Project Insight: Feasibility of a Breast Cancer Screening Decision Support Tool
Phase: NA
Conditions: Breast Cancer Screening, Oncology, Preventative Medicine, Mammography
Sponsor: Washington University School of Medicine

NCT#: NCT04741503 
Title:  Project Insight:  Feasibility of a Breast Cancer Screening Decision Support Tool 

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Project Insight: Feasibility of a Breast Cancer Screening Decision Support Tool 
 
Washington University School of Medicine 
Department of Surgery, Division of Public Health Sciences 
660 South Euclid Avenue, Campus Box 8100 
St. Louis, MO 63110 
 
Protocol #: 202101073 
Version Date: 1 July 2021 
 
 
PI: 
Ashley Housten, MPA, OTD, MSCI 
Phone: (314) 454-7958 
E-mail: ahousten@wustl.edu 
 
 
Sub-Investigators: 
Carolyn Stoll, MPH, MSW 
Michelle Eggers, MA  
Fei Wan, PhD 
 
 
 
 
CONFIDENTIAL 
The information contained in this document is regarded as confidential and, except to the 
extent necessary to obtain informed consent, may not be disclosed to another party unless 
law or regulations require such disclosure. Persons to whom the information is disclosed 
must be informed that the information is confidential and may not be further disclosed by 
them 

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Project Insight: Feasibility of a Breast Cancer Screening Decision Support Tool 
Protocol Revision History 
Initial Approval Version 
03/10/2021 
Amendment #1 Version 
04/13/2021 
  Amendment #2 Version 
 
 
 
 
 
 
  07/02/2021

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Table of Contents 
1.0 
BACKGROUND AND RATIONALE ................................................................................ 4 
2.0 
OBJECTIVES ...................................................................................................................... 6 
3.0 
PATIENT SELECTION ...................................................................................................... 6 
3.1 
Inclusion Criteria .............................................................................................................. 6 
3.2 
Exclusion Criteria ............................................................................................................. 5 
3.3 
Inclusion of Women and Minorities ................................................................................. 6 
4.0 
REGISTRATION PROCEDURES ..................................................................................... 6 
5.0 
STUDY PLAN ..................................................................................................................... 7 
5.1 
Study Design .................................................................................................................... 7 
5.2 
Study Procedures .............................................................................................................. 7 
6.0 
STATISTICAL CONSIDERATIONS ................................................................................. 9 
7.0 
PROTECTION OF HUMAN SUBJECTS ........................................................................ 10 
7.1 
Adverse Event Reporting ............................................................................................... 10 
7.2 
Data and Safety Monitoring Plan ................................................................................... 10 
7.3 
Remuneration ................................................................................................................. 10 
8.0 
REFERENCES .................................................................................................................. 10 
APPENDIX A: Project Insight Decision Tool .............................................................................. 14 
APPENDIX B: NCI Breast Cancer Screening – Patient Version (Control Condition) ................ 21 
APPENDIX C: Measures: Questionnaires, including screening questionnaires and measures, have 
been removed from this protocol and provided to PRMC as a separate document………………21 
 

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1.0       BACKGROUND AND RATIONALE 
 
Breast cancer is the leading cause of cancer and the second leading cause of cancer-related death 
in U.S. women.1,2 Screening mammography is a contested strategy for reducing breast cancer 
mortality. There are considerable differences across guidelines for age of initiation and frequency 
of screening among women at average risk for breast cancer. 3-5 The U.S. Preventive Services 
Task Force (USPSTF) recommends against routine screening for women aged 40-49 years, and 
recommends biennial screening for those aged 50-74 years.6 Conversely, the American Cancer 
Society (ACS) provides a qualified recommendation for the opportunity to initiate annual 
screening mammography for women aged 40-44 years, strongly recommends annual screening for 
women aged 45-54 years, and suggests annual or biennial screening for those 55 years and older. 
2 These conflicting guidelines highlight concerns about the benefits and harms of screening, and 
may impact women’s decision making.2,3,7-10 
 
Women with an immediate family history or personal history of breast cancer, genetic risk factors, 
or prior thoracic or chest wall radiation therapy, and those older in age and with certain modifiable 
risk factors are likely to benefit from screening mammography. 3-5Conversely, women at 
average risk may be more vulnerable to certain harms (i.e., physical and psychological harm, 
financial strain, opportunity costs) associated with screening.11Physical harm may result from 
unnecessary follow-up tests (e.g., biopsies) following the detection of false-positive results 
(detection of a cancer in error) or from unnecessary treatment due to overdiagnosis (detection of 
cancer through screening that would not have caused symptoms or death).11 Most estimates of 
incidence rates for overdiagnosis in screening mammography range from 19%-31%.2,5,12-20 
Women may also experience psychological harm, such as stress or anxiety,21 and financial 
strain might stem from unexpected costs of follow-up tests, loss of income, and concerns about 
future possible costs.11,22- 24Finally, women may experience opportunity costs by having to 
forgo activities (e.g., self-care, leisure, professional) for further testing, treatment, or symptom 
management. 11 Differing guidelines and tradeoffs between the benefits and harms of screening 
may affect women’s ability to make informed decisions about whether or not to undergo 
screening, when to initiate screening, and screening frequency.2,5,25 Women from underserved 
populations (e.g., racial/ethnic minority, low socioeconomic status [SES]) and those with low 
health literacy are at greater risk of misunderstanding screening guidelines,11-14 and are more 
likely to experience disparities in screening mammography and breast cancer incidence and 
mortality. 26-34 
 
Little is known about the best ways of communicating information about the benefits and harms 
of breast cancer screening mammography to racially/ethnically diverse women with varying levels 
of SES and health literacy. There is an urgent need for formative research to better understand 
these issues. Findings will inform strategies to support clinicians in communicating and 
individualizing discussion of the benefits and harms of screening, and will ultimately help enhance 
women’s ability to make informed decisions about screening mammography. This is critical, as 
informed decision making takes into account empirical evidence and individuals’ values and 
preferences, and is associated with better knowledge about screening guidelines and the benefits, 

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risks, and limitations of screening, less decisional conflict and anxiety, greater satisfaction with 
the decision making process or the decision, and active participation in the decision making 
process.35,36 

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The goal of this project is to create decision support tools for Latina, Black, and non-Latina White 
women under age 50 with varying levels of health literacy who are considering breast cancer 
screening mammography. 
 
 
2.0      OBJECTIVES 
 
To evaluate the potential for implementing the developed decision support tools with Latina, 
Black, and non-Latina White women in order to collect feasibility data, including acceptability, 
usability, and limited-efficacy, to prepare for a larger randomized controlled trial. 
 
 
3.0 
PATIENT SELECTION 
 
3.1 
Inclusion Criteria 
 
1. Latina, Black, or non-Latina White woman 
2. Age between 40 and 49 years old (inclusive) 
3. Able to write, read, and understand English 
 
3.2 
Exclusion Criteria 
 
1. Greater than average self-reported risk of breast cancer, defined as any of the following: 
a. Self-reported personal history of breast cancer (invasive, ductal carcinoma in situ 
[DCIS], or lobular carcinoma in situ [LCIS]) 
b. Self-reported personal history of atypical hyperplasia 
c. Self-reported first degree family member with history of breast cancer (parent, 
sibling) 
d. Self-reported known underlying genetic mutation (such as BRCA1/BRCA2 gene) 
e. Self-reported prior thoracic or chest wall radiation therapy 
 
3.3 
Inclusion of Women and Minorities 
 
Latina, Black, or non-Latina White women are eligible for this trial. Women of other races 
are not eligible. 
 
 
4.0 
REGISTRATION PROCEDURES 
 
This study will register summary accrual statistics to the Siteman Cancer Center OnCore Database. 
On a quarterly basis, accrual should  be  grouped  according  to  the  demographic  data  
collected. Demographic information includes gender, age, ethnicity, and race. If any piece of 
demographic information was not collected for those categories, choose unknown. 

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1. In OnCore, navigate to the PC Console for this study and enter the dates of the quarter for 
which you are entering accrual statistics. (These dates must be inclusive of the same year, 
e.g. 1/1/2020 – 3/31/2020, not 12/31/2019 – 3/31/2020.) 
2. Then, enter the accrual number for any subjects who are in the same demographic groups 
of race, ethnicity, gender, and age group. For example, if you have accrued two white non- 
Hispanic males in their 50s, you will enter that demographic as an accrual group of 2. If 
you have also accrued an Asian female in her 40s, you will enter her as a separate accrual 
group (you would enter “1” for the accrual number). 
3. In addition, you will enter “Research Center” in the drop-down field for “Internal Accruing 
Reporting Group” and “No disease” in the drop-down field for “Disease Site.” 
Complete instructions can be accessed in the OnCore Users’ Manual: 
https://cbmiapps.wustl.edu/confluence/display/OSS/6.+Summary+Accruals 
 
 
5.0 
STUDY PLAN 
 
5.1 
Study Design 
 
To conduct a preliminary evaluation of the decision support tool, up to 36 women will be 
recruited to review the decision tool and complete questionnaires to assess informed 
choice, decisional conflict and confidence, and acceptability. To inform the feasibility 
testing, 36 women will be randomized to test randomization, measures, and recruitment. 
 
Following this preliminary evaluation of the decision tool and feasibility testing, 198 
participants will be randomized on a 1:1 basis to review the decision support tool or control 
condition of standard breast cancer screening education. Black, Latina, and Non-Latina 
White participants will be assigned to either the control or intervention condition using 4 
and 2 varying block size. They will complete the pre-questionnaire, review the decision 
support tool/control condition, and complete the post-questionnaire. 
 
5.2 
Study Procedures 
 
5.2.1 Recruitment and Consent 
 
Qualtrics Online Research Panels will be used to recruit participants. Qualtrics 
utilizes samples from traditional, actively managed, double-opt-in market research 
panels. For hard-to-reach groups, Qualtrics utilizes niche panels brought about 
through specialized recruitment campaigns. Qualtrics leverages their partner 
networks to gain access to many hard-to-reach groups. Qualtrics’ sample partners 
randomly select respondents for surveys where respondents are likely to qualify. 
All strategic sample partners use deduplication technology to provide the most 
reliable results and retain the integrity of the survey data. 
 
Written informed consent is not required; participants will receive an information 
sheet, and continued participation (completion of questionnaires, review of 
materials) will be construed as consent. 

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5.2.2 Randomization 
 
The sample will be stratified by racial/ethnic subgroups (Black, Non-White Latina, 
White) for randomization purposes. Participants in these subgroups will be 
randomized to either the intervention or control arm on a 1:1 basis using 4 and 2 
varying block size. The Washington University School of Medicine research team 
will create the randomization table. Qualtrics will program the randomization table 
into the survey. 
 
5.2.3 Participation 
 
Measures will elicit participants’ perceptions of the tool (Appendix A)/control 
condition (Appendix B). These measures assess acceptability and informed choice 
using knowledge, attitudes, intentions, priorities, and values. 
 
Pre-tool/control condition questionnaires are: 
• Sociodemographic characteristics (Appendix J) 
• Knowledge of Screening Mammography Guidelines and Perceived Benefits 
and Harms of Screening Mammography (Appendix D) 
• Decision Conflict Scale (which collects feelings of being fully informed and 
clear about the importance of the components for making informed 
decisions) (Appendix E) 
• Decision Self-Efficacy (Appendix F) 
 
Post-tool/control condition questionnaires are: 
• Acceptability (Appendix G) 
• Preparation for Decision Making Scale (Appendix H) 
• Decision Conflict Scale 
• Decision Self-Efficacy 
• Knowledge of Screening Mammography Guidelines and Perceived Benefits 
and Harms of Screening Mammography 
• Health literacy and health numeracy (Appendix I) 
 
5.2.4 Data Scrubbing 
 
After data collection, records will be removed from the final data set if they meet 
any of the following criteria as determined by members of the research team. 
Members of the research team will keep track of how many records were removed 
and for what reason(s).  
 
Criteria for removal from the final data set: 
• The participants do not meet all of the inclusion criteria; or 
• The time to complete the questionnaire is less than half of the median time 
to complete the questionnaire across the full data set; or 
• Participants do not respond to, provide nonsensical or incomprehensible 
answers to, or give responses in a language other than English to at least 

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four of the eight following knowledge questions:  
o 2.12 Tell me in your own words, what is a mammogram? 
o 2.24. What is meant by the term "overdetection" (also called 
“overdiagnosis”)? Please answer in English. If you are not sure, just 
guess. 
o 2.26. What are some of the benefits of breast cancer screening 
mammograms? Please answer in English. 
o 2.27. What are the risks or downsides of breast cancer screening 
mammograms? Please answer in English. 
o 3.49. Tell me in your own words, what is a breast cancer screening 
mammogram? Please answer in English 
o 3.61. What is meant by the term "overdetection" (also called 
“overdiagnosis”)? Please answer in English. If you are not sure, just 
guess. 
o 3.63. What are some of the benefits of breast cancer screening 
mammograms? Please answer in English. 
o 3.64. What are the risks or downsides of breast cancer screening 
mammograms? Please answer in English. 
 
If a participant completes the questionnaire in less than half the median time, it is 
reasonable to believe that they were unable to process the decision aid(s) in 
sufficient detail to provide accurate responses to the questions.  
 
Failing to adequately complete the knowledge questions (4 of which are pre-
tool/control and 4 post-tool/control) limit the research team’s ability to accurately 
analyze the feasibility, acceptability, usability, and limited-efficacy of the 
tool/control.  
6.0       STATISTICAL CONSIDERATIONS 
 
Stratification will be based on racial/ethnic groups (e.g., Latina, Black, non-Latina White). For 
adequate power, 66 participants from each racial/ethnic group will be enrolled and randomized 
(198 total). 
 
For knowledge, previous research shows that mean knowledge score is 57 out of 100.36 
Compared to usual care, decision aids increased knowledge 13 points (mean difference 13.34 out 
of 100; 95% CI [11.17,15.51]).36 For decisional conflict scale (0-100), those using a decision aid 
were more informed by 7 points (mean difference: -7.26 of 100; 95% CI [-9.73, -4.78]), and 
were more clear 

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about their personal values by 6 points (mean difference: -6.09; 95% CI [-8.50, -3.67]).36 Finally, 
fewer were passive in decision-making (risk ratio 0.66; 95% CI [0.53 to 0.81]).36 Using a one- 
sided Mann-Whitney Test, a sample size of 33 provides 80% power at the 0.05 significance level 
(alpha) to detect a mean knowledge difference of 13 with an estimated standard deviation (SD) of 
20, and to detect a mean decision conflict score difference of 6.5 with an estimated SD of 10. 
Additionally, using a Mantel-Haenszel test, a sample size of 33 provides 80% power at the 0.05 
significance level (alpha) to detect a risk ratio of 1.66 assuming the proportion of the informed 
values-based choice of 0.45 and 0.75 in the control and intervention groups, respectively. 
Subsequently, to detect the differences between groups with 80% power and 5% Type I error, 33 
participants in each control and intervention group will yield a statistically significant preliminary 
effect. We are making multiple comparisons and recognize that the overall Type I error rate in this 
study will be greater than 5%. However, this study will allow us to collect adequate data, for 
planning future large scale studies. 
 
 
7.0 
PROTECTION OF HUMAN SUBJECTS 
 
Participation in this study does not entail any physical or medical risks that are greater than those 
ordinarily encountered in daily life. It is possible that the participant may feel uncomfortable 
completing the questionnaires. If a participant becomes upset, they may exit the study at any time. 
 
There is also a risk of breach of confidentiality. All reasonable steps will be taken to ensure that 
patient privacy is maintained, including not collecting any identifiers with the research data set. 
Electronic data will be stored on a Washington University password-protected server and never 
stored on a portable hard drive or laptop computer. Data will be accessed through the Washington 
University School of Medicine Qualtrics portal through a university-wide site license. 
 
7.1 
Adverse Event Reporting 
 
Participation in this study entails the completion of questionnaires and review of 
educational materials. We expect that the occurrence of a serious adverse event as it relates 
to these study interventions to be extremely rare. If a breach of confidentiality were to 
occur, it would be reported to QASMC and HRPO within 10 days of notification. 
 
7.2 
Data and Safety Monitoring Plan 
 
The study principal investigator and study coordinator will monitor for breaches of 
confidentiality and other adverse events on an ongoing basis. Once the PI or study 
coordinator becomes aware of a reportable adverse event, the event will be reported to 
HRPO and QASMC according to institutional guidelines. This study does not require 
QASMC audit or submission of DSM reports. 
 
7.3 
Remuneration 
 
Participants will be compensated through Qualtrics for being a research participant.

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8.0 
REFERENCES 
1. 
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA: A Cancer Journal for 
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Oeffinger KC, Fontham EH, Etzioni R, et al. Breast cancer screening for women at 
average risk: 2015 guideline update from the american cancer society. JAMA. 
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3. 
Welch HG. Screening Mammography — A Long Run for a Short Slide? New England 
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Miller AB. Conundrums in screening for cancer. International Journal of Cancer. 
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Pace LE, Keating NL. A systematic assessment of benefits and risks to guide breast 
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Siu AL. Screening for Breast Cancer: U.S. Preventive Services Task Force 
Recommendation Statement Screening for Breast Cancer. Annals of Internal Medicine. 
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Hersch J, Jansen J, Irwig L, et al. How do we achieve informed choice for women 
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McPherson K. Screening for breast cancer—balancing the debate. BMJ. 2010;340. 
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Kamerow D. Mammograms, poor communication, and politics. BMJ. 2009;339. 
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Woolf SH. The 2009 breast cancer screening recommendations of the us preventive 
services task force. JAMA. 2010;303(2):162-163. 
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Harris RP, Sheridan SL, Lewis CL, et al. The harms of screening: a proposed taxonomy 
and application to lung cancer screening. JAMA internal medicine. 2014;174(2):281-286. 
12. 
Olsen AH, Agbaje OF, Myles JP, Lynge E, Duffy SW. Overdiagnosis, Sojourn Time, and 
Sensitivity in the Copenhagen Mammography Screening Program. The Breast Journal. 
2006;12(4):338-342. 
13. 
Paci E, Miccinesi G, Puliti D, et al. Estimate of overdiagnosis of breast cancer due to 
mammography after adjustment for lead time. A service screening study in Italy. Breast 
Cancer Res. 2006;8(6):R68. 
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Duffy SW, Agbaje O, Tabar L, et al. Overdiagnosis and overtreatment of breast cancer: 
Estimates of overdiagnosis from two trials of mammographic screening for breast cancer. 
Breast Cancer Research. 2005;7(6):258-265. 
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Puliti D, Duffy SW, Miccinesi G, et al. Overdiagnosis in mammographic screening for 
breast cancer in Europe: a literature review. Journal of Medical Screening. 2012;19(suppl 
1):42-56. 
16. 
Jørgensen KJ, Gøtzsche PC. Overdiagnosis in publicly organised mammography 
screening programmes: systematic review of incidence trends. BMJ. 2009;339. 
17. 
Zahl P-H, Strand BH, Mæhlen J. Incidence of breast cancer in Norway and Sweden 
during introduction of nationwide screening: prospective cohort study. BMJ. 
2004;328(7445):921-924. 
18. 
de Gelder R, Heijnsdijk EAM, van Ravesteyn NT, Fracheboud J, Draisma G, de Koning 
HJ. Interpreting Overdiagnosis Estimates in Population-based Mammography Screening. 
Epidemiologic Reviews. 2011. 
19. 
Welch H, Passow HJ. Quantifying the benefits and harms of screening mammography. 
JAMA Internal Medicine. 2014;174(3):448-454. 
20. 
Jin J. Breast cancer screening: Benefits and harms. JAMA. 2014;312(23):2585-2585. 

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21. 
Tosteson AA, Fryback DG, Hammond CS, et al. Consequences of false-positive 
screening mammograms. JAMA Internal Medicine. 2014;174(6):954-961. 
22. 
Gøtzsche PC, Nielsen M. Screening for breast cancer with mammography. Cochrane 
Database Syst Rev. 2011;1. 
23. 
Elmore JG, Gross CP. The Cost of Breast Cancer Screening in the United States: A 
Picture Is Worth ... a Billion Dollars? Annals of Internal Medicine. 2014;160(3):203-204. 
24. 
Plutynski A. Ethical issues in cancer screening and prevention. Journal of Medicine and 
Philosophy. 2012;37(3):310-323. 
25. 
Screening for Breast Cancer: U.S. Preventive Services Task Force Recommendation 
Statement. Annals of Internal Medicine. 2009;151(10):716-726. 
26. 
Peek ME, Sayad JV, Markwardt R. Fear, Fatalism and Breast Cancer Screening in Low- 
Income African-American Women: The Role of Clinicians and the Health Care System. 
Journal of General Internal Medicine. 2008;23(11):1847-1853. 
27. 
Wells AA, Shon E-J, McGowan K, James A. Perspectives of Low-Income African- 
American Women Non-adherent to Mammography Screening: the Importance of 
Information, Behavioral Skills, and Motivation. Journal of Cancer Education. 2015:1-7. 
28. 
Williams KP, Mabiso A, Todem D, et al. Differences in knowledge of breast cancer 
screening among African American, Arab American, and Latina women. Prev Chronic 
Dis. 2011;8(1):A20. 
29. 
Li CI. Racial and ethnic disparities in breast cancer stage, treatment, and survival in the 
United States. Ethnicity & disease. 2004;15(2 Suppl 2):S5-9. 
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Blackman DJ, Masi CM. Racial and Ethnic Disparities in Breast Cancer Mortality: Are 
We Doing Enough to Address the Root Causes? Journal of Clinical Oncology. 
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31. 
American Cancer Society. Breast Cancer Facts & Figures 2015-2016. In. Atlanta: 
American Cancer Society, Inc.; 2015. 
32. 
Allgood KL, Rauscher GH, Whitman S, Vasquez-Jones G, Shah AM. Validating Self- 
Reported Mammography Use in Vulnerable Communities: Findings and 
Recommendations. Cancer Epidemiology Biomarkers & Prevention. 2014;23(8):1649- 
1658. 
33. 
DeWalt DA, Berkman ND, Sheridan S, Lohr KN, Pignone MP. Literacy and health 
outcomes. Journal of General Internal Medicine.19(12):1228-1239. 
34. 
Kutner M, Jin E, Paulsen C. The Health Literacy of America's Adults: Results From the 
2003 National Assessment of Adult Literacy (NCES 2006-483). National Center for 
Education. Washington DC: U.S. Department of Education; 2006. 
35. 
Davis TC, Williams MV, Marin E, Parker RM, Glass J. Health Literacy and Cancer 
Communication. CA: A Cancer Journal for Clinicians. 2002;52(3):134-149. 
36. 
Stacey D, Légaré F, Lewis K, et al. Decision aids for people facing health treatment or 
screening decisions. Cochrane Database of Systematic Reviews. 2017(4). 

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APPENDIX A: Project Insight Decision Tool 
 

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APPENDIX B: NCI Breast Cancer Screening – Patient Version (Control Condition) 
 
Located at: https://www.cancer.gov/types/breast/patient/breast-screening-pdq 
 
 
 
APPENDIX C: Measures 
Questionnaires including screening questionnaires and measures, have been removed from this 
protocol and provided to PRMC as a separate document with track changes

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