Breast Cancer ScreeningNCT06098118
Adapting a Mammography Decision Aid to Support Women Living in a Community Contaminated by PFAS
A study testing MyMammogram decision aid in people with Breast Cancer Screening, run by Trustees of Dartmouth College at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 39 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Screening
- What is being tested?
- MyMammogram decision aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2024to 23 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 39 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- History of breast cancer, ductal carcinoma in situ, lobular carcinoma in situ
- Cognitive impairment impeding the ability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adapting a Mammography Decision Aid to Support Women Living in a Community Contaminated by Per- and Polyfluoroalkyl Substances (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.
Read the 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.
- Conditions
- Breast Cancer Screening
- Being tested
- MyMammogram decision aid
- Keywords
- per- and polyfluoroalkyl substances, breast cancer screening, decision aid, risk assessment
- Medical subject headings
- Progressive Encephalomyelitis with Rigidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyMammogram decision aidBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Decision Aid | Experimental | Participants will receive the adapted MyMammogram decision aid that includes environmental risk information. Receives: Behavioral: MyMammogram decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Acceptability e-scale,72 a 6-item measure for electronically-delivered interventions
Measured: Within 1 day, post-intervention
Secondary outcomes (4)
Knowledge
10 Knowledge items summed to measure understanding of clinical screening, alternatives, main benefits/risks
Measured: Immediately pre-intervention, within 1 day post-intervention
Decisional Conflict
The "SURE" measure, a 4-item validated checklist to assess decisional conflict, including benefits and risks of test
Measured: Immediately pre-intervention, within 1 day post-intervention
Screening self-efficacy
10-item validated scale measuring self efficacy in obtaining mammography with summed score, range 5-50
Measured: Immediately pre-intervention, within 1 day post-intervention
Screening Intentions
15-point validated scale measuring intentions and 1 decision question (yes/no/unsure)
Measured: Immediately pre-intervention, within 1 day post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start6 May 2024
- Primary completion23 Dec 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trustees of Dartmouth College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine M. Gunn, Trustees of Dartmouth College
- Investigators
- Christine M Gunn, PhD, Principal investigator, Dartmouth College, Geisel School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098118
- Sponsor's protocol ID
- STUDY00032987
- Status last verified
- Aug 2026
- First submitted
- 13 Oct 2023
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual data that has been de-identified will be made available upon reasonable request.
Publications
St Angelo M, Romano ME, Gallagher L, Gunn CM. Supporting informed decisions about breast cancer screening in communities with known environmental contamination: a pre-post study. Cancer Causes Control. 2025 Dec 27;37(1):11. doi: 10.1007/s10552-025-02100-5.
PubMed 41455034
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting a Mammography Decision Aid to Support Women Living in a Community Contaminated by Per- and Polyfluoroalkyl Substances (PFAS)
- ClinicalTrials.gov ID
- NCT06098118
- Acronym / sponsor ID
- STUDY00032987
- Conditions
- Breast Cancer Screening
- Keywords
- per- and polyfluoroalkyl substances, breast cancer screening, decision aid, risk assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Trustees of Dartmouth CollegeUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decision Aid | Experimental | Behavioral: MyMammogram decision aidParticipants will receive the adapted MyMammogram decision aid that includes environmental risk information. |
Who may qualify
- Ages
- 39 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- History of breast cancer, ductal carcinoma in situ, lobular carcinoma in situ
- Cognitive impairment impeding the ability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyMammogram decision aidAn 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. | Behavioural | Decision Aid |
Primary outcome
Acceptability
Time frame: Within 1 day, post-intervention
Acceptability e-scale,72 a 6-item measure for electronically-delivered interventions
4 secondary outcomes
Knowledge
Time frame: Immediately pre-intervention, within 1 day post-intervention
Decisional Conflict
Time frame: Immediately pre-intervention, within 1 day post-intervention
Screening self-efficacy
Time frame: Immediately pre-intervention, within 1 day post-intervention
Screening Intentions
Time frame: Immediately pre-intervention, within 1 day post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Background: PubMed 41455034St Angelo M, Romano ME, Gallagher L, Gunn CM. Supporting informed decisions about breast cancer screening in communities with known environmental contamination: a pre-post study. Cancer Causes Control. 2025 Dec 27;37(1):11. doi: 10.1007/s10552-025-02100-5.
- Individual participant dataSharing planned: Yes. Individual data that has been de-identified will be made available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine M Gunn, PhD principal investigator
Dartmouth College, Geisel School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyMammogram decision aid in people with Breast Cancer Screening, run by Trustees of Dartmouth College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: Within 1 day, post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06098118, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.