Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06098118
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2023-10-13
Brief Title:
Adapting a Mammography Decision Aid to Support Women Living in a Community Contaminated by PFAS
Sponsor:
Trustees of Dartmouth College
Organization:
Trustees of Dartmouth College
Study Overview
Official Title:
Adapting a Mammography Decision Aid to Support Women Living in a Community Contaminated by Per- and Polyfluoroalkyl Substances PFAS
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This community-engaged research project will test an adapted online breast cancer screening decision aid to address the needs of women living in an area where environmental contamination has increased concern about breast cancer risk It will provide novel data on individual experiences with breast cancer risk assessment and decisional determinants of screening choices in a community disproportionately impacted by industrial pollution
Detailed Description:
Environmental contamination is increasingly recognized as a critical driver of cancer disparities and communities impacted by industrial pollution experience greater risk of cancer and higher cancer worry which complicates health decision making Recently the National Academies of Science Engineering and Medicine NASEM released guidance suggesting that per- and polyfluoroalkyl substances PFAS are suggestively associated with breast cancer risk and that individuals with moderate to high blood concentrations of these chemicals should screen for breast cancer according to age and other risk factors as recommended by the US Preventive Services Task Force USPSTF Mammography screening guidelines for women in their 40s increasingly call for the use of risk assessment tools to guide screening initiation and imaging intervals eg every year vs every two years but current tools do not address environmental risk factors that can contribute to breast cancer risk This poses a particular challenge in communities where there is a real or perceived increased risk of breast cancer stemming from an environmental contamination concern There are currently no decision tools tailored to help women living in such communities with their decisions about breast cancer screening Therefore the goal of the proposed work is to test an adapted online decision aid to incorporate environmental risk messaging to increase informed breast cancer screening decisions for women 40-49 years of age living in the greater Merrimack New Hampshire area where known and ongoing PFAS contamination exists In partnership with Merrimack Citizens for Clean Water we will distribute a community survey among screening-eligible women to test the new risk messaging within the decision aid n100 and establish acceptability in an open-label single arm trial The proposed research will contribute novel data on community-driven priorities for information about environmental contaminants that may affect breast cancer risk assessment and screening decisions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None