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临床试验/NCT06098118
NCT06098118已完成不适用

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

Trustees of Dartmouth College2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年5月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Acceptability

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
39 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • History of breast cancer, ductal carcinoma in situ, lobular carcinoma in situ
  • Cognitive impairment impeding the ability to provide informed consent

研究组 & 干预措施

Decision Aid

Experimental

Participants will receive the adapted MyMammogram decision aid that includes environmental risk information.

干预措施: MyMammogram decision aid (Behavioral)

结局指标

主要结局

Acceptability

时间窗: Within 1 day, post-intervention

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

次要结局

  • Screening self-efficacy(Immediately pre-intervention, within 1 day post-intervention)
  • Decisional Conflict(Immediately pre-intervention, within 1 day post-intervention)
  • Screening Intentions(Immediately pre-intervention, within 1 day post-intervention)
  • Knowledge(Immediately pre-intervention, within 1 day post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christine M. Gunn

Assistant Professor

Trustees of Dartmouth College

研究点 (2)

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