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)

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Screening
• Intervention / Treatment: Behavioral: MyMammogram decision aid

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Hanover, New Hampshire, United States, 03755
      • Dartmouth College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Decision Aid; Participants will receive the adapted MyMammogram decision aid that includes environmental risk information.	Behavioral: MyMammogram 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Acceptability e-scale,72 a 6-item measure for electronically-delivered interventions	Within 1 day, post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge	10 Knowledge items summed to measure understanding of clinical screening, alternatives, main benefits/risks	Immediately pre-intervention, within 1 day post-intervention
Decisional Conflict	The "SURE" measure, a 4-item validated checklist to assess decisional conflict, including benefits and risks of test	Immediately pre-intervention, within 1 day post-intervention
Screening self-efficacy	10-item validated scale measuring self efficacy in obtaining mammography with summed score, range 5-50	Immediately pre-intervention, within 1 day post-intervention
Screening Intentions	15-point validated scale measuring intentions and 1 decision question (yes/no/unsure)	Immediately pre-intervention, within 1 day post-intervention

Collaborators and Investigators

• Sponsor: Trustees of Dartmouth College
• Investigators: Principal Investigator: Christine M Gunn, PhD, Dartmouth College, Geisel School of Medicine

Publications and helpful links

General Publications

• St Angelo M, Romano ME, Gallagher L, Gunn CM. Supporting informed decisions about breast cancer screening in communities with known environmental contamination: a pre-post study. Cancer Causes Control. 2025 Dec 27;37(1):11. doi: 10.1007/s10552-025-02100-5.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2024
• Primary Completion (Actual): December 23, 2024
• Study Completion (Actual): December 23, 2024

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 18, 2026
• Last Update Submitted That Met QC Criteria: August 14, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: risk assessment; breast cancer screening; decision aid; per- and polyfluoroalkyl substances
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Progressive Encephalomyelitis with Rigidity
• Other Study ID Numbers: STUDY00032987

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual data that has been de-identified will be made available upon reasonable request.
• IPD Sharing Time Frame: Data will be available after primary paper is published and for up to 3 years.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No