Trial results investigating the behavioral and psychological impact of breast density notification in Latinas were posted on ClinicalTrials.gov on 2025-08-28. The study enrolled 1386 participants to compare different notification approaches.
Background
Breast density is a significant factor in breast cancer screening, as it can mask tumors on mammograms and is an independent risk factor for breast cancer. Effective communication of breast density results to patients is crucial for informed decision-making and adherence to screening guidelines. This study specifically addressed the behavioral and psychological impact of these notifications among Latinas, aiming to improve patient understanding and potentially reduce anxiety associated with receiving such information.
Trial design
This completed study, designated as Phase NA, enrolled 1386 participants. The trial focused on individuals with Breast Cancer, specifically examining the impact of breast density notification. The study utilized a 3-group randomized design, comparing usual written notification (Usual Care) to two educationally enhanced approaches: an Enhanced notification group and an Interpersonal notification group. The objective was to assess behavioral and psychological outcomes associated with these different notification methods.
Key results
The study reported key measurements and analyses across the three intervention groups:
- Knowledge of Breast Density as a Masking Factor at First Follow-up:
- Enhanced group: 101 Participants
- Usual Care group: 104 Participants
- Interpersonal group: 100 Participants
- Anxiety Short Term (Baseline T0 to First Follow-up T1):
- In one measurement, the Usual Care group had 99 Participants, the Enhanced group had 88 Participants, and the Interpersonal group had 70 Participants.
- In another measurement, the Usual Care group had 100 Participants, the Enhanced group had 98 Participants, and the Interpersonal group had 61 Participants.
- BC Risk Assessment - Survey:
- Enhanced group: 114 Participants
- Usual Care group: 110 Participants
- Interpersonal group: 95 Participants
Key analyses using Chi-squared tests revealed:
- For Knowledge of Breast Density as a Masking Factor at First Follow-up, a Chi-squared test showed a p-value of 0.05. This analysis compared the percentage of participants with improved knowledge (defined as having an incorrect response at baseline and a correct response at first follow-up) between study groups.
- For Anxiety Short Term (Baseline T0 to First Follow-up T1), a Chi-squared test showed a p-value of 0.56.
- For BC Risk Assessment - Survey, a Chi-squared test showed a p-value of 0.05.
Further analyses of differences between groups included:
- The difference between the Enhanced (EC) and Usual Care (UC) groups was 2.6, with a 98.3% Confidence Interval of -6.0 to 11.2.
- The difference between the Interpersonal (INT) and Usual Care (UC) groups was 5.0, with a 98.3% Confidence Interval of -4.3 to 14.3.
- The difference between the Interpersonal (INT) and Enhanced (ENH) groups was 2.4, with a 98.3% Confidence Interval of -7.0 to 11.9.
What this means
The results suggest that enhanced educational approaches to breast density notification can significantly improve patients' knowledge regarding breast density as a masking factor and their understanding of breast cancer risk, as indicated by the p-values of 0.05 for both outcomes. This implies that providing more comprehensive or personalized information beyond standard written notification may empower patients with better understanding of their breast health. However, the study also found no significant difference in short-term anxiety levels between the different notification groups (p-value of 0.56), suggesting that while knowledge can be improved, these specific interventions did not substantially alleviate or increase anxiety in the short term. The observed differences between groups for specific parameters, such as the difference of 2.6 between Enhanced and Usual Care, provide quantitative insights into the impact of these educational strategies.
Source
The information for these trial results was sourced from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT02910986 were posted on 2025-08-28 on clinicaltrials.gov.