Clinical trial NCT06098118: Adapting a Mammography Decision Aid to Support Women Living in a Community Contaminated by PFAS
Official title: Adapting a Mammography Decision Aid to Support Women Living in a Community Contaminated by Per- and Polyfluoroalkyl Substances (PFAS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Screening
Keywords: per- and polyfluoroalkyl substances
breast cancer screening
decision aid
risk assessment
Lead sponsor: Trustees of Dartmouth College
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 39
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability
timeFrame: Within 1 day, post-intervention
Secondary outcomes:
measure: Knowledge
timeFrame: Immediately pre-intervention, within 1 day post-intervention
measure: Decisional Conflict
timeFrame: Immediately pre-intervention, within 1 day post-intervention
measure: Screening self-efficacy
timeFrame: Immediately pre-intervention, within 1 day post-intervention
measure: Screening Intentions
timeFrame: Immediately pre-intervention, within 1 day post-intervention
Other outcomes:
Locations:
city: Hanover
country: United States
facility: Dartmouth College
state: New Hampshire
Study officials:
affiliation: Dartmouth College, Geisel School of Medicine
name: Christine M Gunn, PhD
role: PRINCIPAL_INVESTIGATOR
References: