NCT06098118

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

May 6, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2024

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

October 13, 2023

Last Update Submit

January 6, 2025

Conditions

Keywords

per- and polyfluoroalkyl substancesbreast cancer screeningdecision aidrisk assessment

Outcome Measures

Primary Outcomes (1)

  • Acceptability

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

    Within 1 day, post-intervention

Secondary Outcomes (4)

  • Knowledge

    Immediately pre-intervention, within 1 day post-intervention

  • Decisional Conflict

    Immediately pre-intervention, within 1 day post-intervention

  • Screening self-efficacy

    Immediately pre-intervention, within 1 day post-intervention

  • Screening Intentions

    Immediately pre-intervention, within 1 day post-intervention

Study Arms (1)

Decision Aid

EXPERIMENTAL

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

Behavioral: MyMammogram decision aid

Interventions

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.

Decision Aid

Eligibility Criteria

Age39 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth College

Hanover, New Hampshire, 03755, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Progressive Encephalomyelitis with Rigidity

Study Officials

  • Christine M Gunn, PhD

    Dartmouth College, Geisel School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 13, 2023

First Posted

October 24, 2023

Study Start

May 6, 2024

Primary Completion

December 23, 2024

Study Completion

December 23, 2024

Last Updated

January 8, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Individual data that has been de-identified will be made available upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
Data will be available after primary paper is published and for up to 3 years.

Locations