control stimulation at the earlobe, tragus stimulation resulted in greater activation in key brain regions, suggesting that taVNS could be a promising therapeutic approach for influencing brain function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurophysiologic effects of transcutaneous auricular vagus nerve stimulation (taVNS) via electrical stimulation of the tragus: A concurrent taVNS/fMRI study and review. Badran, BW., Dowdle, LT., Mithoefer, OJ., et al.[2020]

Transcutaneous vagus nerve stimulation (tVNS) is a non-invasive and less expensive alternative to invasive vagus nerve stimulation (VNS), which is used to treat conditions like epilepsy and depression, but requires further research to optimize stimulation sites and parameters.

tVNS has the potential to activate various brain areas and may be effective for a wide range of conditions, including medication-refractory epilepsy, depression, migraines, and more, suggesting it could become a standard treatment for enhancing autonomic function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous vagus nerve stimulation - A brief introduction and overview. Hilz, MJ.[2022]

Transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe, with a low incidence of mild and transient adverse effects, such as ear pain, headache, and tingling, reported in only 24.86% of the studies analyzed.

In a systematic review of 177 studies involving 6322 subjects, there was no significant difference in the risk of adverse events between taVNS and control groups, indicating that taVNS is a feasible option for clinical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Kim, AY., Marduy, A., de Melo, PS., et al.[2023]

Transcutaneous auricular Vagal Nerve Stimulation (taVNS) did not show any significant effects on pain perception or nociception in healthy participants, as measured by event-related potentials and sensory testing across three experiments involving 22 and 15 subjects.

Both taVNS and standard cervical VNS (cVNS) failed to produce objective changes in behavioral and cerebral responses to pain stimuli, suggesting that the analgesic effects of taVNS may not be as effective as previously thought.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular VNS applied to experimental pain: A paired behavioral and EEG study using thermonociceptive CO2 laser. Dumoulin, M., Liberati, G., Mouraux, A., et al.[2021]

A significant majority of mammography patients (95.8%) preferred to be informed about breast arterial calcification (BAC) findings, indicating a strong desire for awareness regarding potential cardiovascular risks.

Most patients (62.5%) preferred to receive BAC notifications from the radiology department, and a large portion (87.4%) expressed willingness to undergo coronary artery CT scans for further evaluation, highlighting the importance of effective communication in promoting cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast Arterial Calcification in the Mammogram Report: The Patient Perspective. Margolies, LR., Yip, R., Hwang, E., et al.[2019]

Mammography, widely used for breast cancer screening, can also detect breast arterial calcifications (BAC), which are common incidental findings.

This review explores the potential of BAC as an early imaging biomarker for cardiovascular disease (CVD), suggesting that BAC could help identify individuals at risk for CVD based on mammography results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Incidental Vascular Calcifications at Mammography be Used as a Screening Biomarker for Heart and Kidney Disease? Erbil, D., Onal, EM., Demirel, C., et al.[2020]

Only 60% of Canadian radiologists are aware that breast arterial calcification (BAC) on mammograms is linked to increased cardiovascular risk, which is lower than the awareness levels among European (81%) and American (35%) radiologists.

Only 16% of Canadian radiologists report BAC in mammogram findings, significantly less than their European (62%) and American (15%) counterparts, highlighting a need for improved awareness and the establishment of national reporting guidelines for BAC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation Between Breast Arterial Calcifications and Higher Cardiovascular Risk: Awareness and Attitudes Amongst Canadian Radiologists Who Report Mammography. Heaney, RM., Zaki-Metias, KM., McKee, H., et al.[2023]

A survey of 598 radiologists revealed that while 87% include breast arterial calcification (BAC) in mammogram reports, only 41% report it consistently, indicating a lack of standardization in BAC reporting practices.

Most radiologists recognize BAC as a cardiovascular risk factor, but there is no consensus on whether patients should be informed about it or if BAC reporting should be standardized, with more experienced radiologists being more likely to support these practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting and Perceptions of Breast Arterial Calcification on Mammography: A Survey of ACR Radiologists. Brown, AL., Wahab, RA., Zhang, B., et al.[2022]

A study involving 227 U.S. women over 40 showed that including information about breast arterial calcification (BAC) in mammography results letters can effectively convey BAC status and encourage follow-up cardiovascular care.

Although different message framing (gain vs. loss) did not significantly impact knowledge or behavioral intentions, the study is innovative as it is the first to examine BAC results in mammography letters, suggesting a need for further research on message framing in health communications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining gain- and loss-framed messages in a novel breast cancer screening/cardiovascular context: Does framing matter? Head, KJ., Harrington, NG., Schnur, JB., et al.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vagus nerve stimulation therapy in patients with cognitively preserved structural focal epilepsy: A case series report. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Toward Diverse or Standardized: A Systematic Review Identifying Transcutaneous Stimulation of Auricular Branch of the Vagus Nerve in Nomenclature. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Neurophysiologic effects of transcutaneous auricular vagus nerve stimulation (taVNS) via electrical stimulation of the tragus: A concurrent taVNS/fMRI study and review. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Transcutaneous vagus nerve stimulation - A brief introduction and overview. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular VNS applied to experimental pain: A paired behavioral and EEG study using thermonociceptive CO2 laser. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Breast Arterial Calcification in the Mammogram Report: The Patient Perspective. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Can Incidental Vascular Calcifications at Mammography be Used as a Screening Biomarker for Heart and Kidney Disease? [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Correlation Between Breast Arterial Calcifications and Higher Cardiovascular Risk: Awareness and Attitudes Amongst Canadian Radiologists Who Report Mammography. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Reporting and Perceptions of Breast Arterial Calcification on Mammography: A Survey of ACR Radiologists. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Examining gain- and loss-framed messages in a novel breast cancer screening/cardiovascular context: Does framing matter? [2023]