NCT02910986

Behavioral and Psychological Impact of Returning Breast Density Results to Latinas

Completed NA Results posted Last updated 28 August 2025

What this trial tests

NA trial testing Written educational brochure in Breast Cancer in 1,386 participants. Completed in 15 November 2019.

Timeline

27 October 2016

Primary endpoint
15 November 2019

15 November 2019

Quick facts

Lead sponsor	Mayo Clinic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	1,386
Start date	27 October 2016
Primary completion	15 November 2019
Estimated completion	15 November 2019
Sites	3 locations across United States

Drugs / interventions tested

• Written educational brochure
• Promotora interaction

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Mayo Clinic

Who can join

Adults 40 to 74, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Knowledge of Breast Density as a Masking Factor at First Follow-up Primary · 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

Group	Value	95% CI
Enhanced	101
Usual Care	104
Interpersonal	100

Anxiety Short Term (Baseline T0 to First Follow-up T1) Primary · 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.

Group	Value	95% CI
Usual Care	99
Enhanced	88
Interpersonal	70
Usual Care	100
Enhanced	98
Interpersonal	61

BC Risk Assessment - Survey Primary · 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.

Group	Value	95% CI
Enhanced	114
Usual Care	110
Interpersonal	95

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Evaluating educational interventions to increase breast density awareness among Latinas: A randomized trial in a Federally Qualified Health Center.
   Ridgeway JL, Jenkins SM, Borah BJ, Suman VJ, et al · · 2022 · cited 9× · PMID 34855208 · DOI 10.1002/cncr.34017
2. Behavioral and psychological impact of returning breast density results to Latinas: study protocol for a randomized clinical trial.
   Patel BK, Ridgeway JL, Ghosh K, Rhodes DJ, et al · · 2019 · cited 7× · PMID 31852492 · DOI 10.1186/s13063-019-3939-6
3. Effectiveness of Breast Density Educational Interventions on Mammography Screening Adherence Among Underserved Latinas: A Randomized Controlled Trial.
   Austin JD, Jenkins SM, Suman VJ, Ridgeway JL, et al · · 2025 · cited 3× · PMID 39969957 · DOI 10.1089/jwh.2024.0273
4. 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.
   Ghosh K, Jenkins SM, Ridgeway JL, Austin JD, et al · · 2025 · cited 2× · PMID 40452038 · DOI 10.1186/s12905-025-03818-9