Implementing Breast Reconstruction Clinical Decision Support in Diverse Practice Settings
Phase: NA
Conditions: Breast Reconstruction, Breast Cancer
Sponsor: Washington University School of Medicine

Protocol ID#  
 
 
202005217 
Clinicaltrials.gov number:   
NCT04491591 
Title:   
Implementing Breast Reconstruction Clinical Decision Support in Diverse 
Practice Settings 
Version date: 
01/20/2023 

   
 
Human Research Protection Office 
 
 
 
 
 
660 South Euclid Ave., Campus Box 8089, St. Louis, MO 63110 Phone: (314) 747-6800 
 
IRB ID #: 
202005217 
 
To: 
 
Mary Politi 
 
From:  
The Washington University in St. Louis Institutional Review Board, 
 
Re: 
Implementing Breast Reconstruction Clinical Decision Support in Diverse Practice Settings 
 
 
 
Approval Date: 
01/20/23 
Next IRB Approval 
Due Before: 
01/19/24 
 
2018 Common Rule/Equivalent Protections Yes 
 
Type of Application: 
Type of Application Review:  
Approved for Populations: 
 
 
 New Project  
 Full Board:  
 Children 
 Continuing Review 
Meeting Date:  
 
 Signature from one parent 
 Modification  
 Expedited 
 
 Signature from two parents 
 
 
 
 
 Exempt 
 Prisoners 
 
 
 
 
 Facilitated 
 Pregnant Women, Fetuses, Neonates 
 
 
 
 
 
 Wards of State 
 
 
 
 
 Decisionally Impaired 
 
 
 
 
 
 
 
 
 
 
 
 
 
Criteria for approval are met per 45 CFR 46.111 and/or 21 CFR 56.111 as applicable. 
Project determined to be minimal risk per 45 CFR 46.102(i) and/or 21 CFR 56.102(i) as applicable. 
 
 
 
 
 
 
      
 
 
Source of Support: 
 
 
Agency for Healthcare Research & Quality (DHHS) 
 
 
Implementing Breast Reconstruction Clinical Decision Support in Diverse Practice Settings (Mary Politi, 
PhD; Clara Lee, MD) 

IRB ID#: 202005217   01/20/23   Page 2 of 3  
MATERIALS APPROVED 
 
 
 
 
 
Consent/Assent Materials: 
 
Consent & Assent Forms 
 
 
R18_Aim3_Informed consent_surgeon_9.3.2020clean.rtf 
 
 
R18_Aim 3_Informed consent_patient_1.21.21 clean AC and JV changes (4).rtf 
 
 
R18_Aim 3_phone consent or written waiver_surgeon_9.3.2020 clean.rtf 
 
 
Recruitment/Advertisement Materials: 
 
Recruitment Materials: Ads/Brochures/Posters/News Release/Fliers 
 
 
R18_Aim3_Flyer_3.22.21 (3).rtf 
 
Recruitment: Website 
 
 
Website 7.27.21.rtf 
 
Recruitment Script: Phone 
 
 
R18_Patient_Phone_Script_screening_6.8.21.rtf 
 
Recruitment: Email or letters 
 
 
MyChart_email message to patients_Aim_3_4.28.21.rtf 
 
 
R18_ surgeon screening email 9.3.2020clean.rtf 
 
Recruitment: Other 
 
 
BREASTChoice_Recruitment_Video_(HD_1080_-_WEB_(H264_4000)).mp4 
 
 
Questionnaires: 
 
Subject Data Collection Instruments 
 
 
Patient survey_intervention Aim3_v8.docx 
 
 
Patient survey_control Aim3_v1.docx 
 
 
Clinician survey SDM_Aim 3 pre_post_May2020.docx 
 
 
 
This approval has been electronically signed by IRB Chair or Chair Designee: 
Sunny Warren, MSW 
01/20/23 1351

IRB ID#: 202005217   01/20/23   Page 3 of 3  
IRB Approval:  IRB approval indicates that this project meets the regulatory requirements for the protection of 
human subjects.  IRB approval does not absolve the principal investigator from complying with other institutional, 
collegiate, or departmental policies or procedures. 
 
Recruitment/Consent:  Your IRB application has been approved for recruitment of subjects not to exceed the 
number indicated on your application form.  If you are using written informed consent, the IRB-approved and 
stamped Informed Consent Document(s) are available in myIRB.  The original signed Informed Consent 
Document should be placed in your research files.  A copy of the Informed Consent Document should be given to 
the subject.  (A copy of the signed Informed Consent Document should be given to the subject if your Consent 
contains a HIPAA authorization section.)   
 
Continuing Review:  Federal regulations require that the IRB re-approve research projects at intervals 
appropriate to the degree of risk, but no less than once per year.  This process is called “continuing review.”  
Continuing review for non-exempt research is required to occur as long as the research remains active for long-
term follow-up of research subjects, even when the research is permanently closed to enrollment of new subjects 
and all subjects have completed all research-related interventions and to occur when the remaining research 
activities are limited to collection of private identifiable information. Your project “expires” at midnight on the date 
indicated on the preceding page (“Next IRB Approval Due on or Before”).  You must obtain your next IRB 
approval of this project by that expiration date.  You are responsible for submitting a Continuing Review 
application in sufficient time for approval before the expiration date, however you will receive reminder notice prior 
to the expiration date. 
 
Modifications:  Any change in this research project or materials must be submitted on a Modification application 
to the IRB for prior review and approval, except when a change is necessary to eliminate apparent immediate 
hazards to subjects.  The investigator is required to promptly notify the IRB of any changes made without IRB 
approval to eliminate apparent immediate hazards to subjects using the Modification/Update Form. Modifications 
requiring the prior review and approval of the IRB include but are not limited to:  changing the protocol or study 
procedures, changing investigators or funding sources, changing the Informed Consent Document, increasing the 
anticipated total number of subjects from what was originally approved, or adding any new materials (e.g., letters 
to subjects, ads, questionnaires). 
 
Unanticipated Problems Involving Risks:  You must promptly report to the IRB any unexpected adverse 
experience, as defined in the IRB/HRPO policies and procedures, and any other unanticipated problems involving 
risks to subjects or others.  The Reportable Events Form (REF) should be used for reporting to the IRB. 
 
Audits/Record-Keeping:  Your research records may be audited at any time during or after the implementation 
of your project.  There are Federal, State and Institutional requirements for record retention.  Check with your 
organization and your funding agreement to learn more about what record retention requirements apply to your 
project.  
 
Additional Information:  Complete information regarding research involving human subjects is available in the 
“Washington University Institutional Review Board Policies and Procedures.”  Research investigators are 
expected to comply with these policies and procedures and to be familiar with the Belmont Report, 45CFR46, and 
other applicable regulations prior to conducting the research.  This document and other important information is 
available on the HRPO website http://hrpo.wustl.edu/.  
 
 

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Aim 3: BREASTChoice RCT
PI:
Mary Politi
IRB ID #: 202005217
Project Details
1. Demographics
1.1
Project Title:
Implementing Breast Reconstruction Clinical Decision Support in Diverse Practice Settings
1.2
Short Title (required):
Aim 3: BREASTChoice RCT
1.3
Project is primarily:
Social Science/Behavioral (includes History/Anthropology)
1.4
Type of Study:
Other Interventional
1.4.a
Is your research study one in which one or more human subjects are prospectively assigned to one or more
interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-
related biomedical or behavioral outcomes (NIH clinical trial definition).
Yes
1.5
Select how you plan to obtain consent:
•  Sign a consent document or a consent letter
•  Letter or information sheet with no signature
•  Script for use either in person or over the phone with no signature
2. Source(s) of Support
2.1
Source(s) of Support
Type/Source
Grant Title
Name of PI on
Grant
Status
Federal Agency
Agency for Healthcare Research
& Quality (DHHS)
Implementing Breast Reconstruction Clinical
Decision Support in Diverse Practice Settings
Mary Politi, PhD;
Clara Lee, MD
AWARDED
3. Research Team
3.1
Principal Investigator
Name
E-mail
Title
Schoo
Mary Politi
mpoliti@wustl.edu
Prof of Surgery (Public Health Sciences)
School
3.2Team Members
Research Team Members
Role
Name
Role
Desc
Student
Email
Title
School
Department
Co
PI
Mary Politi, PHD
No
mpoliti@wustl.edu
Prof of
Surgery
(Public
Health
Sciences)
School
of
Medicine
Surgery -
Public Health
Sciences
(PHS)
Krista Cooksey, BA, CER
No
kcooksey@wustl.edu
Public
Health
Research
Coordinator
II
School
of
Medicine
Surgery -
Public Health
Sciences
(PHS)
Randi Foraker, PHD
No
randi.foraker@wustl.edu
Prof of
Medicine
School
of
Medicine
DOM -
General
Medical
Sciences

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Melissa Gendron, BS
No
mgendron@wustl.edu
Business
Analyst l
Central
Fiscal
Unit
(CFU)
CFU - WashU
IT - Capital
Projects
MyDay
Hannah Kinzer, BA, MPH
No
h.kinzer@wustl.edu
Graduate
Fellowship
Brown
School
Brown School
Administration
Terence Myckatyn, BSc(Hon), MD
No
myckatyn@wustl.edu
Prof of
Surgery
(Plastic &
Recon
Surg)
School
of
Medicine
Surgery -
Plastics
Margaret Olsen, PHD
No
molsen@wustl.edu
Statistical
Data
Analyst III
School
of
Medicine
DOM -
Infectious
Diseases
Viktoria Schmitz, BS, Public Health
No
schmitzv@wustl.edu
Public
Health
Research
Coordinator
II
School
of
Medicine
Surgery -
Public Health
Sciences
(PHS)
Team Member Financial Interest
Name
Financial Interests
Mary Politi, PHD
none
Krista Cooksey, BA, CER
none
Randi Foraker, PHD
none
Melissa Gendron, BS
none
Hannah Kinzer, BA, MPH
none
Terence Myckatyn, BSc(Hon), MD
Company/Organization
Types
Allergan Medical and RTI
Surgical
Consulting Services not otherwise specified
No
Margaret Olsen, PHD
none
Viktoria Schmitz, BS, Public Health
none
4. Other Institutional Reviews/Requirements
4.1
Do any of the objectives of this study involve the diagnosis, prevention, screening, evaluation, treatment or support of
cancer patients?
Yes
4.2
Are more than 30% of the patients involved in this study likely to have an active cancer diagnosis?
Yes
4.12
Will a Certificate of confidentiality be used for this research?
No
4.13
Does this project need to be registered on ClinicalTrials.gov?
Yes
4.13.a
Who is the Responsible Party for registering this study in ClinicalTrials.gov?
Principal Investigator
4.21
Mark all that apply to your study:
1. Protocol
1.1
Is there a separate, written protocol that will be submitted in addition to this form? (Note: a grant application is not
considered to be a protocol)
No
1.2
Select up to three key words below that best describe this research study:
•  Public Health
•  Surgery
  • Plastic
1.3
Provide a short summary/abstract of the purpose and procedures of the study proposed in this IRB application.
DO NOT include information on studies not proposed in this application.
Use LAY terminology only. This must be easily understandable by IRB community members and nonscientists.

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DO NOT cut and paste technical abstracts from source of support applications that may not be understood by a
general audience.
Purpose:
Breast reconstruction after mastectomy is a highly personal decision. Although it can restore quality of life for many,
there are numerous risks associated with the procedure. The risk of complications exceeds that of most elective
procedures. A clinical decision support tool, BREASTChoice, with personalized risk information and patient preferences,
was created to be used to address these issues. The randomized control trial will evaluate whether the implementation
of BREASTChoice into usual care is more effective than a control website, at improving the quality of reconstruction
decisions.
Procedures:
This study aim will evaluate the effects of BREASTChoice on post-mastectomy breast reconstruction decision quality,
decisional conflict, and treatment choice in a multi-site randomized trial. After receiving their breast cancer diagnosis
from their breast surgeon and (when possible) before their plastic/reconstructive surgery visit discussing breast
reconstruction, participants will receive a link to the BREASTChoice tool or control website through MyChart or email if
they do not have a MyChart account. Depending on the clinic work-flow, the patients may be sent the tool or control
website: 1) by email, prior to their visit with the plastic or reconstruction surgeon, for them to complete from home or in
the waiting room (ideal and preferred approach); 2) by email or link, in person or virtually at the time of their plastic or
reconstruction visit, for patients that have same-day breast surgeon and plastic reconstruction surgeon visits, with time
to wait in between appointments; or 3) by email, after the plastic surgery appointment, if they have not yet made a
decision about reconstruction after mastectomy (e.g., if they are undergoing neoadjuvant chemotherapy, or they want
or need more time to decide on their surgery choices).
Participants in the intervention group will complete BREASTChoice, and a summary of their risks and preferences will be
sent to their plastic/reconstructive surgeon to view in the electronic health record. All participants will be sent a link to
complete an online survey after their plastic/reconstructive surgery visit. After enrollment, we will monitor participants’
breast reconstruction receipt including whether they opted to have breast reconstruction, and if so, the type and timing
of reconstruction.
Clinicians will be trained on BREASTChoice tool functions and how the tool is integrated into EHR. We will assess
clinicians’ shared decision making pre - and post-trial.
Prior to the beginning of the Randomized Control Trial (RCT), a pilot phase will be launched. The purpose of the pilot
phase is to test the workflow and procedures. We plan to recruit up to 20 patients, continuing until procedures are
smooth and ready for the randomized trial. We will follow the same procedures as the trial (above), other than
randomization, to test the workflow and tool use programming.
1.4
Specify your research question(s), study aims or hypotheses:
The main hypotheses of this study is that a workflow - aware clinical decision support tool, BREASTChoice, is more
effective than a control website at improving the quality of breast reconstruction decisions among women with
stages 0-III breast cancer, eligible for post-mastectomy breast reconstruction.
The goal of this aim is to evaluate the effects of the updated BREASTChoice on decision quality, decisional conflict,
and treatment choice in a randomized controlled trial in a diverse population. Patients considering mastectomy will
be randomized to BREASTChoice or an informational website.
1.5
Background and significance and/or Preliminary studies related to this project:
Decisions about whether to have breast reconstruction following a mastectomy due to breast cancer, when to have
it, and what type of reconstruction are often discordant with patients’ personal preferences about risk, appearance,
recovery, and number of surgeries. There are currently no reliable methods for integrating patient-specific
information into the clinician-patient encounter to personalize these decisions. Incomplete or insufficient information
could lead to unexpected complications, additional operations, and decision regret. Compared to most elective
procedures, major complications from breast reconstructive surgery are high. As many as 50% of patients having
reconstruction, experience wound complication and about 15% of patients experience complications that require
additional surgeries. For some patients, complications lead to 15-20 additional procedures.
Patients often lack knowledge of complication risks for reconstructive surgery. This lack of knowledge can lead to
poor satisfaction and regret. In one study, only 15% of patients understood potential risks and complications of post-
mastectomy reconstruction options. Additionally, gaps exists in how breast reconstruction decision – making is
addressed between clinicians and different populations. For example, Black women report unmet information needs
and have greater knowledge deficits about reconstruction. Older (65+) women are less likely to be offered
reconstruction compared to younger women.
Due to the higher risk of major complications from reconstructive surgery, and gaps in the decision making process,
the BREASTChoice (Breast Reconstruction Education And Support Tool) tool was developed in our earlier work. The
BREASTChoice tool helps women, who are undergoing a mastectomy, make decisions with their clinician about
reconstructive surgery based on their personal risk factors and preferences.
BREASTChoice incorporates personalized, predictive risk analytic modelling, developed and validated using
institutional and national claims data from over 17,000 patients. The tool is an interactive website and can be sent
through My Chart and integrated into the electronic health record. The formative work on this tool and subsequent
pilot testing demonstrated an increase in self-reported knowledge for patients in the intervention group, and
usability was high.
During Aim 1 of the current study, we conducted qualitative interviews with stakeholders including clinicians,
patients, informatics staff and hospital administrators to assess implementation barriers and facilitators, perceptions

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of the tool, views on relative advantages of implementation, difficulty of implementation, timing of implementation,
and external policies and incentives. We modified the tool based on this feedback, and identified clinic work-flow
processes that could impact implementation into usual care. Additionally, the study team updated the risk prediction
model using the latest peer-reviewed research.
Aim 2 of this study includes usability testing of this tool and examines optimal timing of intervention delivery and
refinement of BREASTChoice, focusing on changes that facilitate implementation into existing patient routines and
clinical workflows. We will embed the tool into the Epic EHR environment and facilitate its transferability to other EHR
platforms.
This current Aim (Aim 3) will conduct a multi-site randomized trial to evaluate the tool. This protocol is for our site-
specific procedures at Washington University in St. Louis (other sites will submit their own protocols to their own
IRBs, per discussion and approval by the funders and HRPO).
1.6
Literature cited/references (if attaching a grant enter N/A):
1. Gordon LG, Merollini KMD, Lowe A, Chan RJ. A Systematic Review of Financial Toxicity Among Cancer Survivors:
We Can’t Pay the Co-Pay. The Patient. 2017;10(3):295-309.
2. Zafar SY, Abernethy AP. Financial toxicity, part I: a new name for a growing problem. Oncology (Williston Park,
NY). 2013;27(2):80.
3. Fessele KL. Financial toxicity: Management as an adverse effect of cancer treatment. Clin J Oncol Nurs.
2017;21(6):762-764.
4. Bernard DS, Farr SL, Fang Z. National estimates of out-of-pocket health care expenditure burdens among
nonelderly adults with cancer: 2001 to 2008. Journal of Clinical Oncology. 2011;29(20):2821-2826.
5. Carrera PM, Kantarjian HM, Blinder VS. The financial burden and distress of patients with cancer: Understanding
and stepping‐up action on the financial toxicity of cancer treatment. CA: A Cancer Journal for Clinicians.
2018;68:153-165.
6. Davidoff AJ, Erten M, Shaffer T, et al. Out‐of‐pocket health care expenditure burden for Medicare beneficiaries with
cancer. Cancer. 2013;119(6):1257-1265.
7. Singleterry J. Costs of Cancer. American Cancer Society Cancer Action Network;2017.
8. Gilligan AM, Alberts DS, Roe DJ, Skrepnek GH. Death or Debt? National Estimates of Financial Toxicity in Persons
with Newly-Diagnosed Cancer. The American journal of medicine. 2018;131(10):1187-1199.
9. Abbott DE, Voils CL, Fisher DA, Greenberg CC, Safdar N. Socioeconomic disparities, financial toxicity, and
opportunities for enhanced system efficiencies for patients with cancer. J Surg Oncol. 2017;115(3):250-256.
10. Shankaran V, Jolly S, Blough D, Ramsey SD. Risk factors for financial hardship in patients receiving adjuvant
chemotherapy for colon cancer: A population-based exploratory analysis. Journal of Clinical Oncology.
2012;30(14):1608-1614.
11. Kelly RJ, Forde PM, Elnahal SM, Forastiere AA, Rosner GL, Smith TJ. Patients and physicians can discuss costs of
cancer treatment in the clinic. Journal of Oncology Practice. 2015;11(4):308-312.
12. Jagsi R, Ward KC, Abrahamse PH, et al. Unmet Need for Clinician Engagement Regarding Financial Toxicity After
Diagnosis of Breast Cancer. Cancer. 2018.
13. Zafar SY, Peppercorn JM, Schrag D, et al. The financial toxicity of cancer treatment: a pilot study assessing out-
of-pocket expenses and the insured cancer patient's experience. The oncologist. 2013;18(4):381-390.
14. Wong Y-N, Egleston BL, Sachdeva K, et al. Cancer patients' trade-offs among efficacy, toxicity and out-of-pocket
cost in the curative and non- curative setting. Medical care. 2013;51(9).
15. Zafar SY, Ubel PA, Tulsky JA, Pollak KI. Cost-related health literacy: a key component of high-quality cancer care.
Journal of oncology practice. 2015;11(3):171-173.
16. Schrag D, Hanger M. Medical oncologists' views on communicating with patients about chemotherapy costs: A
pilot survey. Journal of Clinical Oncology. 2007;25(2):233-237.
17. Politi MC, Kaphingst KA, Liu JE, et al. A Randomized Trial Examining Three Strategies for Supporting Health
Insurance Decisions among the Uninsured. Med Decis Making. 2016;36(7):911-922.
18. Housten A, Furtado K, Kaphingst K, et al. Stakeholders’ perceptions of ways to support decisions about health
insurance marketplace enrollment: a qualitative study. BMC Health Services Research. 2016;16(1):634.
19. Zhao J, Mir N, Ackermann N, Kaphingst KA, Politi MC. Show Me Health Plans: Dissemination of a Web-based
Decision Aid for Health Insurance Plan Decisions. Journal of Medical Internet Research. 2018;In press.
20. Smith KT, Monti D, Mir N, Peters E, Tipirneni R, Politi MC. Access is necessary but not sufficient: factors
influencing delay and avoidance of health care services. Medical Decision Making Policy and Practice. 2018.
21. MacQueen KM, McLellan E, Kelly K, Milstein B. A codebook development for team-based qualitative analysis.
Cultural Anthropology Methods Journal. 1998;10:31-36.
22. Coffey A, Atkinson P, eds. Making sense of qualitative data: Complementary research strategies. Thousand Oaks,
CA: Sage Publications; 1996.
23. Dzewaltowski D, Glasgow R, Klesges L, Estabrooks P, Brock E. RE-AIM: Evidence-based standards and a Web
resource to improve translation of research into practice. Annals of Behavioral Medicine. 2004;28(2):75-80.
1.7
Describe EACH of your participant populations
Include description of any control group(s)
Specify the Inclusion/Exclusion criteria for EACH group
Adult women (18+) in one of the study sites over an 18-month period, with a diagnosis of incident or recurrent stage 0-
III breast carcinoma will be eligible.
We will exclude patients with Stage IV disease (treatment is primarily medical, not surgical) or histology type besides
ductal/lobular carcinoma (e.g.,phyllodes, sarcoma; these rare tumors differ in treatment and prognosis). We will exclude
patients who have had prior mastectomy and are seeking delayed reconstruction, so that we can evaluate decisions
about reconstruction timing. We will exclude those without a malignancy (i.e., considering mastectomy for prophylaxis
only) because their reconstructive surgery visit or surgery may occur long after the initial consultation. We will exclude
patients who cannot give informed consent or use our study materials due to self-reported or observed cognitive, visual,

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or emotional barriers.
Plastic and reconstructive surgeons working at Barnes Jewish Hospital Siteman Cancer Center, Barnes Jewish West
County, and Christian Hospital North East, who provide breast reconstruction after mastectomy, are eligible for this
study.
We will exclude plastic and reconstructive surgeons working at other breast clinic locations, and surgeons who do
provider breast reconstruction care to patients who have undergone a mastectomy due to breast cancer.
1.8
Check all materials/methods that will be used in recruiting participants:
•  Telephone script
•  Ads/Brochures/Posters/News Release/Fliers
•  Email or letters
•  Website or Social Media (printed pages)
•  Other Materials  -  Video describing study to put on study website
•  Medical Records or Other PHI
•  Epic - MyChart
Attachment Name
Category
Version
Date Attached
R18_ surgeon screening email 9.3.2020clean.rtf
Recruitment: Email or
letters
3
09/03/20
R18_Patient_Phone_Script_screening_6.8.21.rtf
Recruitment Script: Phone
10
06/11/21
MyChart_email message to
patients_Aim_3_4.28.21.rtf
Recruitment: Email or
letters
11
04/29/21
R18_Aim3_Flyer_3.22.21 (3).rtf
Recruitment Materials:
Ads/Brochures/Posters/News
Release/Fliers
11
09/12/21
Website 7.27.21.rtf
Recruitment: Website
1
07/27/21
BREASTChoice_Recruitment_Video_(HD_1080_-
_WEB_(H264_4000)).mp4
Recruitment: Other
2
09/17/21
1.8.b
List the individual data elements you will access from the medical records (or other source of PHI) to identify potential
participants for recruitment and, if applicable, any individual data elements that you will include on a screening log prior
to consent.
We will review medical records for names, age, race, telephone numbers, mailing addresses, email addresses, language
spoken at home, and breast cancer diagnosis stage and previous breast cancer surgery.
We will collect participants’ reconstruction decision from the electronic health record after enrollment.
1.8.c
What is the plan for individual identifiers obtained to identify participants and, if applicable, those identifiers maintained
on a screening log prior to consent?
Identifiers for those who do NOT enroll will be destroyed at the earliest opportunity, consistent with the conduct of the
research (for example when recruitment and enrollment are completed.)
1.8.d
Does the research team agree that the requested information will not be reused or disclosed to any other person or
entity, except as required by law, for authorized oversight of the study, or for other research for which the use or
disclosure of the requested information would be permitted by the HIPAA Privacy Rule?
Yes
1.10
Describe where the consent discussion will occur (check all that apply):
•  By phone
•  Online
1.11
Participants and/or their legally authorized representative will have (check all that apply to the consent process and
explain process in Question 1.12 below):
•  Limited time based on when they must be treated clinically or when research procedures begin. However they:
Will have an opportunity to thoroughly review the consent materials with knowledgeable members of the
research team, with family and/or friends as appropriate
Will have sufficient time to have all of their questions answered
Will not be asked to consent when under the influence of drugs that have the potential to impact cognitive
abilities such as sedation.
Will not be asked to consent at a time when they may be unable emotionally to fully consider the consent
information (e.g. immediately following significant diagnosis.)
1.12
Provide a description of the enrollment and consent process in sequential order and address EACH of the bulleted points
below:
Describe each study population separately including control population
Describe when recruitment and consent materials are used
Indicate how much time individuals will have to consider participation
If eConsent will be used to obtain an electronic signature, describe how the eConsent will be presented to
participants, how their questions will be answered and how the participant will receive a copy of the final, signed
consent

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Describe the steps that will be taken by the research team to minimize the possibility of coercion or undue influence
during the consent process
The WU project coordinator will screen through EPIC to identify potentially eligible patients at the participating study
sites. They will retrieve the phone numbers, email addresses if available, and mailing addresses of potentially eligible
patients. Patients will be contacted after the patient has received their breast cancer diagnosis.
Then WU research staff can approach eligible patients by phone, after the breast surgery visit and before the
reconstructive surgery visit to provide study information. The patient can choose to complete the consent form 1) in
clinic (with signed consent document), 2) virtually (waiver of documentation of written consent by providing an
information sheet electronically), or the 3) WU research staff can review the consent information sheet with them over
the phone or zoom. The waiver of documentation of consent will be sent via secure email or MyChart (process approved
by the MyChart, Epic1, and BJC clinical informatics teams).
Because of the public health response to COVID19, we anticipate that some patients will have virtual clinical encounters
instead of in-person clinical encounters. If this occurs during the trial, participants would be offered electronic waiver of
documentation of informed consent information sheets or phone consent instead of paper consent forms. Study staff will
be available through phone, zoom or email to answer the participants' questions.
Depending on the circumstances (as described in the following), WU research staff may approach potential participants
in one of three ways.
1) If potential participants may be reached prior to their visit with the plastic or reconstruction surgeon, they will be
approached virtually, by phone, or in-person at the clinic before their appointment (preferred method).
2) For some participating sites that have same-day breast surgeon and plastic surgeon reconstruction visit clinic work-
flows, the study staff will not have a chance to contact these patients by phone for consent prior to their visit with their
plastic/reconstructive surgeon. These potential participants will be approached in person or virtually by the study staff to
provide information about the study and complete informed consent. Potential participants contacted virtually will be
sent e-consent forms.
3) Some potential participants may be approached after their breast reconstruction visit (but before they make their
reconstruction decision) due to clinic workflows that have same day breast and reconstruction surgeon visits, or clinics
that add a patient visit to the clinic schedule that day. These patients with same day breast surgeon and breast
reconstruction appointments will complete consent and study procedures after the reconstruction visits and before their
next reconstruction visit or surgery.
For recruitment, we will approach WUSM faculty who see patients that are eligible for the study. Before the study began,
Dr. Politi and Dr. Myckatyn presented the information about the study to WUSM’s Department of Surgery’s Division of
Plastic and Reconstructive Surgery. At the meeting, clinicians expressed interest in participating in the study. We will
retrieve eligible clinician email addresses and/or phone numbers from the WUSM system.
Eligible surgeons will be emailed by WU research staff with study information. If interested the research coordinator will
call the surgeon and review the phone consent information sheet. The surgeon could alternatively request a waiver of
documentation of informed consent or complete the consent in-person.
1.13
Provide a detailed description in sequential order of the study procedures following the consent process - DO NOT cut
and paste from the Consent Document.
Describe study populations separately if they will be participating in different procedures
DESCRIBE:
Control populations, if applicable
Any randomization, if applicable
What participants will be asked to do/what happens in the study (in sequential order)
The time period over which procedures will occur
Long-term follow-up and how it occurs
After the patient participant consents to be in the study, we will randomize (using computer random assignment, RCT
only) participants to view the clinical decision support tool, BREASTChoice or the attention control website
(https://www.cancer.gov/types/breast/reconstruction-fact-sheet), using block randomization (block size 4). Depending
on the clinic work-flow, the patients may be sent the link to the tool or control website: 1) by email or MyChart
message, prior to their visit with the plastic or reconstruction surgeon, for them to complete from home or in the waiting
room (ideal and preferred approach); 2) by email or MyChart, in person or virtually at the time of their plastic or
reconstruction visit, for patients that have same-day breast surgeon and plastic reconstruction surgeon visits, with time
to wait in between appointments; or 3) by email or MyChart, after the plastic surgery appointment, if they have not yet
made a decision about reconstruction after mastectomy (e.g., if they are undergoing neoadjuvant chemotherapy, or they
want or need more time to decide on their surgery choices). Participants will be sent the link via MyChart unless they do
not have a MyChart account. In that case, they will be sent the link via email. Study staff will be available to answer
questions about MyChart via phone or email.
The following privacy protections will be enacted for all email communications involving PHI; 1) a test email will be sent
to the participant to verify their identify (confirm correct recipient) and that this email will be sent in a secure manner
(i.e., [secure] in subject line); 2) The body of the email will instruct the participant to send all information as a response
to this thread and to not remove the "[secure]" from the subject line; 3) document in your research records the
participant's agreement to provide information over email.

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We will randomly choose to audio-record the visits of 20% of participants with their plastic surgeon. We have included in
our consent documents for patients and clinicians that their visit may be audio recorded. As part of the consent
documents we ask participants if they are willing to have their visit audio recorded. If they say no, they can still be a
part of the study.
Clinicians who consent to participate in the trial will receive a brief virtual training on how BREASTChoice functions and
the features, including placement of the patient tool summary in the electronic health record. Clinicians will complete
pre/post trial survey about shared decision making. Clinician survey participation will take less than 5 minutes. They will
receive a $50 gift card as a thank you for their time.
BREASTChoice will be hosted in a secure location with a secure database, integrated with Epic by the BJC Center for
Clinical Excellence decision support informatics team. This team is working closely with the Epic team for security
compliance. The tool will use security authentication procedures, data encryption, the app Orchard, and exchange
information using Fast Healthcare Interoperability Resource (FHIR). The tool will undergo and receive approval through
the hospital security review process, which includes a vulnerability scan.
The tool will auto-populate patient health information from the electronic record. Participants can modify their personal
health information in the tool in case data such as current health conditions listed in their record are out-of-date, but
cannot modify their personal health information in the electronic medical record. Participants can view a summary at the
end of BREASTChoice that includes the tailored risk information and their values and preferences. The summary will be
sent to their clinician to view in the electronic health record, via the Epic portal. After patients view the BREASTChoice
tool or attention control website, all participants will complete an online survey assessing socio-demographics,
knowledge, values/preferences, health literacy, decisional conflict, measure of patient engagement, health-related
quality of life, preferred decision role, consult time and usability of the tool. All measures were chosen based on their
short length so as not to burden participants. After enrollment, we will monitor reconstruction receipt including type and
timing, and assess clinician satisfaction after Aim 3 study recruitment is complete.
Participation is expected to take about 25 minutes. Participants will receive a $20.00 gift card as a thank you for their
time.
1.14
Will participants be randomized?
Yes
1.15
Will any of the following be used to collect information from the participant or others?
Screening questions or screening/eligibility questionnaires
Surveys
Questionnaires
Stimuli
Any other written assessments
Yes
Attachment Name
Category
Version
Date Attached
Patient survey_intervention
Aim3_v8.docx
Subject Data Collection
Instruments
1
05/29/20
Patient survey_control
Aim3_v1.docx
Subject Data Collection
Instruments
1
05/29/20
Clinician survey SDM_Aim 3
pre_post_May2020.docx
Subject Data Collection
Instruments
1
05/29/20
1.16
Does this project involve creating any audio, video, or photographs?
Yes
1.17
Does the study include any form of deception (e.g., providing participants with false information, misleading information,
or withholding information about certain study procedures)?
Examples:
Procedure includes a cover story that provides a plausible but inaccurate account of the purposes of the research.
Participants will be provided with false information regarding the particular behaviors of interest in the research.
Procedures include a confederate pretending to be another participant in the study.
Participants will be told that the research includes completion of a particular task, when in fact, that task will not be
administered.
Study is designed to introduce a new procedure (or task) that participants are not initially told about.
No
1.18
Indicate any payments or reimbursements to participants (check all that apply)
Gift or Debit Card
1.19
Does this study have a plan to have an individual or committee review combined data from all participants on a periodic
basis (such as summary or aggregate safety and/or efficacy data)?
Yes, but it's not described in an attached protocol
A Data and Safety Monitoring Committee (DSMC) will be convened for this trial to review outcomes data at least
every 6 months following study activation. The DSMC will consist of no fewer than 3 members including 2 clinical

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investigators and a biostatistician. All DSMC members will be familiarized with the research protocols and plans for
data safety and monitoring. Like investigators, DSMC members are subject to university policies regarding standards
of conduct. Individuals invited to serve on the DSMC will disclose any potential conflicts of interest to the trial
principal investigator and/or appropriate university officials, in accordance with institution policies. Potential conflicts
that develop during a trial or a member’s tenure on a DSMC must also be disclosed. The DSMC report will be
prepared by the study statistician with assistance from the study team, will be reviewed by the DSMC.
1.20
What have you done to minimize any risks?
•  Other  -  It is possible participants may feel uncomfortable with some of the questions or photos in the tool. They can
skip any questions they do not want to answer, or skip parts of the tool. Another risk if a participant joins the study is
that confidential information about them may be accidentally disclosed. Their information will be secure, in password-
protected network drives that only the study team can access. We will identify participants by a number and not by
their name. We will report our findings in summary form and not linked to any one person.
1.21
What are the potential benefits related to this project for:
the participant (if any)
benefits to society (if any)
This project may not present a direct benefit to the participants. Some breast cancer patients randomized to the
BREASTChoice arm of the Aim 3 trial may benefit from receiving additional information about breast reconstruction,
their potential risk of complications, and evaluating their preferences. Society may benefit from the development of
new clinical communication tools for discussing breast reconstruction options with patients and clinicians.
1.22
Provide a summary of the analysis methods you will use, including, if applicable, the data points or outcomes you
will analyze.
Descriptive statistics will be calculated for demographic and clinical characteristics (race, age, comorbidities, etc.)
and for knowledge, preference concordance, decisional conflict, and CollaboRATE.
The primary endpoints of knowledge, preference concordance, and decisional conflict will first be evaluated with
univariate analyses through the use of t-tests and chi-square analyses as appropriate. We will explore the use of
transformations and non-parametric alternatives for these responses if necessary. We will use
generalized linear mixed models to explore differences between patients randomized to BREASTChoice and to the
control arm. Models will be adjusted for important clinical and demographic variables and will include relevant
interactions. Specifically, we will include an interaction between group (i.e., BREASTChoice or control)and time, to
test for differences in randomized group over time that could be due to changes in surgeon practices. A random
effect for surgeon will also be included in the model. Missing data will be handled through imputation, and
associations between covariates and the missing indicator will be explored. The same analytic procedure will be used
to examine the impact of BREASTChoice on patient engagement (CollaboRATE).
A secondary goal is to explore whether the intervention is associated with fewer high-risk patients choosing
reconstruction. Patients will be considered high-risk if their risk exceeds 2 times the population average.38 We will
explore whether age or race modifies the association between intervention and decision quality (knowledge and
preference concordance). Descriptive statistics will be calculated for these outcomes, and associations will be
assessed using appropriate chi-square or Fisher’s exact tests.
We also will explore whether provider intention to engage in shared decision making increases during the trial, by
examining changes in the mean of
the CPD-Reaction scale, through the use of the Wilcoxon signed-rank test. Preferred decision role will also be
assessed through chi-square or Fisher’s exact tests.
1.23
Provide the rationale or power analysis to support the number of participants proposed to complete this study.
The sample size needed to detect an effect size of 0.3 and power of at least 80% in decisional conflict, comparable
to what was seen in a similar study,122 is 170 per group. With this sample size,the study will be adequately powered
to detect at least a 15% difference in the percent of patients with knowledge scores > 50%, assuming that the
control group percentage of patients scoring > 50% is 34%.
If instead we wish to compare differences in knowledge score between groups, this same sample size will provide >
90% power to detect a difference of a mean 10 points. The effect size was also chosen based on an RCT aiming to
reduce decisional conflict about breast reconstruction via online decision aid (DA). That
study found that at 1 and 6 months, the DA group had significantly less decisional conflict (effect sizes of 0.35and
0.29, respectively). The DA group scored on average at levels consistent with having made a decision, while the
control group still had scores reflecting indecision. These differences can lead to clinically meaningful differences in
quality of life in cancer patients. In addition, the DA group had a reduction in decisional conflict to a level below a
cutoff for clinically significant scores (score <25), while the control group reported clinically significant decisional
conflict (score > 25).124 Thus, our effect size is both statistically and clinically meaningful.
1.25
Will any data from this project be stored for use in future research studies?
No
1.26
Does this project involve the collection or use of biological samples or genetic data?
No

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1.27
Are you requesting institutional certification to contribute human data or samples to a repository or database for broad
sharing (public or restricted access)?
No
2. Participants
2.1
Will there be any adult participants?
Yes
2.1.a
How many adult participants do you expect to consent or enroll under a waiver for this project?
240
2.1.b
What is the age of the youngest adult participant?
18.0
2.1.c
What is the age of the oldest adult participant?
No age limit
2.2
Will there be any minor participants?
No
2.3
Will there be any emancipated minor participants?
No
2.7
Do you plan to recruit/enroll non-English speaking people?
No
2.8
Do you propose to enroll any of the following in this study as participants?
Employee of the PI or employee of a research team member
Individual supervised by PI or supervised by member of research team
Individual subordinate to the PI or subordinate to any member of the research team
Student or trainee under the direction of the PI or under the direction of a member of the research team
No
2.9
Is this project about pregnant women?
No
2.10
Will this project involve fetuses?
No
2.11
Does this project involve the use of fetal tissue from any source?
No
2.12
Does this project recruit adult participants who may be incompetent or have limited decision-making capacity on initial
enrollment into the study?
No
2.13
Does this project involve prisoners as participants?
No
3. Performance Sites
3.1
Indicate type of site(s) where research will occur (check all that apply):
•  Hospital
•  Academic Institution
3.2
Where will project procedures take place (check all that apply)?
School of Medicine
Other WUSTL campus site - Christian Hospital NE and Barnes Jewish West County WUSM clinics
3.3
Is this project also being conducted by other researchers at their own sites (e.g. a multi-site collaborative project)?
Yes
3.3.a
What is your site's role(s) for this project (check all that apply)?
Clinical/participating site
Data analysis, statistical analysis or data management

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3.3.g
What are participating site roles for this project?
Clinical/participating site - 2
Data analysis, statistical analysis or data management - Ohio State University, Columbus Oh
5. Privacy & Confidentiality
5.1
Indicate your plans to protect the privacy interests of the participants during the conduct of the study (check all that
apply):
•  Only the minimum necessary private information is collected for the purposes of the study
•  Any procedures or interventions conducted as part of the study will be conducted in private setting to the extent
possible
•  Recruitment/consent will occur in a private setting
•  Participants will be able to ask questions in a private setting
5.2
Are you collecting or using the Social Security Number of any participants for any purpose?
Yes
5.2.a
Provide the intended usage of SSN:
To provide compensation to participants
5.3
Project uses paper or hard copy consents, surveys, data collection forms, research subject binders, or other hard copy
materials (check all that apply):
Yes
•  All materials are stored in secured environment
•  Access is limited to research team members only
5.4
Project collects, stores and/or transmits electronic data on mobile devices, desktop computers, servers including cloud
servers, email, or any other information in electronic form (check all that apply):
Yes
•  Password protected
•  Access is limited to research team only
•  Data are encrypted
•  Data in Redcap
•  Other  -  The BREASTChoice tool will be approved by the Barnes Jewish Hospital security review team prior to the
start of the trial and will undergo and pass a vulnerability scan to be approved for use in the clinic. The tool uses
secure authentication methods, Fast Healthcare Interoperability Resource (FHIR), the app Orchard, and is house
outside of the electronic health record.
5.5
Project collects or uses biologic specimens (check all that apply):
No
5.6
Identify any additional protections in place for data and or samples (check all that apply):
•  Formal research staff training process