About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Females
Aged 39-49
Upcoming appointment with a participating primary care provider (within 4 weeks)
English or Spanish-speaking
Disqualifiers
Personal history of breast cancer (including lobular carcinoma in situ and ductal carcinoma in situ or atypical hyperplasia)
Mammogram in the prior 12 months
Trial design
Parallel
Treatments tested in this trial
MyMammogram
BehavioralAn online breast cancer screening decision aid
Provider communication
Other interventionProvider will be provided with information from MyMammogram that includes patient's breast cancer risk and preferences for mammograms prior to the appointment
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Retention feasibility
Proportion of participants enrolled who complete all study survey time points, reported per trial arm
Other outcomes
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).
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).
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).
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).
Sponsors and contacts
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Dartmouth-Hitchcock Medical Center
Lead sponsor
Trustees of Dartmouth College
Collaborator