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RecruitingNCT06522568Updated Sep 24, 2026

Testing a Mammography Decision Intervention in a Rural Setting

An interventional study of MyMammogram and Provider communication in Breast Cancer, sponsored by Dartmouth-Hitchcock Medical Center. Recruiting at 3 sites in United States. Open to female participants aged 39 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
39 Years to 49 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 44 studies in Breast Neoplasms by Dartmouth-Hitchcock Medical Center — 6 open to participants now, 8 under way, none of them phase 3. Breast Neoplasms · Dartmouth-Hitchcock Medical Center.

Planned enrollment
13th of 34
39 · median 30
Started
2025
with 2 others
No phase
19 of 44
3 open now
Registered
40th of 44
by date

Among the 44 studies in Breast Neoplasms by Dartmouth-Hitchcock Medical Center, this one is the 13th largest by planned enrollment of the 34 interventional ones, is one of 3 that started in 2025, is one of 19 with no phase, and was the 40th registered.

By phase

44 studies; the count open now beside each. This study's row is marked.

No phasethis study19 · 3 open
Observational10 · 0 open
Phase 16 · 0 open
Phase 26 · 2 open
Phase 1/21 · 1 open
Phase 2/31 · 0 open
Phase 41 · 0 open

By the year they started

First in 1998; this study’s year is marked. 3 started in 2025.

Size and results

Median enrollment 30 across the 34 interventional studies, 19 across the 10 observational. Of the 35 that completed or were terminated, 10 (29%) have results posted.

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02

Study 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.

Read the 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).

03

Conditions studied

  • Breast Cancer

Browse trials for

Keywords

  • Screening
04

Who can participate

Ages eligible
39 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

Patient Inclusion Criteria:

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

Patient Exclusion Criteria:

  • Personal history of breast cancer (including lobular carcinoma in situ and ductal carcinoma in situ or atypical hyperplasia)
  • Mammogram in the prior 9 months

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

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
39 participants (estimated)

Study arms

  • No intervention
    Usual Care

    Usual care.

  • Experimental
    MyMammogram

    Patient uses MyMammogram prior to appointment.

    Behavioral: MyMammogram

  • Experimental
    MyMammogram plus provider communication

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

    Behavioral: MyMammogram · Other: Provider communication

Interventions

  • BehavioralMyMammogram

    An online breast cancer screening decision aid

  • OtherProvider communication

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

06

What researchers measure

Primary outcomes

  1. Intervention acceptability

    The acceptability e-scale is a 6-item measure for electronically-delivered interventions, where higher scores indicate greater acceptability. Scores range from 6-30.

    Time frame: within one day of completing the intervention

Secondary outcomes

  1. Recruitment feasibility

    Measured as the proportion of eligible participants who receive an initial outreach letter and complete the consent process and enroll prior to their clinical visit.

    Time frame: 4 weeks

  2. Retention feasibility

    Proportion of participants enrolled who complete all study survey time points, reported per trial arm

    Time frame: 8 weeks

Other outcomes

  1. Knowledge

    10-item measure of breast cancer and screening knowledge that is summed for a score from 0-10 (0 indicates lower knowledge, 10 indicates higher knowledge).

    Time frame: enrollment and within one day of completing the intervention

  2. Decisional Quality

    Decisional Quality is measured using the Decisional Conflict Scale for Low Literacy, a 10-item measure. Scores Range 0-100. Lower scores indicate better decisional quality (lower conflict).

    Time frame: enrollment, within one day of completing the intervention, within one day of completing a clinical visit

  3. Screening Intentions

    Screening intentions are using two methods. 1) As the likelihood of obtaining a mammogram in the next year (5-point Likert scale); and 2) Using 2 items to measure age at which someone intends to begin screening (40, 45, 50, other) and interval (annual, biennial, other).

    Time frame: enrollment, within one day of completing the intervention, within one day of completing a clinical visit

  4. Shared Decision-Making

    Shared Decision Making will be assessed with the 3-item, validated CollaboRATE measure. Scored 0-100 (higher scores indicate more shared decision-making).

    Time frame: within one day of completing a clinical visit

  5. Self-efficacy

    Measured using a validated scale measuring perceived confidence one's personal ability to obtain a mammogram. Ten items are summed, with a theoretical score range from 5-10 (higher scores indicate better self-efficacy).

    Time frame: enrollment and within one day of completing a clinical visit

07

Study locations

3 of 3 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Jan 2027, 16 months after the start.

Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 16 months is below that.

Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 17, 2024
First posted
Jul 26, 2024
StartActual
Sep 1, 2025
Primary completionEst.
Jan 20, 2027
CompletionEst.
Jan 20, 2027
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06522568
Collaborators
Trustees of Dartmouth College
Responsible party
Mark A. Creager (Professor of Medicine, Geisel School of Medicine, Dartmouth; Professor of Surgery, Geisel School of Medicine, Dartmouth, Dartmouth-Hitchcock Medical Center) — Principal investigator
First posted
Jul 26, 2024
Start date
Sep 1, 2025
Primary completion
Jan 20, 2027 (estimated)
Completion
Jan 20, 2027 (estimated)
Last update
Sep 24, 2026

Study contacts

Christine M Gunn, PhD
Contact
Christine.M.Gunn@dartmouth.edu
603-646-5430

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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