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Adapting a Mammography Decision Aid to Support Women Living in a Community Contaminated by PFAS

Adapting a Mammography Decision Aid to Support Women Living in a Community Contaminated by Per- and Polyfluoroalkyl Substances (PFAS)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06098118
Enrollment
100
Registered
2023-10-24
Start date
2024-05-06
Completion date
2024-12-23
Last updated
2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Screening

Keywords

per- and polyfluoroalkyl substances, breast cancer screening, decision aid, risk assessment

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 (e.g. 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 (n=100) 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.

Interventions

BEHAVIORALMyMammogram decision aid

An online breast cancer screening decision aid that includes personalized risk assessment, information on benefits and risks of mammography screening, values clarification, outcome expectancies, and a summative document with participant responses.

Sponsors

Trustees of Dartmouth College
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
39 Years to 49 Years
Healthy volunteers
Yes

Inclusion criteria

* Females aged 39-49 * No personal history of breast cancer, * No mammogram in the prior 12 months * Resident of Merrimack, Hillsborough, Rockingham or Bennington counties

Exclusion criteria

* History of breast cancer, ductal carcinoma in situ, lobular carcinoma in situ * Cognitive impairment impeding the ability to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
AcceptabilityWithin 1 day, post-interventionAcceptability e-scale,72 a 6-item measure for electronically-delivered interventions

Secondary

MeasureTime frameDescription
KnowledgeImmediately pre-intervention, within 1 day post-intervention10 Knowledge items summed to measure understanding of clinical screening, alternatives, main benefits/risks
Decisional ConflictImmediately pre-intervention, within 1 day post-interventionThe "SURE" measure, a 4-item validated checklist to assess decisional conflict, including benefits and risks of test
Screening self-efficacyImmediately pre-intervention, within 1 day post-intervention10-item validated scale measuring self efficacy in obtaining mammography with summed score, range 5-50
Screening IntentionsImmediately pre-intervention, within 1 day post-intervention15-point validated scale measuring intentions and 1 decision question (yes/no/unsure)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORChristine M Gunn, PhD

Dartmouth College, Geisel School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026