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Trial Title:
Adapting a Mammography Decision Aid to Support Women Living in a Community Contaminated by PFAS
NCT ID:
NCT06098118
Condition:
Breast Cancer Screening
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
per- and polyfluoroalkyl substances
breast cancer screening
decision aid
risk assessment
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
MyMammogram decision aid
Description:
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.
Arm group label:
Decision Aid
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.
Criteria for 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
Gender:
Female
Minimum age:
39 Years
Maximum age:
49 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Dartmouth College
Address:
City:
Hanover
Zip:
03755
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christine Gunn, PhD
Phone:
603-646-5430
Email:
Christine.M.Gunn@dartmouth.edu
Contact backup:
Last name:
Laura Beidler, MPH
Email:
Laura.Beidler@dartmouth.edu
Start date:
May 6, 2024
Completion date:
September 2024
Lead sponsor:
Agency:
Trustees of Dartmouth College
Agency class:
Other
Source:
Trustees of Dartmouth College
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06098118
