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Trial Title:
Testing a Mammography Decision Intervention in a Rural Setting
NCT ID:
NCT06522568
Condition:
Breast Cancer
Conditions: Keywords:
Screening
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
MyMammogram
Description:
An online breast cancer screening decision aid
Arm group label:
MyMammogram
Arm group label:
MyMammogram plus provider communication
Intervention type:
Other
Intervention name:
Provider communication
Description:
Provider will be provided with information from MyMammogram that includes patient's
breast cancer risk and preferences for mammograms prior to the appointment
Arm group label:
MyMammogram plus provider communication
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Females
- Aged 39-49
- Upcoming appointment with a participating primary care provider
Exclusion Criteria:
- Personal history of breast cancer (including lobular carcinoma in situ and ductal
carcinoma in situ)
- Mammogram in the prior 9 months
Gender:
Female
Gender based:
Yes
Minimum age:
39 Years
Maximum age:
49 Years
Healthy volunteers:
No
Start date:
May 2025
Completion date:
December 2025
Lead sponsor:
Agency:
Dartmouth-Hitchcock Medical Center
Agency class:
Other
Collaborator:
Agency:
Trustees of Dartmouth College
Agency class:
Other
Source:
Dartmouth-Hitchcock Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06522568
