Testing a Mammography Decision Intervention in a Rural Setting
Recruiting · NCT06522568 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
3 locations listed across 1 US state.
- Cheshire Medical Center - Keene, New Hampshire, United States
- New London Hospital Primary Care - New London, New Hampshire, United States
- Newport Health Center - Newport, New Hampshire, United States