Testing a Mammography Decision Intervention in a Rural Setting
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MyMammogram, Provider communication.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 39 years — 49 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Toward Optimization of a Mammography Decision Aid and Clinician Communication Intervention Trial for Rural Settings
Overview
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).
Interventions
- Behavioral MyMammogram
An online breast cancer screening decision aid - Other 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
Primary outcome measures
- Intervention acceptability [Time frame: within one day of completing the intervention]
Secondary outcome measures (2)
- Recruitment feasibility [Time frame: 4 weeks]
- Retention feasibility [Time frame: 8 weeks]
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 12 months
Clinician inclusion: Any practicing primary care provider at a participating site.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 3 centers
- Cheshire Medical Center — Keene
- New London Hospital Primary Care — New London
- Newport Health Center — Newport
Identifiers
NCT: NCT06522568 · STUDY02002381