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Completed

NCT Number: NCT06098118

Adapting a Mammography Decision Aid to Support Women Living in a Community Contaminated by 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.

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Key information

Age range

39 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth College

Hanover, New Hampshire, 03755, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MyMammogram decision aid

Behavioral

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 outcomes

  1. Acceptability

    Time frame: Within 1 day, post-intervention

    Acceptability e-scale,72 a 6-item measure for electronically-delivered interventions

Secondary outcomes

  1. Knowledge

    Time frame: Immediately pre-intervention, within 1 day post-intervention

    10 Knowledge items summed to measure understanding of clinical screening, alternatives, main benefits/risks

  2. Decisional Conflict

    Time frame: Immediately pre-intervention, within 1 day post-intervention

    The "SURE" measure, a 4-item validated checklist to assess decisional conflict, including benefits and risks of test

  3. Screening self-efficacy

    Time frame: Immediately pre-intervention, within 1 day post-intervention

    10-item validated scale measuring self efficacy in obtaining mammography with summed score, range 5-50

  4. Screening Intentions

    Time frame: Immediately pre-intervention, within 1 day post-intervention

    15-point validated scale measuring intentions and 1 decision question (yes/no/unsure)

Sponsors and collaborators

Lead sponsor

Trustees of Dartmouth College

Other

Registry information

Official study title

Adapting a Mammography Decision Aid to Support Women Living in a Community Contaminated by Per- and Polyfluoroalkyl Substances (PFAS)

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2023
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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