Adapting a Mammography Decision Aid to Support Women Living in a Community Contaminated by PFAS
Primary Purpose
Breast Cancer Screening
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MyMammogram decision aid
Sponsored by

About this trial
This is an interventional other trial for Breast Cancer Screening focused on measuring per- and polyfluoroalkyl substances, breast cancer screening, decision aid, risk assessment
Eligibility Criteria
Inclusion Criteria: Females aged 40-49 No personal history of breast cancer, No mammogram in the prior 12 months Resident of Hillsborough County, New Hampshire for at least 5 years (since 2018) Exclusion Criteria: History of breast cancer, ductal carcinoma in situ, lobular carcinoma in situ Cognitive impairment impeding the ability to provide informed consent
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Decision Aid
Arm Description
Participants will receive the adapted MyMammogram decision aid that includes environmental risk information.
Outcomes
Primary Outcome Measures
Acceptability
Acceptability e-scale,72 a 6-item measure for electronically-delivered interventions
Secondary Outcome Measures
Knowledge
10 Knowledge items summed to measure understanding of clinical screening, alternatives, main benefits/risks
Decisional Conflict
The "SURE" measure, a 4-item validated checklist to assess decisional conflict, including benefits and risks of test
Screening self-efficacy
10-item validated scale measuring self efficacy in obtaining mammography with summed score, range 5-50
Screening Intentions
15-point validated scale measuring intentions and 1 decision question (yes/no/unsure)
Full Information
NCT ID
NCT06098118
First Posted
October 13, 2023
Last Updated
October 18, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT06098118
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Screening
Keywords
per- and polyfluoroalkyl substances, breast cancer screening, decision aid, risk assessment
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Decision Aid
Arm Type
Experimental
Arm Description
Participants will receive the adapted MyMammogram decision aid that includes environmental risk information.
Intervention Type
Behavioral
Intervention Name(s)
MyMammogram decision aid
Intervention 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.
Primary Outcome Measure Information:
Title
Acceptability
Description
Acceptability e-scale,72 a 6-item measure for electronically-delivered interventions
Time Frame
Within 1 day, post-intervention
Secondary Outcome Measure Information:
Title
Knowledge
Description
10 Knowledge items summed to measure understanding of clinical screening, alternatives, main benefits/risks
Time Frame
Immediately pre-intervention, within 1 day post-intervention
Title
Decisional Conflict
Description
The "SURE" measure, a 4-item validated checklist to assess decisional conflict, including benefits and risks of test
Time Frame
Immediately pre-intervention, within 1 day post-intervention
Title
Screening self-efficacy
Description
10-item validated scale measuring self efficacy in obtaining mammography with summed score, range 5-50
Time Frame
Immediately pre-intervention, within 1 day post-intervention
Title
Screening Intentions
Description
15-point validated scale measuring intentions and 1 decision question (yes/no/unsure)
Time Frame
Immediately pre-intervention, within 1 day post-intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Females aged 40-49
No personal history of breast cancer,
No mammogram in the prior 12 months
Resident of Hillsborough County, New Hampshire for at least 5 years (since 2018)
Exclusion Criteria:
History of breast cancer, ductal carcinoma in situ, lobular carcinoma in situ
Cognitive impairment impeding the ability to provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine M Gunn, PhD
Phone
603-646-5430
Email
Christine.M.Gunn@dartmouth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Beidler, MPH
Phone
(603) 646-5611
Email
Laura.Beidler@dartmouth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine M Gunn, PhD
Organizational Affiliation
Dartmouth College, Geisel School of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Adapting a Mammography Decision Aid to Support Women Living in a Community Contaminated by PFAS
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