Comparative Effectiveness of Encounter Decision Aids for Early-Stage Breast Cancer Across Socioeconomic Strata
Phase: NA
Conditions: Breast Cancer
Sponsor: Dartmouth-Hitchcock Medical Center

 
1 
 
Comparative effectiveness of encounter decision aids for early 
stage breast cancer across socioeconomic strata 
  
Trial Protocol 
 
Principal Investigator: Glyn Elwyn 
  
Clinical trial registration number: NCT03136367 
  
Funded by: Patient Centered Outcomes Research Institute (PCORI) 
  
Sponsor: Trustees of Dartmouth College 
 
Version number: v3.2 
 
28 April 2020 
 
 
 

 
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Table of Contents 
1 
Protocol Summary .............................................................................................................. 7 
1.1 
Lay Summary ................................................................................................................................. 7 
1.2 
Scientific Abstract ........................................................................................................................ 8 
2 
Research Team ................................................................................................................. 10 
3 
Introduction ...................................................................................................................... 14 
3.1 
Background and Rationale ..................................................................................................... 14 
3.1.1 
Impact of the Condition on the Health of Individuals and Populations ..................... 14 
3.1.2 
Gaps in Evidence ................................................................................................................................ 15 
3.2 
Aims and Objectives ................................................................................................................. 17 
4 
Methods ............................................................................................................................... 20 
4.1 
Design ............................................................................................................................................ 20 
4.1.1 
Design Overview ................................................................................................................................. 20 
4.1.2 
Randomized Controlled Superiority Trial (Aims 1 and 2) ............................................... 20 
4.1.3 
Controlling for Contamination ..................................................................................................... 21 
4.1.4 
Adapting the Decision Quality Instrument ............................................................................. 21 
4.2 
Setting ........................................................................................................................................... 21 
4.3 
Participants ................................................................................................................................. 21 
4.3.1 
Randomized Controlled Superiority Trial (Aims 1 and 2) ............................................... 21 
4.3.2 
DQI Adaptation (Year 1) ................................................................................................................. 22 
4.3.3 
Explore Strategies that Promote the Encounter Decision Aids’ Sustained Use and 
Dissemination (Aim 3) ........................................................................................................................................ 23 
4.3.4 
Feasibility of Recruitment .............................................................................................................. 23 
4.3.5 
Stratification by SES .......................................................................................................................... 24 
4.4 
Interventions and Comparators ........................................................................................... 25 
4.4.1 
Intervention 1: Option Grid ........................................................................................................... 26 
4.4.2 
Intervention 2: Picture Option Grid ........................................................................................... 26 
4.4.3 
Comparator ........................................................................................................................................... 26 
4.5 
Outcomes ..................................................................................................................................... 26 
4.5.1 
Primary Outcome Measure ............................................................................................................ 27 
4.5.2 
Secondary Outcome Measures ..................................................................................................... 28 
4.6 
Translation Procedure ............................................................................................................ 29 
4.6.1 
Cognitive Debrief Interviews for Translation of Study Documents ............................. 29 
4.7 
Procedure .................................................................................................................................... 30 
4.7.1 
Trial Setup ............................................................................................................................................. 30 
4.7.2 
Testing the Information Sheet, Consent Forms, and Study Questionnaires ............. 31 
4.7.3 
Screening for Inclusion in the Randomized Controlled Trial .......................................... 31 
4.7.4 
Consent and Baseline Assessment .............................................................................................. 31 
4.7.5 
Randomization .................................................................................................................................... 33 
4.7.6 
Follow-up Assessments ................................................................................................................... 34 
4.7.7 
Monitoring Enrollment .................................................................................................................... 35 
4.7.8 
Tracking and Retaining Participants ......................................................................................... 35 
4.7.9 
Training .................................................................................................................................................. 36 
4.7.10 
Adherence to Protocol and Supervision ................................................................................... 36 
4.7.11 
Reporting Plan and Study Termination .................................................................................... 36 
4.8 
Analysis ........................................................................................................................................ 36 
4.8.1 
Power Calculation .............................................................................................................................. 36 
4.8.2 
Analysis Plan ........................................................................................................................................ 37 
4.8.3 
Analysis Corresponding to Aim 1 ................................................................................................ 38 
4.8.4 
Analyses Corresponding to Aim 2 ............................................................................................... 39 

 
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4.8.5 
Analyses Corresponding to Aim 3 ............................................................................................... 40 
4.8.6 
Secondary Analyses .......................................................................................................................... 40 
4.8.7 
Missing Data ......................................................................................................................................... 43 
4.8.8 
Heterogeneity of Treatment Effects ........................................................................................... 43 
4.8.9 
Access to the Dataset ........................................................................................................................ 43 
4.9 
Data Management ..................................................................................................................... 44 
4.9.1 
Data and Safety Monitoring Plan ................................................................................................. 44 
5 
Write-up and Dissemination ........................................................................................ 45 
5.1 
Dissemination and Implementation in Other Settings ................................................. 45 
5.1.1 
Academic Channels ........................................................................................................................... 46 
5.1.2 
Patient and Advocacy Organizations ......................................................................................... 46 
5.1.3 
Professional Organizations and Healthcare Delivery Systems ...................................... 47 
5.1.4 
Social Media and Lay Press ............................................................................................................ 47 
5.1.5 
Dissemination Symposia and Clinician Training Module ................................................. 47 
5.2 
Possible Barriers to Dissemination and Implementation ........................................... 48 
5.3 
Making Results Available to Participants ......................................................................... 48 
6 
Timeline .............................................................................................................................. 50 
7 
Engagement Plan ............................................................................................................. 54 
7.1 
Planning the Study .................................................................................................................... 54 
7.2 
Conducting the Study ............................................................................................................... 55 
7.3 
Understanding Patient Engagement in What Matters Most ....................................... 55 
7.4 
Principles for Engagement ..................................................................................................... 56 
7.4.1 
Reciprocal Relationships ................................................................................................................ 56 
7.4.2 
Co-Learning .......................................................................................................................................... 56 
7.4.3 
Partnership ........................................................................................................................................... 56 
7.4.4 
Trust, Transparency, Honesty ...................................................................................................... 57 
8 
Ethical Considerations ................................................................................................... 58 
8.1 
Adapting the Decision Quality Instrument (DQI) Subscale (Year 1) ....................... 58 
8.1.1 
Risk to Human Subjects ................................................................................................................... 58 
8.1.2 
Adequacy of Protection Against Risks ...................................................................................... 59 
8.2 
Years 1, 2, and 3: Randomized Controlled Trial (Aims 1 and 2) ............................... 60 
8.2.1 
Risk to Human Subjects ................................................................................................................... 60 
8.2.2 
Adequacy of Protection Against Risks ...................................................................................... 60 
8.3 
Interviews, field-notes and observations to explore strategies that promote the 
interventions’ sustained use (Aim 3) .............................................................................................. 61 
8.3.1 
Risk to Human Subjects ................................................................................................................... 61 
8.3.2 
Adequacy of Protection Against Risks ...................................................................................... 62 
8.3.3 
Protections Against Risk ................................................................................................................. 62 
8.4 
Education of Key Personnel on the Protection of Human Subject Participants ... 63 
8.5 
Potential Benefits of the Proposed Research to Human Subjects and Others ...... 63 
8.6 
Importance of the Knowledge to Be Gained ..................................................................... 63 
8.7 
Inclusion of Women and Minorities .................................................................................... 63 
8.7.1 
Planned Distribution of Subjects ................................................................................................. 63 
8.7.2 
Subject Selection Criteria ................................................................................................................ 63 
8.7.3 
Outreach Programs ........................................................................................................................... 64 
8.8 
Inclusion of Children ................................................................................................................ 64 
8.8.1 
Justification for the Exclusion of Children ............................................................................... 64 
9 
Study Management and Finance ................................................................................. 65 
9.1 
Trial Steering Group and Research Team ......................................................................... 65 
9.2 
Community Advisory Board .................................................................................................. 65 
9.3 
Data Safety Monitoring Board ............................................................................................... 65 

 
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10 
References .......................................................................................................................... 66 
11 
APPENDIX A. OPTION GRID .......................................................................................... 74 
12 
APPENDIX B. PICTURE OPTION GRID ........................................................................ 75 
13 
APPENDIX C. DECISION QUALITY WORKSHEET .................................................... 79 
14 
APPENDIX D. SAMPLE CONSENT DOCUMENTS ....................................................... 84 
14.1 Appendix D-1. Sample Information Sheet ......................................................................... 84 
14.2 Appendix D-2. Sample Consent Form ................................................................................. 86 
15 
APPENDIX E. TERMS OF REFERENCE ......................................................................... 88 
15.1 Appendix E-1. Community Advisory Board Terms of Reference .............................. 88 
15.2 Appendix E-2. DSMB Terms of Reference ......................................................................... 94 
16 
APPENDIX F. DSMB Charter ........................................................................................ 100 
 
 
 
 

 
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List of Abbreviations 
 
HIPAA 
Health Insurance Portability and Accountability Act  
NYU 
New York University 
PCORI 
Patient Centered Outcomes Research Institute 
SDM 
Shared Decision Making 
SES 
Socioeconomic status 
CITI 
Collaborative Institutional Training Initiative 
PI 
Principal Investigator 
BCS 
Breast-Conserving Surgery 
DQI 
Decision Quality Instrument 
CBPR 
Community-Based Participatory Research 
PRO 
Patient Reported Outcome 
DSMB 
Data & Safety Monitoring Board 
REDCap 
Research Electronic Data Capture 
TSG 
Trial Steering Group 
NH 
New Hampshire 
MO 
Missouri 
NY 
New York 
OOP 
Out-of-Pocket 
  
General Information 
This document provides details regarding the setup, conduct, and analysis of the Patient 
Centered Outcomes Research Institute (PCORI) funded study, “Comparative effectiveness 
of encounter decision aids for early stage breast cancer across socioeconomic strata.”  
 
Compliance 
This study will be conducted in compliance with the The Health Insurance Portability and 
Accountability Act (HIPAA), the Security Breach Notification Rule1, and the principles of the 
declaration of Helsinki, (1964) as revised in Tokyo (2004)2..  
 
 

 
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Key Study Personnel 
Principal Investigator (PI): Dr. Marie-Anne Durand 
Co-Principal Investigator: Dr. Glyn Elwyn 
Co-Investigator (New York University School of Medicine Site PI): Dr. Shubhada Dhage 
Co-Investigator (Washington University in Saint Louis Site PI): Dr. Mary Politi 
Co-Investigator (Montefiore Medical Center Site PI): Dr. Katie Weichman 
Co-Investigator: Dr. Julie Margenthaler 
Co-Investigator: Dr. A. James O’Malley 
Co-Investigator: Dr. Kari Rosenkranz 
Co-Investigator: Dr. Karen Sepucha 
Co-Investigator: Dr. Anna Tosteson 
Co-Investigator: Dr. Dale Vidal 
Consultant: Dr. Sanja Percac-Lima 
Consultant: Dr. Robert Volk 
Consultant: Dr. Elissa Ozanne 
Patient Partner: Eloise Crayton 
Patient Partner: Sherrill Jackson 
Patient Partner: Linda Walling 
Patient Partner: Ann Bradley 
 
Signatures 
The Contact Principal Investigator (M-A Durand), and Principal Investigators (PI) at each site 
have discussed this protocol. The investigators agree to perform the investigations and to 
abide by this protocol except in case of medical emergency or where departures from it are 
mutually agreed in writing. 
  
Name:  …………………………………                      Role: Contact PI 
 
Signature: ……………….……………                       Date: ……………………. 
  
Name:  …………………………………                      Role: Site PI (NYUSOM) 
 
Signature: ……………….……………  
 
Date: ……………………. 
                         
Name:  …………………………………                    
Role: Site PI (WUSTL) 
 
Signature: ……………….……………  
 
Date: ……………………. 
 
Name:  …………………………………                    
Role: Site PI (Montefiore) 
 
Signature: ……………….……………  
 
Date: ……………………. 
 
 
 
 
 
 

 
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1 Protocol Summary 
 
1.1 Lay Summary 
 
 
Nearly one in eight women will be diagnosed with breast cancer. This diagnosis is traumatic 
and life changing for all women. Breast cancer care, breast cancer treatments, and the effect 
on women’s lives are often worse for women of lower socioeconomic status (SES) and lower 
health literacy. They are more likely than women of higher SES to experience lower knowledge 
of breast cancer surgery, higher uptake of mastectomy, increased decision regret, worse 
patient-centered health outcomes, and poorer care. These disparities are differences that are 
unlikely to be explained by the patient’s preferences but are partly explained by difficulties 

 
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accessing and understanding information, doctor-patient communication, lack of involvement 
in treatment decisions, etc. 
 
We aim to understand how best to help women of lower SES make high quality decisions 
about early stage breast cancer treatments. Their choice should ideally be informed by 
adequate knowledge and aligned with their values and preferences. We will be comparing two 
effective patient decision aids used in the health care visit (Option Grid and Picture Option 
Grid) to usual care in women of higher SES and lower SES. We hope that the decision aids 
help all women (irrespective of SES) achieve higher decision quality and a treatment choice 
that is informed by their knowledge and preferences. In addition, we hope to demonstrate that 
women who have used the decision aids are meaningfully involved in treatment decisions, 
have lower anxiety, experience less decision regret and higher quality of life, and perceive 
more coordination and integration of care compared to women who receive usual care. We 
also hope to show that the Picture Option Grid can reduce disparities in decision-making and 
treatment choice between women of higher and lower SES.  
 
This project is important to patients because making the wrong treatment decision for early 
stage breast cancer will have serious consequences on the patient’s life and quality of life. 
This project is likely to change the way patients and clinicians make decisions about breast 
cancer surgery, regardless of SES.  
 
Patient and stakeholder partner involvement is an essential aspect of this study. Patient and 
stakeholder partners have been involved in designing the study, identifying the research 
questions, and choosing the outcomes to be measured. They will also be involved in 
conducting the study and monitoring progress and risks. At each site, one patient associate 
(a former breast cancer patient) will recruit patients with a research assistant and will collect 
data and contribute to data analysis. The patient associates’ continuous input in designing, 
planning, conducting, and managing the study will maximize the success of recruitment and 
data collection procedures as well as the applicability and implementation potential of the 
findings and intervention(s).  
 
1.2 Scientific Abstract 
Background: Breast cancer is the most commonly diagnosed malignancy in women. Despite 
improvements in survival, women of lower SES diagnosed with early stage breast cancer 
(compared to women of higher SES): 
- Continue to experience poorer doctor-patient communication, lower satisfaction with surgery 
and decision-making, and higher decision regret; 
- More often play a passive role in decision-making; 
- Are less likely to undergo breast-conserving surgery (BCS); 
- Are less likely to receive optimal care. 
 
Those differences are disparities that predominantly affect women of low SES with early stage 
breast cancer, irrespective of race or ethnicity. For early stage breast cancer, low SES is a 
stronger predictor of poorer outcomes, treatment received, and death than race or ethnicity. 
We define low SES as having a lower income and uninsured or state-insured status. We will 

 
9 
 
not use educational attainment as part of the inclusion criteria but will examine it using multiple 
informants analysis as an indicator of lower SES (see Section 4.7 Statistical Analysis).  
 
BCS is the recommended treatment for early stage breast cancer (stages I to IIIA) although 
research confirms equivalent survival between mastectomy and BCS. Both options are offered 
yet have distinct harms and benefits, valued differently by patients. Research shows that 
women of low SES are not usually involved in an informed, patient-centered dialogue about 
surgery choice. There is no evidence that women of low SES have distinct preferences that 
explain a lower uptake of BCS and limited engagement in decision-making. Further, 
communication strategies are not typically adapted to women of low SES and low health 
literacy. Most patient decision aids for breast cancer have been designed for people at high 
literacy levels and have low accessibility and readability. It is critical to determine how to 
effectively support women of low SES in making informed breast cancer surgery choices. 
There is some evidence that simpler, shorter decision aids delivered by clinicians in the clinical 
encounter (encounter decision aids) may be more beneficial to underserved patients and 
reduce disparities, but further research is needed. 
 
Objectives: First, we will assess the comparative effectiveness of two encounter decision aids 
(Option Grid and Picture Option Grid) against usual care on a patient-reported measure of 
decision quality (primary outcome), shared decision-making, treatment choice, and other 
secondary outcomes across socioeconomic strata (Aim 1). Second, we aim to explore the 
effect of the Picture Option Grid on disparities in decision-making (decision quality, knowledge, 
and shared decision-making) and treatment choice, as well as mediation and moderation 
effects (Aim 2). Third, in order to maximize the implementation potential, we will explore 
strategies that promote the encounter decision aids’ sustained use and dissemination using a 
theoretical implementation model (Aim 3).  
 
Design: We will conduct a three-arm, multi-site randomized controlled superiority trial with 
stratification by SES (Aims 1 and 2) and randomization at the clinician level. Six hundred (half 
higher SES and half lower SES) will be recruited from four large cancer centers. In preparation 
for the trial (Year 01), we will conduct semi-structured interviews with women of lower SES 
who have completed treatment for early stage breast cancer at all four participating sites, to 
adapt the “What Matters Most to You” subscale of the Decision Quality Instrument (DQI) for 
women of lower SES. Lastly, we will use interviews, field-notes, and observations to explore 
strategies that promote the interventions’ sustained use and dissemination using the 
Normalization Process Theory (Aim 3). Community-Based Participatory Research (CBPR) 
methods will be used throughout the trial with continuous patient and stakeholder involvement.  
 
Population: We will include women at least 18 years of age with a confirmed diagnosis of 
early stage breast cancer (I to IIIA) from both higher and lower SES, provided they speak 
English, Spanish, or Mandarin Chinese.  
 
Interventions: Both interventions have been developed, tested, and shown to be effective. 
The Option Grid (intervention 1) is a one-page, evidence-based summary of available options 
presented in a tabular format, listing the trade-offs that patients normally consider when 
making breast cancer surgery decisions. The Picture Option Grid (intervention 2) uses the 
same evidence and tabular layout, but it is tailored to women of lower SES and low health 
literacy by having simpler text and images. Because patient decision aids are not routinely 

 
10 
 
available in real-world settings, usual care is a legitimate, reasonable comparator. Usual care 
will include the provision of routinely available informational resources about breast cancer.  
 
Outcomes: The primary outcome measure is the 16-item validated Decision Quality 
Instrument. Secondary outcome measures include CollaboRATE, a three-item validated 
measure of shared decision-making, PROMIS, an eight-item validated anxiety short form, the 
validated five-item Decision Regret scale, Chew’s validated one-item health literacy screening 
item, EQ-5D-5L, the validated 6-item quality of life measure, IntegRATE, a four-item measure 
of integration of health care delivery, four items from COST, an 11-item validated measure of 
financial toxicity, and one patient-reported measure of out-of-pocket expenses. All measures 
will be available in English, Spanish, and Mandarin Chinese. Observer OPTION5 will be used 
to rate the level of shared decision-making in the clinical encounter in a subsample of 
consultations. 
 
Analysis: We will use a regression framework (logistic regression, linear regression, mixed 
effect regression models, generalized estimating equations) and mediation analyses. We will 
use multiple informants’ analysis to measure and examine SES and use multiple imputation 
to manage missing data. We will also perform heterogeneity of treatment effects analyses for 
SES, age, ethnicity, race, literacy, language, and study site. 
2 Research Team 
Marie-Anne Durand, BSc, MSc, MPhil, PhD, CPsychol (Principal Investigator) is an assistant 
professor at The Dartmouth Institute for Health Policy and Clinical Practice at the Geisel 
School of Medicine. She is the study contact PI and brings considerable experience of 
managing and leading research on the development and evaluation of interventions designed 
to improve patient engagement in health care and address healthcare disparities by targeting 
and empowering those who are underserved. She will be supported and mentored by 
Professor Glyn Elwyn. Drs. Durand and Elwyn will have shared decision-making authority and 
responsibility for planning, directing, and executing the proposed study. Dr. Durand, as contact 
PI, will be responsible for day-to-day logistical project management.  
 
Glyn Elwyn, MD, MSc, FRCGP, PhD (co-Principal Investigator) is a tenured professor and 
physician-researcher at The Dartmouth Institute for Health Policy and Clinical Practice at the 
Geisel School of Medicine. As co-Principal Investigator, he brings substantial experience and 
internationally recognized expertise in research that seeks to understand how to effectively 
facilitate and implement SDM in routine clinical care.  
 
Shubhada Dhage, MD, FACS (Site Principal Investigator) is a breast surgeon at Bellevue 
Hospital Center, associate director of Diversity in Cancer Research at New York University, 
and co-director at Bellevue Breast Clinic, New York, NY. She has interest and expertise in 
promoting informed choice in underserved and low literacy patients and reducing healthcare 
disparities in breast cancer care. She works with patients who originate from over 80 countries, 
and who, for the majority, do not speak English. Dr. Dhage is committed to facilitating the 
involvement of the entire breast care team in the randomized controlled trial and will coordinate 
the recruitment of patients at Bellevue Hospital Center and NYU Langone Medical Center.  
 
Mary C. Politi, PhD (Site Principal Investigator) is a clinical psychologist and associate 
professor in the Division of Public Health Sciences, Department of Surgery at Washington 

 
11 
 
University School of Medicine, St. Louis, MO. Her research focuses on using systematic 
methods to help patients work through the uncertainties of health decisions through 
developing and evaluating patient decision tools, examining techniques to aid patient-clinician 
discussions about health decisions, and exploring ways to improve communication about 
risks. She also investigates the influence of numeracy and health literacy on medical decision-
making. She will oversee the study design, recruitment activities, data analysis and 
dissemination of findings in the St. Louis region. 
 
Katie E. Weichman, MD (Site Principal Investigator) is a breast reconstruction surgeon at the 
Montefiore Einstein Center for Cancer Care, Bronx, NY. She has interest and expertise in 
reducing health care disparities in breast cancer care and works with one of the most diverse 
populations in the country. Dr. Weichman is committed to facilitating the involvement of the 
entire breast care team in the trial and will coordinate the recruitment of patients and execution 
of the trial at Montefiore.  
 
Julie Margenthaler, MD (Co-Investigator) is a professor of surgery at Washington University 
School of Medicine and the Director of the Joanne Knight Breast Health Center, St. Louis, 
MO. She has undergone fellowship training in breast diseases and breast surgical procedures 
with specific training and expertise in key research areas for this application. One of her clinical 
and research areas of interest has been in the investigation of breast cancer outcomes using 
large epidemiological databases. Dr. Margenthaler will facilitate recruitment in the Joanne 
Knight Breast Health Center and will work with Dr. Politi on dissemination of findings in the St. 
Louis region. 
 
A. James O’Malley, PhD (Co-Investigator) is a professor of biostatistics at The Dartmouth 
Institute for Health Policy and Clinical Practice, Geisel School of Medicine. He will bring high-
level expertise in statistical methodology and comparative effectiveness research and will 
provide leadership and guidance to the project manager in the development and maintenance 
of data management systems and the analysis of trial data.  
 
Anna Tosteson, ScD (Co-Investigator) is the James J. Carroll Professor in Oncology and 
professor of Medicine, of Community and Family Medicine, and of The Dartmouth Institute for 
Health Policy and Clinical Practice at the Geisel School of Medicine. She co-directs the Cancer 
Control Program at the Norris Cotton Cancer Center (NCCC) and directs both NCCC’s Office 
of Cancer Comparative Effectiveness Research (CER) and The Dartmouth Institute’s CER 
Program. She will provide expertise on the impact of decision technologies on breast cancer 
care using her experience across the cancer spectrum, from screening to diagnosis to 
treatment. 
 
Renata W. Yen, MPH (Project Coordinator) will provide operational management of the project 
and will be responsible for the following aspects of the trial: managing all trial set-up activities 
including site enrollment and IRB approval, trial registration, record keeping, data 
management and maintenance, coordinating patient and stakeholder engagement activities 
including facilitating and coordinating all research meetings and relationships with our patient 
and stakeholder partners (i.e., monthly research team meeting, quarterly CAB meetings, 
quarterly trial steering group meetings), monitoring progress at other sites, and ensuring 
adherence to the trial protocol across all four study sites.  
 

 
12 
 
Research Assistants. The individuals in this role will have responsibility for recruiting patients 
into the study at each study site and will work closely with the patient associate to consent and 
randomize patients, and ensure that all study procedures detailed in the trial protocol are duly 
followed. At DHMC, the research assistant will also assist the project manager in coordinating 
recruitment across all four sites. In Year 01, the research assistants will be responsible for 
recruiting 10 to 15 participants for the adaptation of the Decision Quality Instrument subscale 
and will conduct focus groups and interviews with the project manager. At DHMC, the research 
assistant will also be responsible for analyzing all data related to the DQI interviews and focus 
groups from all participating sites. In years 01, 02, and 03, the research assistants will focus 
on recruiting eligible patients for the randomized controlled trial at each site. In years 02 and 
03, the research assistants will also conduct interviews with participants already enrolled in 
the trial and clinicians and other stakeholders at each site (Aim 3). At DHMC, the research 
assistant will also be responsible for the analysis of all Aim 3 data.  
 
Sherrill Jackson (Patient Partner) is an African American who has 24 years of experience as 
a breast cancer survivor. She is a nurse practitioner and has devoted her time to working in 
medically underserved and uninsured committees. She was employed at two Federally 
Qualified Health Centers and established their radiology and mammography departments. 
Both facilities were located in “hotspots” of the city where African American women were 
presenting with late stage breast cancer. On-site screening resulted in an increased number 
of women screened and, over time, a reduction in the mortality rate. Sherrill is also the 
president and founder of The Breakfast Club, Inc. (founded in 1997), primarily serving African 
American women residing in North St. Louis and the surrounding county.  
 
Eloise Crayton (Patient Partner) is an African American breast cancer caregiver and retired 
registered nurse who is committed to providing breast health education for low-income 
uninsured and underinsured women in the St. Louis, MO community. She is the program 
director and grant writer of The Breakfast Club, Inc., a group of breast cancer survivors and 
co-survivors focusing on reducing disparities in access to care and education in the 
community.  
 
Linda Walling (Patient Partner) is a breast cancer survivor who received a diagnosis of early 
stage breast cancer four years ago. She wished she had received more evidence based 
information and decisional support from her breast care team in making the best decision for 
her and coping with the aftermath of breast cancer. She immediately accepted to become a 
patient partner and has been involved in all aspects of study design and planning. She will 
play a pivotal role in planning and executing the study.  
  
Ann Bradley, BS, M.Ed. (Patient Partner and Patient Associate) is a registered nurse, who 
has recently retired and was previously working as a pastoral care coordinator and parish 
nurse of the Church of Christ at Dartmouth College, Hanover, NH. She has spent her 
professional life in the area of health education, health promotion, and health prevention. She 
is also a 23-year breast cancer survivor with a family history of breast cancer. Ann has already 
been involved in planning and designing the study and will continue to provide consultation as 
our patient partner. As the patient associate at Dartmouth, she will be responsible for helping 
with the recruitment of patients at NCCC and calling and reminding participants to complete 
all follow-up assessments. She will undergo relevant research training and will be trained and 
mentored in conducting research in clinical settings by the project coordinator. 

 
13 
 
  
Dale Collins Vidal, MD, MS (Stakeholder Partner) is the executive director of the Multi-
Specialty Clinic (MSC) at Alice Peck Day Memorial Hospital, Lebanon, NH. She is a former 
professor of surgery at Geisel School of Medicine at Dartmouth and the former medical 
director of the Center for Shared Decision Making at Dartmouth-Hitchcock Medical Center. 
She led the efforts to promote and implement patient centered care at Dartmouth for the past 
six years. Dr. Vidal will be available to the project on an as needed basis. 
  
Kari Rosenkranz, MD (Stakeholder Partner) is an associate professor of surgery and medical 
director of the Breast Cancer Program at Dartmouth-Hitchcock Medical Center. She will 
support the research team in recruiting patients and coordinating the randomized controlled 
trial at the Norris Cotton Cancer Center.  
  
Sanja Percac-Lima, MD (Consultant) is a primary care physician at Massachusetts General 
Hospital Chelsea Community Health Care Center, Boston, MA, serving predominantly low-
income, Latino, and immigrant populations. Her community work over the past 10 years has 
focused on improving equity in cancer care. She will be able to share the experience and 
perspectives of the low income, Latino communities she serves. 
  
Robert J. Volk, PhD (Consultant) is a professor of health services research at the University 
of Texas MD Anderson Cancer Center in Houston, TX. He heads the Decision Support Lab 
and new Shared Decision Making Collaborative at MD Anderson. He will provide expertise on 
evaluating decision aids in patients of lower SES and lower literacy with the aim to reduce 
disparities. He developed the computerized decision aid for breast cancer, which was 
evaluated in women of low literacy and was the only decision aid for breast cancer (until the 
Picture Option Grid) to be targeted at underserved patients.   
 
Karen Sepucha, PhD (Consultant) is the director of the Health Decision Sciences Center at 
Massachusetts General Hospital and assistant professor of medicine at Harvard Medical 
School. She will provide expertise in shared decision-making and measurement of decision 
quality and will advise the research team in adapting the Decision Quality Instrument (DQI) 
she developed for women of lower SES. She will also contribute to the analysis and 
interpretation of the adapted DQI. 
 
Elissa M. Ozanne, PhD (Consultant) is an associate professor of population health science at 
University of Utah School of Medicine. She will provide substantial expertise of conducting 
research in breast cancer prevention and treatment as well as developing and evaluating 
decision aids in clinical trials. 
 
 
 

 
14 
 
3 Introduction 
3.1 Background and Rationale 
3.1.1 Impact of the Condition on the Health of Individuals and Populations  
Breast cancer is the most commonly diagnosed malignancy and second leading cause of 
death in women3,4. Despite significant improvements in overall breast cancer survival, 
disparities persist in breast cancer treatment, communication in healthcare, long-term health 
outcomes and mortality5,6. Extensive evidence suggests that women of lower socioeconomic 
status (SES) diagnosed with early stage breast cancer have significantly poorer 
communication with their clinicians, lower knowledge of breast cancer surgery options, higher 
uptake of mastectomy, and worse cancer-related and patient-centered health outcomes 
compared to women of higher SES5-13. They also tend to receive breast cancer care that is 
inferior to that offered to women of higher SES and that deviates from established clinical 
guidelines (e.g., inconsistent use of radiation after breast conserving surgery; BCS)6,12. For 
the purpose of recruiting participants into the study, we define low SES as meeting the 
following two criteria: 1) 138% of the Federal Poverty Level or below and 2) uninsured or 
government-insured status (Medicaid or Medicare without supplemental insurance) or 
Accountable Care Act (ACA) marketplace plans14,15. Although educational attainment will not 
be used as part of the inclusion criteria, we will examine it using multiple informants analysis 
(see analysis section) and include it in our overall definition of lower SES. This definition is 
considered valid and relevant to the populations and outcomes under study14,16. 
 
SES-linked differences in early stage breast cancer care meet the Institute of Medicine (IOM)’s 
definition of a health service disparity: a difference in treatment or access not justified by 
differences in health status or preferences of the population groups17. There is no evidence 
that women of lower SES have distinct values and preferences that explain a significantly 
lower uptake of BCS and limited engagement in decision-making6,10,11. Differences in 
treatment received, doctor-patient communication, engagement in decision-making, and 
patient-centered health outcomes are disparities that predominantly affect women of low SES 
with early stage breast cancer, irrespective of race or ethnicity5,11,18. For early stage breast 
cancer, low SES is a stronger predictor of poor outcomes and treatment received than race or 
ethnicity19,20. 
 
Although BCS is the recommended treatment for early stage breast cancer (stages I to IIIA), 
research confirms equivalent survival between mastectomy and BCS21-24. Both options are 
offered routinely yet have distinct harms and benefits, which are valued differently by each 
patient25. In this context, patient preferences play an essential role in decision-making. 
According to the IOM, patient participation in decision-making should be promoted to improve 
the quality of health care, particularly for cancer care26-30. Our patient and stakeholder partners 
have emphasized the critical importance of supporting women in making high-quality breast 
cancer surgery decisions that are informed by adequate knowledge of breast cancer surgery 
and aligned with their values and preferences, regardless of SES and health literacy31,32. Only 
44 to 51% of women with early stage breast cancer across all socioeconomic strata achieve 
the degree of participation in decision-making they desire7,8,33-36. Poor knowledge of breast 
cancer surgery is commonly reported7,8,33-36. Women of lower SES with early stage breast 
cancer tend to experience lower knowledge of breast cancer surgery, receive lower quality of 
care, play a passive role in decision-making, and have higher decision regret and lower 

 
15 
 
satisfaction with both surgery and decision-making6,7,10,11,13. Research also suggests that 
surgeons tend to spend more time communicating and engaging with more educated, affluent 
patients than with patients from lower socioeconomic strata13. A review demonstrated that 
patients of lower SES received significantly less information and socio-emotional support while 
experiencing less partnership building and a more directive approach than patients of higher 
SES37. 
3.1.2 Gaps in Evidence 
Evidence Gap 1: How Can We Effectively Involve Women of Low SES in Breast Cancer 
Treatment Decisions? 
 
The gap analysis identified a number of reviews and systematic reviews that have highlighted 
the association between SES, participation in decision-making, and breast cancer 
disparities5,6,9,11,12,18. Hurd’s and Polacek’s reviews demonstrate that healthcare disparities 
cannot be eliminated unless underserved patients are appropriately informed and supported 
in making informed breast cancer surgery decisions6,11. It remains unclear, however, how best 
to promote participation in decision-making, improve decision quality and knowledge, and 
reduce disparities across socioeconomic strata11,38,39. 
 
Limitations and Benefits of Decision Aids for Patients of Low SES. Patient decision aids 
provide evidence-based information about the harms and benefits of reasonable healthcare 
options to help individuals deliberate about their preferences40. For breast cancer, they have 
been shown to influence treatment decisions, increase BCS uptake, reduce decisional conflict, 
increase knowledge and satisfaction with the decision-making process, and in some 
instances, improve quality of life32,41,42. However, research confirms that most communication 
strategies (including decision aids) are designed for highly literate audiences, have poor 
accessibility and readability, and are not tailored to the needs of women of low SES and low 
health literacy32,38,41,43-47. Except for one computerized pre-encounter decision aid evaluated 
in low-literacy women, decision aids for breast cancer have always been evaluated in women 
of higher SES39. 
 
The PI’s recent systematic review and meta-analysis indicate that decision aids significantly 
improved outcomes in underserved patients across disease areas38. Further, decision aids 
that were specifically tailored to underserved patients’ needs appeared most effective. The 
narrative synthesis also suggested that disparities in knowledge, decisional conflict, 
uncertainty, and treatment preferences between disadvantaged and more privileged patients 
tended to disappear after using a decision aid. Underserved populations may therefore benefit 
more than advantaged groups from such interventions. Despite guidelines suggesting that 
decision aids use plain language and high readability48, only a minority of decision aids use 
formats, layout, and content that are tailored to underserved patients’ needs38,44,45,48. 
 
Encounter Decision Aids. To date, most decision aids have been introduced to patients 
ahead of clinical encounters (i.e., pre-encounter decision aids). They have focused on 
providing extensive information, often on the Internet, with poor accessibility and readability44-
47. A systematic review of the readability and cultural sensitivity of web-based decision aids 
for cancer screening and treatment indicated that the vast majority of decision aids had low 
readability, complicated text, and a lack of cultural sensitivity47. Further, research has shown 
that although decision aids improve outcomes in controlled settings (with literate audiences), 

 
16 
 
their use in routine care remains rare because of resistance to implementation49. Clinicians 
argue that consultation time is limited and that complex pre-encounter decision aids are not 
designed for use in face-to-face encounters and disrupt workflows49-55. 
Shorter, simpler decision aids designed 
for 
use 
in 
clinical 
encounters—
encounter 
decision 
aids—have 
received less attention than complex 
pre-encounter 
interventions56. 
An 
encounter decision aid (see Fig. 1) 
provides evidence-based information 
about significant harms and benefits of 
available options, is used in the clinic 
visit to facilitate the elicitation of patient 
values and preferences, and enables 
clinicians to tailor information to patients’ 
needs and characteristics. They have 
been shown to increase patients’ knowledge and participation in decision-making, to improve 
risk perception, and in some instances, to influence choice and improve adherence to 
treatments57-62.  
 
Recent evidence suggests that encounter decision aids are successfully used by clinicians, 
do not increase consultation time, and are becoming routinely adopted in usual care with 
integration in the electronic medical record59,63-65. They are showing great promise in 
overcoming common implementation challenges63,64. Politi (Co-Investigator) et al. suggest that 
underserved patients may prefer and benefit more from shorter, paper-based encounter 
decision aids than from complex, digital interventions43. However, the effect of encounter 
decision aids in patients of low SES and low health literacy, and their potential to 
reduce disparities across socioeconomic strata, have never been evaluated. 
 
Tailoring Information to Reduce Disparities. When preparing information for low SES 
populations, it is imperative to recognize the barriers of limited health literacy and numeracy 
and to consider the use of images and easy-to-access formats such as paper-based 
interventions. Approximately 80 million US adults, many of whom have low SES, have low 
textual literacy and limited health literacy66-68. Healthcare professionals consider low health 
literacy a major barrier to involving patients in treatment decisions44,69,70. Patients’ abilities to 
benefit from decision aids largely depend on their capacity to understand and use the 
interventions available to them44,70. Tailoring information to patients of low SES, who typically 
have low health literacy, is essential, though it is largely overlooked11,45.  
Our proposal seeks to challenge this highly 
textual 
literacy-assuming 
paradigm, 
by 
comparing 
a 
validated 
pictorial 
encounter 
decision aid (Picture Option Grid) to a validated 
text-based encounter decision aid (Option Grid) 
across socioeconomic strata. 
Pictorial superiority is defined as the tendency to 
understand and remember concrete items more 

 
17 
 
easily when they are presented as pictures rather than words (see Fig. 2)71. Pictures facilitate 
conceptual processing and demand less cognitive effort than words72,73. There is evidence of 
visual literacy in people of lower textual literacy74. Research confirms that the use of pictures 
promotes understanding, compliance, and recall associated with health education 
information74,75. No studies have yet to compare the effectiveness of a pictorial encounter 
decision aid to a text-based encounter decision aid across socioeconomic strata. 
 
Evidence Gap 2: Why are Women of Low SES More Likely to Choose Mastectomy? 
 
 
Treatment disparities in breast cancer care have been extensively examined5,11,12,18,76-81. The 
literature suggests that treatment disparities are associated with patient-, clinician-, and 
system-level factors76,82. The reasons women of low SES are more likely to choose 
mastectomy over BCS, however, are not well defined10. A higher uptake of mastectomy in this 
group would not be a concern, provided that this choice was the result of an informed 
preference and not a treatment disparity (i.e., treatment not justified by differences in health 
status or preferences of the population group). In fact, there is no evidence that women of low 
SES 
have 
clear 
preferences 
for 
mastectomy10. 
Based 
on 
extensive 
research 
evidence5,6,9,11,12,18, we hypothesize that there is indeed a treatment disparity, which is strongly 
associated with less effective communication, lower knowledge of breast cancer surgery, and 
less participation in decision-making10,11,13. 
 
Other factors, such as limited financial resources and lack of insurance coverage, do not seem 
to predict decision-making for early stage breast cancer surgery83. There is no significant 
difference in monetary cost to patients between BCS and mastectomy, as BCS has higher 
short-term cost but lower long-term cost84. For many women of low SES, Medicare and other 
programs targeted at lower SES groups would cover the costs of either treatment, thus 
minimizing the impact of cost on decision-making. Other patient-level factors, such as 
childcare, transportation expenses, and other financial pressures (e.g., a need to return to 
work quickly) may be strong influences on the treatment choices of women of low SES 
irrespective of knowledge and participation in decision-making. The impact of these factors, 
however, is unclear and has not been demonstrated to date85,86. According to the literature, 
communication, accessible information, and participation in decision-making seem to play a 
significant (possibly the most significant) role in decision-making5,6,9,11,12,18. We hypothesize 
that encounter decision aids can address these issues and reduce disparities across 
socioeconomic strata. However, since it remains unclear how other factors (limited financial 
resources and other socioeconomic barriers) may affect decision-making, we will explore, in 
Aim 2, factors that may be mediating and moderating the intervention’s effect10,11,13,39. 
3.2 Aims and Objectives 
The three specific aims will be realized in the context of the logic model shown in Fig. 3: 
 
AIM 1: Assess the comparative effectiveness of two effective encounter decision aids (Option 
Grid and Picture Option Grid) against usual care on shared decision-making (SDM), decision 
quality, treatment choice and other direct outcomes in women, and differentially by 
socioeconomic status (SES).  
 

 
18 
 
Hypothesis 1. The encounter decision aids will increase SDM in the clinic visit and improve 
decision quality, knowledge, and quality of life in women of higher and lower SES compared 
to usual care. We also anticipate that they will reduce decision regret and improve the 
perceived integration of healthcare delivery (see Fig. 3). 
 
Hypothesis 2. The Picture Option Grid will be more effective than the Option Grid at 
improving primary and secondary outcomes in women of lower SES. There will be no 
difference between the effects of the two encounter decision aids in women of higher SES.  
 
AIM 2:  Measure the effect of the Picture Option Grid on disparities in decision-making 
(decision quality, knowledge, and SDM) and treatment choice, and conduct an exploratory 
analysis of the mediation and moderation effects.  
 
Hypothesis 1. Compared to the Option Grid and usual care arms, the Picture Option Grid will 
reduce disparities in decision quality, knowledge and participation in shared decision-making 
between women of lower and higher SES. It is also likely to reduce disparities in treatment 
choice.  
 
Hypothesis 2. The effect of the Picture Option Grid on treatment choice will be mediated by 
post-intervention knowledge, shared decision-making, and post-intervention values (reported 
in ‘What Matters Most to You’ subscale of DQI, e.g., keeping breast, removing breast to gain 
peace of mind, avoiding radiation, etc.) (see Fig. 4). 
 
Hypothesis 3. For women of lower SES, socioeconomic barriers (e.g., resource constraints, 
as reported in the Decision Quality Instrument) will affect treatment choice and thereby 
moderate the intervention’s effect. 
 
AIM 3: Explore strategies that promote the encounter decision aids’ sustained use and 
dissemination using a theoretical implementation model.  
 
Hypothesis 1. Pre-visit planning, minimal clinician training, flexibility of use, and integration 
into the workflow and EMR will facilitate sustained use. 
 
Hypothesis 2. Successful use by patients and their families will be determined by the 
perceived acceptability of the intervention and integration into workflows.  
 
 
 
 
 
 
 
 
 
 
 
 
 

 
19 
 
Fig. 3. Logic model of study 
 
 
* See Fig. 4 for mediation pathways. 
Legend: blue text = Personal level factors according to Cooper’s framework, green text = Clinician & system level factors 
according to Cooper’s framework, - - - - outline = outputs and outcomes of the randomized controlled trial  
 
 
Fig. 4. Causal model for patients enrolled in the trial 
 
 
 
 
Legend: Arrows depicted in green, red and blue represent causal relationships of one variable on another. The presence of 
green arrows will be examined in Aim 1. The presence of blue arrows (mediation effects) and red arrows (moderation effects) will 
be examined in an exploratory analysis in Aim 2. 
 
 

 
20 
 
4 Methods 
4.1 Design 
4.1.1 Design Overview 
We will use a three-arm, multi-site randomized controlled superiority trial with stratification by 
SES and parallel design (Aims 1 and 2). One thousand one hundred patients (half higher SES 
and half lower SES) will be recruited from four large cancer centers over a 18-month period. 
Randomization will be at the clinician level, nested within study sites, and will involve data 
analyst blinding. In preparation for the trial, we will conduct semi-structured interviews in Year 
1 with women of lower SES who have completed treatment for early stage breast cancer to 
adapt the “What Matters Most to You” subscale of the Decision Quality Instrument (DQI) for 
women of lower SES. For Aim 3, we will use interviews, field-notes, and observations to 
explore strategies that promote the encounter decision aids’ sustained use and dissemination 
using a theoretical implementation model. See study Gantt Chart on page 46.  
4.1.2 Randomized Controlled Superiority Trial (Aims 1 and 2) 
According to Cooper et al., the most appropriate design for evaluating interventions that aim 
to eliminate disparities is a classic experimental design with random assignment to 
experimental and control groups, with measurements of key variables pre- and post-
interventions82. We have thus chosen to conduct a three-arm, multi-site randomized controlled 
superiority trial with stratification by SES (high versus low) and randomization at the clinician 
level (nested within study sites) (see Fig. 5). 
 
Fig. 5. CONSORT* Study Flow Diagram 
 
*CONSORT stands for Consolidated Standards of Reporting Trials, as reported in the CONSORT statement87.  
 
At each site, we will use a cross-sectional study design and randomize participating clinicians 
(three to five clinicians per site) to one of three arms (Picture Option Grid, Option Grid, or usual 

 
21 
 
care). We will use an R script written by the study statistician to complete the surgeon 
randomization. At each site, patients who have given informed consent and are seeing one of 
the participating clinicians will be allocated to the clinician’s corresponding arm (Picture Option 
Grid, Option Grid, or usual care). Approximately the same number of patients in each 
socioeconomic stratum will be allocated to each arm. We will monitor accrual within each arm 
for each socioeconomic stratum at each site to ensure that a similar number of patients in 
each socioeconomic stratum receive each treatment. The total number of patients recruited at 
each site will be allowed to vary. 
4.1.3 Controlling for Contamination  
Since the randomization occurs at the clinician level, we are confident that the risk of 
contamination will be minimal88. However, to control for any potential contamination and 
assess the fidelity of delivering each intervention, we will audio-record a sample of clinical 
encounters. We will record consented patients. The digital recorder will be constantly present 
in the consulting room and a research assistant will be present to turn the recorder on when 
required. The research assistant will enter the room each time so the breast surgeon does not 
know when they are being recorded. The recording light on each recorder will be taped over 
so recording status can not be discerned. We will also ask all patients to indicate at T2 which 
intervention was used in the encounter, using images of each intervention, and will use both 
intention-to-treat and as-treated analyses. We will train all clinicians in delivering the 
intervention according to their allocated arm. Clinicians in usual care will not be trained in the 
use of the interventions. If there is residual contamination, the bias will be towards a null effect. 
We will therefore be confident that any significant findings are actual and arise as a result of 
the interventions. Since there are many more physicians than centers, we anticipate having 
greater power with physician level randomization than with site level randomization, even if 
the effect size we estimate is reduced by contamination.   
4.1.4 Adapting the Decision Quality Instrument 
In preparation for the comparative effectiveness trial, we will adapt the “What Matters Most to 
You” subscale of the Decision Quality Instrument (DQI)89. We aim to capture the factors 
(including potential barriers) that are important to women of lower SES when deciding about 
early stage breast cancer treatments and that are not currently captured in the DQI. We will 
conduct up to 45 semi-structured interviews with women of lower SES in both urban and rural 
settings.  
4.2 Setting 
The DQI adaptation interviews and randomized controlled trial will be conducted at four large 
cancer centers in the USA. The four study sites include: 
● Dartmouth-Hitchcock, Lebanon, NH and Manchester, NH 
● New York University (NYU) School of Medicine, New York, NY 
● Montefiore Medical Center, Bronx, NY 
● Joanne Knight Breast Health Center, St. Louis, MO 
4.3 Participants 
4.3.1 Randomized Controlled Superiority Trial (Aims 1 and 2) 
We will include 600 women at least 18 years of age with a confirmed diagnosis of early stage 
breast cancer (I to IIIA) (see inclusion/exclusion criteria below). Approximately half will be on 

 
22 
 
Medicaid or Medicare without supplemental insurance, or uninsured (lower SES population) 
and about half will be women with private insurance or Medicare with supplemental insurance 
(higher SES population) (see 4.3.4 for stratification by SES). 
Participants will be recruited across the four study sites over 18 months.  
 
To facilitate recruitment and retention, participants will be compensated for their time with a 
$15 gift card at T2, T3, T4, and T5. 
 
Participant Inclusion Criteria 
 
The study team at each study site will use the following inclusion criteria: 
 
● Assigned female at birth; 
● At least 18 years of age; 
● Confirmed diagnosis (via biopsy) of early stage breast cancer (stages I-IIIA); 
● Eligible for both breast-conserving surgery and mastectomy based on medical records 
and clinician’s opinion before surgery; 
● Spoken English, Spanish, or Mandarin Chinese. 
 
Participant Exclusion Criteria 
 
The following exclusion criteria will be used:  
 
● Transgender men and women; 
● Women who have undergone prophylactic mastectomy; 
● Women with visual impairment (because of the visual nature of the Picture Option 
Grid); 
● Women with a diagnosis of severe mental illness or severe dementia; 
● Women with inflammatory breast carcinoma. 
 
Women who are receiving neoadjuvant therapy will be invited to take part in the study in the 
first nine months of the trial in order to be able to complete all follow-up assessments before 
the end of the trial. Their T3 assessment will occur after the neoadjuvant therapy has been 
completed and post-surgery. This may occur up to 7 months after T0 (baseline).  
 
4.3.2 DQI Adaptation (Year 1) 
We will recruit up to 45 women of lower SES who have completed treatments for early stage 
breast cancer in the past three years to adapt the What Matters Most subscale of the DQI. We 
will use purposive sampling. Participants will receive a $15 gift card. 
 
 
Participant Inclusion Criteria 
 
- 
Assigned female at birth; 
- 
Between the ages of 18 and 74 years of age; 
- 
Government insured (without supplemental insurance) or uninsured (as well as ACA 
marketplace plans);  

 
23 
 
- 
138% of the federal poverty level or below; 
- 
Breast cancer surgery and radiation have been completed in the past three years; 
- 
At least spoken English. 
 
Participant Exclusion Criteria 
 
The following exclusion criteria will be used:  
 
- 
Transgender men and women; 
- 
Women who have undergone prophylactic mastectomy; 
- 
Women >74 years of age (as other treatment options may be relevant); 
- 
Women who are unable to complete the study procedures due to mental health 
impairment, cognitive impairment, or visual issues, as determined by the research staff 
or medical chart; 
- 
Women with inflammatory breast carcinoma.  
4.3.3 Explore Strategies that Promote the Encounter Decision Aids’ Sustained Use 
and Dissemination (Aim 3) 
We will conduct up to 100 interviews in total for Aim 3. A purposive sample  of 60 participants 
balanced in arm, SES, and age will be invited to take part in a semi-structured interview after 
completion of the final follow-up assessment (T4). We will also encourage the participant’s 
family or caregivers who are supporting the patient in making treatment decisions to attend 
the interview and share their perspective. Patients will be compensated with a $30 gift card. 
We will also include up to 10 healthcare professionals and other stakeholders per site, with 
and without involvement in the trial (up to 40 in total).  
4.3.4 Feasibility of Recruitment 
We aim to recruit 317 patients at Dartmouth-Hitchcock, Montefiore Medical Center, and 
Washington University in St. Louis (this number may vary depending on stratification and 
patient volume). Given the lower patient volume at NYU School of Medicine, we will aim to 
recruit 150 patients. At Dartmouth-Hitchcock, the screening exercise revealed that 339 women 
would have been eligible for participation in this study in 2014. This represents about 452 
women potentially eligible over 18 months. At the Joanne Knight Breast Health Center 
(Washington University in St. Louis), 724 women would have been eligible to take part in the 
proposed study in 2014, representing approximately 965 eligible participants over 18 months. 
At Montefiore Medical Center, 443 women would have been eligible to take part in the 
proposed study in 2014. This represents a total of approximately 591 eligible participants over 
18 months. Given a revised target sample size of 600 and varying recruitment by site, the per 
site enrollment will not reach these numbers, however we have accounted for this (see section 
4.8 - Analysis). 
 
Barriers to enrollment will be overcome by employing a research assistant and patient 
associate at each site throughout the study, by offering compensation for baseline and follow-
up assessments, by informing participants of the study in advance of their surgical 
consultation, by developing materials with our patient and stakeholder partners using plain 
language and translations into Spanish and Mandarin Chinese, by offering several modes of 
questionnaire completion, and by working with our Community Advisory Board (see section 

 
24 
 
7.2 Conducting the Study for more detail on the Community Advisory Board) and patient and 
stakeholder partners to overcome potential issues with recruitment. We have allocated two 
extra months for the analysis and write-up of the findings, in case recruitment would need to 
be extended. We anticipate that the attrition rate will be minimal given the brevity of the trial, 
and will implement various strategies to maximize recruitment and retention. 
 
Table 1. Recruitment Plan for the Randomized Controlled Trial 
Estimated number of potentially eligible study participants 
Based on administrative data: 2474 
Total number of study participants expected to be screened 
2400 
Total number of study participants expected to be eligible 
2200 
Target sample size 
600 
Total number of practices/centers that will enroll participants 
  4 
Projected month first participant enrolled 
September 2017 
Projected month last participant enrolled 
February 2018 
Projected rate of monthly enrollment  
40 
 
Table 2. Estimated Final Racial/Ethnic and Gender Enrollment 
Race 
Male (N) 
Female (N) 
Total (N) 
American Indian/Alaska Native 
N/A (women only) 
7 
7 
Asian 
N/A 
95 
95 
Black/African American 
N/A 
288 
288 
Hawaiian/Pacific Islander 
N/A 
3 
3 
White 
N/A 
596 
596 
Multirace 
N/A 
111 
111 
Ethnicity 
Male (N) 
Female (N) 
Total (N) 
Hispanic (Latino/Latina) 
N/A 
267 
267 
Non-Hispanic 
N/A 
833 
833 
 
4.3.5 Stratification by SES 
Insurance status (obtained from the patient’s records) will be used to screen for higher and 
lower SES (lower SES: uninsured, on Medicaid or Medicare without supplemental insurance 
or ACA Marketplace plans; higher SES: privately insured or Medicare with supplemental 
insurance). At baseline, we will collect information about median household income and 
highest educational attainment. Considering the populations and outcomes being studied, and 

 
25 
 
no existing gold standard for the measurement of SES, using household income (commonly 
used in US research and census data) and highest educational attainment to measure SES 
(in combination with insurance status) is considered an acceptable and relevant approach and 
one that follows Braveman et al.’s recommendations for the measurement of SES14,16,90. For 
each included participant, we will verify whether her income is consistent with the higher or 
lower SES group designation made at the initial screening. As part of the analysis, we will also 
examine educational attainment and use a multiple-informants analysis to examine SES (see 
Statistical Analysis). 
 
We will ensure that study participants are representative of the target population (i.e., women 
of higher and lower SES diagnosed with early stage breast cancer) by recruiting patients from 
four large cancer centers located in geographically diverse areas of the United States that 
provide a combination of urban (Joanne Knight Breast Health Center, St. Louis, MO, New 
York University School of Medicine, New York, NY, and Montefiore Medical Center, Bronx, 
NY) and rural (Dartmouth-Hitchcock, Lebanon, NH and Manchester, NH) settings as well as 
racially and ethnically diverse populations. The US Census Bureau rates the Bronx as the 
most diverse area in the US, with more than 50% of Hispanic or Latino origin91. Women 
diagnosed with early stage breast cancer at Bellevue Hospital Center (one of the hospitals 
associated with NYU School of Medicine) originate from approximately 80 countries, with 
varying race, ethnicity, and languages spoken (the majority of patients are Spanish and 
Mandarin Chinese speakers). In St. Louis, the proportion of African American women 
(approximately 23%) is higher than in the general US population. Dartmouth-Hitchcock serves 
a large and primarily rural population of patients in New England.  
4.4 Interventions and Comparators 
Encounter decision aids have been shown to increase patient knowledge, involvement in 
decision-making, decisional comfort, satisfaction, treatment adherence, and in some contexts, 
to influence choice56-60,92. They are showing great promise in controlled contexts and routine 
clinical settings63,64,93 and demonstrate efficacy and acceptability among underserved 
patients94-97. Their comparative effectiveness across socioeconomic strata is unknown.  
 
The interventions we have chosen are paper-based and range from one to four pages in 
length. The Picture Option Grid (specifically designed for women of low SES and low health 
literacy) has a Flesh-Kincaid grade level of 6.5. The Option Grid was written in plain language 
(in collaboration with the Plain English Campaign: www.plainenglish.co.uk) but was not 
specifically designed for women of low SES with a Flesh-Kincaid grade level of 6.6.  
 
Both interventions are delivered and used by the surgeon during the surgical consultation. By 
using the same medium and delivery mode, we have facilitated a direct comparison. 
 
Both interventions have been developed, tested, validated, and are already used in routine 
care (see below)59,94,95,97-99. 

 
26 
 
4.4.1 Intervention 1: Option Grid 
The Option GridTM encounter decision aid for early stage breast cancer surgery is a one-
page, evidence-based summary of available options presented in a tabular format (see 
Appendix A). The efficacy of Option GridTM decision aids has been tested in a stepped wedge 
trial, where they were shown to increase patients’ knowledge and SDM during the clinic visit59. 
Similar results were achieved using qualitative methods63,65,100,101. Option Grid decision aids 
are used in routine clinical practice and downloaded over 5,000 times a month 
(www.optiongrid.org)61. The Option Grid for breast cancer surgery was developed in 2010 and 
downloaded 1,346 times in 2016. It is evidence-based and was initially adapted from a web-
based decision aid shown to facilitate readiness to decide and strengthen surgery 
intentions98,99.   
4.4.2 Intervention 2: Picture Option Grid 
The Picture Option Grid was derived from the Option Grid for early stage breast cancer (see 
Appendix B). It uses the same evidence and integrates images and simpler text, thus 
exploiting pictorial superiority73,75. The Picture Option Grid has been specifically designed for 
women of lower SES and low health literacy. It was iteratively developed and tested in 
underserved community settings with lay women and breast cancer patients of low SES using 
CBPR97. We have tested its acceptability, feasibility, and perceived impact in 278 women of 
lower SES diagnosed with early stage breast cancer and with health professionals, comparing 
it to the Option Grid and to a comic strip pictorial encounter decision aid94,95. Most women of 
lower SES and health professionals deemed the Picture Option Grid most acceptable and 
usable. Several clinicians have since elected to use the Picture Option Grid in routine practice. 
4.4.3 Comparator 
Because decision aids are not routinely available in clinical settings, usual care is a 
legitimate comparator. For the purpose of this trial, usual care will include the provision of 
typical information resources about breast cancer that are currently available at each study 
site. These resources differ across study sites. To capture differences and ensure accurate 
portrayal of usual care at each site, we will collect detailed information about usual care at 
each site using methods derived from ethnography. We will also include questions about 
usual care at T2. 
4.5 Outcomes 
We have chosen outcome measures that are patient-centered and relevant to our target 
population with our patient and stakeholder partners. To accommodate varying levels of 
literacy and health literacy of our target group and to comply with patient partners’ advice, we 
will use validated short-form questionnaires whenever possible. All patient and stakeholder 
partners have deemed the chosen measures important and relevant, highlighting their impact 
on patients’ lives in both the short-term (e.g., treatment choice, anxiety) and longer-term (e.g., 
quality of life, decision regret). Aside from the Observer OPTION5 scale102, all are patient-
reported outcome (PRO) measures. All included scales and tests are validated and have been 
developed and tested with patients. The demographic questions and item assessing the 
amount of out-of-pocket expenses incurred by the participant over the past month have not 
been validated.  
 

 
27 
 
We will measure outcomes at baseline (T0), during the clinic visit (T1), immediately after the 
visit (T2), one week post-surgery or around the first post-operative visit (T3) and 12 weeks 
post-surgery or around the second post-operative visit (T4). For all participants who receive 
surgery before May 2018, we will also measure decision regret and financial toxicity one year 
post-surgery (T5).   
4.5.1 Primary Outcome Measure 
The primary outcome measure (see Table 3) is the validated 16-item Decision Quality 
Instrument (DQI) for breast cancer (see Appendix C), which includes a knowledge subscale89. 
The DQI, designed to be administered post-decision, will be assessed at T2 and T3. It aims 
to measure the extent to which patients are informed about their options, are involved in the 
decision-making process, and receive a surgery (mastectomy or BCS) aligned with their 
values, attitude towards risks, and preferences. It produces three scores: (1) knowledge, (2) 
concordance, and (3) decision process. Validation demonstrated good feasibility with minimal 
missing data and good 4-week retest reliability for both knowledge (ICC = 0.70) and 
concordance (ICC > 0.72). Discriminant validity was acceptable89. 
 
Table 3. Outcome Measures According to Data Collection Periods 
 
TIMEPOINT 
 
-T0 
T0 
Baseline 
T1 
In-Visit 
T2 
Post-
Visit 
T3 
1 wk PS* 
T4 
12 wks 
PS** 
T5 
1 yr PS 
CONSENT AND ENROLLMENT 
Eligibility Screen 
X 
 
 
 
 
 
 
Informed Consent 
X 
 
 
 
 
 
 
Allocation (via surgeon 
confirmation) 
X 
 
 
 
 
 
 
INTERVENTIONS 
Arm 1: Option Grid 
 
 
X 
 
 
 
 
Arm 2: Picture Option Grid 
 
 
X 
 
 
 
 
Arm 3: Usual Care 
 
 
X 
 
 
 
 
OUTCOME MEASURES 
Rates of recruitment – 
documented and tracked in 
REDCap 
 
X 
 
 
 
 
 
Discontinuation rates – 
documented and tracked in 
REDCap 
 
X 
 
X 
X 
X 
X 
Demographic data – 6 items, 
self-reported 
 
X 
 
 
 
 
 
Health literacy – 1-item Chew’s 
health literacy screening  
 
X 
 
 
 
 
 
Decision quality (primary 
outcome measure) – validated 
16-item DQI, subscale adapted 
for low SES 
 
 
 
X 
X 
 
 

 
28 
 
Knowledge – validated 5-item 
DQI knowledge subscale 
 
X 
 
(X) 
(X) 
 
 
Treatment intention – self-
reported via DQI 
 
 
 
(X) 
 
 
 
Treatment choice – obtained 
from medical records 
 
 
 
 
X 
 
 
Quality of life –  
validated 6-item EQ-5D-5L 
 
X 
 
 
 
X 
 
Anxiety – validated 8-item 
PROMIS anxiety short form 
 
X 
 
X 
X 
X 
 
Shared decision-making 
(observed) – validated OPTION5 
 
 
X 
 
 
 
 
Shared decision-making (self-
reported) –  
validated 3-item CollaboRATE 
 
 
 
X 
 
 
 
Decision regret –  
validated 5-item decision regret 
scale 
 
 
 
 
X 
X 
X 
Integration of health care 
delivery –  
validated 4-item IntegRATE 
 
X 
 
 
 
X 
 
Financial toxicity – four items 
from validated COST measure 
and self-report of out-of-pocket 
medical expenses in the past 
month 
 
 
 
 
X 
X 
X 
Intervention’s patterns of use – 
questions and photos of 
intervention 
 
 
 
X 
X 
 
 
System level factors + 
feasibility and acceptability in 
routine care 
Ethnographic methods 
Semi-structured interviews 
 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
X 
 
PS: post-surgery 
(X) included in full DQI 
* or first post-operative visit 
** or second post-operative visit  
 
 
4.5.2 Secondary Outcome Measures 
Secondary outcome measures will include treatment choice, assessed at T3 using patients’ 
medical records, treatment intention, the validated three-item CollaboRATE measure of 
shared decision-making (SDM)103,104, Chew’s validated one-item health literacy screening 
question105, PROMIS, an eight-item validated short form measure of anxiety106, EQ-5D-5L, the 
validated, standardized six-item quality of life measure107, the five-item validated decision 
regret scale108, and four items from COST, a validated financial toxicity measure109,110. We will 
also ask participants to estimate the out-of-pocket (OOP) portion of their medical expenses 

 
29 
 
over the past month. We will use the recordings of clinical encounters to analyze the extent to 
which SDM occurs using the five-item validated observer-rated OPTION5 scale102. We will also 
include a fidelity-of-use checklist derived from Wyatt’s work to assess the actual use of 
encounter decision aids56. Finally, we will use IntegRATE, a four-item generic patient-reported 
measure of integration of healthcare delivery111,112. At T2 and T3, we will also investigate each 
intervention’s patterns of use. At T2, the research assistant or patient associate will take a 
picture of each intervention post-consultation to determine how the intervention has been used 
and whether the patient/family and/or clinician have annotated it. At T3, participants will be 
asked to indicate how many times they used the intervention post-surgical consultation and 
whether family members, relatives, or caregivers have used the intervention. 
4.6 Translation Procedure 
For Spanish speakers, we will use the existing certified Spanish translations of the DQI, 
PROMIS anxiety short form, decision regret, EQ-5D-5L, and Chew’s one item health literacy 
screening question and will translate CollaboRATE, IntegRATE, COST, and OOP expenses 
question into Spanish. For Mandarin Chinese speakers, we will use the certified translation of 
EQ-5D-5L, PROMIS anxiety short form, and decision regret. We will translate all other 
measures into simplified Mandarin Chinese in Year 1. 
 
Our research group at the Preference Laboratory, Dartmouth College, has recently completed 
a review of best practices in translation of health-related materials for patients. On the basis 
of this review, we have developed a standard operating procedure for the translation of text 
into non-English languages comprising four stages: 
 
1. Two translators who are suitably qualified and native speakers of the target language 
create independent translations of the original text; 
2. A bilingual reviewer (who is a native speaker of the target language) compares the 
original text, Translation 1, and Translation 2, and either selects the preferred 
translation and offers revisions to the preferred translation, or produces a third 
translation that builds on the previous two; 
3. The translation committee (i.e., two independent translators together with the bilingual 
reviewer) meets to review and reconcile translations by consensus; 
4. The resulting translation is tested via cognitive debrief interviews with a small sample 
of patients fluent in the target language (see section 4.5.4). 
 
We have successfully adopted the above procedure in the translation of patient reported 
outcomes measures into Latin American Spanish113 and Polish. 
 
We will follow the above steps for the translation of all study-related documents.  
Spanish and Chinese interpreters or ‘language lines’ will also be available at each site 
before, during and after the clinic visit.  
4.6.1 Cognitive Debrief Interviews for Translation of Study Documents 
The study team has identified one Spanish and one Mandarin Chinese bilingual reviewer for 
the duties described in section 4.6. Daniela Agusti will be the Spanish bilingual reviewer. 

 
30 
 
Simon Chen will be the Mandarin Chinese bilingual reviewer. These reviewers will each 
conduct cognitive debrief interviews with four to five individuals to test the final translation of 
study documents. Participants in these interviews will be native speakers of the target 
language and identified through a purposive sampling strategy. Participants will be 
compensated the equivalent of $10 USD for their time. The bilingual reviewers will use the 
findings in the cognitive debrief interviews to finalize the translated study documents. 
4.7 Procedure 
4.7.1 Trial Setup 
Between November 2016 and May 2017, the study team will seek ethical approval from 
Dartmouth College’s Committee for the Protection of Human Subjects (CPHS) for the 
adaptation of the DQI and for Aims 1, 2, and 3. Dartmouth College’s CPHS will be the 
primary ethics committee reviewing those documents on behalf of Montefiore Medical 
Center. NYU School of Medicine and Washington University in St Louis will seek and obtain 
approval from their own committee for the protection of human subjects. We anticipate that 
ethical approval will be granted for all study activities by August 2017.  
 
In parallel, other study setup activities will include: 
 
1) Recruiting a research assistant and patient associate at each site. 
 
2) Designing all study documents in partnership with our patient partners, Community 
Advisory Board, and broader study team in preparation for the trial recruitment start 
date of September 2017.  
 
3) Translating all study documents (outcome measures, information sheets, 
interventions, etc.) into Spanish and simplified Mandarin Chinese. We have allocated 
10 months for the translation of these documents using the translation procedures 
outlined in section 4.5.3.  
 
4) Development and launch of the study website by the end of February 2017. 
 
5) Registration of trial on ClinicalTrials.gov. 
 
6) Establishing the Community Advisory Board (see section 7, Engagement Plan). 
 
7) Establishing the Data Safety and Monitoring Board. 
 
8) Carrying-out initial study site visits (January 2017).  
 
9) Ensuring that all relevant study team members and patient associates have 
undergone CITI training and made their COI declarations.  
 
10) Training all clinicians prior to the recruitment start date. This is likely to occur in early 
September 2017.  
 

 
31 
 
4.7.2 Testing the Information Sheet, Consent Forms, and Study Questionnaires 
 
The information sheet, trial consent document, and study questionnaires will be tested using 
one to two focus groups in Lebanon, NH and St. Louis, MO. Focus group participants will be 
recruited using a convenience sample based on availability, local contacts, and willingness to 
participate. Participants will be women aged 18-74, of both lower and higher SES, who have 
had breast cancer. They will be compensated with $15 gift cards for their participation. Food 
and beverages will be served at each focus group meeting. 
4.7.3 Screening for Inclusion in the Randomized Controlled Trial 
Insurance status (self-reported or obtained via EMR) will be used to screen for women of lower 
SES. For each included participant, we will check whether her income is consistent with the 
higher or lower SES group designation made at the initial screening or whether the patient 
belongs to the other group. As part of the analysis, we will also examine educational 
attainment and use a multiple-informants analysis to examine SES. 
 
At each study site, our research assistants will screen for eligible participants using the 
inclusion criteria outlined in section 4.3.1. Eligible participants will be identified in advance of 
each breast clinic by the breast care team and through the outpatient appointment system and 
pathology reports.  
 
At the Joanne Knight Breast Health Center and D-H patients who are eligible will receive an 
information sheet describing the study, sent on behalf of the breast care team at least one 
week before their surgical consultation. The information sheet will be short, written using plain 
language and pictures, and carefully developed with our patient partners, patient associates, 
and Community Advisory Board to address the needs of women of lower SES and low 
literacy/low health literacy. An introduction letter will accompany the information sheet. The 
letter will explain that the research team will call them a few days before their surgical 
consultation to discuss the study, support their decision on whether or not to take part, and 
help them complete the short baseline questionnaire over the phone using standardized 
interviews should they decide to participate. 
 
At NYU School of Medicine and Montefiore Medical Center the research assistant will 
approach pre-screened patients when they come for surgical consultations and discuss the 
study and potential for participation while they are waiting to see the surgeon. Patients will 
receive the information sheet at this time. At all sites, the patients may also receive a letter 
signed by the surgeon that briefly introduces the study.   
4.7.4 Consent and Baseline Assessment 
To promote patient-centeredness and facilitate recruitment among women of lower SES, a 
research assistant and a patient who has had breast cancer and has completed all treatments 
(“patient associate”) will recruit and consent all eligible participants at each study site. Each 
patient associate will be recruited from breast cancer advocacy groups, existing patient 
networks, and contacts already established at each site. An effort will be made to recruit 
patient associates from lower socioeconomic backgrounds.  
 

 
32 
 
Consent procedures will vary slightly at each site based on the patient flow and individual 
needs of each clinic however at each site the research assistant will be the primary role 
responsible for obtaining consent. At each site, written consent will be obtained for 
participation in the trial. 
 
At the Joanne Knight Breast Health Center, the patient associate and research assistant will 
send the information sheet and introduction letter to all potentially eligible patients and call 
them a few days before their scheduled appointment. They will go over the information sheet 
and offer to discuss the study in more detail with the patient over the phone. Each eligible 
patient will be told that she is potentially eligible for participation in the What Matters Most 
study but that eligibility will be confirmed by her surgeon during the appointment. Eligible 
patients will have an opportunity to ask any questions they may have and decline participation 
in the study at this stage. Once all questions have been answered, if patients choose to 
participate, they will give verbal consent to take part in the study, assuming their surgeon 
confirms eligibility during their upcoming clinic visit. Finally, the patient associate or research 
assistant will ask the patient a series of questions using standardized interviews to complete 
the baseline questionnaire. We have successfully used this approach with low SES groups 
before. An interpreter will also be involved when necessary. 
 
At Dartmouth-Hitchcock, the patient associate and research assistant will send the information 
sheet and introduction letter from their surgeon and on department letterhead to all patients 
deemed eligible based on medical record review and surgeon confirmation. They will call each 
patient a few days before their scheduled appointment to go over the information sheet and 
offer to discuss the study in more detail with the patient over the phone. Each eligible patient 
will be told that she is eligible for participation in the What Matters Most study based on her 
surgeon’s review of her medical record. Patients will have an opportunity to ask any questions 
they may have and decline participation in the study at this stage. Once all questions have 
been answered, if patients choose to participate, they will give verbal consent to take part in 
the study. Finally, the patient associate or research assistant will ask the patient a series of 
questions using standardized interviews to complete the baseline questionnaire. We have 
successfully used this approach with low SES groups before. An interpreter will also be 
involved when necessary. 
 
At Montefiore Medical Center and NYU School of Medicine the study team will approach pre-
screened and eligible patients when they come in for the surgical consultation. The research 
assistant and/or patient associate will introduce the study and discuss their interest in 
participation. Patients will receive the information sheet and may also receive a letter signed 
by the surgeon. If they decide to participate, provide written consent and complete the baseline 
questionnaire before the surgical consultation. This recruitment approach will also be followed 
at D-H in scenarios where the surgeon hasn’t confirmed eligibility prior to the appointment with 
enough time given to conduct verbal consent and the baseline assessment over the phone. 
 
At all four sites, in the event that a patient is unaware of her diagnosis prior to her surgical 
consultation, the surgeon will inform the patient of the study during the consultation and use 
the intervention (if in an intervention arm). After the appointment, the surgeon will introduce 

 
33 
 
the study and notify study staff if the patient is interested in participation at which point the 
research staff will obtain written consent and administer the questionnaires from T0 and T2. 
The study staff will approach the patient and introduce the study if the surgeon doesn’t mention 
the study to the patient after the consultation. 
Additionally, at all four sites, we will recruit participants after their surgical consultation if they 
explicitly request this when first approached about the trial. For these patients, research 
staff will obtain written consent and administer the questionnaires from T0 and T2 after the 
patient has her surgical consultation. 
 
See Appendix D for a sample information sheet and consent form.  
 
At all study sites, the patient associate and/or research assistant will attend the clinic whenever 
eligible patients are scheduled to attend a surgical consultation. They will be notified that the 
eligible patient has arrived by the registration staff.  
 
At the Joanne Knight Breast Health Center, surgeons will give a card with the study name and 
researchers’ contact details to all patients whose eligibility has been confirmed. The patient 
associate and/or research assistant will approach all patients who leave the consultation room 
with a card. The patient associate and/or research assistant will then check eligibility with the 
patient, obtain the signed consent, and help the patient complete the first follow-up 
assessment (T2).  
 
At D-H, if verbal consent and the baseline assessment were done over the phone, the patient 
associate and/or research assistant will obtain the written consent (either before or after the 
surgical consultation), and help the patient complete the first follow-up assessment (T2). If for 
any reason, the patient is deemed ineligible after their consultation with the surgeon, they will 
be unenrolled in the study.  
 
At NYU School of Medicine and Montefiore Medical Center, the first follow-up assessment will 
also be completed immediately after the surgical consultation.  
 
At all sites, the research assistant or patient associate will read the questions to patients who 
cannot read or write by using standardized interviewing procedures in a private room. We will 
document whether the questionnaires were read to the patient using a standardized interview 
and whether the assistance of an interpreter was needed. 
4.7.5 Randomization 
Randomization will be at the clinician level, nested within study sites. We will use an R script 
written by the study statistician for randomization of the surgeons. The statistician will be 
blinded to surgeon identification. At each site, patients who have given informed consent and 
are seeing one of the participating clinicians will be allocated to the clinician’s corresponding 
arm (Option Grid, Picture Option Grid, or usual care).  
 

 
34 
 
Approximately the same number of patients in each socioeconomic stratum will be allocated 
to each arm. We will monitor accrual within each arm for each socioeconomic stratum at each 
site to ensure that each arm has a similar number of patients in each socioeconomic stratum. 
The total number of patients recruited at each site will be allowed to vary. 
 
In the intervention conditions, each participant whose eligibility has been confirmed by the 
surgeon during the consultation will be given a copy of the Option Grid or Picture Option Grid 
by their surgeon and will use it in the clinic visit. 
 
In the usual care condition, the patients will receive care as usual and will be given a study 
card at the end of the consultation to signal to the research assistant or patient associate that 
the patient has been enrolled into the study.  
4.7.6 Follow-up Assessments  
During the clinic visit, we will audio-record clinical encounters with consented patients to 
assess the fidelity of intervention delivery (T1). After the visit, participants will be asked to 
complete a second questionnaire (T2). Two additional follow-up assessments will occur 
around 1-2 weeks (T3) and 12 weeks post- surgery (T4) (Fig. 5). For participants recruited in 
the first nine months of the trial, we will also conduct a follow-up assessment 1 year post-
surgery (T5). 
 
Follow up questionnaires will be administered in the clinic, when possible, and aligned with 
regularly scheduled return clinic visits. If this is not possible, follow-ups will be conducted either 
over the phone, online (sent as an email via REDCap), or on paper (sent via mail with a pre-
stamped, self-addressed envelope).  
 
To minimize respondent burden and disruption and to accommodate varying levels of literacy 
and health literacy, validated short-form questionnaires will be used. Each follow-up 
assessment (T2, T3, T4, and T5) comprises 10-34 items.  
 
We expect that T0 (baseline assessment) will take between 15 and 30 minutes. All subsequent 
assessments will take approximately 10 minutes.  
 
For each assessment, the outcome measures will be combined into one questionnaire to 
improve ease of use (see Table 4).  
 
Table 4. Number of items according to data collection point 
Measure 
Number of 
Items 
T0 
Baseline 
T2 
Post-Visit 
T3 
1 Week 
Post-
Surgery* 
T4 
12 Week 
Post-
Surgery** 
T5 
1 Year 
Post-
Surgery 
Health literacy  
1 
X 
 
 
 
 
Demographic survey 
6 
X 
 
 
 
 
Decision quality  
16 
 
X 
X 
 
 
Knowledge (5-item subscale of DQI)  
5 
X 
(X) 
(X) 
 
 

 
35 
 
Treatment intention (self-reported) 
1 
 
(X) 
 
 
 
Quality of life  
6 
X 
 
 
X 
 
Anxiety  
8 
X 
X 
X 
X 
 
Shared decision-making (self-reported)  
3 
 
X 
 
 
 
Decision regret  
5 
 
 
X 
X 
X 
Integration of healthcare delivery 
4 
X 
 
 
X 
 
Financial toxicity 
5 
 
 
X 
X 
X 
Total number of items 
 
30 
27 
34 
28 
10 
* or first post-operative visit  
** or second post-operative visit  
 
4.7.7 Monitoring Enrollment 
The research assistant will closely monitor enrollment at each site on a weekly basis. The 
number of patients screened by the breast care team, proportion eligible (and sent an 
information sheet), and proportion consented and recruited in-clinic (according to SES strata) 
will be collected on a screening log. We plan to share information on recruitment numbers with 
the core team on a weekly basis and with each clinic every two weeks. Should a participant 
drop out, the research assistant will notify the breast care team who will review the electronic 
medical record to identify a potential reason for attrition. We will specifically monitor 
recruitment in the lower SES strata on a weekly basis. Should recruitment in this group prove 
slower than expected, we will solicit the advice and expertise of our patient partners, patient 
associates, and Community Advisory Board members to identify solutions and implement 
additional recruitment strategies. 
4.7.8 Tracking and Retaining Participants 
The research assistant or patient associate employed at each site will track participants and 
ensure that they are called in advance of the follow-up assessments and provided with a 
questionnaire in the format of their choice. Interpreter services will be used whenever 
necessary. Telephone calls will also be made by the patient associates whenever they are 
available.  
 
Retention among patients of lower SES will be maximized by: 
- 
Using short-form validated measures; 
- 
Translating those measures into Spanish and simplified Mandarin Chinese; 
- 
Using interpreter services whenever necessary; 
- 
Calling (or emailing at Dartmouth) all participants three to five days before each follow-
up assessment  is due, prompting patients to complete the questionnaires and offering 
to conduct a standardized interview over the phone. The latter is likely to be particularly 
helpful in patients of lower SES and lower literacy/health literacy; 
- 
Conducting follow-up assessments in-person when possible; 
- 
Giving patients a choice of questionnaire format for the completion of baseline and 
follow-up assessments (online via email, paper-based, or standardized interviews); 
- 
Compensating participants for their time: $15 gift card at T2, T3, T4, and T5 for patients 
who complete the questionnaires. Brueton et al. identified monetary incentives as an 
effective way of improving participant retention114. 

 
36 
 
4.7.9 Training 
All participating clinicians will receive training in using the intervention they are randomized to 
and in how to adhere to the trial protocol. The training will include basic communication and 
risk communication skills. We will use videos and role-plays. For clinicians who are not able 
to attend a training session in person, an online module and video will be available.  
4.7.10 Adherence to Protocol and Supervision 
To maximize adherence to the trial protocol, we will train all co-investigators, research 
assistants, and patient associates at each site in recruiting patients according to the 
procedures outlined in the protocol and will ensure that all principal stakeholders have 
received appropriate CITI training. 
 
For the DQI adaptation interviews, the PI and research project coordinator will monitor 
adherence to the interview guide by reviewing the 1st and 5th interview transcript at each study 
site and providing feedback to the research assistants conducting interviews. We will follow 
the same process for the Aim 3 interviews.  
 
In addition, the protocol will be made available to all research team members and key 
stakeholders in a password protected section of the website. We will provide supervision, 
feedback and additional training to clinicians and other study staff, as necessary at 3 months, 
6 months, and 12 months into recruitment. Feedback will be provided using a preliminary 
analysis of the audio recordings of selected consultations across all three arms and field-
notes. 
4.7.11 Reporting Plan and Study Termination 
Our reporting plan will diligently adhere to the updated guidelines set-out in the CONSORT 
2010 statement for reporting randomized trials87 and will be sufficiently transparent and 
comprehensive to allow for assessment of the study’s internal and external validity. 
 
For participants recruited in the first nine months of the study, the study will end after 
completing the T5 assessment (1 year post-surgery). For all other participants, the study will 
end 12 weeks post-surgery or after Aim 3 interviews have been conducted (where applicable). 
Depending on the participant, the Aim 3 interview will take place at T4 or T5. All participants 
will resume usual care once the study has ended. 
4.8 Analysis 
4.8.1 Power Calculation 
For Aim 1, hypothesis 1, we base the effect size estimation on published data from randomized 
controlled trials of decision aids for breast cancer surgery32,41,115,116, suggesting that a 
reasonable effect size for DQI is 9.34, that the standard deviation between patients in the 
intervention arms compared to usual care is 12.00, and that a within-physician intra-class 
correlation (ICC) of 0.05 is reasonable. This ICC is justified because treatment varies within 
clinic, thereby allowing heterogeneity that occurs between physicians across centers to be 
blocked. We assume that four physicians will participate in the study at each of the four clinics 
(at least one assigned to each of the three trial arms at each center) and assume a patient 
attrition rate of 20%. Under these assumptions, a study of 1,100 participants (68.75 
participants per physicians and 366.66 per treatment group) has power of greater than 99.8% 

 
37 
 
to reject the null hypothesis that the encounter decision aid groups and the control group have 
equal means, using a two-sided 0.05 level test when the true mean difference is 9.34. Given 
recruitment difficulties due to seasonal trends in breast cancer diagnoses and a lower number 
of eligible patients than planned based on the feasibility assessments (see reasons in 
modification letter), the sample size has been revised to 600 participants. The power will 
remain above 80% for all primary hypotheses. 
 
A crucial feature of this power calculation is that the design-effect equals 4.04, implying that 
approximately 4 times as many patients are needed to obtain the same power as for a study 
with patient-level randomization. Power remains above the traditional 80% threshold with an 
ICC greater than 0.19, implying that the power remains adequate even if the level of clustering 
of patients within physicians is greater than anticipated. Further, the attrition rate of 20% is 
expected to be an overestimate given the brevity of the trial. The standard deviation between 
patients’ DQI values deliberately errs on the side of an overestimate; hence, power may be 
substantially greater. For hypothesis 2, we are basing the effect size estimation on the 
comparison between Picture Option Grid and Option Grid in women of lower SES. Because 
we anticipate obtaining a similar number of women in the higher and lower SES categories, 
the same power calculation is performed on a sample size of half the size. With 550 patients 
in total (34.375 patients on average per physician), under the same assumptions as above, 
the power for this subgroup test is 99% with ICC = 0.05 and 80% with ICC = 0.175. 
 
For Aim 2, the power of the test for disparities between higher and lower SES is necessarily 
lower than the overall test at the same effect size, as four groups are compared (Picture Option 
Grid higher SES, Picture Option Grid lower SES, Option Grid and usual care higher SES, 
Option Grid and usual care lower SES). However, because patient SES varies within 
physician, power can be conservatively computed as if the patient-level variance was doubled 
and the total number of patients halved. If the true difference in the effect of the Picture Option 
Grid on DQI between the higher and lower SES groups is 8.5 compared to Option Grid or 
compared to usual care, the power for a two-sided alpha-level test at the 0.05-level is just 
above 80%. With a revised sample size of 600 participants, the power is unlikely to reach 
80%. However, given those power calculations are resting on assumptions that may not be 
entirely accurate, we will know once we start the analysis if we have enough power for aim 2 
hypotheses with a sample size of 600 participants. A significant finding is even more likely to 
be obtained if the estimated variability in the data turns out to be much smaller than assumed 
here. It could indeed be the case with the revised sample size. It is not critical to account for 
multiple testing because in both the primary (Aim 1) and secondary (Aim 2) analyses, a single 
pair of groups is compared. 
 
We are assuming an effect size of 9.34 based on past studies of decision aids for breast 
cancer surgery32,41,115. 
4.8.2 Analysis Plan 
All data will be entered into REDCap, a secure research electronic data capture database 
(developed for the trial), and subsequently transferred to Stata for analysis. Initial examination 
of data will include descriptive statistics, frequency distributions, and histograms in order to 
identify outliers and missing data. All participants will be asked to indicate at T2 which 

 
38 
 
intervention they have received by being shown an image of each. Using this information, we 
will perform both an intention-to-treat and as-treated analysis. 
4.8.3 Analysis Corresponding to Aim 1 
Adapting the Decision Quality Instrument in Year 01. 
 
We will use a two-step thematic analysis derived from descriptive phenomenology, assisted 
by the computer software ATLAS-ti. First, the transcripts will be coded to identify DQI items 
and instructions that require adaptation. In a second and more detailed analysis, the 
interview transcripts will be coded according to all the themes discussed in the interviews, 
including spontaneously emerging themes. Similar codes will be merged and subsequently 
grouped into families of codes and networks. Dual independent coding will be used for 100% 
of all interview transcripts, to ensure reliability of coding and to agree the themes and family 
of codes for all remaining interview transcripts. Discrepancies among raters will be 
discussed until agreement is reached.   
 
Aim 1: Assess the comparative effectiveness of two effective encounter decision aids (Option 
Grid and Picture Option Grid) against usual care, on shared decision-making, decision quality, 
treatment choice and other direct outcomes in women, and differentially by SES. 
 
We will first perform separate analyses for each follow-up period using linear and logistic 
regression models as appropriate for continuous (decision quality, SDM, quality of life, anxiety, 
decision regret, and IntegRATE) and binary (treatment choice) outcomes, respectively. The 
results will provide potentially valuable insights into how rapidly each intervention affects 
outcomes. Outcomes measured multiple times after T0 (anxiety, regret, decision quality, and 
financial toxicity) may also be analyzed using a longitudinal model. If the interventions are 
found to have an effect, a secondary analysis that adds predictors for the number of prior 
Option Grid and Picture Option Grid patients seen by the healthcare professional will examine 
whether there are physician learning effects under either intervention. 
 
We will adopt a regression framework for all analyses as it allows seamless transition between 
basic analyses involving a single predictor (or two indicators corresponding to each 
intervention versus the comparator) and more complex analyses involving additional 
predictors (mediation variables, control covariates, time-trends, interaction terms or effect 
modifiers). Further, the regression framework allows clustering of observations due to 
repeated measurements on patients across time, nesting of health professionals within sites, 
and patients within health professionals, to be accurately accounted for using mixed-effect 
regression models117 or generalized estimating equations118,119. Multiple comparisons will be 
accounted for using Scheffe’s method120. 
 
The secondary outcomes (SDM, anxiety, integration of healthcare delivery, decision regret, 
quality of life and financial toxicity) have in excess of 10 levels and will be analyzed as 
continuous variables. To assess whether the results of each analysis are trustworthy, we will 
analyze the residuals to check if the assumptions of the model hold121. For treatment choice, 
a clearly defined binary variable based on medical record data, we will adapt the model to a 
logistic regression model. 

 
39 
 
 
As mentioned above, insurance status will be used to screen for higher and lower SES groups 
and invite participants into the study. It is an accepted proxy for SES15. At baseline, we will 
also collect information about median household income and highest educational attainment. 
For each included participant, we will check whether income and education confirm the initial 
screening allocation to higher or lower SES group or whether the patient belongs to the other 
group. The three measures of baseline socio-economic status: (1) insurance status, (2) 
highest educational attainment, and (3) median household income, will be analyzed separately 
for a multiple informants analysis122, or, provided they are not excessively collinear, we will 
enter them in the model together and test their combined effect. For income, we will use a 
poverty income ratio: the ratio of household income accounting for household size and poverty 
line published by the Census Bureau in the calendar year in which recruitment begins123. To 
aid interpretation of our results, we will report the consequence of reassigning a patient from 
above median SES group to below median SES group, even if for added precision, it makes 
sense to base significance tests on continuous measures. 
 
To gain insight into whether the Picture Option Grid and Option Grid will be more effective in 
certain subpopulations, we will add each SES measure and its interaction with the intervention 
indicator variables to the model. If the SES intervention interaction is non-significant, we will 
remove them from the model and test if the overall effect of SES is significant. Otherwise, we 
will perform stratified analyses of the interventions’ effects by SES status. 
4.8.4 Analyses Corresponding to Aim 2 
Aim 2: Measure the effect of the Picture Option Grid on disparities in decision-making (decision 
quality, knowledge and shared decision-making) and treatment choice, and conduct an 
exploratory analysis of the mediation and moderation effects. 
 
A logistic regression model will be used to test for differences in decision quality, knowledge, 
participation in SDM, and treatment choice between the Picture Option Grid group and the 
usual care and Option Grid groups, within subpopulations (higher SES versus lower SES). A 
reduction of disparity due to the interventions will be claimed if the effect of SES on outcomes 
is significantly smaller for the Picture Option Grid group than for the other two groups at follow-
up. As for Aim 1, a linear regression model will be used for the decision quality analysis while 
an analogous set of other predictors will be included as covariates in the model. The 
assumptions of the models will be evaluated for adequacy using residual analysis and other 
model fit diagnostics121. Our exploratory mediation analyses seek to identify and explicate the 
mechanism or process that underlies the relationship between the Picture Option Grid and a 
dependent variable via the inclusion of a third explanatory variable, known as a mediator 
variable (e.g., knowledge, values, SDM). We are specifically interested in whether 
interventions operate through the mediator as opposed to directly affecting the outcome. We 
will perform these analyses even if the findings from Aim 1 and Aim 2 (hypothesis 1) are non-
significant in order to determine whether the null effect was due to a null effect of the 
intervention on the mediator or a null effect of the mediator on the outcome. To determine the 
generalizability of these mechanisms and identify subpopulations for whom mediation is most 
pronounced, we will compare the mediation effects across different subgroups (e.g., higher 
SES versus lower SES). 
 

 
40 
 
The traditional and often-used approach to estimating mediation effects is the causal steps 
approach, which originated in Baron and Kenny (1986)124. However, due to the limitations of 
that approach, we will estimate the mediation effect using the product of coefficients 
method125. Standard errors will be evaluated using the bootstrap126 or the PRODCLIN 
program127. Software exists for sensitivity analysis to violations of sequential ignorability and 
other assumptions required for causality in mediation analyses128,129. We will apply this 
software and any additional procedures available to our analyses in order to obtain the most 
robust and defendable results. 
4.8.5 Analyses Corresponding to Aim 3 
Aim 3: Explore strategies that promote the encounter decision aids’ sustained use and 
dissemination using a theoretical implementation model. 
 
We will use a framework analysis, guided by Normalization Process Theory (NPT)130,131, 
having successfully used this approach previously63,101,132,133. Observations and field-notes will 
be included in the analysis. Initial descriptive codes will be generated by two independent 
researchers based on the four NPT constructs. In-vivo coding will also be used to capture 
other naturally occurring exchanges. Categorical codes that group initial and in-vivo codes will 
be developed in a third round of coding. In addition, 100 photos of the interventions taken at 
T2 (approximately 50 of Option Grid and 50 of Picture Option Grid) will be included in the 
analysis to answer questions 1 and 2. Triangulation of data will also be performed.  
 
NPT was developed to understand how complex interventions become implemented in routine 
healthcare settings96. NPT is built around four theoretical constructs: 1) Sense-making: 
processes of individual and communal sense-making of a complex intervention regarding its 
use and value; 2) Participation: processes of ‘cognitive participation’ that promote or hinder 
users’ buy-in and commitment to the intervention; 3) Action: processes of ‘collective action’ 
that determine or hinder whether the intervention is being used by all as intended; and 4) 
Monitoring: Processes of communal and individual appraisal of the effect of the intervention. 
We will use NPT as an analytical lens to consider the data collected according to our 
hypotheses and the following five questions: (1) how the interventions were perceived and 
used in and outside the clinical encounter (including with family and caregivers), (2) preferred 
ways for introducing and using the intervention in routine clinical settings, from several 
perspectives: patients, family, health professionals, administrators (3) perceived fit in clinic 
workflow as well as reported barriers and facilitators to routine integration, (4) other perceived 
patient-, physician- and system-level barriers and facilitators to routine use, and (5) perceived 
generalizability and feasibility in routine care.  
 
4.8.6 Secondary Analyses 
The consultation recordings and transcriptions will be used to conduct several secondary data 
analyses:  
 
Cost discussions analysis 
In this analysis we will aim to (1) examine the prevalence and characteristics of cost 
discussions in the surgical consultations (2) investigate whether having a mention of cost in 
the Picture Option Grid has an effect on cost conversations, the length of the cost 

 
41 
 
conversation, and whether surgeons make referrals to outside providers or resources for 
patients to learn more about costs, and (3) study whether patients’ financial toxicity, age, race, 
and/or ethnicity influence our outcomes. Our primary outcome measure will be whether or not 
cost was discussed in the surgical consultation. Our secondary outcome measures will include 
who initiated the cost conversations and the length of the conversations, if they occurred. We 
will also explore the number of times cost was discussed, and whether a referral had been 
made to address cost. 
 
We will adapt a checklist to analyze the cost discussions from previous published literature 
and use it to code the recordings.134,135 Reviewers will use a combination of audio and 
transcription files to code each consultation. Two reviewers will dual code a subsample of the 
recordings, after which kappa and percent agreement will be calculated until kappa reached 
.75 and percent agreement is over 90%. Once these threshholds are met, the two reviewers 
will independently code the remaining consultations. A third reviewer will code a 20% 
subsample of all consultations to ensure consistency.   
 
We will link our analysis with patient-reported demographics (including age, race, and 
socioeconomic status), patient-reported financial toxicity at one week and 12 weeks post-
surgery, and surgery choice as documented in the patient’s electronic health record.  
 
We will conduct linear or logistic regression analyses to examine whether our primary and 
secondary outcomes varied by arm (Picture Option Grid vs. Option Grid and usual care). We 
will explore whether financial toxicity scores, age, race, or ethnicity influenced our primary 
outcome. We will also conduct logistic regression analyses to evaluate whether the presence 
of a cost discussion influenced surgical choice. 
 
Treatment discourse analysis 
In this analysis we will aim to (1) examine whether and how breast cancer surgeons give 
surgical recommendations to early stage breast cancer patients eligible for both lumpectomy 
and mastectomy, (2) compare surgeon recommendation talk with suggested shared decision 
making practices, and (3) study the impact effect of clinician decision aid use (Option Grid and 
Picture Option Grid) on communication, conversational turn-taking, and surgical stance, and 
overall surgical recommendations. We will compare to usual care in the context of the decision 
about lumpectomy or mastectomy for early stage breast cancer. 
 
We will analyze a sample of surgical consultations transcripts. Roughly an equal number of 
transcripts in each group will be coded. We will code transcripts until we reach saturation in 
themes (estimated at approximately thirty transcripts per arm). 
  
The study team will devise the codebook by adapting the framework developed by Stivers’ 
and Barnes’ 2017 paper “Treatment recommendation as actions.”136 We modified their coding 
dimensions slightly by removing references to medications, which is not applicable in the 
breast cancer surgery decision, and removing the “opportunity space” code which identified 
turn-constructional unit boundaries by conversation analysis. We also added the following 
codes based on a preliminary review of transcripts: “offers comparable options,” “offers time 
to deliberate,” “patient states preferences,” and “patient preferences incorporated”.  
 

 
42 
 
We will code the transcripts using qualitative coding software (NVivo and Atlas.ti) by one 
researcher with a 20% subsample by a second reviewer. The study team will be available for 
review when questions or discrepancies arise.  
Aberrant transcripts in which only one option was made available by the physician due to 
imaging or other medical indications (as opposed to physician preference) will be excluded. 
Codes will be applied according to the agreed upon code description and the context of the 
transcript. Coding specifics are as follows: 
 
• 
We will only factors relevant to the breast cancer surgery decision. For example, we 
will not code detailed information on different types of radiation will, but we will code 
radiation as a consideration for the lumpectomy decision. 
• 
We will not focus on the surgical logistics after a decision has been made by the 
patient.  
• 
We will not code standard of care surgical treatments. For example, we will not code 
details about the sentinel node biopsy (performed during both mastectomy and 
lumpectomy) because this procedure is standard of care and does not involve 
comparable options. 
 
We will code all conversations with all clinicians (including surgeons, residents, and medical 
students)about the early stage breast cancer surgery decision. Conversations between 
patients and their family members outside of the surgical consultation are occasionally 
recorded. Although these conversations will not be coded as they are not systematically 
included for all patients, interesting excerpts about the surgical decision may be marked for 
later consideration. After reading a transcript, coders will utilize the “memos” feature to 
document notes and comments on the transcripts. 
 
We will identify major and minor themes from transcripts based on our study framework. We 
will select representative quotes to illustrate these themes. Additionally, a trained discourse 
analyst will conduct in-depth analysis of transcripts identified by coders as particularly 
interesting or representative. 
 
Analysis of spoken plain language  
 
We have three primary aims in this secondary analysis: 
 
1. Qualitatively determine the extent to which clinicians use plain language in the 
context of breast cancer surgical visits,  
2. Quantitatively develop a ‘listenability’ score and determine clinicians’ individual 
listenability scores to analyze how clinicians communicate with their patients,  
3. Compare the qualitative and quantitative results across arms and according to select 
patient characteristics, and 
4. Use existing readability software to analyze the de-identified transcripts for readability 
scores. 
 
Qualitative analysis 
 
We will use Atlas.ti to conduct a dual independent qualitative analysis of the transcripts. We 
will perform a deductive analysis using the US federal plain language guidelines137-139. We will 
develop a codebook from these guidelines as a team, pilot it on 2-3 transcripts, assess for 

 
43 
 
usability, make necessary changes then code all transcripts. We will also conduct inductive 
thematic analysis of the transcripts allowing for new codes to emerge as appropriate138,140. 
 
Quantitative analysis 
 
For our quantitative analysis, we will develop a quantitative scoring method, adapted from the 
Listenability Style Guide and apply it to each recording141. We will then conduct analyses 
based on listenability scores and participant characteristics. Additionally, we will use 
readability software on each de-identified transcript to determine the “readability score” of 
each included transcript. 
 
4.8.7 Missing Data 
Most data collection will be via online questionnaires (i.e., at T0, T2, T3, T4, and T5), which 
provide opportunities for preventing and monitoring missing data. We will offer other formats 
for questionnaire completion (including paper and standardized interviews), thus minimizing 
missing data. We will prompt each patient, by telephone (or email at Dartmouth), to complete 
the follow-up questionnaires (i.e., T3, T4, and T5) or reach them in the clinic during their post-
surgery appointments. Given the brevity of the trial and the procedures described above, we 
do not anticipate more than 5% of missing data. However, should there be more than a trivial 
amount of missing data, we will use multiple imputation to cope with missing baseline, interim, 
and outcome data. We will record and report all reasons for dropout and missing data. Multiple 
imputation creates multiple completed data sets by drawing random values of missing 
outcome or predictor variables from the predictive distribution of these variables given the 
observed variables142. This approach will address both generalizability and causal validity 
bias. We will also examine sensitivity of inferences. 
4.8.8 Heterogeneity of Treatment Effects 
The main goals of the heterogeneity of treatment effects (HTE) analyses are to estimate 
treatment effects in clinically relevant subgroups and to predict whether an individual might 
benefit from exposure to the decision aid. As the HTE analyses are exploratory rather than 
hypothesis-driven, exploratory subgroup analyses will be conducted to identify hypotheses for 
future evaluation. Patient characteristics will be considered for treatment by covariate 
interactions and include SES, age, ethnicity, race, literacy, language, and study site143. As 
described in the analytic plans for testing interactions by SES in Aims 1 and 2, interaction tests 
will be conducted to determine if subgroup analyses of the intervention effects by the levels of 
that predictor are warranted. If the interaction is significant, then the treatment effect is 
estimated separately at each level of the categorical variable used to define mutually exclusive 
subgroups. 
4.8.9 Access to the Dataset 
Only the statistician and core research team will have access to the final data set. 
All data used in conducting the final analysis of the randomized controlled trial will be made 
available to PCORI in a de-identified copy for archival purposes in no more than nine 
months from the end of the final analysis. We will also provide a strategy for making de-
identified subsets of data for collaborating researchers and organizations within nine months 
of completion. We also plan to develop a Data Access, Analysis, and Expression of Interest 
submission and review process for formal requests to make use of the data so as to prevent 

 
44 
 
duplication in analysis and publication. Given the data sharing plans, we will provide a 
detailed description of these plans to all participants during the informed consent process to 
ensure that participants are aware of all potential uses of data.   
4.9 Data Management 
Data management for the study will be done through REDCap, a HIPAA-compliant web-
based data management system. REDCap will be hosted at Dartmouth-Hitchcock Medical 
Center for data collected at DHMC. Data collected from all other sites will be hosted on 
REDCap at Dartmouth College. REDCap is designed to support data capture for research 
studies, providing 1) an intuitive interface for validated data entry; 2) audit trails for tracking 
data manipulation and export procedures; 3) automated export procedures for seamless 
data downloads to common statistical packages; and 4) procedures for importing data from 
external sources144. Access will only be granted to study team members designated to 
manage the study data and will require a dedicated username and password. Study team 
members with access at participating study sites will only have access to the data at their 
corresponding institution This database management system is designed to comply with the 
ICH Good Clinical Practice (GCP) guidelines.  
 
Data entry into REDCap will be done by research assistants and patient associates at each 
site using standardized data collection forms. Samples of the data collection forms will be 
available once they are finalized. 
 
In addition, each study site will have a data-protected, encrypted external hard drive for the 
local storage of sensitive study-related materials. Each of the study sites will return the hard 
drives to Dartmouth College at the end of the trial. Dartmouth will store the encrypted data 
for six years after the conclusion of the trial, after which all data will be destroyed. No 
personally identifiable data will be transferred or stored outside of REDCap and encrypted 
hard drives. 
 
Signed consent forms will be kept in a locked file cabinet in a secure location at each study 
site and kept for six years after the conclusion of the trial.  
4.9.1 Data and Safety Monitoring Plan 
A Data and Safety Monitoring Board (DSMB) will be appointed to provide additional oversight 
in the trial. The DSMB will meet and review data bi-annually throughout the project. The DSMB 
will include key stakeholders in the participating communities (one patient representative and 
breast surgeon) as well as academics with expertise in statistics, patient engagement in health 
care, breast cancer surgery, and health disparities. The DSMB will operate independently from 
the study sponsor. 
 
The DSMB will review the protocol, data collected to date, advise the PI on any potential risks 
and risk mitigation plans. The DSMB recommendations will be discussed with the PI as well 
as the Trial Steering Group, which meets quarterly (see section 7.2). Those recommendations 
will also be fed back to PCORI every six months as part of the bi-annual reports. The Trial 
Steering Group will consider all DSMB recommendations and revise relevant aspects of the 
trial accordingly. All data will be reviewed for protocol adherence, including a data verification 
check that the appropriate outcome measures are given at the appropriate time points. 

 
45 
 
 
We do not expect any Serious Adverse Events (SAE) or Adverse Events (AE) in the trial that 
would require immediate reporting. There are no invasive procedures related to the 
interventions. However, some patients, particularly those with diagnosed mental illness or 
patients who are finding it difficult to cope with their recent cancer diagnosis, may find it 
stressful to be randomized to one of the two encounter decision aids or to usual care. All 
members of the research and medical care team who are involved in patient recruitment and 
follow-up assessments will be asked:  
 
- 
Ahead of recruitment: To identify available counseling/psychological support. This 
information will be included in the cover letter and information sheet; 
- 
During recruitment: To refer participants (who are distressed as a result of participating 
in the trial) to relevant counseling/psychological support services;  
- 
During recruitment: To remind the participant that she is free to withdraw from the trial 
at any time without providing any reason; 
- 
During recruitment: To notify the study PI of any participants who are withdrawing from 
the trial because of psychological distress or anxiety directly related to trial 
participation. 
- 
During recruitment: All research assistants and patient associates will know who to 
refer patients to when patients have clinical questions or need additional information 
or support.  
 
In addition, during each DSMB meeting, the DSMB will review data on subject withdrawals 
from the study and will be provided with the stated reason for withdrawal and the study 
subject anxiety score (measured  PROMIS) for each withdrawal. 
 
If for any reason, an SAE or AE were reported to the Principal Investigator (PI), the IRB at 
Dartmouth would be immediately notified as well as the appropriate safety board at the 
participating sites. The DSMB would convene urgently and review the SAE/AE. 
 
5 Write-up and Dissemination 
5.1 Dissemination and Implementation in Other Settings 
This study is highly relevant to patient-centered care as we seek to promote the involvement 
of women of low SES in breast cancer treatment decisions and address disparities in this area. 
Currently, women of low SES are more likely to make treatment decisions based on 
incomplete or uninformed preferences, potentially leading to poor decision quality, poorer 
quality of life, and decision regret. This study hopes to identify solutions that effectively 
improve outcomes across socioeconomic strata and reduce disparities in quality of care (Aim 
1 and 2). Addressing the current disparity in care based on SES requires effective 
dissemination of the results, maximizing implementation potential, and  embedding these 
protocols into routine care (Aim 3) 
 

 
46 
 
It is often a challenge to bridge the gap between health research and health action and to 
effectively communicate results of studies to practicing clinicians, policy-makers, and patients. 
By dedicating a full 12 months of this project to this aim, we hope to successfully change the 
way shared decision-making is implemented in breast cancer treatment and provide better 
accessibility to women of lower SES. The study outputs will likely interest a wide variety of 
target audiences, ranging from patient and advocacy groups, healthcare professionals, and 
healthcare organizations, to academics, policy makers, and decision aid developers. This 
diverse group of audiences will maximize the potential for implementation and dissemination. 
We will work with each target audience to create dissemination and implementation strategies 
that are tailored to their needs and interests, understandable, and pertinent to them. Since the 
interventions are easily accessible and inexpensive to update and disseminate, 
implementation in routine care could occur immediately post-project completion. We plan to 
disseminate findings through the following various channels. 
5.1.1 Academic Channels 
Although peer-reviewed scientific journals are not commonly accessed by patients, it remains 
the primary source of knowledge and dissemination of research findings to influence health 
professionals, policy makers, and healthcare organizations. These channels will be used to 
ensure that clinicians have access to the study findings and are able to rapidly and 
successfully implement the intervention(s) in routine clinical settings. In order to promote 
access to patients and other non-academic stakeholders, we will publish all study outputs in 
open-access journals. Recently, some journals (i.e., New England Journal of Medicine) have 
begun including a short video abstract alongside the article. We will try to publish in academic 
journals with this video functionality with the aim of making the material accessible to a broader 
audience.  
 
Given the vast amount of information available, many clinicians do not have time to keep up 
with all research literature and instead focus on clinical practice guidelines145. We hope that 
recommendations arising from this study about optimal ways to engage patients of low SES 
in breast cancer surgery decisions can be incorporated into clinical practice guidelines at the 
participating institutions and beyond.  
 
We will also present the findings at up to four domestic and international scientific conferences 
(e.g., International Shared Decision Making Conference) and professional meetings to 
promote wider dissemination of the study findings. We hope to do a pre-conference workshop 
in order to train clinicians using interactive role-play and instructive videos (replicating the 
training of physicians in our study). It is our hope that these dissemination activities will be 
enhanced through networking and have a ripple effect where workshop participants will return 
to their own workplaces and integrate the use of successful intervention(s) into clinical 
practice.  
5.1.2 Patient and Advocacy Organizations 
We will prioritize working with national groups (e.g., Susan G Komen, Breast Cancer Alliance) 
and local patient advocacy groups at each participating site (e.g., Breakfast Club, Inc., Living 
Beyond Breast Cancer) to disseminate findings to patients, their families and caregivers, and 
other community stakeholders. Our research team members have established relationships 
with several national breast cancer and generic patient and advocacy organizations (e.g., e-

 
47 
 
Patient Dave, Society for Participatory Medicine), which we will approach to promote the 
dissemination of our findings. We will compile a final report that is accessible and readable to 
patients and other non-academic stakeholder partners, using plain language and a lay 
summary. This report will serve as a summary of project findings and recommendations for 
implementation among organizations, health professionals, patients, and other community 
stakeholders. We will also create newsletters and press releases using lay language. All 
documents will be written in partnership with our patient partners and CAB members, and they 
will be freely available on the study website. 
5.1.3 Professional Organizations and Healthcare Delivery Systems 
Members of the research team and our panel of stakeholders are members of professional 
and clinical organizations, including the American Medical Association, American College of 
Surgeons, Society of Surgical Oncology, American Society of Breast Surgeons, American 
Society of Clinical Oncology, American College of Surgeons Diversity Issues Committee, 
International Patient Decision Aids Standards Collaboration, American College of Radiology 
Imaging Network, and Society for Medical Decision Making, among many others. We will 
disseminate our findings and successful intervention(s) to these influential professional 
organizations to inform practice recommendations and implement lasting changes in routine 
care. Further, Dartmouth-Hitchcock is part of the High Value Healthcare Collaborative, a 
consortium of 13 healthcare delivery systems across the United States. Communicating our 
findings to these healthcare systems will offer a direct opportunity for widespread 
dissemination, implementation, and impact. 
5.1.4 Social Media and Lay Press 
Increasingly, patients desire to be involved in the decisions of their care and want information 
that is easily accessible, relevant, and tailored to their own needs146. With the help of 
community members and patients participating in our study, we hope to create an informative, 
accesible video through YouTube to share the experience of study participants, the results of 
this study,  and how they can empower patients to be more active in their healthcare choices. 
Additionally, we hope to provide patient-focused informational summaries and diagrams that 
focus on the key points and are easy to understand. 
 
We will also use social media and partner with patient advocacy groups and patient 
engagement experts (e.g., e-Patient Dave, e-Patients.net, Mighty Casey) that are active on 
Twitter and other social media platforms to disseminate key study messages. We will work 
with our CAB and selected patient engagement experts (as listed above) to plan an effective 
social media campaign using regular Twitter feeds, blogs on the study website, and planned 
“tweet chats”. We will also reach the lay public who may not have access to social media by 
using newspaper editorials, lay press, and magazine print. 
5.1.5 Dissemination Symposia and Clinician Training Module 
Lastly, we will organize a symposium at each participating study site. The dissemination 
symposia will be guided by patients and community stakeholders to disseminate knowledge 
locally, facilitate knowledge transfer at each site, and foster opportunities to disseminate the 
research findings nationally. We will also release a brief shared decision-making training 
module on our website that will be based on the training delivered to clinicians in the trial and 
are available to health professionals to implement the interventions in routine care. We will 

 
48 
 
also disseminate this training module using the professional organizations and healthcare 
delivery systems mentioned in section 5.1.3. 
5.2 Possible Barriers to Dissemination and Implementation 
We understand that one of the greatest challenges to implementing results in clinical settings 
is finding sustainable partnerships, where patient-centeredness is a priority. Partnerships with 
patient-groups, clinicians, and patients are essential, and we have therefore made 
considerable efforts to achieve these goals. 
 
We have reached out to recognized leaders in the field of patient-centered care who focus on 
breast cancer care (Dr. Anna Tosteson, Dr. Julie Margenthaler, Dr. Robert Volk, Dr. Karen 
Sepucha, Dr Dale Vidal and Dr. Sanja Percac-Lima). We have also involved several patient 
and stakeholder partners who will be engaged in all aspects of the project, including its 
dissemination and implementation. We have designed the project around a representative 
sample of patients, which determined our choice of four geographically diverse sites by region 
and population. We will ensure that the findings are effectively disseminated at each site as 
well as nationally using the channels listed above.  
 
Another clear barrier to disseminating findings to patients, clinicians, and non-academic 
audiences is the difficulty in communicating information in a way that is clear and meaningful 
to each stakeholder group. We will work closely with our patient partners and clinician 
stakeholder partners to produce reports, newsletters, and informative videos that are 
understandable and pertinent. 
 
We also recognize that barriers to sustained implementation are often due to poor clinical 
engagement whereby research conducted in controlled settings finds limited use in routine 
care. From the outset, we have been mindful to maximize the implementation and 
dissemination potential of the study and interventions by continuously involving clinicians and 
patients in every aspect of the planned trial and development of both interventions. These 
tools have been demonstrated to be both feasible and acceptable to clinicians in routine care 
with minimal impact on the consultation length63,65,92. Implementation will also depend on 
ensuring that our approach is flexible enough to be widely applicable across diverse settings 
and within diverse communities. This is why we will take great care to translate interventions 
and measures into Spanish and Mandarin Chinese and have pilot-tested them with patients 
from various SES, ethnic, and racial backgrounds. 
5.3 Making Results Available to Participants 
As described above, we will produce a study report in collaboration with our patient and 
stakeholder partners and share it with all participants after study completion. The report will 
also be freely available to all on the study website. Further, our dissemination plan also 
includes organizing a local research symposium at each participating study site as a way to 
“meet patients and stakeholders in their own communities” and showcase findings. The PI has 
experience of organizing patient/stakeholder-led symposia to promote knowledge translation 
and disseminate research findings. These events have been shown to have a significant 
impact on the entire community with repercussions nationally. 

 
49 
 
 
 
 
 
 

 
50 
 
 
6 Timeline 
The study will last 36 months, starting on November 1, 2016. See Gantt Chart below for a 
detailed timeline.  
 
Figure 7. Study Timeline 
 
 
 
The following milestones will be achieved:  
 
Table 5. Study Milestones 
  
Milestone Name 
Description 
Projected 
Completion 
Date 
A 
Effective Date 
Start of contract award 
11/1/16 
B1 
Study team meeting 
First study team meeting (monthly thereafter until 
study completion) 
11/1/16 
B2 
Community Advisory Board Meeting 
First community advisory board (CAB) meeting, which 
will include patient and stakeholder partners (held 
quarterly until study completion) - submitt CAB 
meeting minutes with interim progress reports. 
1/31/17 
B3 
Protocol Complete 
Final trial protocol completed 
2/28/17 
B4 
IRB Approval Obtained 
Obtain IRB Approval(s) for study and submit approval 
letter(s) to PCORI. 
2/28/17 
B5 
Select and register project at appropriate site 
for the study design (Clinicaltrials.gov, RoPR, 
or other as approved by PCORI before study 
start date) 
Study Identification Number and the Primary 
Research Completion Date must be sent to PCORI.  
2/28/17 
B6 
Study website 
Study website launched 
2/28/17 
B7 
Steering Committee Meeting 
First trial Steering Committee meeting (held quarterly 
until study completion) - submit meeting minutes with 
interim progress reports. 
2/28/17 
B8 
DSMB meeting 
DSMB meeting (occurs every six months until study 
completion) - submit meeting minutes with interim 
progress reports. 
4/30/17 
B9 
Engagement Update 
For the 6-month time intervals (i.e., 6 months, 18 
months, 30 months, etc. but not at 12 months or 24 
months), provide specific examples of the impact of 
engagement on project activities during the reporting 
5/1/17 
2016
2016
Project/Task
Jul
Aug
Sep
Oct
Nov
Dec
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
0
0
0
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
Set-up pre-grant
Recruit personnel
Internal IRB application
Management & governance
Convene Community Advisory Board (CAB)
Convene Data Safety Monitoring Board (DSMB)
CAB meetings and minutes
Study team meetings
Trial steering group meeting and minutes
DSMB meetings and minutes
Study website developed and launched
Engagement update or report (full report @ 12, 24, 36 mo)
Progress Report Submission
Trial set-up
Complete trial protocol and register clinical trial
IRB application and approval at each study site
Adaptation of DQI for women of low SES
Data analysis and revision of DQI subscale
Spanish/Mandarin Chinese translations of interventions and measures
Preparation and review by CAB of all questionnaires & study materials
Site enrollement (n=4)
Publication of study protocol
Randomized controlled trial 
Recruitment (target total=1,100)
25%
50%
75%
100%
Follow-up assessments (post-visit, 1 and 12 weeks post-surgery)
25%
50%
75%
100%
Semi-structured interviews
One-year post-decision regret data collection
Interim analysis managed by the DSMB
Data analysis
Write-up
Conferences
Publications
Dissemination campaign and symposia
2016
2016
Jul
Aug
Sep
Oct
Nov
Dec
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
0
0
0
0
1
2
3
4
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8
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2017
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51 
 
period.  Report this in the Engagement Report section 
of the PCORI interim progress report. 
B 
Progress Report Submission  
Submit 6-month Interim Progress Report - use 
PCORI interim progress report template 
5/1/17 
C1 
DQI adaptation 
Decision Quality Instrument subscale "What Matters 
Most to You" adaptation 
6/30/17 
C2 
Publish study protocol 
Submission for publication of study protcol in peer 
review journal 
6/30/17 
C3 
Outcome measures translated 
Translation of study outcome measures into Spanish 
and Mandarin completed 
8/31/17 
C4 
Study materials review by CAB 
Preparation and review of all questionnaires and 
study materials by CAB and research team 
8/31/17 
C5 
Recruitment begins 
Enrollment begins for study participants (N=1,100) 
9/30/17 
C6 
Follow-up data collection begins 
Follow-up assessments begin for T2, T3, and T4  
9/30/17 
C7 
DSMB meeting 
DSMB meeting (occurs every six months until study 
completion) - submit meeting minutes with interim 
progress reports. 
10/30/17 
C8 
Engagement Report 
For each annual report (i.e., at year 1, year 2, etc. 
but not at 6 months or 18 months), additional 
descriptive information on engagement of patients 
and/or other stakeholders should be reported at 
https://live.datstathost.com/PCORI-
Collector/Survey.ashx?Name=Engagement_Report_
Login.  Confirmation code should be reported in the 
Engagement Report section of the PCORI interim 
progress report. 
11/1/17 
C 
Progress Report Submission  
Submit 12-month Interim Progress Report - use 
PCORI interim progress report template 
11/1/17 
D1 
25% recruitment  
Completion of 25% of study enrollment/recruitment 
(275/1100) 
12/31/17 
D2 
25% follow-up data collection 
Completion of 25% of follow-up data collection 
3/30/18 
D3 
Begin interviews 
Begin semi-structured interviews (Aim 3) 
3/30/18 
D4 
50% recruitment 
Completion of 50% of study enrollment/recruitment 
(300/600) 
5/30/18 
D5 
DSMB meeting 
DSMB meeting (occurs every six months until study 
completion) - submit meeting minutes with interim 
progress reports. 
4/30/18 
D6 
Engagement Update 
For the 6-month time intervals (i.e., 6 months, 18 
months, 30 months, etc. but not at 12 months or 24 
months), provide specific examples of the impact of 
engagement on project activities during the reporting 
period.  Report this in the Engagement Report section 
of the PCORI interim progress report. 
5/1/18 
D 
Progress Report Submission  
Submit 18-month Interim Progress Report - use 
PCORI interim progress report template 
5/1/18 
E1 
50% follow-up data collection 
Completion of 50% of follow-up data collection 
7/31/18 
E2 
75% recruitment 
Completion of 75% of study enrollment/recruitment 
(450/600) 
9/30/18 
E3 
One year post decision regret data and 
financial toxicity data collection begins 
Begin collecting decision regret measure and 
financial toxicity (COST) one year post-decision for all 
women who received surgery in the first nine months 
of the trial. 
10/30/18 
E4 
DSMB meeting 
DSMB meeting (occurs every six months until study 
completion) - submit meeting minutes with interim 
progress reports. 
10/30/18 
E5 
Engagement Report 
For each annual report (i.e., at year 1, year 2, etc. 
but not at 6 months or 18 months), additional 
descriptive information on engagement of patients 
and/or other stakeholders should be reported at 
https://live.datstathost.com/PCORI-
Collector/Survey.ashx?Name=Engagement_Report_
Login.  Confirmation code should be reported in the 
Engagement Report section of the PCORI interim 
progress report. 
11/1/18 

 
52 
 
E 
Progress Report Submission  
Submit 24-month Interim Progress Report - use 
PCORI interim progress report template 
11/1/18 
F1 
75% follow-up data collection 
Completion of 75% of follow-up data collection 
11/30/18 
F2 
Completion of study enrollment 
Completion of 100% of study enrollment/recruitment 
(600/600) 
2/28/19 
F3 
One year post decision regret and financial 
toxicity data collection completed 
Completion of collecting decision regret and financial 
toxicity measures one year post-decision for all 
women recruited in the first nine months of the trial. 
5/31/19 
F4 
Completion of follow-up data collection 
Completion of follow-up data collection 
4/30/19 
F5 
Completion interviews 
Completion of semi-structured interviews (Aim 3) 
5/30/19 
F6 
DSMB meeting 
DSMB meeting (occurs every six months until study 
completion) - submit meeting minutes with interim 
progress reports. 
4/30/19 
F7 
Engagement Update 
For the 6-month time intervals (i.e., 6 months, 18 
months, 30 months, etc. but not at 12 months or 24 
months), provide specific examples of the impact of 
engagement on project activities during the reporting 
period.  Report this in the Engagement Report section 
of the PCORI interim progress report. 
5/1/19 
F 
Progress Report Submission  
Submit 30-month Interim Progress Report - use 
PCORI interim progress report template 
5/1/19 
G1 
Final analyses 
Final analyses completed 
8/31/19 
G2 
Dissemination of findings 
Dissemination of research findings 
10/30/19 
G3 
Dissemination symposium 
Dissemination symposium at each participating study 
site 
10/30/19 
G4 
DSMB meeting 
DSMB meeting (occurs every six months until study 
completion) - submit meeting minutes with interim 
progress reports. 
10/30/19 
G5 
Engagement Report 
For each annual report (i.e., at year 1, year 2, etc. 
but not at 6 months or 18 months), additional 
descriptive information on engagement of patients 
and/or other stakeholders should be reported at 
https://live.datstathost.com/PCORI-
Collector/Survey.ashx?Name=Engagement_Report_
Login.  Confirmation code should be reported in the 
Engagement Report section of the PCORI interim 
progress report. 
11/1/19 
G 
Final Progress Report Submission 
Submit Final Progress Report - use PCOR final 
progress report template 
11/1/19 
H 
Research Project Period End Date 
  
11/1/19 
I 
Primary Research Completion Date 
A Primary Research Completion Date must be 
provided when registering the study in 
Clinicaltrials.gov. For studies that are not clinical trials 
or observational studies registered on 
ClinicalTrials.gov, the Awardee and PCORI shall 
agree on a primary completion date as a milestone 
that precedes the agreed-upon date to submit a Draft 
Final Research Report.  
4/30/19 
J 
Results submitted to ClinicalTrials.gov or 
appropriate database. 
Awardee ensures results are submitted to 
ClinicalTrials.gov or appropriate database. For 
ClinicalTrials.gov, the generated tables are a required 
section in the Draft Final Research Report. 
4/30/20 
K 
Draft Final Research Report Submission 
Submit Draft Final Research Report according to 
instructions found at http://www.pcori.org/awardee-
resources 
 
*Draft Final Research Report must be submitted 
no later than 30 days from when results are 
posted to clinicaltrials.gov or other applicable 
website. 
5/30/20 
L 
Final Research Report 
Upon receipt of written summary, and as 
applicable, PI will make revisions and submit 
revised Draft Final Research Report for 
acceptance as directed by PCORI.                              
11/30/20 
M 
Approval / sign off of the Lay Abstract 
Sign off must be no later than 90 days beyond the 
date PCORI accepts the final report 
11/30/20 
N 
Contract Term Date 
- 
11/30/20 

 
53 
 
O 
Final Expenditure Report 
Submit Final Expenditure Report (See Contract 
for Instructions) 
2/28/21 
P 
Notification of Publication Acceptance 
See Contract for Instructions 
Within 30 
Days of 
Acceptance 
 
 

 
54 
 
7 Engagement Plan 
7.1 Planning the Study 
The involvement of patient and stakeholder partners has been instrumental in designing and 
planning the study. The topic was originally identified from conducting a systematic review and 
a broader gap analysis of the literature focusing on patient and clinician perspectives. Our 
findings and preliminary research questions were discussed with our initial patient partner, 
Linda Walling, and subsequently introduced to nine other patient and stakeholder partners in 
a focus group and research meetings. The literature search identified important gaps in efforts 
to increase decision quality and mitigate disparities in early stage breast cancer care. Our 
patient and stakeholder partners immediately echoed those findings and insisted on the short-
term (e.g., increased anxiety) and long-term implications (such as poor quality of life) of playing 
a passive role in healthcare decisions and failing to make an informed choice about breast 
cancer treatments. 
 
From the start, we have engaged patient partners from different locations (New Hampshire, 
California, and Missouri) and backgrounds. We have also engaged the broader stakeholder 
community in developing the research questions and testing and validating the Picture Option 
Grid, adapted from the validated Option Grid for women of low SES. Our stakeholder partners 
included breast surgeons, a parish nurse, two social workers, the executive director of the 
Upper Valley Haven (a nonprofit organization that provides temporary shelter and educational 
programming for homeless families and adults), and a breast cancer patient advocate who 
facilitates the “Living Beyond Breast Cancer” telephone group (three of which have been 
named on in this protocol). All patient and stakeholder partners have been actively involved in 
regular research meetings and have attended a focus group where the research questions, 
study outcomes, study design, and characteristics of the study participants were discussed. 
Their input has significantly shaped and influenced the study design. For instance, they have 
identified ways to minimize disruption to study participants by suggesting the involvement of 
a patient associate and by using short-form validated measures whenever possible. To 
promote retention among women with varying literacy and health literacy levels, our patient 
partners suggested calling or emailing participants before each follow-up assessment was due 
and offering to complete the questionnaire on the phone using standardized interviews. 
 
Our patient and stakeholder partners were also involved in identifying the goals and outcomes 
of the interventions. Our patient partners emphasized the surge of fear and anxiety associated 
with their breast cancer diagnosis and subsequent treatment decisions. They also 
underscored the impact of the diagnosis and treatment on their quality of life. One of our 
patient partners recalled having trouble sleeping and worrying about the implications of her 
disease and treatment choice and described the impact on her quality of life. Our patient 
partners felt that it was essential to measure anxiety and quality of life. These measures were 
thus chosen and reviewed with them. 
 
Finally, our patient and stakeholder partners were involved in writing and reviewing the 
Research Plan and Abstract. They helped us simplify language for the public abstract and 
ensure that their views were accurately represented. 

 
55 
 
7.2 Conducting the Study 
To facilitate recruitment, and taking into account the fact that a diagnosis of early stage breast 
cancer is emotionally sensitive and anxiety provoking, the research team (in consultation with 
patient partners) has deliberately chosen to include one patient associate at each site. The 
patient associate is a former breast cancer patient who will be recruited at each study site from 
local breast cancer patient groups or advocacy programs. She will partner with each research 
assistant by approaching, informing, and gaining patients’ informed consents in clinics. She 
will receive appropriate research and CITI training. She will also collect baseline and follow-
up data with the research assistant and conduct some Aim 3 interviews in the second and 
third year of the project. Lastly, the patient associate will be involved in analyzing the data. 
One of our patient partners strongly advocated for including a patient associate because, in 
her words, a former patient “has already been through similar experiences” and will approach 
patients from a more empathic perspective. 
 
We recognize that patient groups at each site will vary. To meet site-specific needs and be 
consistent with the CBPR approach, we will include Community Advisory Board (CAB) 
members from each study site, who will monitor and report back to the steering group. The 
CAB will include multiple stakeholders whose role is to meet quarterly, examine trial progress, 
and report findings to the steering committee. The patient associates will also be invited to join 
all CAB meetings. One member of the CAB (as well as all patient partners named as key 
personnel) will be invited to attend all Trial Steering Group meetings and relay the CAB’s 
discussion and action points: 
 
- 
A Trial Steering Group that will involve all key personnel (including patient and 
stakeholder partners and invited CAB members) will meet every three months using 
videoconferencing; 
- 
Research Team meetings will be held on a monthly basis and will include key 
personnel from each study site including patient and stakeholder partners. 
 
In addition, all study documents including information sheets, consent forms, questionnaires, 
and interview schedules will be developed with patient partners, patient associates, and the 
CAB. 
7.3 Understanding Patient Engagement in What Matters Most 
In order to learn more about patient engagement in the What Matters Most study, we will 
conduct interviews with our patient and community stakeholders.  
 
An external researcher will interview the patient associates midway through and after 
recruitment is complete. The interview guide will assess the patient associate’s feelings 
about research and their involvement with the research team, recruiting patients, challenges 
they face, and their thoughts about the involvement of patient associates in future research. 
Patient associates also sent reflections and notes intermittently to the study team. An 
external researcher will also interview WMM patient partners about their participation in the 
study. The interview guide will ask about the patient partner’s engagement with the research 
team and their experiences on with the various groups involved in the study (e.g., monthly 

 
56 
 
study meeting, quarterly trial steering group meeting). A research team member will 
interview patients that sit on the CAB to learn more about the distinguishing features of the 
CAB and the patients’ experience on this board. 
 
These interviews are expected to last about 30 minutes each. An information sheet detailing 
the purpose and confidentiality of the interview will be provided to each participant. The 
interviews will be recorded, provided the interviewee provides consent to recording. 
Recordings will be securely maintained and transcribed verbatim. 
 
We will also reach out to the research assistants to ask them about their experience working 
with patient associates during the study. We will send them an anonymous survey link which 
includes questions around their role in the study and what it was like to work with the patient 
associate at their site. 
7.4 Principles for Engagement 
7.4.1 Reciprocal Relationships 
As part of the initial planning process, we asked all research partners, including patient 
partners and stakeholders, to contribute their opinions and expertise to the development and 
design of the project. We will take this approach forward into the funded project and are 
committed to fostering reciprocal relationships among all members of the research team, the 
CAB, and steering committee throughout the trial set-up, data collection and data analysis 
phases. Consistent with the CBPR approach, this implies that all partners are equally 
accountable for decisions, project changes, and study processes. Consequently, we have 
assigned all patient and stakeholder partners as “key personnel,” recognizing each 
contributor’s critical role and responsibilities. 
7.4.2 Co-Learning 
Our research team has a long history of developing decision aids that are both patient-
centered and patient-led and that follow user-centered design principles105. Consequently, we 
view patients and stakeholders as teachers as well as partners. They are experts on their lived 
experiences, attitudes toward risks and benefits, and informed values and preferences. We 
ensure that others learn from their expertise by including patients and stakeholders as authors 
on manuscripts and, where possible, have them contribute to academic and non-academic 
presentations. We will ensure that this level of involvement continues during this project by 
adopting plain-language standards and asking our patient and stakeholder partners to review 
and contribute to all study outputs. No distinction has been, or will be, made between the roles 
of patients, stakeholders, clinicians, or researchers during any decision-making process. Our 
patient associates will also take part in all aspects of data collection and data analysis, where 
possible. 
7.4.3 Partnership 
From the outset, we have valued the contributions of our patient and stakeholder partners by 
applying suggested modifications to the study design, research questions, and intervention 
design. For example, we have changed the title of the interventions to ‘What’s right for me?’, 
which was deemed more explicit and accessible than ‘Picture Option Grid’. We are committed 
to this process and have made every effort to include regular CAB and steering committee 
sessions to capture patient and stakeholder opinions, thus ensuring a consistent feedback 

 
57 
 
loop to keep project goals consistent with patient-centered principles. We will be 
compensating patient and stakeholder partners at a rate that has been agreed with them ($100 
per hour) and that reflects their commitment and expertise. 
7.4.4 Trust, Transparency, Honesty 
A foundation of our work is based on principles of trust and transparency—the building blocks 
of strong relationships. These underpin our research team’s approach by ensuring all 
members of the research team, including patient and stakeholder partners, are constantly 
updated by email or conference call to monitor the study’s progress, solve potential issues, 
and discuss any alterations to the research plan and trial protocol. Ultimately, we recognize 
that trust is built over time through transparency and honest approaches to communication, 
data collection, analysis, and reporting. To keep true to our word, we will share materials at 
all stages of the study process, provide access to our project website, and actively seek the 
opinions and feedback of patient and stakeholder partners as well as the CAB. All major 
decisions will be made collaboratively and discussed at scheduled meetings with the research 
team (including patient and stakeholder partners) or via email correspondence for any urgent 
matters. 
 
 
 

 
58 
 
8 Ethical Considerations 
Human subjects will be involved in this research in: 
 
- 
The adaptation of the DQI subscale for women of lower SES in year 1; 
- 
Cognitive debrief interviews to test translation of study documents; 
- 
Focus groups to test the information sheet and informed consent form; 
- 
The randomized controlled trial in years 1, 2, and 3 (Aims 1 and 2); 
- 
Interviews, field-notes, and observations to explore strategies that promote the 
interventions’ sustained use (Aim 3). 
 
In designing this study, we have taken steps to minimize the probability and magnitude of all 
or any physical or psychological harm to human subjects. We have also ensured that any 
potential risks are offset by potential benefits to study participants and to the population of 
women who will receive a diagnosis of breast cancer in the future. All participants will be able 
to provide voluntary informed consent prior to data collection. All data collected will be stored 
securely with restricted access, thereby minimizing risks to the privacy of all human subjects 
involved in the study. Institutional Review Board (IRB) approval will be obtained from the 
Dartmouth College Committee for the Protection of Human Subjects (CPHS) prior to the 
involvement of human subjects in the research. We will adhere strictly to all protocols and 
ensure that all potential risks to human subjects are reviewed by the DSMB every six months 
(see section 6 Timeline). 
8.1 Adapting the Decision Quality Instrument (DQI) Subscale (Year 1) 
8.1.1 Risk to Human Subjects 
Human Subjects Involvement, Characteristics, and Design 
In preparation for the comparative effectiveness trial, we will adapt the “What Matters Most to 
You” subscale of the Decision Quality Instrument. We will conduct up to 45 semi-structured 
interviews with women of lower SES at all four cancer centers involved in the trial. As 
mentioned in the Research Strategy section, we will include women over 18 years of age of 
lower SES who are uninsured or on Medicaid or Medicare without supplemental insurance (or 
ACA marketplace plans) who have completed treatments in the past three years. We will 
exclude women over 75 years of age and those with visual impairment, a diagnosis of 
psychosis or severe dementia, or inflammatory breast carcinoma. 
Sources of Materials 
In conducting the semi-structured interviews, we will collect information on participant 
characteristics (i.e., age, race, ethnicity, median household income, insurance status, highest 
educational attainment, and health literacy). The interviews will seek to understand which 
factors affect women’s treatment decisions related to breast cancer in women of lower SES. 
We will remove any identifying information from the audio-recording transcripts. We will not 
require participants to provide written consent to take part in the interviews but will audio-
record participants’ verbal consent at the interview’s outset. At the Joanne Knight Breast 
Health Center, written informed consent will be obtained. Each audio recording will be labeled 
with a unique, anonymous study identification (SI) number. A record of the names, contact 

 
59 
 
details of the participants, and their unique SI numbers will be stored securely in the REDCap 
database and separately from the audio recordings. 
Potential Risks 
We do not anticipate any physical, financial, legal, or other risks to the interview participants 
beyond those of natural occurrence. We anticipate potential risks to be limited to psychological 
discomfort. If this were to occur, we will immediately terminate the interview and ensure that 
appropriate support (such as access to a psychologist or social worker) is provided. Interviews 
will be conducted in private. 
8.1.2 Adequacy of Protection Against Risks 
Recruitment and Informed Consent 
Eligible participants will be identified by co-investigators and stakeholder partners at each 
participating site and through existing patient support and advocacy groups. Participants’ 
names and contact details will be transferred to the research team using the REDCap 
database. No personally identifiable information will be transferred or stored outside the 
REDCap and encrypted hard drives. Eligible participants will be sent an information sheet by 
mail describing the study aims and methodology. Subsequently, potential participants will be 
contacted by phone or in person and given an opportunity to ask questions before deciding 
whether or not to take part in the study. To facilitate recruitment, we will offer $30 gift cards 
for participation in the semi-structured interviews. We will interview participants in person, by 
phone, or at their home, whichever is more convenient for them. 
Protections Against Risk 
We anticipate minimal potential risks. Information on eligible participants solicited from the 
study sites and shared with researchers from Dartmouth College and subcontracting 
institutions will be stored safely in the REDCap database. The names and contact details of 
participants who decline to take part in the study will be immediately deleted from the 
database. 
 
As part of the standard consent process, participants will be advised that they are free to 
withdraw from the study at any time without providing any reason and without any impact on 
them or on the medical care they receive. Participant compensation of $15 has been carefully 
chosen and discussed with our patient and stakeholder partners so as not to exert undue 
influence on participation. 
 
All data will be stored in encrypted external hard drives and in the REDCap database. 
Anonymized data will be retained for six years after the conclusion of the study, per 
Dartmouth’s CPHS requirements, and then destroyed. Although potential risks to patients are 
minimal, the Data Safety Monitoring Board will review the interview data at their October 2017 
meeting. We do not foresee any risks or adverse events. 
 
Interview recordings will be transcribed using a HIPAA-compliant company. Recording files 
and subsequent transcripts will be transferred using a secure FTP.  

 
60 
 
8.2 Years 1, 2, and 3: Randomized Controlled Trial (Aims 1 and 2) 
8.2.1 Risk to Human Subjects 
Human Subjects Involvement, Characteristics, and Design 
We plan to recruit 600 women (approximately 300 higher SES and approximately 300 lower 
SES). Participants eligible for the trial will be women (a) with a confirmed diagnosis of early 
stage breast cancer (I to IIIA); (b) eligible for both BCS and mastectomy; (c) at least 18 years 
old; and (d) with at least a basic comprehension (6th grade level) of English, Spanish or 
Mandarin Chinese (e) assigned female sex at birth. We will exclude: 
- 
Transgender men and women; 
- 
Women who have undergone prophylactic mastectomy; 
- 
Women with diagnosis of psychosis or severe dementia; 
- 
Women with inflammatory breast carcinoma.  
 
Sources of Materials 
Using five questionnaires (at T0, T2, T3, T4, and T5), we will collect information on primary 
and secondary outcome measures. The questionnaires will also assess patient characteristics 
(e.g., age, race, ethnicity, median household income, insurance status, highest educational 
attainment, and health literacy). All information will be stored securely on the REDCap 
database and in encrypted external drives. 
Potential Risks 
We do not anticipate any physical, financial, legal, or other risks to the participants beyond 
those of natural occurrence. We anticipate potential risks to be limited to psychological 
discomfort. If this were to occur, we would ensure that appropriate support (such as access to 
a psychologist or social worker) is made available at each participating site. 
8.2.2 Adequacy of Protection Against Risks 
Recruitment and Informed Consent 
Eligible participants will be identified in advance by the breast-care team at each study site 
and through the outpatient appointment system and pathology reports. Eligible participants at 
Washington University in St. Louis will receive an information sheet and an introduction letter 
in the mail in advance of their surgical consultation. The information sheet will be short, written 
using plain language, and include pictures to describe the study.  
The letter will explain that a patient associate (i.e., a former breast cancer patient) or research 
assistant will call during the week before the consultation to answer any questions about the 
study, discuss the consent process, and help complete baseline questionnaire should they 
wish to participate. Each eligible patient will be told (in letter and on the phone/face-to-face) 
that she is potentially eligible to participate in the study but that eligibility will be confirmed by 
her sureon during her surgical consultation. Once all questions have been answered, patients 
will give verbal consent to take part in the study and, if her surgon confirms her eligibility, a 
written consent following the consultation.  
At other sites, the patient associate or research assistant will be in the clinic to meet the 
patients before the surgical consultation. Together with the patient associate and research 
assistant, the patients will have an opportunity to (a) review the information sheet if they have 
not yet had a chance to do so; (b) ask any questions they may have about the study; (c) give 

 
61 
 
consent, should they wish to take part; and (d) complete the baseline questionnaire before 
seeing their surgeon.  
Participants will be subsequently allocated to receiving Option Grid, Picture Option Grid, or 
usual care depending on the surgeon they are scheduled to see that day. The purpose of 
involving a patient associate is to promote patient-centeredness and facilitate recruitment in a 
context that is highly sensitive and emotional for potential participants given their recent cancer 
diagnosis. All signed consent forms will be stored securely in locked cabinets at each study 
site and collected by the PI at regular intervals.  
 
Protections Against Risks 
We anticipate minimal potential risks. First, privacy of individuals and confidentiality of data 
will be protected using the following procedures. Information on eligible participants collected 
at each study sites prior to consent and in the questionnaires after consent will only be shared 
with IRB-trained researchers from Dartmouth College and subcontracting institutions. It will be 
stored securely on the REDCap database. Names and contact details of participants who 
decline to take part in the study will be immediately deleted from the database. 
 
Patients who have consented to take part in the study will be assigned a unique, anonymous 
study identification number. All identifying patient information will be deleted prior to analysis. 
Any printed forms with patient data (including the consent forms) will be stored in a locked 
cabinet or shredded. All digital data will be stored in encrypted external hard drives and in the 
REDCap database. Anonymized data will be retained for six years after the conclusion of the 
study, per Dartmouth’s CPHS requirements, and then destroyed. Paper-based signed consent 
forms will be shredded six years post study completion date. 
 
As part of the standard consent process, participants will be advised that they are free to 
withdraw from the study at any time, without providing any reason or any impact on them or 
on the care they receive. Participant compensation of $15 for the baseline and post-visit 
assessment in clinic, as well as subsequent $15 gift cards for each follow-up questionnaire, 
has been carefully chosen and discussed with our patient and stakeholder partners so as not 
to exert undue influence on patient consent. 
8.3 Interviews, field-notes and observations to explore strategies that 
promote the interventions’ sustained use (Aim 3) 
8.3.1 Risk to Human Subjects 
Human Subjects Involvement, Characteristics, and Design 
In order to facilitate implementation in routine clinical settings, we will assess the perceived 
acceptability and feasibility of the Picture Option Grid and Option Grid in routine clinical 
settings. We will also assess perceived patient-, physician-, and system-level barriers and 
facilitators to routine use and explore strategies for promoting the interventions’ sustained use. 
At each site, we will select a purposive sample of up to 15 trial participants of varying SES, 
age, race, ethnicity, and language spoken in both intervention arms. These identified 
participants will be invited to take part in a semi-structured interview after they have completed 
the final follow-up assessment (T4). We will also encourage a family member, caregiver, or 
close relative to attend the interview and share their views. Patients will be compensated with 

 
62 
 
a $30 gift card. Additionally, we will  conduct interviews with up to 10 clinicians, social workers, 
administrators, and other stakeholders at each site, with and without involvement in the trial. 
Healthcare professionals and other stakeholders will not be compensated for their 
participation. We will conduct up to 100 interviews in total at T4. 
Sources of Materials 
As part of the semi-structured interviews, we will collect no new personal information from 
patients other than what has already been collected in the trial. We will collect information 
about occupation, time in current position, age, gender, race, and ethnicity from all 
participating healthcare professionals and other stakeholders at each study site. All personal 
participant information will be stored securely in the REDCap database. No personally 
identifiable information will be transferred or stored outside REDCAp and encrypted hard 
drives. 
 
Potential Risks 
We do not anticipate any physical, financial, legal, or other risks to the participants beyond 
those of a natural occurrence. Interviews will be conducted in private, and no identifying 
information or information on a participant’s health status will be actively sought. We anticipate 
potential risks to be limited to psychological discomfort. If this were to occur, we would ensure 
that appropriate support (such as access to a psychologist or social worker) is made available 
at each participating site. 
8.3.2 Adequacy of Protection Against Risks 
Recruitment and Informed Consent 
In Years 2 and 3, and after the patient’s T4 follow-up assessment has been completed, we 
will recruit a convenience sample of participants who have taken part in the randomized 
controlled trial to ensure involvement of patients of varying SES, trial arms, age, race, ethnicity, 
and language spoken. We will contact each participant by phone to ask whether they consent 
to take part in a telephone semi-structured interview. Verbal consent will be audio-recorded 
on the telephone at the interview onset. 
 
Once the last patient has been recruited for these T4 interviews, we will recruit a small sample 
of up to 10 healthcare professionals and other stakeholders at each study site. We will email 
each of them and invite them to participate in a telephone or in-person semi-structured 
interview. Verbal consent will be audio-recorded on the telephone before the interview begins. 
8.3.3 Protections Against Risk 
We anticipate minimal potential risks. As part of the standard consent process, participants 
will be advised that they are free to withdraw from the study at any time. Participant 
compensation of $30 has been carefully chosen and discussed with our patient and 
stakeholder partners so as not to exert undue influence on participation. Healthcare 
professionals and other stakeholders will not be compensated for their participation. 
 
All data will be stored in encrypted external hard drives and in the REDCap database. 
Anonymized data will be retained for six years after the conclusion of the study, per 
Dartmouth’s CPHS requirements, and then destroyed. 

 
63 
 
8.4 Education of Key Personnel on the Protection of Human Subject 
Participants 
Before data collection starts, all key study personnel (i.e., all study personnel except the 
scientific consultants) will be required to undertake appropriate Collaborative Institutional 
Training Initiative (CITI), including, but not limited to, Health Insurance Portability and 
Accountability Act (HIPAA) training. 
8.5 Potential Benefits of the Proposed Research to Human Subjects and 
Others 
Women who participate in this study and are allocated to the intervention arms will benefit 
from one of two interventions, which have been shown to increase knowledge and shared 
decision-making in the clinical encounter, at the minimum. All participants will have an 
opportunity to provide feedback on the communication patterns they have experienced with 
their doctor and care team and on the extent to which shared decision-making was fostered. 
Women who take part in the Aim 3 interviews will also get a chance to provide feedback on 
the optimal use of an encounter decision aid in routine clinical settings. Lastly, the knowledge 
gained from this project will determine the strategy that is most effective in promoting high-
quality breast cancer treatment choices in women of low SES and in potentially reducing 
healthcare disparities. 
8.6 Importance of the Knowledge to Be Gained 
The knowledge to be gained in this study is critical to understanding how best to empower 
women of low SES in making high-quality, informed decisions about breast cancer treatment. 
The interventions evaluated in this comparative effectiveness trial are likely to improve 
decision quality and the alignment between treatment chosen, knowledge about key 
differences, harms and benefits of those options, women’s values and preferences, and 
quality of life, while reducing anxiety and decision regret. We also anticipate that disparities 
between women of higher and lower SES will be reduced. 
8.7 Inclusion of Women and Minorities 
8.7.1 Planned Distribution of Subjects 
For all aims and activities, we will be recruiting women (assigned female at birth) only. Given 
that the study is focused on early stage breast cancer in women and that the intervention is 
targeted at women, men will be excluded from the study. Transgender men will also be 
excluded as their treatment course would be managed on a case-by-case basis. 
8.7.2 Subject Selection Criteria 
We have selected women of different ethnicity and race to represent the diversity of women 
of higher and lower SES who will be diagnosed with early stage breast cancer (I to IIIA) at all 
four participating study sites. We will ensure that study participants are representative of the 
target population (i.e., women of higher and lower SES diagnosed with early stage breast 
cancer) by recruiting patients from four large cancer centers located in geographically diverse 
areas that provide a combination of urban (Joanne Knight Breast Health Center, St. Louis, 
MO; Montefiore Medical Center, Bronx, NY; NYU School of Medicine, New York, NY) and rural 
settings (Dartmouth-Hitchcock, Lebanon, NH and Manchester, NH) as well as racially and 
ethnically diverse populations. 

 
64 
 
Men are excluded from this study because: 
- Early stage breast cancer is about 100 times less common in men than in women; 
- There are fewer options for men given the relative paucity of breast tissue. These 
shared decision-making resources do not, therefore, apply to this small sub-set of 
patients; 
- The intervention was specifically targeted at women diagnosed with early stage breast 
cancer (e.g., images of female anatomy only). 
8.7.3 Outreach Programs 
In order to recruit patients of different race, ethnicity, and languages spoken, we will work with 
the Community Advisory Board, patient advisors, and patient associates. We will also work 
closely with research assistants, patient associates, and research coordinators at each clinic 
to ensure that patients with varying levels of literacy are adequately supported to use the 
interventions and complete the questionnaires. We will also involve interpreters at each site 
as and when necessary. All study materials including the interventions will be translated into 
Spanish and Mandarin Chinese. 
8.8 Inclusion of Children 
8.8.1 Justification for the Exclusion of Children 
Children are excluded from the proposed study because: 
- Breast cancer is not diagnosed in patients under the age of 18. Most breast tumors in 
children are fibroadenomas and are thus benign. The interventions that we have 
developed are not applicable to children with benign clinical diagnoses; 
- The interventions being studied were developed and tested with adults at least 18 
years of age and include images and text that are tailored to older adults. This resource 
is not designed to be usable and acceptable in this young population. 
 
  

 
65 
 
9 Study Management and Finance 
Dr. Durand, as contact PI, will be responsible for day-to-day logistical management, and will 
have financial responsibility for the trial. She will be supported and mentored by Professor 
Glyn Elwyn, Co-PI, who holds a tenured chair at Dartmouth College. He is also Co-PI on a 
trial of encounter decision aids for family planning funded by PCORI, and initiator of the 
Option Grid Collaborative. Their complementary expertise and longstanding collaboration 
will be pivotal in successfully leading and managing this project.  
9.1 Trial Steering Group and Research Team 
A Trial Steering Group will involve all key personnel (including patient and stakeholder 
partners and invited CAB members) and will meet every three months using 
videoconferencing. Research team meetings will also be held on a monthly basis and will 
include key personnel from each study site, including patient and stakeholder partners. The 
duties of the TSG will include supervising the trial, monitoring trial progress, as well as 
reviewing and acting on all DSMB recommendations. Dartmouth College will have 
responsibility for centralized study management and general oversight. The research team 
at Dartmouth will maintain all aspects of the trial and work closely with each study site to 
coordinate all trial activities. 
9.2 Community Advisory Board 
We recognize that patient groups at each site will vary. To meet site-specific needs, and 
consistent with the CBPR approach, we will include Community Advisory Board (CAB) 
members from each study site, who will monitor and report back to the steering group. The 
CAB will include multiple stakeholders whose role is to meet quarterly and examine trial 
progress and report findings to the steering committee. The patient associates will also be 
invited to join each CAB meetings. One member of the CAB (as well as all patient partners 
named as key personnel) will be invited to attend all Trial Steering Group meetings and relay 
the CAB’s discussion and action points. See Appendix E-1 for the CAB Terms of Reference. 
9.3 Data Safety Monitoring Board 
A Data and Safety Monitoring Board (DSMB) will be appointed to provide additional oversight 
in the trial (see section 4.9.1 for additional information). DSMB membership will comprise of 
seven members including experts in or representatives of the fields of shared decision making, 
breast cancer surgery, patient advocacy, statistics, and clinical trials methodology. The DSMB 
will operate independently from the study sponsor. See Appendix E-2 for the DSMB Terms of 
Reference and Appendix F for the DSMB charter. 
 

 
66 
 
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11 APPENDIX A. OPTION GRID 
 
 
 
 
 
 
 
 
Editors:)Marie&Anne)Durand)(Lead)Editor),)Glyn)Elwyn,)Lisa)Caldon,)Kari)Rosenkranz,)Dale)Collins)Vidal,)Stephanie)Sivell,)Malcolm)Reed))
Evidence)document:)http://optiongrid.org/admin/resources/grid/evidences/9.pdf?x=WBZ1nd4YE))
This)Option)Grid)does)not)constitute)medical)advice,)diagnosis,)or)treatment.)See)Terms)of)Use)and)Privacy)Policy)at)www.optiongrid.org.)
Publication)date:)23)August)2017))Expiry)date:)23)August)2019)))
Breast)cancer:)surgical)options)
)
Use)this)Option)Grid™)decision)aid)to)help)you)and)your)healthcare)professional)talk)about)how)to)best)treat)
your)breast)cancer.)This)decision)aid)is)for)women)with)early)stage)breast)cancer)(stages)I)to)IIIA).))
)
Frequently)asked)
questions)
Lumpectomy)with)radiation)
Mastectomy)
What)is)removed?)
The)cancer)lump)is)removed,)with)some)
surrounding)tissue.)
The)whole)breast)is)removed.))
Which)surgery)is)best)
for)longEterm)survival?)
Long&term)survival)rates)are)the)same)
for)both)surgeries.)
Long&term)survival)rates)are)the)same)
for)both)surgeries.))
What)are)the)chances)
of)cancer)coming)back)
in)the)breast?)
Breast)cancer)will)come)back)in)the)
breast)in)about)5)to)10)in)100)women)
(5&10%))in)the)10)years)after)a)
lumpectomy.)
Breast)cancer)will)come)back)in)the)area)
of)the)scar)in)about)5)to)10)in)100)
women)(5&10%))in)the)10)years)after)a)
mastectomy.)))
Will)I)need)more)than)
one)surgery?)
Possibly,)20)in)100)women)(20%))may)
need)another)surgery)to)remove)breast)
tissue)or)lymph)node)that)have)cancer.)
Possibly,)if)your)lymph)nodes)have)
cancer.))
Yes,)if)you)choose)breast)reconstruction.)
How)long)will)it)take)to)
recover?)
Most)women)are)home)within)24)hours)
of)surgery.)))
Most)women)are)home)within)24)hours)
of)surgery.)It)may)take)longer)with)
reconstruction.))
Will)I)need)radiation)
after)surgery?))
Yes,)for)up)to)seven)weeks)after)surgery.) Radiation)is)not)usually)given)after)
mastectomy.)
Will)my)lymph)nodes)
be)removed?)
If)cancer)has)spread)to)the)lymph)nodes)
under)your)arm,)your)doctor)will)discuss)
with)you)whether)you)need)more)
treatment)such)as)surgery)or)
radiotherapy.))
If)cancer)has)spread)to)the)lymph)nodes)
under)your)arm,)your)doctor)will)discuss)
with)you)whether)you)need)more)
treatment)such)as)surgery)or)
radiotherapy.)
Will)I)need)
chemotherapy?)
You)may)be)offered)chemotherapy,)but)
this)does)not)depend)on)the)surgery)you)
choose.))
You)may)be)offered)chemotherapy,)but)
this)does)not)depend)on)the)surgery)you)
choose.)
Will)I)lose)my)hair?)
Hair)loss)is)common)after)
chemotherapy.)
Hair)loss)is)common)after)
chemotherapy.)
)

 
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13 APPENDIX C. DECISION QUALITY WORKSHEET 
 
 

 
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14 APPENDIX D. SAMPLE CONSENT DOCUMENTS  
14.1 Appendix D-1. Sample Information Sheet 
 

 
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14.2 Appendix D-2. Sample Consent Form 
 

 
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15 APPENDIX E. TERMS OF REFERENCE 
15.1  Appendix E-1. Community Advisory Board Terms of Reference 
 
 

 
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15.2 Appendix E-2. DSMB Terms of Reference 
 

 
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16 APPENDIX F. DSMB Charter 
 
 

 
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