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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1386 participants

Primary outcome timeframe

Baseline (T0) to first follow-up (T1, 2 weeks to 180 days from education end)

Results posted on

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

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

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

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

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 end

Population: 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

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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Enhanced

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Interpersonal

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Celine M. Vachon, Ph.D.

Mayo Clinic

Phone: 507 293-3247

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place