Trial Outcomes & Findings for Behavioral and Psychological Impact of Returning Breast Density Results to Latinas (NCT NCT02910986)
NCT ID: NCT02910986
Last Updated: 2025-08-28
Results Overview
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
COMPLETED
NA
1386 participants
Baseline (T0) to first follow-up (T1, 2 weeks to 180 days from education end)
2025-08-28
Participant Flow
There were 10 patients who were found to be ineligible (n=2) or withdrew consent prior to randomization.
Participant milestones
| Measure |
Usual Care
Breast density notification using standard language reporting for dense and non-dense breasts within the mammogram results notification letter
|
Enhanced
Usual Care plus a written educational brochure
Written educational brochure: Written educational brochure about breast density
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
460
|
456
|
461
|
|
Overall Study
COMPLETED
|
349
|
334
|
260
|
|
Overall Study
NOT COMPLETED
|
111
|
122
|
201
|
Reasons for withdrawal
| Measure |
Usual Care
Breast density notification using standard language reporting for dense and non-dense breasts within the mammogram results notification letter
|
Enhanced
Usual Care plus a written educational brochure
Written educational brochure: Written educational brochure about breast density
|
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
|
|---|---|---|---|
|
Overall Study
non-Latina
|
14
|
13
|
12
|
|
Overall Study
Failure to return T! survey
|
72
|
84
|
72
|
|
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
Behavioral and Psychological Impact of Returning Breast Density Results to Latinas
Baseline characteristics by cohort
| Measure |
Usual Care
n=349 Participants
Breast density notification using standard language reporting for dense and non-dense breasts within the mammogram results notification letter
|
Enhanced
n=334 Participants
Usual Care plus a written educational brochure
Written educational brochure: Written educational brochure about breast density
|
Interpersonal
n=260 Participants
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
|
Total
n=943 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47 years
n=99 Participants
|
46 years
n=107 Participants
|
47 years
n=206 Participants
|
47 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
349 Participants
n=99 Participants
|
334 Participants
n=107 Participants
|
260 Participants
n=206 Participants
|
943 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
349 Participants
n=99 Participants
|
334 Participants
n=107 Participants
|
260 Participants
n=206 Participants
|
943 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 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
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
349 Participants
n=99 Participants
|
334 Participants
n=107 Participants
|
260 Participants
n=206 Participants
|
943 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
349 participants
n=99 Participants
|
334 participants
n=107 Participants
|
260 participants
n=206 Participants
|
943 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Enhanced
n=334 Participants
Usual Care plus a written educational brochure
Written educational brochure: Written educational brochure about breast density
|
Usual Care
n=349 Participants
Breast density notification using standard language reporting for dense and non-dense breasts within the mammogram results notification letter
|
Interpersonal
n=260 Participants
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
|
|---|---|---|---|
|
Knowledge of Breast Density as a Masking Factor at First Follow-up
|
101 Participants
|
104 Participants
|
100 Participants
|
PRIMARY outcome
Timeframe: Change from baseline anxiety (T0) to T1: 2 weeks to 180 days after education endPopulation: 516 Latina participants with complete follow-up over all three time points
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.
Outcome measures
| Measure |
Enhanced
n=199 Participants
Usual Care plus a written educational brochure
Written educational brochure: Written educational brochure about breast density
|
Usual Care
n=186 Participants
Breast density notification using standard language reporting for dense and non-dense breasts within the mammogram results notification letter
|
Interpersonal
n=131 Participants
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
|
|---|---|---|---|
|
Anxiety Short Term (Baseline T0 to First Follow-up T1)
Decreased or stayed normal
|
99 Participants
|
88 Participants
|
70 Participants
|
|
Anxiety Short Term (Baseline T0 to First Follow-up T1)
Increased or stayed moderate/severe
|
100 Participants
|
98 Participants
|
61 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Enhanced
n=334 Participants
Usual Care plus a written educational brochure
Written educational brochure: Written educational brochure about breast density
|
Usual Care
n=349 Participants
Breast density notification using standard language reporting for dense and non-dense breasts within the mammogram results notification letter
|
Interpersonal
n=260 Participants
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
|
|---|---|---|---|
|
BC Risk Assessment - Survey
|
114 Participants
|
110 Participants
|
95 Participants
|
Adverse Events
Usual Care
Enhanced
Interpersonal
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