Testing a Mammography Decision Intervention in a Rural Setting

NCT ID: NCT06522568

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-05-01

Brief Summary

The overall objective of this COBRE pilot project is to enhance the design of a 3-arm cluster randomized trial that will test the efficacy and mechanism of effect of the MyMammogram DA with or without a provider communication intervention. This will be accomplished through two aims: (1) Refine, with community partner input, a clinical trial protocol to optimize engagement among patients and primary care providers (PCPs) practicing in rural settings. In consultation with patients, PCPs, and informatics experts, the study team will refine site selection, randomization, patient and PCP recruitment, and data collection protocols to meet the needs of the rural health care delivery system and participants. The result of this aim will be a modified protocol and intervention strategy that is acceptable to partners. (2) Adapt and test trial and intervention implementation features to achieve protocol acceptance and adherence. The investigators will pilot the adapted three-arm randomized trial protocol in rural primary care settings that compares the MyMammogram DA with or without a risk summary provided to the PCP pre-visit, relative to usual care. Implementing the trial in two phases (n=15 each) will systematically identify barriers and facilitators to trial participation to refine protocols. Participants will receive acceptability surveys and investigators will conduct qualitative interviews with patients and PCPs to understand experiences with trial implementation from multiple perspectives.

Detailed Description

This is a three-arm randomized pilot trial that will enroll 30 participants over two study phases. The main objective is to achieve data on trial feasibility (recruitment, retention, randomization, adherence, and acceptability). The primary outcome is Intervention Acceptability.

Procedures: PCPs will be randomized to one of the three arms to prevent contamination across patients (usual care, decision aid, decision aid + clinician communication). Patients will be considered for enrollment if they are aged 40-49, English or Spanish-speaking, have an upcoming primary care visit within 4 weeks, no history of breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or atypical hyperplasia, and no mammogram within the past 12 months. These patients will be identified via the electronic health record using routine data reports provided to the study team.

Data Collection: Surveys will be conducted at baseline (pre-intervention), post-DA and Post-Visit. Mammography screening information will be collected via medical records, and implementation data will be completed with patients and clinicians who were exposed to the decision aid intervention.

Analysis: All feasibility metrics will be summarized quantitatively, distributions examined for central tendency and spread, and all data assessed for completeness. Data will be presented in a tabular format, with means and standard deviations summarized for the Acceptability of Intervention Measure. Process data will likewise be summarized, reporting proportions of participants meeting each metric (recruitment, retention, randomization, adherence).

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Usual Care

Usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

MyMammogram

Patient uses MyMammogram prior to appointment.

Group Type: EXPERIMENTAL

MyMammogram

Intervention Type: BEHAVIORAL

An online breast cancer screening decision aid

MyMammogram plus provider communication

Patient uses MyMammogram prior to appointment. Provider receives a summary from MyMammogram prior to appointment.

Group Type: EXPERIMENTAL

MyMammogram

Intervention Type: BEHAVIORAL

An online breast cancer screening decision aid

Provider communication

Intervention Type: OTHER

Provider will be provided with information from MyMammogram that includes patient's breast cancer risk and preferences for mammograms prior to the appointment

Interventions

MyMammogram

An online breast cancer screening decision aid

Intervention Type: BEHAVIORAL

Provider communication

Provider will be provided with information from MyMammogram that includes patient's breast cancer risk and preferences for mammograms prior to the appointment

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Females
• Aged 39-49
• Upcoming appointment with a participating primary care provider (within 4 weeks)
• English or Spanish-speaking

Exclusion Criteria

• Personal history of breast cancer (including lobular carcinoma in situ and ductal carcinoma in situ or atypical hyperplasia)
• Mammogram in the prior 12 months

Clinician inclusion: Any practicing primary care provider at a participating site.

• Minimum Eligible Age: 39 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Trustees of Dartmouth College

OTHER

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Mark A. Creager

Professor of Medicine, Geisel School of Medicine, Dartmouth; Professor of Surgery, Geisel School of Medicine, Dartmouth

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cheshire Medical Center

Keene, New Hampshire, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christine M Gunn, PhD

Role: CONTACT

Christine.M.Gunn@dartmouth.edu

603-646-5430

Facility Contacts

Christine Gunn, PhD

Role: primary

Christine.M.Gunn@dartmouth.edu

603-646-5430

Other Identifiers

STUDY02002381

Identifier Type: -

Identifier Source: org_study_id