Understanding Affective Processing of Scientific Evidence to Promote Informed Choice for Breast Cancer Screening
Phase: PHASE2
Conditions: Breast Cancer
Sponsor: University of Colorado, Denver

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w 
COMIRB Protocol 
COLORADO MULTIPLE INSTITUTIONAL REVIEW BOARD 
CAMPUS BOX F-490    TELEPHONE:  303-724-1055  Fax:  303-724-0990 
 
 
 
Protocol #: 20-1866 
Project Title: Understanding Affective Processing of Scientific Evidence to Promote Informed 
Choice for Breast Cancer Screening 
Principal Investigator: Laura Scherer, PhD 
Version Date: 5.10.2021 
 
I. Hypotheses and Specific Aims: 
 
Cancer screening for the right patients at the right level of cancer risk can save lives. However, 
over the last several years most expert groups have de-intensified many screening 
recommendations as a result of emerging evidence of net harms for certain populations. Newer 
recommendations for mammography screening highlight a tailored approach based on age and risk 
and comorbidities, aiming to minimize harms and target women who could benefit the most.1 
Although there is still widespread disagreement about when and how frequently certain populations 
of women should receive breast screening, one point of agreement is that women should make an 
informed choice with their doctor about when to start, when to stop, and how frequently to screen.2–
4  
 
However, the change in emphasis from uniformly promoting mammography to promoting 
informed choice constitutes a medical reversal in the sense that this new message is very different 
from past messages and people’s expectations.1,5–7 The result is a delicate situation in which there 
is need to convey the evidence to women, but also a need to do it in a way that maintains credibility 
and trust despite this reversal. Research suggests that many women react negatively to 
mammography evidence, responding with Reactance (e.g., “this is trying to manipulate me”, “this is 
trying to ration healthcare”), self-Exemption (e.g., “this doesn’t apply to me”), Disbelief (e.g., “you 
can’t believe all the research”), or Source derogation (e.g., “I don’t trust this source”),6,8,9 which we 
refer to together as REDS. These responses reflect different ways of rejecting of the evidence, 
stand in the way of informed choice, and could lead to distrust in future screening health 
messages. 
 
AIM 1: Identify the prevalence and predictors of REDS in reaction to evidence about 
mammography benefits and harms, and consequences for decision-making and trust. Research 
has not yet systematically identified the proportion of women who respond negatively (vs. 
positively) to mammography evidence, or attempted to explain these responses by examining 
theory-driven predictors. We will develop and conduct a probability-based nationally representative 
survey in which we communicate mammography evidence using the current best practices in risk 
communication, and identify theory-driven predictors of REDS responses, and identify 
consequences of these responses for decision-making and trust. 
 
II. Background and Significance: 
 
 
A1. Screening recommendations have changed considerably over recent years. 
Breast cancer is the second leading cause of cancer death among women in the U.S., and early 
detection can result in a cure before it spreads. For many years mammography was strongly 
promoted, with the aim of maximizing screening uptake.10–12 However, mammography guidelines 
have changed considerably as a result of accumulating evidence showing that screening has less 
benefit for some populations of women, and can cause harm.13–15 Harms include false positive 
results requiring follow-up tests and biopsies, and overdiagnosis—the diagnosis of asymptomatic 
cancer that will not cause symptoms or harm in a person’s lifetime—and resultant overtreatment.16–
18 Although routine mammography is still strongly recommended for women in specific age ranges 

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and with certain risk factors, many expert groups, including the United States Preventive Services 
Task Force (USPSTF) and the American Cancer Society (ACS), have de-intensified screening 
recommendations and expanded the role of informed choice.2,4 Most guidelines now emphasize 
that women should receive balanced information about the benefits and harms of mammography 
so that they can engaged in shared decision making (SDM) and make an informed choice with their 
doctor about when to start, when to stop, and how frequently to screen.19  
 
A2. A balanced presentation of both screening benefits and harms is very different 
from previous unequivocal recommendations to screen, and can strongly contradict 
women’s preexisting beliefs. Controversies about breast cancer screening continues to receive 
attention in the news media but many women are still unaware of the evidence.20,21 Most women 
greatly overestimate their lifetime breast cancer risk,22 and overestimate their risk even after they 
have been counseled on their objective risk.23 A recent systematic review found that in 8 of 9 
studies reviewed, a majority (i.e. >50%) of women overestimated the benefit of mammography.24 
Most people (women and men) have little or no prior knowledge of harm from overdiagnosis, which 
is a counterintuitive concept that contradicts common beliefs about how cancer grows and 
spreads.5,25–28 In a 2016 survey, only 16% of women were aware of overdiagnosis as a harm of 
mammography.6 Screening is rarely discussed in clinical encounters in a balanced way; for 
example, in one survey only 19% of women reported that their provider had discussed the harms of 
screening in addition to the benefits.29 The public is also very enthusiastic about cancer 
screening.10,30,31 For example, in a recent study we found that 43% of women and men expressed 
a desire for breast/prostate cancer screening even if it would not reduce the chance of cancer 
death or extend the length of life.30  
 
A3. Mammography evidence and revised guidelines can be emotionally charged. “It 
feels like just when it became okay to talk about breasts and screening, and we convinced 
insurance to pay for it, and we started getting it to low income women, now we’re told that it’s 
maybe not that great and it should be a choice. How are we supposed to believe that?” (personal 
communication with PI Scherer). Given that many women overestimate their breast cancer risk and 
the benefits of screening, are unaware of the harms of screening, and are very enthusiastic about 
screening, it should come as no surprise that mammography evidence and the recommendation for 
informed choice can elicit negative reactions. Qualitative research has shown that some women 
are suspicious and resistant to screening evidence, particularly the notion of overdiagnosis.32 In a 
2016 U.S. survey less than 1-in-4 women thought both overdiagnosis and overtreatment were 
“believable”.6 The notion of risk-based screening—that is, creating a screening plan tailored to a 
woman’s objective cancer risk—is concerning for some women, and can raise suspicions of 
healthcare rationing.20 In a recent study, women rated a leaflet that described the balance of 
benefits and harms as less helpful than one that promoted only the benefits, which the authors 
interpreted as potentially indicating a reluctance to accept information about harms.33 In recent 
focus groups involving 42 U.S. adults, participants placed enormous value on cancer screening 
and expressed hostility toward guidelines suggesting doing less screening.34 Recently we 
conducted 16 patient interviews in anticipation of this proposal in which we showed women a 
breast cancer screening decision support tool35 and asked how they felt about the benefits and 
harms presented. Here is how one woman responded to the idea of harm from overdiagnosis: “I 
think this might give people a false sense of security. Like it’s giving them permission to not 
do screening. So I don’t think that this is reassuring, and I don’t think it accurately 
represents the actual risk. This whole thing kinda makes me mad. I find it very frustrating 
because it, it feels like…it feels like propaganda.”   
 
Altogether, the weight of the evidence suggests that communicating mammography 
screening evidence can elicit negative reactions. The types of negative reactions that we are 
particularly concerned about include Reactance (i.e. perceived manipulation or influence, e.g. “this 
is trying to ration healthcare”), self-Exemption (e.g., “this doesn’t apply to me”), Disbelief (e.g., 
“you can’t believe all the research anyway”), and Source derogation (e.g., “I don’t trust this 
source”), which we shorten to REDS.8,9 These responses are sometimes referred to collectively as 
“defensive coping”,36 although we prefer “REDS” to refer directly to the four types of responses. To 
date, no research has examined REDS systematically to assess their prevalence and causes in the 
context of communicating mammography screening evidence. And even though many women 

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react negatively to screening information, many women also want to be informed and be able to 
make a choice.37 The result is a delicate situation in which there is need to convey the evidence to 
women, but also a need to do it in a way that maintains credibility and trust. 
 
III. Preliminary Studies/Progress Report:   
 
IV. Research Methods 
 
A. Outcome Measure(s): 
 
The primary outcome measures in this survey are REDS responses and screening intentions. 
See Table 1 below for all survey measures. 35,55,56,61,66,72,96–99 
 
 
 
B. Description of Population to be Enrolled: 
 
Inclusion: 
• 
Female 
• 
Between 39-49 years of age 
• 
No history of breast cancer 
• 
No known BRCA1/2 mutation 
 
Exclusion: 
• 
Non-English or Spanish Speaking 
• 
Persons unable to provide informed consent (e.g. severe dementia or cognitive 
disability or illiterate) 
• 
History of breast cancer 
• 
Known BRCA1/2 mutation 
 
Pilot Survey: We will pilot test questions to measure REDS and cognitive reactions to assess 
item variability, internal consistency, and reduce the total number of items. We will recruit 700 
women through Dynata. Dynata manages an online participant panel of millions of adults 
across the United States. Participants who are part of Dynata’s panel have agreed to 
participate in surveys in exchange entry into lotteries for small cash prizes. 

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Pilot Interviews: We will recruit up to 15 women from Carmen Lewis’s Internal Medicine clinic at 
UCHealth. These interviews will focus on assessing overall knowledge and understanding of 
the information presented in the decision aid. Participants will receive a $25 gift card for 
participating in the interview. 
 
Nationally Representative Survey: We will recruit 700 women age 40-49 through Ipsos Public 
Affairs. Ipsos manages an online participant panel allowing population inferences using 
probability sampling methods and providing Internet access to households that do not have it. 
 
Nationally Representative Interviews: We will recruit up to 40 women from the Ipsos survey 
who agreed to be contact for a follow-up phone interview. We will specifically recruit women 
who expressed negative reactions to mammography evidence, so that we can assess how to 
improve the BCS-DA using insights from those who were negatively affected. We will attempt 
to recruit at least 25% non-White participants for these interviews. 
 
C. Study Design and Research Methods 
 
The survey flow is displayed 
in the figure below and will 
unfold as follows: First, 
women will be asked 
premeasure questions 
displayed in the figure below. 
Second, women will learn 
their objective cancer risk 
estimate, and will report their 
affective, deliberative and 
experiential risk perceptions. 
56  Third, women will react 
separately to the three 
distinct components of 
mammography evidence 
(benefits, false positives, 
overdiagnosis). The purpose 
of assessing reactions to 
each component of the 
evidence is to identify how 
positively or negatively each 
part is received. We 
anticipate that overdiagnosis 
may be received most 
negatively. Measured 
reactions will include REDS 
responses, and cognitive 
reactions as previously 
described (i.e. whether the 
information is compatible or 
not with other knowledge). 
Finally, after all of the 
information has been 
presented, women will 
provide overall reactions to 
the evidence using the same measures. Next women will report overall positive responses, 
e.g., the extent to which they appreciated receiving the information, felt empowered by it, and 

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want to talk to their provider about it. Lastly, women will repeat some of the pre-measures (e.g. 
knowledge, trust) and report demographics and individual differences. 
 
Pilot Survey: Recruitment and survey distribution with be done by Dynata. All data will be 
collected electronically using Qualtrics. 
 
Nationally Representation Survey: Recruitment and survey distribution with be done by Ipsos. 
All data will be collected electronically using Qualtrics. 
 
All Interviews: Patients will be invited to schedule a phone call for the interview (using a regular 
phone or using Zoom), and audio will be recorded and transcribed. 
 
D. Description, Risks and Justification of Procedures and Data Collection Tools: 
 
Benefit from participating in the research cannot be claimed. Women will learn about 
mammography benefit and harm, which may lead to more informed screening decisions. 
Learning how to help communicate more effectively about counterintuitive and surprising 
medical evidence is an area in great need of attention. The intervention is designed to improve 
communication and decision quality and enhance the overall decision making. Given that the 
risks are minimal and the benefits great (to both patients, clinicians, and society as a whole) we 
believe that the benefits of the proposed project outweigh any risks. 
 
E. Potential Scientific Problems: 
 
The length of the survey may be an issue since we are recruiting through Ipsos. 
 
There is a possibility that not a sufficient amount of subjects with voluntarily self-identify for the 
follow-up interviews. 
 
F. Data Analysis Plan: 
 
Pilot Survey: We will check the variability of each questionnaire item to assess suitability for 
exploratory factor analysis.  Exploratory factor analysis will be used to identify the factor 
structure of the REDS items. Items that do not load onto any factor will be dropped. Reliability 
of the remaining items 
 
Nationally Representative Survey: Summary statistics will estimate the prevalence of REDS to 
each part of the BCS-DA. Simple within-subjects tests (e.g. ANOVA) will compare REDS in 
response to screening benefits, false positives, and overdiagnosis. 
 
All Interviews: We will conduct exploratory content analysis of these qualitative interviews using 
the analytic program Dedoose to extract themes in patients’ reactions to the presented 
information. 
 
Safety Oversight: 
 
The principal investigator will be responsible for the conduct of this study, overseeing 
participant safety, executing the data and safety monitoring (DSM) plan, and complying with all 
reporting requirements to local and federal authorities. This oversight will be accomplished 
through additional oversight from the Data and Safety Monitoring Committee (DSMC) at the 
University of Colorado Cancer Center (CU Cancer Center).  The DSMC is responsible for 
ensuring data quality and study participant safety for all trials at the CU Cancer Center.   A 
summary of the DSMC’s relevant activities is as follows: 
  
• Conduct of internal audits 

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• Has the authority to suspend studies for safety or conduct issues 
• May submit recommendations for corrective actions to the CU Cancer Center’s Executive 
Committee 
  
Study audits conducted by the DSMC will consist of a review of the regulatory documents, 
consent forms, and source data verification.  Documentation of the audit conducted by the 
DSMC will then need to be submitted to the IRB of record at the time of the IRB’s continuing 
review of this trial (if applicable). 
 
G. Summarize Knowledge to be Gained: 
 
Our preliminary data suggest that there are important problems with current approaches to 
communicating screening evidence. The proposed studies are designed to generate 
knowledge that will lead to improved communication strategies and real-world improvements in 
informed patient choice. Because virtually little work has systematically studied this issue, a 
deeper understanding of how women respond to screening evidence will have widespread 
clinical applicability. 
 
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