An observational study in Breast Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Completed at 2 sites in United States. Open to female participants aged 25 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Observational
This study seeks to develop an explanatory framework for breast MRI utilization to inform future interventions. The Health Services Utilization Model (HSUM) will guide the selection of specific participant-level factors for examination, including predisposing characteristics (knowledge, health/cultural beliefs), enabling resources (social support, cost/insurance coverage), and perceived need (perceived susceptibility, provider recommendation).
H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women will be recruited from mammography and primary care clinics, community-based outreach events, or via Facebook
Exclusion Criteria:
150 women with a high lifetime breast cancer risk will be recruited from mammography and primary care clinics. Researchers will assess HSUM factors influencing screening breast MRI utilization. Results will identify participant-level HSUM factors significantly associated with screening outcomes.
Behavioral: Self-Report Survey
Researchers will randomly select 30 participants from group 1 and will use semi-structured qualitive interviews exploring factors impacting utilization of screening breast MRI
Behavioral: Qualitative Interviews
The self-report survey will be created using the Health Services Utilization Model (HSUM)
Researchers will randomly select 30 participants from group 1 and will use semi structured qualitive interviews exploring factors impacting utilization of screening breast MRI
Reporting Receipt of MRI Breast Screening at Any Time
Participant-reported receipt of screening breast MRI at any time in the past.
Time frame: Baseline
Reporting Receipt of MRI Breast Screening in the Last 24 Months
Participant-reported receipt of screening breast MRI in the last 24 months
Time frame: Baseline
Reporting Receipt of Mammogram
Participant-reported receipt of breast cancer screening mammogram in the last 24 months
Time frame: Baseline
Reporting Receipt of Ultrasound
Participant-reported receipt of breast cancer screening ultrasound in the last 24 months
Time frame: Baseline
Reporting Receipt of Chemoprevention
Participant-reported receipt of chemoprevention at any point in time (including currently receiving).
Time frame: Baseline
Reporting Receipt of Genetic Testing
Participant-reported receipt of genetic testing at any time in the past
Time frame: Baseline
Reporting Receipt of Genetic Counseling
Participant-reported receipt of genetic counseling at any time in the past
Time frame: Baseline
| Milestone | Group 1: Self-Report Surveys Only | Group 2:Self-Report Survey and Qualitative Interviews |
|---|---|---|
| Started | 172 | 63 |
| Completed | 172 | 63 |
| Not completed | 0 | 0 |
Participant-reported receipt of screening breast MRI at any time in the past.
| percentage of participants | All Participants |
|---|---|
| Reporting Receipt of MRI Breast Screening at Any Time | 32.34 |
Participant-reported receipt of screening breast MRI in the last 24 months
| percentage of participants | All Participants |
|---|---|
| Reporting Receipt of MRI Breast Screening in the Last 24 Months | 25.11 |
Participant-reported receipt of breast cancer screening mammogram in the last 24 months
| percentage of participants | All Participants |
|---|---|
| Reporting Receipt of Mammogram | 71.06 |
Participant-reported receipt of breast cancer screening ultrasound in the last 24 months
| percentage of participants | All Participants |
|---|---|
| Reporting Receipt of Ultrasound | 34.04 |
Participant-reported receipt of chemoprevention at any point in time (including currently receiving).
| percentage of participants | All Participants |
|---|---|
| Reporting Receipt of Chemoprevention | 18.30 |
Participant-reported receipt of genetic testing at any time in the past
| percentage of participants | All Participants |
|---|---|
| Reporting Receipt of Genetic Testing | 42.99 |
Participant-reported receipt of genetic counseling at any time in the past
| percentage of participants | All Participants |
|---|---|
| Reporting Receipt of Genetic Counseling | 39.57 |
Collected over Adverse Events were not collected for this project.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants | — | — | — |
| Age, Customized(Participants) | Group 1: Self-Report Surveys Only | Group 2: Self-Report Survey and Qualitative Interviews | Total |
|---|---|---|---|
| 25-29 | 20 | 3 | 23 |
| 30-39 | 62 | 18 | 80 |
| 40-49 | 38 | 12 | 50 |
| 50-59 | 28 | 19 | 47 |
| 60-69 | 17 | 10 | 27 |
| 70-79 | 5 | 1 | 6 |
| 80-85 | 2 | 0 | 2 |
| Sex: Female, Male(Participants) | Group 1: Self-Report Surveys Only | Group 2: Self-Report Survey and Qualitative Interviews | Total |
|---|---|---|---|
| Female | 172 | 63 | 235 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Group 1: Self-Report Surveys Only | Group 2: Self-Report Survey and Qualitative Interviews | Total |
|---|---|---|---|
| Hispanic or Latino | 8 | 3 | 11 |
| Not Hispanic or Latino | 164 | 60 | 224 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Group 1: Self-Report Surveys Only | Group 2: Self-Report Survey and Qualitative Interviews | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 3 |
| Asian | 3 | 1 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 10 | 5 | 15 |
| White | 149 | 54 | 203 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 8 | 1 | 9 |
| Region of Enrollment(participants) | Group 1: Self-Report Surveys Only | Group 2: Self-Report Survey and Qualitative Interviews | Total |
|---|---|---|---|
| United States | 172 | 63 | 235 |
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H. Lee Moffitt Cancer Center and Research Institute