Clinical trial NCT06522568: Testing a Mammography Decision Intervention in a Rural Setting
Official title: Toward Optimization of a Mammography Decision Aid and Clinician Communication Intervention Trial for Rural Settings
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Screening
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Trustees of Dartmouth College
First posted: 2024-07-26
Enrollment: 39
Sex: FEMALE
Minimum age (years): 39
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Intervention acceptability
timeFrame: within one day of completing the intervention
Secondary outcomes:
measure: Recruitment feasibility
timeFrame: 4 weeks
measure: Retention feasibility
timeFrame: 8 weeks
Other outcomes:
measure: Knowledge
timeFrame: enrollment and within one day of completing the intervention
measure: Decisional Quality
timeFrame: enrollment, within one day of completing the intervention, within one day of completing a clinical visit
measure: Screening Intentions
timeFrame: enrollment, within one day of completing the intervention, within one day of completing a clinical visit
measure: Shared Decision-Making
timeFrame: within one day of completing a clinical visit
measure: Self-efficacy
timeFrame: enrollment and within one day of completing a clinical visit
Locations:
Study officials:
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