Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assessing Health Services Utilization Model (HSUM) | 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. |
| |
| Qualitative Interviews | Researchers will randomly select 30 participants from group 1 and will use semi-structured qualitive interviews exploring factors impacting utilization of screening breast MRI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-Report Survey | Behavioral | The self-report survey will be created using the Health Services Utilization Model (HSUM) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reporting Receipt of MRI Breast Screening at Any Time | Participant-reported receipt of screening breast MRI at any time in the past. | Baseline |
| Reporting Receipt of MRI Breast Screening in the Last 24 Months | Participant-reported receipt of screening breast MRI in the last 24 months | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Reporting Receipt of Mammogram | Participant-reported receipt of breast cancer screening mammogram in the last 24 months | Baseline |
| Reporting Receipt of Ultrasound | Participant-reported receipt of breast cancer screening ultrasound in the last 24 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
The lifetime risk for breast cancer in men is very low (1.2% for male BRCA1 mutation carriers and 6.8% for male BRCA2 mutation carriers).
Women will be recruited from mammography and primary care clinics, community-based outreach events, or via Facebook
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susan Vadaparampil, PhD, MPH | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown Lombardi Comprehensive Cancer Center | Washington D.C. | District of Columbia | 20007 | United States | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | Group 2: Self-Report Survey and Qualitative Interviews |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reporting Receipt of MRI Breast Screening at Any Time | Participant-reported receipt of screening breast MRI at any time in the past. | 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. | Posted | Number | percentage of participants | Baseline |
|
Adverse Events were not collected for this project.
Adverse Events were not collected for this project.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | All participants who completed self-report surveys in addition to participants who completed self-report surveys and also completed semi structured interviews. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan T. Vadaparampil, PhD, MPH | Moffitt Cancer Center | 813-745-1997 | Susan.Vadaparampil@moffitt.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 4, 2021 | Oct 17, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Qualitative Interviews | Behavioral | Researchers will randomly select 30 participants from group 1 and will use semi structured qualitive interviews exploring factors impacting utilization of screening breast MRI |
|
| Baseline |
| Reporting Receipt of Chemoprevention | Participant-reported receipt of chemoprevention at any point in time (including currently receiving). | Baseline |
| Reporting Receipt of Genetic Testing | Participant-reported receipt of genetic testing at any time in the past | Baseline |
| Reporting Receipt of Genetic Counseling | Participant-reported receipt of genetic counseling at any time in the past | Baseline |
| Moffitt Cancer Center |
| Tampa |
| Florida |
| 33612 |
| United States |
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Reporting Receipt of MRI Breast Screening in the Last 24 Months | Participant-reported receipt of screening breast MRI in the last 24 months | 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. | Posted | Number | percentage of participants | Baseline |
|
|
|
| Secondary | Reporting Receipt of Mammogram | Participant-reported receipt of breast cancer screening mammogram in the last 24 months | 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. | Posted | Number | percentage of participants | Baseline |
|
|
|
| Secondary | Reporting Receipt of Ultrasound | Participant-reported receipt of breast cancer screening ultrasound in the last 24 months | 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. | Posted | Number | percentage of participants | Baseline |
|
|
|
| Secondary | Reporting Receipt of Chemoprevention | Participant-reported receipt of chemoprevention at any point in time (including currently receiving). | 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. | Posted | Number | percentage of participants | Baseline |
|
|
|
| Secondary | Reporting Receipt of Genetic Testing | Participant-reported receipt of genetic testing at any time in the past | 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. | Posted | Number | percentage of participants | Baseline |
|
|
|
| Secondary | Reporting Receipt of Genetic Counseling | Participant-reported receipt of genetic counseling at any time in the past | 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. | Posted | Number | percentage of participants | Baseline |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |