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| ID | Type | Description | Link |
|---|---|---|---|
| R01MD009682 | U.S. NIH Grant/Contract | View source | |
| MC1936 | Other Identifier | Mayo Clinic |
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| Name | Class |
|---|---|
| Mountain Park Health Center | UNKNOWN |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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This study will examine behavioral and psychological outcomes of breast density notification using a 3-group randomized design comparing usual written notification to two educationally enhanced approaches.
This is a 3-group randomized clinical trial to compare usual care to two educationally enhanced approaches to breast density notification. Usual care involves sending written notification along with the mammogram report; all women will receive usual care. In addition, some women will receive written educational materials about breast density, with or without interaction with a promotora (culturally congruent health educator). Study outcomes include short and long term assessments of psychological (anxiety, knowledge) and behavioral (continued mammography screening, discussion with primary care provider) outcomes. The study also includes qualitative inquiry and a cost analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Breast density notification using standard language reporting for dense and non-dense breasts within the mammogram results notification letter | |
| Enhanced | Active Comparator | Usual Care plus a written educational brochure |
|
| Interpersonal | Active Comparator | Usual Care plus Enhanced plus interaction with a promotora (lay health educator) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Written educational brochure | Behavioral | Written educational brochure about breast density |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge of Breast Density as a Masking Factor at First Follow-up | Percentage of women who provided an incorrect response as to whether dense breasts impact the ability of a mammogram to correctly detect cancer at T0 but provided a correct response at T1 Comparisons of the difference between the intervention groups in percentage of women who provided an incorrect response as to whether dense breasts impact the ability of a mammogram to correctly detect cancer at T0 but provided a correct response to the question at T1 | Baseline (T0) to first follow-up (T1, 2 weeks to 180 days from education end) |
| Anxiety Short Term (Baseline T0 to First Follow-up T1) | The State-Trait Anxiety Inventory-State (STAI-S) s a 20-item self-report assessment. Items are answered on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much so), with the total score ranging from 20 to 80, with higher scores indicating higher levels of anxiety symptoms. Anxiety was dichotomized as: normal (STAI score < 30) or moderate to severe (STAI score ≥ 30). The primary outcome was the percentage of participants who maintained or decreased to 'normal' anxiety levels at T1 from T0. | Change from baseline anxiety (T0) to T1: 2 weeks to 180 days after education end |
| BC Risk Assessment - Survey | Percentage of women who provided incorrect response at baseline (T0) but a correct response at 14 to 180 days after completion of education to the question: 'Women who have dense breasts are at greater risk for getting breast cancer' (true, false, or I don't know). Comparisons of the difference in percentage of women who provided correct response to the single question: 'Women who have dense breasts are at greater risk for getting breast cancer' (true, false, or I don't know) between intervention groups. | T0 (baseline) to T1 (14 to 180 days after completion of education) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Celine M. Vachon, Ph.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mountain Park Health Center | Phoenix | Arizona | 85004 | United States | ||
| Mayo Clinic in Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34855208 | Result | Ridgeway JL, Jenkins SM, Borah BJ, Suman VJ, Patel BK, Ghosh K, Rhodes DJ, Norman A, Ramos EP, Jewett M, Gonzalez CR, Hernandez V, Singh D, Sosa M, Radecki Breitkopf C, Vachon CM. Evaluating educational interventions to increase breast density awareness among Latinas: A randomized trial in a Federally Qualified Health Center. Cancer. 2022 Mar 1;128(5):1038-1047. doi: 10.1002/cncr.34017. Epub 2021 Dec 2. | |
| 35033304 | Result | Patel BK, Ridgeway JL, Jenkins S, Rhodes DJ, Ghosh K, Borah B, Suman V, Norman A, Leaver J, Jewett M, Hruska C, Gonzalez C, Singh D, Vachon CM, Breitkopf CR. Breast Density Knowledge and Awareness Among Latinas in a Low-Resource Setting. J Am Coll Radiol. 2022 Jan;19(1 Pt B):155-161. doi: 10.1016/j.jacr.2021.08.025. |
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There were 10 patients who were found to be ineligible (n=2) or withdrew consent prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Breast density notification using standard language reporting for dense and non-dense breasts within the mammogram results notification letter |
| FG001 | Enhanced | Usual Care plus a written educational brochure Written educational brochure: Written educational brochure about breast density |
| FG002 | Interpersonal | Usual Care plus Enhanced plus interaction with a promotora (lay health educator) Written educational brochure: Written educational brochure about breast density Promotora interaction: Promotora education about breast density |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
These analyses included 943 Latinas who completed the T0 and T1 surveys per protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Breast density notification using standard language reporting for dense and non-dense breasts within the mammogram results notification letter |
| BG001 | Enhanced | Usual Care plus a written educational brochure Written educational brochure: Written educational brochure about breast density |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Knowledge of Breast Density as a Masking Factor at First Follow-up | Percentage of women who provided an incorrect response as to whether dense breasts impact the ability of a mammogram to correctly detect cancer at T0 but provided a correct response at T1 Comparisons of the difference between the intervention groups in percentage of women who provided an incorrect response as to whether dense breasts impact the ability of a mammogram to correctly detect cancer at T0 but provided a correct response to the question at T1 | 943 participants who completed baseline and first follow-up | Posted | Count of Participants | Participants | Baseline (T0) to first follow-up (T1, 2 weeks to 180 days from education end) |
|
Patients completed T1 surveys within 14-180 days from the end of study education and T2 surveys were completed within 275-545 days from the end of study education
Changes in anxiety were addressed as a primary endpoint. There were no other specific survey questions addressing other potential adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Breast density notification using standard language reporting for dense and non-dense breasts within the mammogram results notification letter |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Celine M. Vachon, Ph.D. | Mayo Clinic | 507 293-3247 | Vachon.Celine@mayo.edu |
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| 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 | Aug 12, 2022 | Jun 2, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: English Consent | Jul 18, 2019 | Jan 14, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Spanish Consent | Jul 18, 2019 | Jan 14, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Promotora interaction | Behavioral | Promotora education about breast density |
|
| Scottsdale |
| Arizona |
| 85259 |
| United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| 38383839 | Result | Austin JD, Jenkins SM, Suman VJ, Raygoza JP, Ridgeway JL, Norman A, Gonzalez C, Hernandez V, Ghosh K, Patel BK, Vachon CM. Breast Cancer Risk Perceptions Among Underserved, Hispanic Women: Implications for Risk-Based Approaches to Screening. J Racial Ethn Health Disparities. 2025 Apr;12(2):1150-1158. doi: 10.1007/s40615-024-01949-7. Epub 2024 Feb 21. |
| 40452038 | Derived | Ghosh K, Jenkins SM, Ridgeway JL, Austin JD, Borah BJ, Patel B, Rhodes DJ, Norman AD, Ramos EP, Jewett M, Gonzalez CR, Hernandez V, Singh D, Vachon CM, Suman VJ. A randomized trial to evaluate the impact of breast density notification on anxiety, breast cancer worry, and perceived risk among Latinas at a federally qualified health center : Breast density notification and anxiety, breast cancer worry, and perceived risk among Latinas. BMC Womens Health. 2025 Jun 2;25(1):274. doi: 10.1186/s12905-025-03818-9. |
| 31852492 | Derived | Patel BK, Ridgeway JL, Ghosh K, Rhodes DJ, Borah B, Jenkins S, Suman VJ, Norman A, Jewett M, Singh D, Vachon CM, Radecki Breitkopf C. Behavioral and psychological impact of returning breast density results to Latinas: study protocol for a randomized clinical trial. Trials. 2019 Dec 18;20(1):744. doi: 10.1186/s13063-019-3939-6. |
| T1 Survey not 14-180 post education |
|
| Withdrew after randomization prior to start of intervention |
|
| BG002 | Interpersonal | Usual Care plus Enhanced plus interaction with a promotora (lay health educator) Written educational brochure: Written educational brochure about breast density Promotora interaction: Promotora education about breast density |
| BG003 | Total | Total of all reporting groups |
| years |
|
| 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 |
|
| OG001 | Usual Care | Breast density notification using standard language reporting for dense and non-dense breasts within the mammogram results notification letter |
| OG002 | Interpersonal | Usual Care plus Enhanced plus interaction with a promotora (lay health educator) Written educational brochure: Written educational brochure about breast density Promotora interaction: Promotora education about breast density |
|
|
|
| Primary | Anxiety Short Term (Baseline T0 to First Follow-up T1) | The State-Trait Anxiety Inventory-State (STAI-S) s a 20-item self-report assessment. Items are answered on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much so), with the total score ranging from 20 to 80, with higher scores indicating higher levels of anxiety symptoms. Anxiety was dichotomized as: normal (STAI score < 30) or moderate to severe (STAI score ≥ 30). The primary outcome was the percentage of participants who maintained or decreased to 'normal' anxiety levels at T1 from T0. | 516 Latina participants with complete follow-up over all three time points | Posted | Count of Participants | Participants | Change from baseline anxiety (T0) to T1: 2 weeks to 180 days after education end |
|
|
|
|
| Primary | BC Risk Assessment - Survey | Percentage of women who provided incorrect response at baseline (T0) but a correct response at 14 to 180 days after completion of education to the question: 'Women who have dense breasts are at greater risk for getting breast cancer' (true, false, or I don't know). Comparisons of the difference in percentage of women who provided correct response to the single question: 'Women who have dense breasts are at greater risk for getting breast cancer' (true, false, or I don't know) between intervention groups. | Posted | Count of Participants | Participants | T0 (baseline) to T1 (14 to 180 days after completion of education) |
|
|
|
|
| 0 |
| 349 |
| 0 |
| 349 |
| 0 |
| 349 |
| EG001 | Enhanced | Usual Care plus a written educational brochure Written educational brochure: Written educational brochure about breast density | 0 | 334 | 0 | 334 | 0 | 334 |
| EG002 | Interpersonal | Usual Care plus Enhanced plus interaction with a promotora (lay health educator) Written educational brochure: Written educational brochure about breast density Promotora interaction: Promotora education about breast density | 0 | 260 | 0 | 260 | 0 | 260 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| difference between EC and UC |
| 2.6 |
| 2-Sided |
| 98.3 |
| -6.0 |
| 11.2 |
| Other |
| difference between INT and UC | 5.0 | 2-Sided | 98.3 | -4.3 | 14.3 | Other |
| difference between INT and ENH | 2.4 | 2-Sided | 98.3 | -7.0 | 11.9 | Other |