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

Sponsor
Dartmouth-Hitchcock Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06098118
Collaborator
(none)
100
1
6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: MyMammogram decision aid
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Adapting a Mammography Decision Aid to Support Women Living in a Community Contaminated by Per- and Polyfluoroalkyl Substances (PFAS)
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Decision Aid

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

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.

Outcome Measures

Primary Outcome Measures

  1. Acceptability [Within 1 day, post-intervention]

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

Secondary Outcome Measures

  1. Knowledge [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 [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 [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 [Immediately pre-intervention, within 1 day post-intervention]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Dartmouth-Hitchcock Medical Center

Investigators

  • Principal Investigator: Christine M Gunn, PhD, Dartmouth College, Geisel School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christine Gunn, Assistant Professor, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT06098118
Other Study ID Numbers:
  • STUDY02002204
First Posted:
Oct 24, 2023
Last Update Posted:
Oct 24, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Christine Gunn, Assistant Professor, Dartmouth-Hitchcock Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 24, 2023