Title: 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
Version: 3 Date: 16 Feb 2024
Reviewer's report:
This manuscript presents results from a three-arm randomized controlled trial of mammographic
breast density (MBD) notification methods among Latinas presenting for care at a Federally
Qualified Health Center (FQHC). This is the second manuscript from this RCT, and focuses
on the outcomes of anxiety, breast cancer worry, and perceived breast cancer risk. The three
interventions compared in this trial were usual care, enhanced care (usual care + MBD brochure),
and interpersonal care (usual care + MBD brochure + phone-based promotora education).
At baseline, participants reported high levels of anxiety and breast cancer worry. Many
(25%) participants at average breast cancer risk overestimated their risk. In addition, 50% of
participants with elevated breast cancer risk underestimated their risk. A significant proportion
of the sample reported persistent high worry/anxiety or increasing worry/anxiety from baseline
to post-intervention, and from baseline to the 12-month follow-up. The proportion reporting
persistent or increasing worry/anxiety did not vary by MBD notification method. The manuscript
also reports factors associated with anxiety, breast cancer worry, and perceived breast cancer
risk. The authors conclude that these data suggest future work is needed to address anxiety and
breast cancer worry and improve risk perception in this population.
Overall, this manuscript presents interesting psychological data about a timely issue
(mammographic breast density) in an underserved population (Latina women). However, the
combining of outcome trajectories (e.g., stable high and increase grouped together) makes
it difficult to interpret the results. Although the authors posit in the Introduction that MBD
notification may increase anxiety, it is difficult for the reader to ascertain whether that is the
case based on the results as they are currently presented. In addition, I feel that the Discussion
emphasizes overestimation of breast cancer risk and minimizes the significant underestimation
that was also observed in this study. Finally, I had some clarifying questions regarding the study
methods. These and additional concerns are detailed in my comments below:
Major Concerns:
(1) The way the results are currently reported obfuscates the trajectories of anxiety, perceived
BC risk, and worry. As a reader, it would be helpful to see results presented separately
for participants with increased anxiety/worry/perceived risk versus those with persistent high
anxiety/worry/perceived risk. Unfortunately, when the groups are combined, it makes it difficult
to evaluate the research question as noted in the Introduction section (e.g., does MBD
notification increase anxiety/worry/perceived risk).
(2) The analyses currently compare anxiety/worry/perceived risk at both T1 and T2 to T0. I am
curious why T2 was compared to T0 instead of T1. Could the authors provide their rationale
for this choice?
(3) As a reader, I found the description of the assessment timing to be rather confusing. To
my understanding, the T1 assessment could have been completed any time from 2 weeks
post-intervention to 6 months post-intervention. Similarly, the T2 assessment could have been
completed any time from 9 months to 18 months post-intervention. These seem like very wide
assessment windows, and the choice to lump assessments together into the T1 and T2 categories
may have affected the results presented. Did the authors consider using time since education as
a continuous variable, rather than creating the T1 and T2 assessment categories? This approach
might provide more insight into trajectories of anxiety, worry, and perceived risk over time since
the MBD notification intervention.
(4) I understand that this study was previously published, but additional information about the
interventions would be helpful for readers of this paper. I have noted some specific questions
below:
(4a) What was the duration of the promotora-led intervention? Was it a one-time interaction?
(4b) What exactly was the content of the interventions for the 47% of participants who did not
have dense breasts? Did they still receive information about breast density, even though it did
not apply to them? What content did the promotora cover in the education sessions with the
women who did not have dense breasts?
(5) In the Discussion section (p.15-16), the discussion of perceived breast cancer risk focuses
almost exclusively on the participants at average risk per the Gail model who overestimated their
breast cancer risk. However, there was also a significant proportion of women with elevated risk
(50%) who underestimated their breast cancer risk. I think this is a unique finding that warrants
mention in the Discussion section.
(6) In the Discussion section (p.16-17), the authors note that their findings are similar to those
presented by Dolan et al. (2022). However, Dolan et al. (2022) found that anxiety, confusion, and
worry all increased after MBD notification. The results presented here demonstrate that worry
and anxiety increased OR persisted following MBD notification. As I noted above in Comment
#1, the way that these data are presented do not allow the reader to understand how many patients
reported increased anxiety/worry and how many had persistent anxiety/worry. Given that, it is
difficult to know whether the authors are observing the same phenomenon as Dolan et al. (2022).
Minor Concerns:
(7) Is “self-perceived risk” the same as “perceived risk”? I feel that most of the breast cancer
screening literature uses the term “perceived risk”, so I was not sure whether the authors were
intending to differentiate the construct measured in this study.
(8) The Introduction section (p.6) states: “Most studies that have compared promotora
interventions vs. print or mailed educational materials in the context of mammography screening
have favored the promotora.” However, the next sentence provides an example of an intervention
focused on cervical cancer screening and HPV knowledge. If available, I think it would be
helpful to replace this example with an example from the breast cancer screening space.
(9) Are the STAI cutoffs for normal/moderate/severe anxiety based on prior literature? If so, I
would encourage the authors to provide a citation for these cutoffs.
(10) In the Results section (p. 11, first paragraph), there is a sentence reporting the percentage
of participants with dense breasts and the Gail model sample mean. This sentence is included
two times in this paragraph.