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

Breast Cancer Screening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06098118
• Other study ID #: STUDY00032987
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2024
• Est. completion date: September 2024

Study information

• Verified date: June 2024
• Source: Trustees of Dartmouth College
• Contact: Christine M Gunn, PhD
• Phone: 603-646-5430
• Email: Christine.M.Gunn[@]dartmouth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 39 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Screening
• Breast Neoplasms

Intervention

Behavioral:
• MyMammogram decision aid
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.

Locations

Country	Name	City	State
United States	Dartmouth College	Hanover	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Trustees of Dartmouth College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability	Acceptability e-scale,72 a 6-item measure for electronically-delivered interventions	Within 1 day, post-intervention
Secondary	Knowledge	10 Knowledge items summed to measure understanding of clinical screening, alternatives, main benefits/risks	Immediately pre-intervention, within 1 day post-intervention
Secondary	Decisional Conflict	The "SURE" measure, a 4-item validated checklist to assess decisional conflict, including benefits and risks of test	Immediately pre-intervention, within 1 day post-intervention
Secondary	Screening self-efficacy	10-item validated scale measuring self efficacy in obtaining mammography with summed score, range 5-50	Immediately pre-intervention, within 1 day post-intervention
Secondary	Screening Intentions	15-point validated scale measuring intentions and 1 decision question (yes/no/unsure)	Immediately pre-intervention, within 1 day post-intervention