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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
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

40 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    October 13, 2023
    Last Updated
    October 18, 2023
    Sponsor
    Dartmouth-Hitchcock Medical Center
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    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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