Trial Outcomes & Findings for Barriers to Screening Breast MRI Utilization Among Patients at Elevated Risk (NCT NCT04257474)
NCT ID: NCT04257474
Last Updated: 2024-03-18
Results Overview
Participant-reported receipt of screening breast MRI at any time in the past.
COMPLETED
265 participants
Baseline
2024-03-18
Participant Flow
Participant milestones
| Measure |
Group 1: Self-Report Surveys Only
Women with a high lifetime breast cancer risk were recruited from mammography and primary care clinics. Group 1 took a self-report survey that was created using the Health Services Utilization Model (HSUM)
|
Group 2:Self-Report Survey and Qualitative Interviews
Women with a high lifetime breast cancer risk were recruited from mammography and primary care clinics.
Self-Report Survey: The self-report survey was created using the Health Services Utilization Model (HSUM)
Researchers randomly selected participants from group 1 who took self-report Survey and held semi-structured qualitive interviews exploring factors impacting utilization of screening breast MRI
|
|---|---|---|
|
Overall Study
STARTED
|
172
|
63
|
|
Overall Study
COMPLETED
|
172
|
63
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Barriers to Screening Breast MRI Utilization Among Patients at Elevated Risk
Baseline characteristics by cohort
| Measure |
Group 1: Self-Report Surveys Only
n=172 Participants
Women with a high lifetime breast cancer risk were recruited from mammography and primary care clinics. Group 1 took a self-report survey that was created using the Health Services Utilization Model (HSUM)
|
Group 2: Self-Report Survey and Qualitative Interviews
n=63 Participants
Women with a high lifetime breast cancer risk were recruited from mammography and primary care clinics.
Self-Report Survey: The self-report survey was created using the Health Services Utilization Model (HSUM)
Researchers randomly selected participants from group 1 who took self-report Survey and held semi-structured qualitive interviews exploring factors impacting utilization of screening breast MRI
|
Total
n=235 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
25-29
|
20 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Age, Customized
30-39
|
62 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Age, Customized
40-49
|
38 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Age, Customized
50-59
|
28 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Age, Customized
60-69
|
17 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Age, Customized
70-79
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Age, Customized
80-85
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
172 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
235 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
164 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
224 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
149 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
203 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
172 participants
n=99 Participants
|
63 participants
n=107 Participants
|
235 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: This study uses a mixed-methods design. All data from participants who completed self-report surveys were analyzed as one group. Semi-structured interviews were done to understand more about the patients decisions, not to compare any group against another.
Participant-reported receipt of screening breast MRI at any time in the past.
Outcome measures
| Measure |
All Participants
n=235 Participants
All participants who completed self-report surveys in addition to participants who completed self-report surveys and also completed semi structured interviews.
|
|---|---|
|
Reporting Receipt of MRI Breast Screening at Any Time
|
32.34 percentage of participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: This study uses a mixed-methods design. All data from participants who completed self-report surveys were analyzed as one group. Semi-structured interviews were done to understand more about the patients decisions, not to compare any group against another.
Participant-reported receipt of screening breast MRI in the last 24 months
Outcome measures
| Measure |
All Participants
n=235 Participants
All participants who completed self-report surveys in addition to participants who completed self-report surveys and also completed semi structured interviews.
|
|---|---|
|
Reporting Receipt of MRI Breast Screening in the Last 24 Months
|
25.11 percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: This study uses a mixed-methods design. All data from participants who completed self-report surveys were analyzed as one group. Semi-structured interviews were done to understand more about the patients decisions, not to compare any group against another.
Participant-reported receipt of breast cancer screening mammogram in the last 24 months
Outcome measures
| Measure |
All Participants
n=235 Participants
All participants who completed self-report surveys in addition to participants who completed self-report surveys and also completed semi structured interviews.
|
|---|---|
|
Reporting Receipt of Mammogram
|
71.06 percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: This study uses a mixed-methods design. All data from participants who completed self-report surveys were analyzed as one group. Semi-structured interviews were done to understand more about the patients decisions, not to compare any group against another.
Participant-reported receipt of breast cancer screening ultrasound in the last 24 months
Outcome measures
| Measure |
All Participants
n=235 Participants
All participants who completed self-report surveys in addition to participants who completed self-report surveys and also completed semi structured interviews.
|
|---|---|
|
Reporting Receipt of Ultrasound
|
34.04 percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: This study uses a mixed-methods design. All data from participants who completed self-report surveys were analyzed as one group. Semi-structured interviews were done to understand more about the patients decisions, not to compare any group against another.
Participant-reported receipt of chemoprevention at any point in time (including currently receiving).
Outcome measures
| Measure |
All Participants
n=235 Participants
All participants who completed self-report surveys in addition to participants who completed self-report surveys and also completed semi structured interviews.
|
|---|---|
|
Reporting Receipt of Chemoprevention
|
18.30 percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: This study uses a mixed-methods design. All data from participants who completed self-report surveys were analyzed as one group. Semi-structured interviews were done to understand more about the patients decisions, not to compare any group against another.
Participant-reported receipt of genetic testing at any time in the past
Outcome measures
| Measure |
All Participants
n=235 Participants
All participants who completed self-report surveys in addition to participants who completed self-report surveys and also completed semi structured interviews.
|
|---|---|
|
Reporting Receipt of Genetic Testing
|
42.99 percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: This study uses a mixed-methods design. All data from participants who completed self-report surveys were analyzed as one group. Semi-structured interviews were done to understand more about the patients decisions, not to compare any group against another.
Participant-reported receipt of genetic counseling at any time in the past
Outcome measures
| Measure |
All Participants
n=235 Participants
All participants who completed self-report surveys in addition to participants who completed self-report surveys and also completed semi structured interviews.
|
|---|---|
|
Reporting Receipt of Genetic Counseling
|
39.57 percentage of participants
|
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place