Breast Cancer
Conditions
Keywords
Mammography, Breast Density, Hispanic
Brief summary
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.
Detailed description
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.
Interventions
Written educational brochure about breast density
Promotora education about breast density
Sponsors
Study design
Eligibility
Inclusion criteria
* Female * Attending screening mammography at Mountain Park Health Center * Speak English or Spanish
Exclusion criteria
* Male * Current diagnosis of breast cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge of Breast Density as a Masking Factor at First Follow-up | Baseline (T0) to first follow-up (T1, 2 weeks to 180 days from education end) | 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 |
| Anxiety Short Term (Baseline T0 to First Follow-up T1) | Change from baseline anxiety (T0) to T1: 2 weeks to 180 days after education end | 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. |
| BC Risk Assessment - Survey | T0 (baseline) to T1 (14 to 180 days after completion of education) | 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. |
Countries
United States
Participant flow
Pre-assignment details
There were 10 patients who were found to be ineligible (n=2) or withdrew consent prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Breast density notification using standard language reporting for dense and non-dense breasts within the mammogram results notification letter | 349 |
| Enhanced Usual Care plus a written educational brochure
Written educational brochure: Written educational brochure about breast density | 334 |
| 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 | 260 |
| Total | 943 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Failure to return T! survey | 72 | 84 | 72 |
| Overall Study | non-Latina | 14 | 13 | 12 |
| Overall Study | T1 Survey not 14-180 post education | 25 | 25 | 115 |
| Overall Study | Withdrew after randomization prior to start of intervention | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Usual Care | Total | Interpersonal | Enhanced |
|---|---|---|---|---|
| Age, Continuous | 47 years | 47 years | 47 years | 46 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 349 Participants | 943 Participants | 260 Participants | 334 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 349 Participants | 943 Participants | 260 Participants | 334 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 349 participants | 943 participants | 260 participants | 334 participants |
| Sex: Female, Male Female | 349 Participants | 943 Participants | 260 Participants | 334 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 349 | 0 / 334 | 0 / 260 |
| other Total, other adverse events | 0 / 349 | 0 / 334 | 0 / 260 |
| serious Total, serious adverse events | 0 / 349 | 0 / 334 | 0 / 260 |
Outcome results
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.
Time frame: Change from baseline anxiety (T0) to T1: 2 weeks to 180 days after education end
Population: 516 Latina participants with complete follow-up over all three time points
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced | Anxiety Short Term (Baseline T0 to First Follow-up T1) | Decreased or stayed normal | 99 Participants |
| Enhanced | Anxiety Short Term (Baseline T0 to First Follow-up T1) | Increased or stayed moderate/severe | 100 Participants |
| Usual Care | Anxiety Short Term (Baseline T0 to First Follow-up T1) | Decreased or stayed normal | 88 Participants |
| Usual Care | Anxiety Short Term (Baseline T0 to First Follow-up T1) | Increased or stayed moderate/severe | 98 Participants |
| Interpersonal | Anxiety Short Term (Baseline T0 to First Follow-up T1) | Decreased or stayed normal | 70 Participants |
| Interpersonal | Anxiety Short Term (Baseline T0 to First Follow-up T1) | Increased or stayed moderate/severe | 61 Participants |
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.
Time frame: T0 (baseline) to T1 (14 to 180 days after completion of education)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced | BC Risk Assessment - Survey | 114 Participants |
| Usual Care | BC Risk Assessment - Survey | 110 Participants |
| Interpersonal | BC Risk Assessment - Survey | 95 Participants |
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
Time frame: Baseline (T0) to first follow-up (T1, 2 weeks to 180 days from education end)
Population: 943 participants who completed baseline and first follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced | Knowledge of Breast Density as a Masking Factor at First Follow-up | 101 Participants |
| Usual Care | Knowledge of Breast Density as a Masking Factor at First Follow-up | 104 Participants |
| Interpersonal | Knowledge of Breast Density as a Masking Factor at First Follow-up | 100 Participants |