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NCT Number: NCT06522568

Testing a Mammography Decision Intervention in a Rural Setting

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

39 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cheshire Medical Center, Keene, New Hampshire, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 12 months

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

Treatment and study plan

MyMammogram

Behavioral

An online breast cancer screening decision aid

Provider communication

Other

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

Primary outcomes

  1. Intervention acceptability

    Time frame: within one day of completing the intervention

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

Secondary outcomes

  1. Recruitment feasibility

    Time frame: 4 weeks

    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.

  2. Retention feasibility

    Time frame: 8 weeks

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

Other outcomes

  1. Knowledge

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

    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).

  2. Decisional Quality

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

    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).

  3. Screening Intentions

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

    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).

  4. Shared Decision-Making

    Time frame: within one day of completing a clinical visit

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

  5. Self-efficacy

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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Christine M Gunn, PhD

CONTACT

[email protected]

603-646-5430

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Trustees of Dartmouth College

Registry information

Official study title

Toward Optimization of a Mammography Decision Aid and Clinician Communication Intervention Trial for Rural Settings

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 26, 2024
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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