Individualizing Surveillance Mammography for Older Breast Cancer Survivors
Phase: NA
Conditions: Breast Cancer
Sponsor: Dana-Farber Cancer Institute

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PROTOCOL TITLE: 
Individualizing Surveillance Mammography for Older Breast Cancer Survivors 
 
PRINCIPAL INVESTIGATOR: 
Rachel A Freedman, MD, MPH 
Medical Oncology 
617-632-3800 
Rachel_freedman@dfci.harvard.edu 
 
VERSION NUMBER: 
Version 3 
 
NCT03865654 
 
DATE: 
07/01/2020 

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Table of Contents 
1.0 
Objectives .....................................................................................................................3 
2.0 
Background ..................................................................................................................3 
3.0 
Inclusion and Exclusion Criteria ..................................................................................7 
4.0 
Study-Wide Number of Subjects* ................................................................................9 
5.0 
Study-Wide Recruitment Methods ...............................................................................9 
6.0 
Multi-Site Research ....................................................................................................12 
7.0 
Study Timelines ..........................................................................................................12 
8.0 
Study Endpoints .........................................................................................................13 
9.0 
Procedures Involved ...................................................................................................14 
10.0 Data and Specimen Banking ......................................................................................16 
11.0 Data Management* and Confidentiality ...................................................................166 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects ............................177 
13.0 Withdrawal of Subjects ............................................................................................177 
14.0 Risks to Subjects ......................................................................................................177 
15.0 Potential Benefits to Subjects……………………………………………………….17      
16.0   Vulnerable Populations ...............................................................................................17 
17.0 Community-Based Participatory Research* ..............................................................18 
18.0 Sharing of Results with Subjects ..............................................................................188 
19.0 Setting .......................................................................................................................188 
20.0 Resources Available .................................................................................................188 
21.0 Prior Approvals ........................................................................................................188 
22.0 Recruitment Methods ...............................................................................................188 
23.0 Local Number of Subjects ........................................................................................188 
24.0 Provisions to Protect the Privacy Interests of Subjects ............................................188 
25.0 Compensation for Research-Related Injury .............................................................188 
26.0 Economic Burden to Subjects ..................................................................................199 
27.0 Consent Process ..........................................................................................................19 
28.0 Process to Document Consent ....................................................................................19 
29.0 Drugs or Devices ........................................................................................................19 
Appendix A Blessed Orientation Memory Concentration Test 
Appendix B Draft communication tool 
Appendix C Draft Scripts for the interviews and focus groups 
Appendix D Draft surveys for Aim 1.2 (pilot intervention) 
Appendix E Verbal consent for patient phone interviews  
Appendix F Information and Verbal consent for pilot intervention 
Appendix G Informational flyer about the study 
Appendix H Draft email to providers for patients potentially eligible for the pilot intervention 
(Aim 1.2) 
 
 

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1.0 
Objectives 
 
In this multistep study, we will build on our prior efforts1 to develop consensus on surveillance 
mammography and follow-up for breast cancer survivors who are age ≥75 by further 
developing expert-panel recommendations, examining clinician and patient attitudes towards 
these recommendations, and testing a strategy for communication of expert recommendations 
on mammography cessation through direct engagement of specialists, primary care clinicians 
(PCs), and patients. Specifically, we will work to reduce overscreening of older patients 
through the following aims: 
1.1 Develop a communication tool that summarizes recommendations for clinicians and 
patients for surveillance mammography and follow-up care for breast cancer survivors 
age ≥75. This will build off the work of a multidisciplinary expert panel which will come 
together for a meeting to develop draft recommendations (OHRS exempt protocol #18-
526). 
• 
Interview up to 30 patients through telephone-based patient interviews and focus 
groups and interview oncologists and primary care providers (PCs) through 4-6 
focus groups to learn their perceptions and thoughts about when to stop surveillance 
mammography, how to thoughtfully incorporate life expectancy into decision-
making, how to communicate the benefits/risks of surveillance mammography, 
obtain feedback on the communication tool, and to explore optimal strategies for 
integrated and unified care between disciplines  
• 
Perform cognitive testing of the communication tool in up to 10 Dana-Farber breast 
cancer patients and further refine it for Aim 1.2 
1.2 Test the surveillance mammography communication tool with older breast cancer 
survivors and their oncology clinicians  
• 
In a pre-post intervention study, examine the effect of the communication tool 
among 45 breast cancer survivors age ≥75 years (with low risk of in-breast 
recurrences) seen by oncologists on women’s intentions for and knowledge of the 
pros and cons of surveillance mammography.  
 
We hypothesize that our communication tool will lead to fewer women intending to receive 
surveillance mammography in the next year and women having more knowledge of the benefits and 
risks of surveillance mammography.  
 
2.0 
Background 
2.1 Increasing burden of breast cancer in older women. Women age ≥75 are among the 
fastest growing segments of the U.S. population.2 Meanwhile, breast cancer is the most 
common non-cutaneous cancer in U.S. women3 and breast cancer risk increases with 
age.4 With an anticipated increase in the number of older breast cancer patients over 
time5 and the improving longevity of older breast cancer survivors, more women are 
living many years after a breast cancer diagnosis and most are dying of non-breast cancer 
causes6,7 without more risk for in-breast events than screening populations.1,8   

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2.2 Research and guideline gaps. Despite the growing number of older breast cancer survivors, 
there are limited data to guide their optimal follow-up care, particularly in the setting of 
advanced comorbidity.9 Older women with breast cancer are under-represented in nearly 
every large, prospective clinical trial to date,10 with exception of rare therapeutic trials 
dedicated to older patients.11,12 Although recommendations for screening mammography in 
aging populations have recently acknowledged the limitations in applying uniform 
guidelines to all women,13,14 many clinicians struggle with discussions around cessation of 
mammography15-18 and mammography rates have remained stable over time, regardless of 
age.19,20 Similarly and likely as a result of a lack of prospective data, guidelines for older 
breast cancer survivors regarding surveillance mammography and follow-up care lack 
consistency or specific attention to the needs of older patients. There are no prospective 
studies which specifically examine the benefits of surveillance mammography in older 
patients, let alone those with limited life expectancy, and the use of indefinite 
mammography in this growing patient population has been questioned by recent National 
Comprehensive Cancer Network (NCCN) Older Adult Guidelines21 and in a literature 
review by our study team.1 These NCCN guidelines21 suggest that decisions about 
mammography in older breast cancer survivors be based on patient preference and life 
expectancy, with a recommendation to stop surveillance mammography if life expectancy 
is ≤5 years. However, how to discuss mammography cessation and how to optimally 
approach follow-up care are not addressed in these guidelines. Further, these NCCN 
recommendations have not been endorsed in the more widely cited survivorship guidelines 
from the American Cancer Society and the American Society of Clinical Oncology 
(ASCO),22,23 which still recommend annual mammography in all breast cancer survivors 
with residual breasts, regardless of life expectancy.  
2.3 Benefits and Harms of Surveillance Mammography in Older Women. The goal of 
surveillance mammography is to detect in-breast recurrences and/or new breast cancers that 
impact survival. Overall, approximately 4-5% of all breast cancer survivors will develop an 
ipsilateral or contralateral breast cancer in the 5-10 years after initial diagnosis (which is 
similar to the risk for breast cancer in aging, screening populations),1,8 but the risk for these 
events decreases with increasing age, favorable disease biology, and with the use of 
hormonal therapy in the setting of hormone receptor-positive disease.24-31  
Among screening populations, it is estimated to take ≥10 years before one breast cancer 
death is prevented among 1000 women aged 50-74 undergoing mammographic screening.32 
Although the lag-time and degree of benefit from surveillance mammography has not been 
quantified for older breast cancer survivors, it is likely similar or perhaps even less 
beneficial, given the lower risk of in-breast events with increasing age,28,29,33 and the lower-
risk tumors that most older patients develop.34,35 Although some studies suggest ongoing 
benefit of mammography with increasing age,36,37 they are limited by the inherent biases of 
retrospective studies, where healthy, older breast cancer survivors are more likely to 
undergo surveillance than sicker ones and are thus more likely to survive longer. In a single 
institution study38 examining mammography use in women aged ≥80 with a history of early-
stage breast cancer during a mean of 50 months, 429 women underwent 1,466 
mammograms that detected 13 non-palpable cancers (0.9%), while 9 additional cancers 
were detected by physical exam. Although the study did not assess long-term breast cancer 
or survival outcomes, these findings raise questions about the added value of surveillance 

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mammography in older women. Unlike the potential benefits, the harms of surveillance 
mammography are immediate and include over-diagnosis, false positive results, unnecessary 
biopsies, and associated pain and anxiety.38-47 Further, with comorbidity present in many 
older patients and very low risk of breast cancer death,7,34,48 over-diagnosis and the ensuing 
overtreatment are even more significant risks for older versus younger patients.39-43 
2.4 Summary. Better strategies are needed for breast cancer surveillance in older survivors, a 
growing population of women for whom prospective evidence and expert consensus is 
lacking. Strategies are needed to individualize follow-up care to avoid medical interventions 
from which patients are unlikely to benefit (or from which they will not benefit for many 
years) and are likely to inflict immediate harm. We anticipate that our framework for 
follow-up care for older breast cancer survivors will significantly improve survivorship care, 
decrease overuse of unnecessary testing, and improve quality of life, with an enhanced 
understanding of the pros/cons of mammography in the context of having a better 
understanding of one’s life expectancy. Our project will work on how to deliver this 
information in compassionate, thoughtful, and informative way. Further, we anticipate that 
clinicians will feel more informed, empowered, and supported to make recommendations 
for their older breast cancer survivors if they are endorsed by expert consensus. We 
recognize that conversations on cessation of mammography with breast cancer survivors 
may be particularly challenging because of their personal experiences with cancer. 
However, if women understand their individualized risks and benefits, they will at least 
have the opportunity to make informed decisions rather than have the false security that 
routine mammograms may indefinitely improve their longevity. Figure 1 below shows the 
general framework for our approach and some of the considerations in developing 
guidelines and patient materials.  
2.5 Innovation of this Project. How to optimally address surveillance mammography in older 
patients has never been specifically addressed. We will develop a novel and much needed 
approach to optimize surveillance mammography use and follow-up care for older women, 
provide a foundation for discussion about cessation of mammography when appropriate, and 
better coordinate primary and specialty care. The key innovations of this proposal include: 
(1) This study focuses on follow-up care for older breast cancer survivors, and will develop 
expert-based recommendations on mammography use and follow-up care for this 
population. (2) This is the first study to directly engage patients and clinicians in follow-up 
care of older breast cancer survivors which will foster consensus and optimize care 
integration. It will directly engage patients and national experts from complementary 
specialties around decision-making for mammography and communication of recommended 
approaches for when mammography cessation should occur. (3) This is the first study to 
evaluate how to optimally and sensitively incorporate life expectancy into the decision-
making process for surveillance mammography in older breast cancer survivors.  (4) This 
study will develop an easy-to-use novel communication tool describing the pros/cons of 
surveillance mammography for patients and clinicians that we anticipate will lead to more 
informed decisions on mammography use and less over-utilization.  
2.6 Preliminary Studies. Our study team has extensive experience in examination of practice 
patterns for older cancer patients, utilization of mammography, and validation of life 
expectancy measures. Dr. Freedman is a medical oncologist who has expertise in the care of 

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older patients with breast cancer10,49-52 and in addressing the value of surveillance 
mammography in older breast cancer survivors when life expectancy is limited.1,53 Dr. 
Schonberg is a PC physician, and is an expert in optimizing use of mammography screening 
in older women without a breast cancer history. She has developed widely cited models that 
predict life expectancy for community-dwelling adults.6,13,34,44,45,54-66 In addition, she has 
significant experience recruiting older women to participate in qualitative and survey-based 
studies. Dr. Keating is a PC physician and health services researcher with wide-ranging 
expertise in examining patterns of care and outcomes for patients with cancer as well as 
interpretation of mammography guidelines and patterns of mammography use.1,19,53,67-70 
This proposal builds nicely on our collective, prior work and combined expertise. 
Literature review: We recently completed a systematic review of the available literature on 
surveillance mammography in older populations,1 concluding that discussions about 
surveillance and cessation of surveillance should include estimating life expectancy, risk for 
future in-breast recurrences or new cancers, the anticipated risks/benefits of testing, and 
preferences. In our review, we suggested specific approaches for follow-up care for older 
patients and provided talking points for discussing mammography cessation with patients. In 
Aim 1, we will engage an expert panel of clinician and patient stakeholders to further refine 
our literature review and recommendations for surveillance mammography and follow-up 
care. 
 
Utilization of surveillance mammography by life expectancy. We examined use of 
surveillance mammography by life expectancy (using the Schonberg Index)55,56,61,71 among 
1,040 breast cancer survivors interviewed as part of the National Health Interview Survey 
(NHIS).53 We found that nearly 80% of survivors age ≥65 reported having mammography in 
the last year, similar to other reports of surveillance mammography use.68 Use of 
mammography decreased with worsening life expectancy, but 57% of those with estimated 
≤5-year life expectancy reported having mammography in the last year. Conversely, 14.1% 
of those with life expectancy >10 years did not report mammography. These results provide 
important preliminary work for our proposal and highlight the pressing need to optimize and 
tailor follow-up care for older patients. We will work to provide information on life 
expectancy in a compassionate and constructive way.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 1. General framework for impacting decision-making on mammography 

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2.7 Study Impact. The long-term goals of this work are to optimize mammography use (and 
decrease overscreening) for older breast cancer survivors, a group in critical need of 
evidence-based, unified approaches to their follow-up care. Older patients are not 
adequately represented in any screening or surveillance clinical trials, and the proposed 
study will address significant knowledge gaps through expert consensus and prospective 
data collection. In addition, the study will provide a framework for discussions on 
how/when to stop surveillance mammography in the context of life expectancy framing 
and how to prioritize follow-up strategies, with the goal to enhance communication 
between patients and clinicians as well as between PCs and specialists. This study will 
provide preliminary data for a prospective, randomized study evaluating the use of our 
expert recommendations among patients and PC and oncology clinicians in a larger, 
geographically diverse setting, with the ultimate goal to further assess impact, standardize 
practice, improve coordination of care, and disseminate our novel and urgently needed 
intervention. 
3.0 
Inclusion and Exclusion Criteria – the eligibility differ by protocol aim/step and 
whether it is a patient or provider component of the study. Please see specifics for each aim 
below. 
3.1 Aim 1.1: Clinician focus groups. We will recruit a broad, national sample of academic 
and community clinicians for focus groups. Two groups will include DFCI oncology 
clinicians, two groups will include Brigham and Women’s (BWH) PCs and geriatricians, 
and two groups will be held virtually via web-ex and will include a broad, national 
inclusion of physicians.  
3.2 Aim 1.1: Patient phone interviews and focus groups. Patients will be eligible if they meet 
the following criteria: 
• Female gender, given that screening guidelines do not exist for men 
• Receiving part or all of their care at DFCI 
• Ages 75-79 (approximately 10 patients) 
• Age ≥80 (approximately 10 patients)  
Older patient with breast cancer entering follow-up care
DECISION-MAKING REGARDING SURVEILLANCE PLAN
FACTORS TO CONSIDER:
•
Disease characteristics
•
Risk of future in-breast events
•
Risks of mammography
•
Benefits of mammography
•
Patient preferences
•
Provider Preferences
•
Competing mortality
•
Life expectancy
Communication Tool Applied
Decision on follow-up care (mammography, exam)
ASSESS IMPACT:
•
Patient and provider satisfaction
•
Time added/saved
•
Patient knowledge
•
Care coordination
•
Cancer outcomes
•
Frequency of risks and benefits
•
Decisions over time
Consensus 
recommendations

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• Age 60-74 (approximately 10 patients, given that some advocacy groups have 
patients in this age range who will contribute) 
• History of stage 0-II breast cancer 
• We will try to include patients with ≥1 Charlson comorbidity present72, defined 
as one of the following (though this is not mandatory): 
o Diabetes 
o Liver disease 
o History of or other active malignancy other than non-melanoma skin 
cancers 
o HIV or AIDS 
o Chronic kidney disease 
o History of myocardial infarction and/or congestive heart failure 
o Chronic lung disease (emphysema/chronic bronchitis/chronic 
obstructive pulmonary disease [COPD], interstitial lung disease) 
o Peripheral vascular disease 
o Cerebrovascular disease (history of TIA or stroke) 
o Dementia 
o Hemiplegia/paralysis 
o Connective tissue disorder 
• Underwent treatment of this cancer 
• Completed all active breast cancer therapy >3 months prior to enrollment (i.e. 
any chemotherapy, trastuzumab, radiation). Ongoing hormonal therapy or 
enrollment in survivorship clinical trials (aspirin, exercise, etc) is allowed.  
• English-speaking and reading (for this initial work) 
 
3.3 Aim 1.1. Cognitive testing of the communication tool. The criteria for this are 
intentionally more flexible than in other aims, as we are simply working to initially test 
the tool and its readability and understandability. Patients will be eligible to cognitively 
test the tool if they meet the following criteria: 
• Female gender 
• Previous diagnosis of breast cancer  
• Age ≥75  
• Receive some/all care at Dana-Farber Cancer Institute 
• English speaking-reading 

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3.4 
Aim 1.2. Pilot testing the communication tool in clinic. These criteria have been 
updated to assure as much generalizability as possible in study design with ease of screening 
patients.   
•  Previous diagnosis of stage 0-II breast cancer  
• Receive some/all care at Dana-Farber Cancer Institute and affiliated satellite sites 
(Boston’s main campus, South Shore Hospital, or St. Elizabeth’s Medical Center) 
• Completed any active breast cancer therapy >/=12 months prior to enrollment (i.e. 
any chemotherapy, trastuzumab, radiation). Ongoing hormonal therapy or 
enrollment in survivorship clinical trials (aspirin, exercise, etc) is allowed.  
• Age ≥75 
• Had breast-conserving surgery to treat this cancer  
• Provider does not opt out of the patient’s enrollment via email notification 
• English speaking and reading 
 
For all study aims, we will exclude patients who: 
• 
are unable to consent 
• 
who do not read and write English (for this initial pilot) 
 
4.0 
Study-Wide Number of Subjects* 
4.1 For Aim 1.1, we will recruit up to 30 patients and up to 48 providers for the qualitative 
focus group/interview component, and 5-10 patients for the cognitive interviewing of the 
tool. For Aim 1.2, we will recruit 45 patients and the providers taking care of those 
patients.  
5.0 
Study-Wide Recruitment Methods 
5.1 Procedures for interview and focus group (and cognitive testing) recruitment- Patients 
(Aim 1.1). Due to due potential challenges in gathering multiple focus groups of older 
patients who may have issues with mobility and transportation, the potential sensitivity 
of topics to be discussed (i.e. life expectancy), and because we would like to obtain in-
depth, individualized opinions, we will conduct a mixture of one-on-one telephone 
interviews (30-60 minutes each) by trained DFCI staff. For this aim, we will recruit 
approximately 10 patients ages 60-74, 10 patients ages 75-79 and 10 patients age ≥80 
with a history of stage 0-II breast cancer (thus at low-average risk for in-breast 
recurrences) and ideally ≥1 Charlson comorbidity72 (targeting those with shorter life 
expectancy) who underwent breast surgery and have completed any active breast cancer 
therapy (i.e. any chemotherapy, radiation >3 months ago) and who are either entering or 

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are already in the follow-up phase of cancer care. This is an ideal time to recruit patients 
as they are transitioning to less frequent follow-up and mammography plans are being 
made and even scheduled. We will purposively recruit a diverse sample based on 
race/ethnicity and socioeconomic status, including patient advocacy groups in Boston 
and beyond. In order to identify this focused population of patients, we will use our 
patient advocacy network (Patient and Family Advisory Council [PFAC] at DFCI, breast 
cancer advocates in New England, Pink and Black in Boston). We will also reach out to 
our oncology providers at DFCI for any patients who come to mind that fit our 
eligibility and the clinical research coordinator (CRC) will also scan DFCI breast 
oncology clinician schedules for patients who meet these criteria. Appendix G has a 
flyer/email content for advertising the project. The CRC or study PI will ask each 
patient’s oncologist and/or NP/PA for permission to contact their patient, with providers 
having the option to opt out if they feel that patient is not appropriate to be approached. 
We will then mail or email potential patients an invitation to the telephone interview or 
focus group and a number to call to opt out. The CRC will call patients who do not opt 
out 2 weeks later to assess their interest in participating. Dr. Freedman, the study PI, will 
also reach out to patient advocacy groups with an introductory email (Appendix G) to 
the study to assess for interest though the patient advocates working on this project (on 
the expert panel). To accommodate scheduling, we will offer flexible interview and 
focus group times. Once an interview or focus group is scheduled, we will mail or email 
the patient the communication tool (Draft tool in Appendix B and will be further iterated 
based on feedback and Aims that precede its use) before the interview with a sensitive 
introduction to the tool (to minimize any stress associated with receiving it in advance), 
explaining that the tool will be used during the interview. All patient phone interviews 
and focus groups will be led by a trained qualitative researcher from the DFCI Survey 
and Data Management Core (‘Core’), Dr. Freedman, or a research assistant trained by 
the Core. The Core is a very experienced and well-established team that readily 
organizes and facilitates focus groups, phone interviews, and performs qualitative data 
analyses. They have a long track record of successful and effective work in this area and 
their expertise will also be utilized to adapt the communication tool at completion of this 
qualitative aim. For patients, a waiver of written consent will be requested and verbal 
consent will be obtained. Patients interviewed by phone only will undergo a brief 
cognitive function (Blessed Orientation-Memory-Concentration test [BOMC])73 and 
capacity evaluation (Appendix A) and will proceed with the interview if they score <10 
points on the BOMC and answer ≥4 capacity questions correctly. Upon interview 
completion, patients will be sent a gift card for $50. Snacks and parking will be provided 
for any focus group that requires travel. 
5.2 Procedures for recruiting focus groups - Providers (Aim 1.1). Dr. Freedman will email 
her colleagues at Brigham and Women’s and DFCI to recruit them for a 60- minute 
focus group discussion, aimed to occur at a regular weekly/monthly meeting for a 
particular PCP or medical oncology practice. We will provide beverages and snacks for 
the meeting. We will visit the practice at BWH or DFCI to conduct the focus groups 
and any virtual focus groups will take place by phone via webex. Dr. Freedman will 
also reach out to her broad network of physicians outside of DFCI to recruit oncologists 
from around the country for the virtual focus group (which will occur via 

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webex/phone). Dr. Freedman (who is experienced in leading clinician-based focus 
groups) will lead all clinician focus groups. All discussions will be recorded and 
professionally transcribed. At the start of the clinician focus groups, verbal consent 
from each participant will be obtained and providers will be provided a written copy of 
the verbal consent in person or via email. We do not intend to register providers in 
Oncpro.  
5.3 Procedures for recruiting providers and patients for the tool intervention (Aim 1.2) 
We will then test the communication tool at DFCI, DFCI at South Shore Hospital , and 
DFCI at St. Elizabeth’s breast medical oncology practices. Dr. Freedman will recruit 
10-12 medical oncology colleagues who each agree to test the communication tool in 
≤5 of their older patients over a 4-6-week period.  
Before the visit. To identify mammography-eligible patients with low-to-average risk 
for in-breast recurrences, the dedicated CRC will scan participating clinician schedules 
daily over a 4-6-week period at DFCI/St. E’s/South Shore Hospital for breast cancer 
patients with stage 0-II breast cancer who have completed any chemotherapy, surgery, 
and/or radiation ≥12 months prior and who are aged ≥75 and who had breast-
conserving surgery. If a patient meets criteria for possible enrollment, the CRC will 
email the clinician (Appendix H) to confirm that mammography would typically be 
discussed at this visit and to ask permission to offer the study to the patient.  
If the clinician agrees, the CRC will send information and what will be used for verbal 
consent (Appendix F) to the patient with an opt-out number and email followed by a 
phone call (to those who do not opt out) to explain the study’s purpose and obtain 
verbal consent for participation. The CRC will share a blank communication tool to the 
patient with the ‘pre’survey to be filled out before the visit (clinic visit can be virtual or 
in person), and notify the clinician when a patient enrolls. This can be sent to the 
patient by mail or email in advance of their virtual/in person clinic visit. If the patient 
prefers the materials to be given to them in person, the CRC will arrange to meet the 
patient 30 minutes before their scheduled clinic visit. If the clinic visit is virtual, the 
CRC can call the patient anytime ahead of the provider visit to review the materials.  
The study team will be utilizing standard clinical workflows and may involve virtual 
substitution of office visits such as the use of Zoom Video Communications 
application. Although in-person office visits are preferred on site, virtual visits via 
Zoom conferences, which are HIPPA compliant and protected, can provide a safer and 
efficient alternative for patients. 
Visit Day. The day before the clinic visit (virtual or in-person), the CRC will call or 
email the patient to remind them to fill out the ‘pre’-survey and send it to the study 
team. We will also remind the clinician that the patient is coming/being seen virtually 
and will email or hand-deliver a blank communication tool before the visit so they are 
aware it may be discussed. The CRC may meet the patient in the waiting room or 
communicate by phone/email before their appointment to collect the ‘pre’ survey (if not 
already received via email/mail) A copy of the verbal consent can also be given in 
person or via email/mail if not already done ahead of this visit. Clinicians will be 
reminded to incorporate the communication tool in a way that feels comfortable to them 
to facilitate routine practice but without specific instructions. After the visit, the CRC 

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will ask the patient to complete the paper ‘post’ surveys in person, by mail, or by email 
within 7 days of the appointment, concluding the study for that patient. To understand 
how providers feel about the communication tool, the experience using it, and the 
comfort with it as a guide for discussions, the clinician will be asked to complete one 
brief survey per patient enrolled (no provider consent planned but a short introduction 
to the survey will be provided-see Appendix D), after all of their participating patients 
have completed their visits. Each patient will be registered to document their 
participation by DFCI study staff and will receive a $40 gift card for their participation 
and clinicians will receive a $40 gift card after the all surveys for participating patients 
have been completed. All data will be entered by the CRC into the secure, REDCap.  
 
5.4 Registration Procedures 
The eligibility checklist (Aim 1.2 only) will be filled out and submitted by the DFCI 
Study Coordinator for registration within 30 days of the patient participant providing 
verbal consent at the time of the survey. The other qualitative aims will not require study 
registration. Registered study participants from Aim 1.2 will be entered on study centrally 
at DFCI by the Study Coordinator after providing verbal consent. All registrations must 
occur within 30 days of the survey date.  
 
The Study Coordinator will follow DF/HCC policy (REGIST-101) and register eligible 
participants on the protocol using the Clinical Trials Management System (CTMS) 
OnCore. Following registration, the Study Coordinator will use the participant study 
number for identification of all patients. 
 
Participant information, including receipt of verbal consent, will be tracked in a 
password-protected, secure, on-line, web-based system. We will also secure patient 
contact information on this portal in addition to a tracking sheets on the number of phone 
calls made and any contact made with potential participants.  Anyone failing screening or 
declining enrollment will be logged internally (not centrally by ODQ) and confidentially 
by study staff with the reason for failure or decline. 
 
6.0 
Multi-Site Research 
 
All patient research will be conducted on site at DFCI, DFCI at South Shore Hospital, and DFCI 
at St. Elizabeth’s, or by phone. Provider focus groups will take place at DFCI, Brigham and 
Women’s, or virtually/by phone. Although Dr. Schonberg is a collaborator on this study, no 
research will take place at BIDMC. 
 
7.0 
Study Timelines 
7.1 Duration of the study: 
• 
The patient and providers are each involved for one time-point.  
• 
We anticipate that all aims will be completed by December 31, 2020.  
 

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8.0 
Study Endpoints, Statistical Plan, and Sample Size Considerations 
8.1 Aim 1.1 (provider focus groups and patient interviews). For each discussion, the 
transcribed data will be analyzed according to standard comprehensive qualitative analysis 
methods,74-76 which consists of a two-stage coding process: level 1 structural coding and 
level 2 thematic coding. All analyses will be conducting by the DFCI Core. Structural 
coding will follow the structure of the focus group/interview guide, in which every 
question receives a code that is applied to the appropriate text. Thematic coding will be 
based on themes that arise from the structural coding and will be applied in a second pass 
analysis. Thematic coding allows for a grounded theoretical approach to analysis. These 
methods will be enhanced by ethnographic data management software (N’Vivo). This 
state-of-the-art program uses an organizer indexing system for coding, categorizing, 
searching, retrieving, and attaching analytical memos, creating a conceptual relationship 
network in textual data that has been taxonomically coded. Quotes that exemplify themes 
will also be extracted. Once the thematic analysis is complete, Dr. Freedman will lead the 
preparation of the comprehensive thematic analysis report. Answers to the discrete items 
at the start of discussions will be tabulated. 
8.2 Sample Size Considerations (Aim 1.1). In qualitative research, sampling is recommended 
until thematic saturation is reached and this typically occurs after including 30 participants 
or ≥4 focus groups with 6-8 participants per group.77,78 Therefore, we will recruit 30 patients 
and ≥24 clinicians (≥4 focus groups). We will begin with 1 DFCI oncology, 1 BWH PC, and 
1 oncology virtual focus groups. However, if we do not achieve thematic saturation, we will 
recruit 3 more groups to reach thematic saturation. The DFCI ‘Core’ will provide the 
analytic expertise for the qualitative data analyses an thematic summaries.  
8.3 Summary Aim 1.1 At the conclusion of Aim 1.1, we will summarize findings in the 
thematic analysis report, incorporate suggestions, and revise the recommended guidelines 
and communication tool to reflect the issues raised by our qualitative analysis.  
8.4 Outcomes and Analyses for Aim 1.2. The outcomes of interest are shown in Table 2 below 
and have been adapted from Dr. Schonberg’s prior survey study testing a decision aid for 
screening mammography for older women.66 We will focus on a primary outcome of 
intentions for mammography and will examine how various factors (race, health literacy, 
numeracy, anxiety, life expectancy) impact intentions. We use the sign rank and exact 
McNemar’s testing to compare the ‘pre’ vs. ‘post’ results for the continuous score for 
intention and proportion who indicate ‘yes’, respectively. To account for clustering by 
clinician, we will utilize random effects models if parametric assumptions hold, or 
alternatively using bootstrap resampling techniques to compute 95% confidence intervals 
for the change in intention. We anticipate a low number of missed surveys because of the 
CRC follow-up planned by phone, mail, or email if necessary. If a patient is missed for her 
‘pre’ test survey, we will replace her to ensure enrollment of 45 with ‘pre’ and ‘post’ 
surveys. We will compare characteristics of those with missing surveys and missing 
questions to those with complete surveys to assess for any notable differences.  
Table 2. Outcomes of Interest for Aim 1.2 
Outcome(s) of Interest 
Outcome definitions, planned analyses 

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Primary Outcomes:  
Patients: Frequency of change in intentions for 
mammography in the next year 
15 point validated scale to assess ‘pre’ vs ‘post’ survey 
responses where scores 1-5 = yes to having mammography, 6-
10 = unsure, 11-15 = no for mammography. We will use a 
continuous outcome of 1-15.66,79  
Patients & Clinicians: Acceptability & Feasibility 
Length, clarity; tabulate responses80; 75% report the tool is 
useful 
Secondary Outcomes: 
Clinicians: satisfaction, time added/removed 
Tabulate responses, prepare descriptive analyses 
Patients: preferred decision-making role 
‘Pre’ survey: Examine preferences for active, shared, passive 
decision-making 81 
Patients: Decisional conflict 
‘Pre’ vs. ‘Post’ survey: 16 item scale, Calculate total and sub-
scale responses. Scores range 1-100, lower scores indicating 
higher quality decision-making82,83 
Patients: Knowledge about mammography 
Number of correct (10) knowledge questions on ‘pre’ vs. 
‘post’ surveys. 66,84,85 
Patients: intentions vs. actual decisions for 
mammography 
‘Post’: Examine whether patient intentions for mammography 
agree with whether mammography is scheduled or not (using 
chart abstraction) 
Patients & Clinicians: Agreement in intentions  
‘Post’ for patients and providers: degree of agreement on 
scores 1-15 
Patients & Clinicians: life expectancy wishes 
‘post’ for patients and providers: tabulate responses for 
willingness to discuss 
 
8.5 
Primary Outcomes for Aim 1.2: We will focus on the primary outcomes of 
intentions for mammography and acceptability/ feasibility. We use the 
sign rank and exact McNemar’s testing to compare the ‘pre’ vs. ‘post’ 
results for the score for intention and proportion who indicate ‘yes’, 
respectively. To account for clustering by clinician, we will utilize random 
effects models if parametric assumptions hold, or alternatively using 
bootstrap resampling techniques to compute 95% confidence intervals for 
the change in intention. We anticipate a low number of missed surveys 
because of the CRC follow-up planned by phone if necessary. If a patient 
is missed for her ‘pre’ test survey, we will replace her to ensure enrollment 
of 45 with ‘pre’ and ‘post’ surveys. We will compare characteristics of 
those with missing surveys and missing questions to those with complete 
surveys to assess for any notable differences. For feasibility, we will 
declare the tool feasible if ≥75% of patients and physicians report 
usefulness of the tool. 
 
At the conclusion of this am, we will have preliminary data on how the 
communication tool impacted care, its feasibility, and about multiple 
exploratory, secondary endpoints. If we have difficulties with recruitment 
of patients or clinicians for this project, we will contact additional 
clinicians and patients to reach our desired accrual goals. Given the high 
volume of breast cancer patients and clinicians in our system, we 
anticipate that accrual will occur with ease.  
 
9.0 
Procedures Involved 
9.1  
Procedures for provider focus groups/ patient interviews. Dr. Freedman 
(who is experienced in leading clinician-based focus groups) will lead all 

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clinician focus groups. All patient focus group and phone interviews will 
be led by a trained qualitative researcher, Dr. Freedman, or a trained CRC 
from the DFCI Survey and Data Management Core (‘Core’). All 
discussions will be recorded and professionally transcribed. The Core is a 
very experienced and well-established team that readily organizes and 
facilitates focus groups and performs qualitative data analyses. They have a 
long track record of successful and effective work in this area and their 
expertise will also be utilized to adapt the communication tool at 
completion of this qualitative aim. At the start of the clinician focus groups, 
verbal consent from each participant will be obtained. For patients (who are 
interviewed by phone), a waiver of written consent will be requested and 
verbal consent will be obtained. Patients will undergo a brief cognitive 
function (Blessed Orientation-Memory-Concentration test [BOMC])73 and 
capacity evaluation (Appendix A) and will proceed with the interview if 
they score <10 points on the BOMC and answer ≥4 capacity questions 
correctly.  
9.2 
Discussion Content. Clinicians will be asked to comment on (a) the panel 
recommendations from DFCI OHRS exempt protocol 18-526, (b) how 
they currently talk with patients about surveillance and whether and how 
they might incorporate risk or life expectancy in conversations, (c) the 
draft communication tool (including exploring whether electronic tools 
appeal to clinicians), and (d) ideal communication strategies for PCs and 
oncologists to coordinate follow-up care. Patients will first be asked a 
short series of discrete questions which will be followed by discussion of 
topics focused on the patient experience and comfort in hearing 
information about life expectancy, whether they have ever discussed 
cessation of mammography, and their preferences for receiving the 
information presented on the communication tool (mailed to them ahead 
of time). We will also inquire about whether electronic versions of the tool 
might appeal to patients and clinicians or whether they prefer paper 
versions. Draft scripts for clinician and patient focus group and phone 
interviews are provided in Appendix C. These will be amended as 
appropriate before initiation of this component of the study. 
 
9.3 
Survey Instruments. The draft ‘pre’/’post’ patient surveys and a post-visit 
clinician survey (all three draft surveys) are in Appendix D. Surveys 
contain closed-ended questions (except for solicited comments at the end) 
and are adapted from Dr. Schonberg’s prior, validated surveys conducted 
before and after the use of a decision aid for screening mammography in 
older women.66 We will ask about demographics, health literacy and 
numeracy (‘pre’ patient), mammography intentions (‘pre’ and ‘post’ 
patient), mammography knowledge (‘pre’ and ‘post’ patient), anxiety 
about recurrence (‘pre’ patient), acceptability of the communication tool 
(‘pre’ patient and clinician), comfort level and interest in discussions 
about life expectancy (‘pre’ and ‘post’ patient and clinician), decisional 

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conflict (‘pre’ and ‘post’ patient), preferences for a paper/online tool 
(‘post’ patient and clinician), and time added to appointments (‘post’ 
clinician).  
 
10.0 Data and Specimen Banking – there is no specimen banking as part of this 
protocol 
 
11.0 Data Management and Confidentiality 
11.1 The data analysis plan and procedures are described in Section 8.  
11.2 Data Management Plan: We will use a secure, password-protected REDCap 
database to capture information for the intervention part of this study (Aim 
1.2). Data elements to be included in the centralized study data repository 
will include baseline demographics, comorbidity, medications, date of 
diagnosis, disease characteristics, and survey information. All survey data 
will be specifically entered and maintained securely in password protected 
systems.  
All study components will be run from Dana-Farber Cancer Institute. Study 
staff will computerize the data from the patient questionnaires in this 
observational study. In addition, study staff will computerize medical 
information on each of the study participants into the centralized, secure 
database. For patients invited into the study but who choose not to 
participate, there will be no retention of patient identifiers. Study staff will 
record the age, race, date of diagnosis and surgery for all patients who 
decline participation to allow for demographic comparison of participants 
and nonparticipants. All original copies of data will be kept in file cabinet 
locked in study staff offices. Computerized databases will be password 
protected. Data will be collected, coded, and managed by study staff only. 
The name and address file will be stored on a separate computer with 
password protection from the data files to protect the identity of 
respondents. Data and software will be backed up on a nightly basis as per 
our institutional norm. 
11.3 Data Security. All data files will be stored on password-protected, secure 
servers. Access to the data will be limited to members of the research team. 
All patient names and contact information will be kept strictly confidential 
in a password-protected file stored separately at each study site, separate 
from the survey and medical record data. The survey/medical record data 
files will contain the CASE ID only, a unique study identification number, 
and only that number will be included in analytic databases shared by team 
members. Patient contact information will be stored in a separate password-
protected database, for use by the study team only. This list will be used 
only for tracking potential participants, specifically for documenting 
attempts to reach patients. A separate password-protected file containing the 
crosswalk between the patient name and unique ID will be maintained 

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separately.  Upon enrolling a patient, the study staff will use the unique 
study ID and will enter survey responses directly into the database from the 
computer interface.  All answers to survey questions will be linked with the 
case ID only and no identifying information.   
11.4 The study protocol will strictly adhere to all HIPAA and Dana-Farber 
regulations. Confidentiality of the subjects will be maintained. The study 
team will be utilizing standard clinical workflows and may involve virtual 
substitution of office visits such as the use of Zoom Video Communications 
application. Although in-person office visits are preferred on site, virtual 
visits via Zoom conferences, which are HIPPA compliant and protected, can 
provide a safer and efficient alternative for patients. No data will be linked 
to a particular name or personal identifiers. The individual results will not be 
disclosed. The de-identified dataset will be provided to the investigators for 
analysis. The composite results will be analyzed and summarized for 
presentation and publication. We will minimize risks regarding 
confidentiality by strictly following the practices described above. 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
 
This is not a therapeutic intervention study. If a patient notes distress or physical 
concerns, we will immediately notify her treatment team.  
 
13.0 Withdrawal of Subjects 
 
Patients may withdraw at any time if they wish to end their involvement of the study.  
 
14.0 Risks to Subjects 
We anticipate that this study will entail minimal physical and psychological risk on the part of 
the subjects. In the letter of introduction and in verbal consent, patients will be advised to contact 
their physicians or a study representative with any questions or concerns. Individual patient 
results will be kept confidential. As with any collection of individually identifiable health 
information, there is a risk of breach of confidentiality. However, adequate safeguards will be in 
place to ensure that these risks are minimized, including the following measures described 
below.  
 
15.0 Potential Benefits to Subjects 
There are no direct benefits to study participants, but the study team will show our appreciation 
for study enrollment with gift cards as described. We hope that patients will be satisfied with 
having participated in and contributed to a study where there is great need for prospective data.  
 
16.0 Vulnerable Populations 
We aim to include older patients, a vulnerable patient group who is in urgent need of more 
prospective evidence to guide their care. We also aim to have a diverse sample by socioeconomic 
and race/ethnicity factors.  
 

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17.0 Community-Based Participatory Research 
For optimal generalizability, we are working with DFCI, DFCI at South Shore Hospital, 
DFCI at St. Elizabeth’s,and Brigham and Womens Hospital primary care physicians and 
geriatricians on this project. We will also have a virtual component for providers so that 
we get input from providers outside of Boston. We aim to be very inclusive of providers 
caring for patients in our study including primary care providers and oncologists.  
 
18.0 Sharing of Results with Subjects 
We will not directly share results with patients but they will be widely available once published 
and disseminated..  
 
19.0 Setting 
See sections above- this study will take place at DFCI main campus/St. Elizabeth’s/South Shore 
Hospital, Brigham and Women’s Hospital,, and on the phone/virtually, depending on the study 
component. 
 
20.0 Resources Available 
Dr. Freedman (along with her collaborators) is well poised to execute the proposed research 
focusing on older breast cancer patients because of her training, expertise, and experiences as a 
clinician-researcher focused in this area of study. The work planned in this study logically builds 
on her prior work and on the prior work of her study collaborators.  Dr. Freedman will have all 
of the recourses available to her at DFCI for the duration of this study, including statistical, 
research, and nursing support in addition to grants support and the support of the collaborating 
institutions participating in this work (DFCI satellites and affiliates).  
 
21.0 Prior Approvals – N/A 
 
22.0 Recruitment Methods – See Section 5 
 
23.0 Local Number of Subjects- See Section 4 
 
24.0 Provisions to Protect the Privacy Interests of Subjects 
Study staff will obtain permission from the primary medical oncologist before contacting 
potential subjects. Only study staff who have completed institutional training and are familiar 
with the protocol will contact patients for an informed verbal consent. Only staff who have 
completed training can access Epic or other patient medical record databases. Study staff may 
conduct a limited review of a patient’s medical record in order to confirm eligibility; they may 
continue to access their records. 
 
25.0 Compensation for Research-Related Injury  
This study involves Minimal Risk to subjects. Therefore, there is no compensation available to 
subjects in the event of research-related injury.  
 

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26.0 Economic Burden to Subjects 
We plan to approach patients when they are already at their provider visits and will call them if 
time point is missed in person. We do not anticipate any additional costs to patients while 
participating in this study. Participants are given gift cards for their time. 
 
27.0 Consent Process 
All participating patients (interviews) and providers (focus groups) will provide informed verbal 
informed consent at the start of their interview/focus group (Appendix E). All participating 
patients for Aim 1.2 (pilot intervention) will provide verbal informed consent (Appendix F) 
before any study procedures are performed. Patients and providers will receive a copy of their 
verbal consent. Ethical standards for human subjects will be strictly followed. We will not obtain 
written consent as it is practically prohibitive for this short survey-based intervention. The 
consent script will include all required information commonly included on signed consent forms.  
Moreover, the participant will explicitly be asked if he or she consents to participate prior to 
commencing the survey.  
 
All investigators and research assistants will have undergone full training in Human Subjects 
Protection Certification. In addition, all research team members will undergo formal training 
regarding the research procedures, including the informed consent process. The purpose, 
procedures, duration, risks, and alternatives of the study will be explained to potential subjects. It 
will be emphasized in the verbal consent that participation is completely voluntary and that 
patients may choose to withdraw at any time without adverse consequence to their medical care 
or loss of benefits to which they are otherwise entitled. Patients will be informed of the research 
nature of this project.  Extent of confidentiality provided and procedures for protecting 
confidentiality will be discussed in specifics, such as the need to review medical records to 
confirm cancer treatments. Informed verbal consent will be contingent upon the patient’s full 
awareness and affirmation of these ethical standards. Once all questions have been addressed and 
the individual indicates she would like to participate, informed consent will be obtained. 
Individuals who are unable to provide informed consent will be excluded from participation in 
the study.  
 
 
 
28.0 Process to Document Consent in Writing 
28.1 Because this research presents no more than minimal risk of harm to 
subjects and involves no procedures for which written documentation of 
consent is normally required outside of the research context, we waive the 
requirement to obtain written documentation of consent as noted above. 
29.0 Drugs or Devices -N/A 
 
 
 
 
 

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REFERENCES 
 
 
1. 
Freedman RA, Keating NL, Partridge AH, et al: Surveillance Mammography in 
Older Patients With Breast Cancer-Can We Ever Stop?: A Review. JAMA Oncol, 2016 
 
2. 
United States Census Bureau. www.census.gov/. Accessed March 8, 2017.  
 
3. 
Amercian Cancer Society. Cancer Facts & Figures 2017. 
https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-
cancer-facts-and-figures/2017/cancer-facts-and-figures-2017.pdf. Accessed March 8, 2017.  
 
4. 
American Cancer Society. Breast Cancer Facts and Figures 2015-2016. 
http://www.cancer.org/acs/groups/content/@research/documents/document/acspc-046381.pdf. 
Accessed November 18, 2016.  
 
5. 
Smith BD, Smith GL, Hurria A, et al: Future of cancer incidence in the United 
States: burdens upon an aging, changing nation. J Clin Oncol 27:2758-65, 2009 
 
6. 
Schonberg MA, Marcantonio ER, Ngo L, et al: Causes of death and relative 
survival of older women after a breast cancer diagnosis. J Clin Oncol 29:1570-7, 2011 
 
7. 
Yancik R, Wesley MN, Ries LA, et al: Effect of age and comorbidity in 
postmenopausal breast cancer patients aged 55 years and older. Jama 285:885-92, 2001 
 
8. 
American Cancer Society. Breast Cancer Facts and Figures 2015-2016. 
http://www.cancer.org/acs/groups/content/@research/documents/document/acspc-046381.pdf  
 
9. 
Jacobsen PB, Rowland JH, Paskett ED, et al: Identification of Key Gaps in 
Cancer Survivorship Research: Findings From the American Society of Clinical Oncology 
Survey. J Oncol Pract 12:190-3, 2016 
 
10. 
Freedman RA, Foster JC, Seisler DK, et al: Accrual of Older Patients With Breast 
Cancer to Alliance Systemic Therapy Trials Over Time: Protocol A151527. J Clin Oncol 35:421-
431, 2017 
 
11. 
Muss HB, Berry DA, Cirrincione CT, et al: Adjuvant chemotherapy in older 
women with early-stage breast cancer. N Engl J Med 360:2055-65, 2009 
 
12. 
Hughes KS, Schnaper LA, Berry D, et al: Lumpectomy plus tamoxifen with or 
without irradiation in women 70 years of age or older with early breast cancer. N Engl J Med 
351:971-7, 2004 
 
13. 
Schonberg MA: Decision-Making Regarding Mammography Screening for Older 
Women. J Am Geriatr Soc, 2016 
 
14. 
Oeffinger KC, Fontham ET, Etzioni R, et al: Breast Cancer Screening for Women 
at Average Risk: 2015 Guideline Update From the American Cancer Society. JAMA 314:1599-
614, 2015 
 
15. 
Schonberg MA, Ramanan RA, McCarthy EP, et al: Decision making and 
counseling around mammography screening for women aged 80 or older. J Gen Intern Med 
21:979-85, 2006 
 
16. 
Torke AM, Schwartz PH, Holtz LR, et al: Older adults and forgoing cancer 
screening: "I think it would be strange". JAMA Intern Med 173:526-31, 2013 
 
17. 
Hoffman RM, Elmore JG, Pignone MP, et al: Knowledge and values for cancer 
screening decisions: Results from a national survey. Patient Educ Couns 99:624-30, 2016 
 
18. 
Fairfield KM, Gerstein BS, Levin CA, et al: Decisions about medication use and 
cancer screening across age groups in the United States. Patient Educ Couns 98:338-43, 2015 

PROTOCOL TITLE: 
 
Page 21 of 65 
 
 
19. 
Pace LE, He Y, Keating NL: Trends in mammography screening rates after 
publication of the 2009 US Preventive Services Task Force recommendations. Cancer 119:2518-
23, 2013 
 
20. 
Breen N, Gentleman JF, Schiller JS: Update on mammography trends: 
comparisons of rates in 2000, 2005, and 2008. Cancer 117:2209-18, 2011 
 
21. 
National Comprehensive Care Network (NCCN) Guidelines: Older Adult 
Oncology http://www.nccn.org/professionals/physician_gls/pdf/senior.pdf. Assessed April 1, 
2016. .  
 
22. 
Runowicz CD, Leach CR, Henry NL, et al: American Cancer Society/American 
Society of Clinical Oncology Breast Cancer Survivorship Care Guideline. J Clin Oncol 34:611-
35, 2016 
 
23. 
Runowicz CD, Leach CR, Henry NL, et al: American Cancer Society/American 
Society of Clinical Oncology Breast Cancer Survivorship Care Guideline. CA Cancer J Clin 
66:43-73, 2016 
 
24. 
Nguyen PL, Taghian AG, Katz MS, et al: Breast cancer subtype approximated by 
estrogen receptor, progesterone receptor, and HER-2 is associated with local and distant 
recurrence after breast-conserving therapy. J Clin Oncol 26:2373-8, 2008 
 
25. 
Liu FF, Shi W, Done SJ, et al: Identification of a Low-Risk Luminal A Breast 
Cancer Cohort That May Not Benefit From Breast Radiotherapy. J Clin Oncol 33:2035-40, 2015 
 
26. 
Arvold ND, Taghian AG, Niemierko A, et al: Age, breast cancer subtype 
approximation, and local recurrence after breast-conserving therapy. J Clin Oncol 29:3885-91, 
2011 
 
27. 
Kunkler IH, Williams LJ, Jack WJ, et al: Breast-conserving surgery with or 
without irradiation in women aged 65 years or older with early breast cancer (PRIME II): a 
randomised controlled trial. Lancet Oncol 16:266-73, 2015 
 
28. 
Chen Y, Thompson W, Semenciw R, et al: Epidemiology of contralateral breast 
cancer. Cancer Epidemiol Biomarkers Prev 8:855-61, 1999 
 
29. 
Nichols HB, Berrington de Gonzalez A, Lacey JV, Jr., et al: Declining incidence 
of contralateral breast cancer in the United States from 1975 to 2006. J Clin Oncol 29:1564-9, 
2011 
 
30. 
Rasmussen CB, Kjaer SK, Ejlertsen B, et al: Incidence of metachronous 
contralateral breast cancer in Denmark 1978-2009. Int J Epidemiol 43:1855-64, 2014 
 
31. 
Cuzick J, Sestak I, Baum M, et al: Effect of anastrozole and tamoxifen as 
adjuvant treatment for early-stage breast cancer: 10-year analysis of the ATAC trial. Lancet 
Oncol 11:1135-41, 2010 
 
32. 
Lee SJ, Boscardin WJ, Stijacic-Cenzer I, et al: Time lag to benefit after screening 
for breast and colorectal cancer: meta-analysis of survival data from the United States, Sweden, 
United Kingdom, and Denmark. BMJ 346:e8441, 2013 
 
33. 
Early Breast Cancer Trialists' Collaborative G, Darby S, McGale P, et al: Effect 
of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer 
death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet 
378:1707-16, 2011 
 
34. 
Schonberg MA, Marcantonio ER, Li D, et al: Breast cancer among the oldest old: 
tumor characteristics, treatment choices, and survival. J Clin Oncol 28:2038-45, 2010 
 
35. 
Howlader N, Altekruse SF, Li CI, et al: US incidence of breast cancer subtypes 
defined by joint hormone receptor and HER2 status. J Natl Cancer Inst 106, 2014 

PROTOCOL TITLE: 
 
Page 22 of 65 
 
 
36. 
Lash TL, Fox MP, Buist DS, et al: Mammography surveillance and mortality in 
older breast cancer survivors. J Clin Oncol 25:3001-6, 2007 
 
37. 
Buist DS, Bosco JL, Silliman RA, et al: Long-term surveillance mammography 
and mortality in older women with a history of early stage invasive breast cancer. Breast Cancer 
Res Treat 142:153-63, 2013 
 
38. 
Massimino KP, Jochelson MS, Burgan IE, et al: How Beneficial is Follow-Up 
Mammography in Elderly Breast Cancer Survivors? Ann Surg Oncol, 2016 
 
39. 
Hubbard RA, Kerlikowske K, Flowers CI, et al: Cumulative probability of false-
positive recall or biopsy recommendation after 10 years of screening mammography: a cohort 
study. Ann Intern Med 155:481-92, 2011 
 
40. 
Braithwaite D, Zhu W, Hubbard RA, et al: Screening outcomes in older US 
women undergoing multiple mammograms in community practice: does interval, age, or 
comorbidity score affect tumor characteristics or false positive rates? J Natl Cancer Inst 105:334-
41, 2013 
 
41. 
Marmot MG, Altman DG, Cameron DA, et al: The benefits and harms of breast 
cancer screening: an independent review. Br J Cancer 108:2205-40, 2013 
 
42. 
Harding C, Pompei F, Burmistrov D, et al: Breast Cancer Screening, Incidence, 
and Mortality Across US Counties. JAMA Intern Med 175:1483-9, 2015 
 
43. 
Welch HG, Schwartz L, Woloshin S: Over-diagnosed. Making People Sick in the 
Pursuit of Health. , Beacon Press, 2012  
 
44. 
Walter LC, Schonberg MA: Screening mammography in older women: a review. 
JAMA 311:1336-47, 2014 
 
45. 
Schonberg MA, Silliman RA, Ngo LH, et al: Older women's experience with a 
benign breast biopsy-a mixed methods study. J Gen Intern Med 29:1631-40, 2014 
 
46. 
Houssami N, Abraham LA, Miglioretti DL, et al: Accuracy and outcomes of 
screening mammography in women with a personal history of early-stage breast cancer. JAMA 
305:790-9, 2011 
 
47. 
Sinclair N, Littenberg B, Geller B, et al: Accuracy of screening mammography in 
older women. AJR Am J Roentgenol 197:1268-73, 2011 
 
48. 
Satariano WA, Ragland DR: The effect of comorbidity on 3-year survival of 
women with primary breast cancer. Ann Intern Med 120:104-10, 1994 
 
49. 
Freedman RA, Vaz-Luis I, Barry WT, et al: Patterns of chemotherapy, toxicity, 
and short-term outcomes for older women receiving adjuvant trastuzumab-based therapy. Breast 
Cancer Res Treat 145:491-501, 2014 
 
50. 
Freedman RA, Muss HB: Managing metastatic human epidermal growth factor 
receptor 2 (HER2)-positive breast cancer in the older patient. J Geriatr Oncol 5:2-7, 2014 
 
51. 
Vaz-Luis I, Keating NL, Lin NU, et al: Duration and toxicity of adjuvant 
trastuzumab in older patients with early-stage breast cancer: a population-based study. J Clin 
Oncol 32:927-34, 2014 
 
52. 
Freedman RA, Pitcher B, Keating NL, et al: Cognitive function in older women 
with breast cancer treated with standard chemotherapy and capecitabine on Cancer and 
Leukemia Group B 49907. Breast Cancer Res Treat 139:607-16, 2013 
 
53. 
Freedman RA, Keating NL, Pace LE, et al: Use of Surveillance Mammography 
among Older Breast Cancer Survivors by Life Expectancy. J Clin Oncol, in press, 2017.  

PROTOCOL TITLE: 
 
Page 23 of 65 
 
 
54. 
Schonberg MA, Silliman RA, Marcantonio ER: Weighing the benefits and 
burdens of mammography screening among women age 80 years or older. J Clin Oncol 27:1774-
80, 2009 
 
55. 
Schonberg MA, Breslau ES, McCarthy EP: Targeting of mammography screening 
according to life expectancy in women aged 75 and older. J Am Geriatr Soc 61:388-95, 2013 
 
56. 
Schonberg MA, Li V, Marcantonio ER, et al: Predicting Mortality up to 14 Years 
among Community-Dwelling Adults Aged 65 and Older, in press. J Am Geriatr Soc, 2016 
 
57. 
Schonberg MA, Birdwell RL, Bychkovsky BL, et al: Older women's experience 
with breast cancer treatment decisions. Breast Cancer Res Treat 145:211-23, 2014 
 
58. 
Schonberg MA, Breslau ES: Mammography screening for women aged 70 and 
older: at a crossroads. J Am Geriatr Soc 63:170-2, 2015 
 
59. 
Schonberg MA, McCarthy EP: Mammography screening among women age 80 
years and older: consider the risks. J Clin Oncol 27:640-1; author reply 641-2, 2009 
 
60. 
Breslau ES, Gorin SS, Edwards HM, et al: An Individualized Approach to Cancer 
Screening Decisions in Older Adults: A Multilevel Framework. J Gen Intern Med 31:539-47, 
2016 
 
61. 
Schonberg MA, Davis RB, McCarthy EP, et al: Index to predict 5-year mortality 
of community-dwelling adults aged 65 and older using data from the National Health Interview 
Survey. J Gen Intern Med 24:1115-22, 2009 
 
62. 
Schonberg MA, McCarthy EP, York M, et al: Factors influencing elderly 
women's mammography screening decisions: implications for counseling. BMC Geriatr 7:26, 
2007 
 
63. 
Schonberg MA, Davis RB, McCarthy EP, et al: External validation of an index to 
predict up to 9-year mortality of community-dwelling adults aged 65 and older. J Am Geriatr Soc 
59:1444-51, 2011 
 
64. 
Schonberg MA, Kistler CE, Nekhlyudov L, et al: Evaluation of a Mammography 
Screening Decision Aid for Women Aged 75 and Older: Protocol for a Cluster-randomized 
Controlled Trial. J Clin Trials 4:191, 2014 
 
65. 
Schonberg MA, Smith AK: Discussing Long-term Prognosis in Primary Care: 
Hard but Necessary. JAMA Intern Med 176:678-80, 2016 
 
66. 
Schonberg MA, Hamel MB, Davis RB, et al: Development and evaluation of a 
decision aid on mammography screening for women 75 years and older. JAMA Intern Med 
174:417-24, 2014 
 
67. 
Pace LE, Keating NL: Risk and benefits of screening mammography--reply. 
JAMA 312:649-50, 2014 
 
68. 
Keating NL, Landrum MB, Guadagnoli E, et al: Factors related to underuse of 
surveillance mammography among breast cancer survivors. J Clin Oncol 24:85-94, 2006 
 
69. 
Keating NL, Pace LE: New Guidelines for Breast Cancer Screening in US 
Women. JAMA 314:1569-71, 2015 
 
70. 
Pace LE, Keating NL: A systematic assessment of benefits and risks to guide 
breast cancer screening decisions. JAMA 311:1327-35, 2014 
 
71. 
Schonberg MA, Breslau ES, Hamel MB, et al: Colon cancer screening in U.S. 
adults aged 65 and older according to life expectancy and age. J Am Geriatr Soc 63:750-6, 2015 
 
72. 
Charlson ME, Pompei P, Ales KL, et al: A new method of classifying prognostic 
comorbidity in longitudinal studies: development and validation. J Chronic Dis 40:373-83, 1987 

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Page 24 of 65 
 
 
73. 
Katzman R, Brown T, Fuld P, et al: Validation of a short Orientation-Memory-
Concentration Test of cognitive impairment. Am J Psychiatry 140:734-9, 1983 
 
74. 
Pope C, Ziebland S, Mays N: Qualitative research in health care. Analysing 
qualitative data. BMJ 320:114-6, 2000 
 
75. 
Richie JP, Spencer L. Qualitative Data Analysis for Applied Policy Research in 
The Qualitative Researchers Companion. Huberman, A.M and M.B. Miles eds. London: Sage 
Publications. 2002.  
 
76. 
Creswell. J.W. 2013 Qualitative Inquiry & Research Design: Choosing among 
Five Approached. 3rd edition. Sage Publications.  
 
77. 
Krueger RA & Casey MA (2000) Focus Groups: A Practical Guide for Applied 
Research, 3rd edn. Sage Publications Inc., Thousand Oaks, CA.  
 
78. 
Morgan DL (1998) Focus Group Kit Volume 1: Focus Group Guidebook. Sage 
Publications Inc., Thousand Oaks, CA.  
 
79. 
O'Connor, A.M. User Manual-Measures of Decision/Choice Predisposition. 
Ottawa: Ottawa Hospital Research Institute. 1996:5. Available from 
http://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_ChoicePredisposition_Decision.pdf.  
 
80. 
O'Connor, A.M. User Manual- Accectability. Ottawa: Ottawa Hospital Research 
Institute; copyright 1996:5. 
https://decisionaid.ohri.ca/docs/develop/Tools/Acceptability_osteoporosis.pdf.  
 
81. 
Degner LF, Kristjanson LJ, Bowman D, et al: Information needs and decisional 
preferences in women with breast cancer. JAMA 277:1485-92, 1997 
 
82. 
O'Connor AM: Validation of a decisional conflict scale. Med Decis Making 
15:25-30, 1995 
 
83. 
O'connor, A.M. User Manual- Decisional Conflict Scale. 
https://decisionaid.ohri.ca/docs/develop/Tools/DCS_English.pdf.  
 
84. 
Mathieu E, Barratt A, Davey HM, et al: Informed choice in mammography 
screening: a randomized trial of a decision aid for 70-year-old women. Arch Intern Med 
167:2039-46, 2007 
 
85. 
van Agt H, Fracheboud J, van der Steen A, et al: Do women make an informed 
choice about participating in breast cancer screening? A survey among women invited for a first 
mammography screening examination. Patient Educ Couns 89:353-9, 2012 
 
 
 
 

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APPENDIX A 
Blessed Orientation-Memory Concentration Test 
 
Cognition: Orientation-Memory-Concentration Test73 
  
 
 
 

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APPENDIX B 
 
Updated (May 2020) Communication Tool 
(adapted and revised from Dr. Schonberg’s prior and ongoing decision aid work) 
[Schonberg, M.A. et al JAMA Intern Med, 2014. 174(3):417-424] 
 
 
 

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APPENDIX C DRAFT FOCUS GROUP SCRIPTS 
 
**Draft Focus Group Script Outline – Provider Discussions  
 
**Scripts will vary slightly with regard to focus surveillance vs. screening, depending  
on whether the group is comprised of primary care providers, oncologists, or both)**  
 
Total time = 60 mins 
Part A  
INTRODUCTION, CONSENT, GRAB BREAKFAST/LUNCH (during the first 10 minutes) 
Good morning/good afternoon. My name is Rachel Freedman and I am a medical oncologist who works 
at Dana-Farber. This is [insert note taker], she/he also works at Dana-Farber and will be helping by 
taking notes today. First, we would like to thank you for taking the time to participate in today’s 
discussion about follow-up care and mammography. 
 
There are no right or wrong answers in our discussion today, and your honest feedback and insight are 
the best way for us to better understand your opinions. We want to welcome all perspectives, so while it 
is OK to disagree with each other, please be respectful towards your fellow group members, even if you 
have a different point of view.  We also want to make sure that we provide a welcoming space for 
everyone to participate.  I encourage you to speak to each other, and I will be here to listen and ask some 
specific questions. In order to be respectful of your time and the task at hand, I may need to interrupt at 
times in order to move us on.  Thank you for your cooperation if those circumstances arise. 
 
Your ideas and perspective are tremendously important and we don’t want to miss anything. With your 
permission, I would like to audio record this interview to make sure that we capture your comments and 
accurately represent your perspectives. Our conversation will be kept strictly confidential and you will 
not be identified in any reports or write-ups.  Today’s discussion will last about 1 hour, and you will 
receive $50 in appreciation for your time today.  
 
To begin I would like to go around the room and do introductions. Please tell us your first name and tell 
us where you are from (purpose is to make people feel comfortable and encourage participation). Thank 
you all for sharing, I really look forward to learning more about your experiences.  
 
PART B (to be discussed during the next 35-45 minutes) 
I will first provide an overview of this project, the intent, and will briefly review the current screening 
and surveillance guidelines for mammography in older patients. We will also briefly look at the data for 
recurrence with regard to the subtype and past treatments a woman has received and risk factors for 
local recurrences. (Dr. Freedman will present a short slide presentation on these topics for background.) 
 
DISCUSSION OUTLINE 
 
**START RECORDING** 
 

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Topic 1: Cessation of testing. We are interested in how you approach an older patient with a 
history of breast cancer with regard to her surveillance mammography (or secondary screening) 
[for primary care clinicians can add that we realize they may do more screening discussions than 
surveillance- we are interested in their opinions on all of this] 
 
• In general, how would you describe your approaches/standards pertaining to mammography for 
patients (with a history of breast cancer) as they get older? 
• Who typically orders surveillance mammography for your breast cancer survivors? 
o  In general, how comfortable do you feel having conversations about surveillance with 
older patients? 
• Thinking about women who have a history of breast cancer, what role does age, particularly 
advanced age, play in their mammogram recommendations from you? 
o When, if at all, do you think women should stop having routine screening 
mammography? 
o When do you think breast cancer survivors should stop having regular surveillance 
mammography? 
• Have you discussed cessation of mammography with your patients?  
o If so, how did you approach this topic? How did it go?   
o Does your approach differ in the screening vs. surveillance setting?  
• For those who discuss stopping surveillance mammography, are there any tools you use to help 
with these conversations? Decision aids? Life expectancy tools? Other graphics? 
 
Topic 2: Life expectancy discussions 
• What role does life expectancy play in your conversations about screening and or surveillance 
mammography?Do you routinely incorporate life expectancy into conversations about 
screening/surveillance? 
o If yes, how? And how does it go with patients? 
o If no, why not? (Have you done it in the past and it went poorly, anxious to have 
conversations, etc) 
• Do you feel comfortable incorporating life expectancy into conversations with patients? What 
has worked or not worked? What are you concerns about this? How do you think this can be 
done well? Do you think it is important? 
• Do you think if you had more guidance on using life expectancy in conversations with patients, it 
would be easier? 
• How do you estimate your older patients’ life expectancy? (website, took, personal estimation) 
 
 
Topic 3: Communicating risks and benefits of surveillance mammography? 
• When discussing surveillance mammography, which topics do you emphasize the most in these 
discussions? 
o Do you typically discuss the potential risks and benefits of testing? 
o How do you discuss this? 
o If you don’t typically discuss surveillance mammography with patients, how do you 
typically discuss the risks and benefits of screening mammography? 
• Do you use any tools to help such as aids, graphics, etc. to help discuss mammography? 

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Topic 4: Communication tool review (pass out the tool [draft in Appendix 1] for review to the 
group) This tool is meant to provide breast cancer survivors and their clinicians a framework for 
discussions on cessation of mammography, incorporating risks and benefits of surveillance 
mammography, information on life expectancy, and to help with decisions about mammography.  
• What are your initial impressions of this tool? 
• What do you think about the amount of information this tool contains?  
• What do you think about the content/information found in this tool? 
o How about the way risks and benefits are displayed? 
o How do you feel about how the information regarding life expectancy is displayed? 
• What do you think of the tool design? (layout, photos, colors, fonts, etc.) 
• Are you comfortable with the language used in the tool? 
• Could you envision using this tool in your discussions with patients? Why/why not? 
• Do you anticipate any barriers to incorporating this into your work? 
• How do you think the patients would react to receiving this handout? 
• How do you think the life expectancy component looks and will go with patients? 
• How would you like to access this tool?  (Probe: embedded in an electronic medical record or 
web-based rather than paper) 
 
Topic 5: Communication between primary care and oncology clinicians 
We also are exploring ways that follow up care can be better coordinated between oncology and primary 
care clinicians. 
• From your perspective, what issues are most important to consider when trying to improve 
communication around patient care and cessation of mammography between these patients?   
• Do you think this tool could help communication between disciplines? 
• What other ideas do you have about how to improve care coordination to promote unified 
messaging about use of surveillance mammography and other follow up care? 
 
Topic 6: Any additional comments or feedback on improving older women’s decision making around 
surveillance mammography? 
 
PART C (5 minutes) 
CLOSING: 
We thank you for participating in this focus groups. Here is a $50 in appreciation of your time and 
opinions.  
 
 

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**Draft Patient Phone Interview and Focus Script** 
– TOTAL IS 30-60 MINS and may vary slightly depending on setting of group or one-on-one 
interview 
 
Part A (To be discussed during the first 5 minutes) 
INTRODUCTION AND VERBAL CONSENT – SEE APPENDIX E 
 
**START RECORDING** 
 
We are working on strategies to better tailor follow up care for women aged 75 and older who have a 
history of breast cancer. We are a deeply interested in understanding patients’ perspectives about how 
doctors and patients can work together to make decisions about follow up care. In the mail, you 
should have received a packet. Please keep this packet with you during our conversation. We will 
have you open the seal on it during our interview, a bit later on.  
 
PART B  
BACKGROUND QUESTIONNAIRE (10 minutes) 
We will first ask you a series of questions that help us learn about you and your cancer history.  
 
1. Orientation-Memory-Concentration Test Short Blessed Test (SDT) – Scores filled in by 
interviewer (http://geriatrictoolkit.missouri.edu/cog/bomc.pdf)- Entire Part B is for patient one-on-
one interviews only 
Question  
Maximum Error 
Score X 
Weight 
What year is it now? 
1 
____ x 4 
= ____ 
What month is it now? 
Repeat this phrase and I will ask you to 
remember it and tell it to me later: 
John Brown, 42 Market Street, Chicago 
1 
____ x 3 
= ____ 
About what time is it? (within one hour) 
1 
____ x 3 
= ____ 
Count backwards 20 to 1 
2 
____ x 2 
= ____ 
Say the months in reverse order 
2 
____ x 2 
= ____ 
Repeat the phrase just given 
5 
____ x 2 
= ____ 
Total error score = _____             
 
(If patient scores >10, she is ineligible. Thank her for her time, let her know she is not eligible) 
 
We will next ask you about your breast cancer and current follow up plan.  
 
2. When was your breast cancer diagnosed?   
o Less than one year ago 
o More than one but less than 2 years ago 
o Between 2 and 5 years ago 
o More than 5 years ago 
o Not sure 

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3. Do you still see a medical oncologist or a nurse practitioner/physician assistant in the medical 
oncologist’s office regularly?  
o Yes → If yes, how often? 
o No → If no, when was the last time you had follow up with your medical oncologist? 
o Not sure 
 
4. Do you still see a surgical oncologist or an NP/PA in their office?  
o Yes → If yes, how often?  
o No → If no, when was the last time you had follow up in your surgeon’s office? 
 
5. Do you see anyone else for follow up of your cancer? 
o Yes→ who? 
o No 
o Not sure 
 
6. Does your primary care provider discuss your breast cancer history with your regularly? 
o Yes 
o No 
o Not sure 
o Other ______________________________ 
 
7. Do you still get mammograms?  
o Yes → If yes, when was your last mammogram? → Who typically orders your 
mammograms? (Oncologist, PCP, someone else?) 
o No → If no, when was your last mammogram? 
 
8. Have you ever had a biopsy of your breast since your cancer was diagnosed that wasn’t cancer? 
o Yes 
o No 
o Not sure 
 
Next, I want to ask you some questions about you and your health. 
 
9. How old are you? (points are for interviewer calculation only and will not be read aloud to patient) 
o 75-79 (0 points) 
o 80-84 (2 points) 
o 85 and older (4 points) 
 
10. How much do you weigh?  
o More than 130 lbs.? (0 points) 
o 130 lbs. or less? (2 points) 
 
11. Would you say your health is… 
o excellent (0 points) 
o very good (0 points) 

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o good (1 point) 
o fair (2 points) 
o poor (2 points) 
 
12. Have you ever been told by a doctor/health professional that you had…  
 
Emphysema or chronic bronchitis or COPD? 
o No (0 points) 
o Yes (2 points) 
 
Cancer other than breast cancer (do not include skin cancer unless it was melanoma)? 
o No (0 points) 
o Yes (2 points) 
 
Diabetes? 
o No (0 points) 
o Yes (2 points) 
 
13. Because of physical mental, or emotional problem, do you need help from other people with routine 
needs? These include everyday household chores, shopping, or getting around for other purposes? 
o No (0 points) 
o Yes (2 points) 
 
14. By yourself and without using any special equipment, how difficult is it for you to walk a ¼ mile or 
3 city blocks? 
o Not at all difficult (0 points) 
o A little to very difficult (3 points) 
o Can’t do/do not do/can only do with cane or walker (3 points) 
 
15. Which best describes your cigarette use?  
o Never smoked or smoked less than 100 cigarettes in your life (0 points) 
o Former smoker (1 point) 
o current smoker (3 points) 
 
16. During the past 12 months, how many times were you hospitalized overnight?  
o None (0 points) 
o Once (1 point) 
o Twice or more (3 points) 
 
Interviewer quickly calculates life expectancy based on the Schonberg Index by adding up all of the 
points for responses to questions 9-16. If points 15 or higher, that patient has a >50% 5-year mortality 
risk (or life expectancy <5 years). If points are 10 or higher, a patient has >50% 10-year mortality risk 
(≥10 points) or a life expectancy ≤10 years 
 
 
 

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PART C. OPEN-ENDED QUESTIONS: FURTHER DISCUSSION (20-30 mins) 
We will next ask you some questions about your feelings and perspectives around mammograms. 
Please know that there are no right or wrong answers, and your insight and experience are very 
valuable.  
 
• How do you feel about having mammograms?  
• How do you decide about whether or not to have a mammogram? 
o What influences your decision? 
• What do you think are the advantages of having regular mammograms?  
• What do you think these downsides are?   
o Could probe with: Have you ever had discomfort or anxiety or other symptoms related to 
having mammograms?   
o Have you ever had a mammogram that required you to come back for additional testing? 
[describe] How did it turn out? Did you have another cancer? Was it benign? 
• Do you think mammograms are worthwhile for everyone? 
• Do you think that there are any women who might not benefit from mammograms? 
• How do you feel about seeing your oncologist or primary care physician for regular follow up visits?  
• Has a healthcare professional ever discussed with you the downsides of getting mammograms?  
• If you are still having mammograms, have you ever thought about stopping them? 
• What if a doctor told you that you no longer needed mammograms? How would you feel about that? 
Have you ever thought about this before? 
 
Using the answers to the questions about your health I asked you earlier, there are ways to help 
estimate your life expectancy, which is an estimate of how long you may have to live.   
 
• Is this something your doctors have ever discussed with you? If so, how did it go?  
• If not, would you be interested in hearing this information? (If no, why not? ) 
• If yes, how would do you think it might be discussed in a way you were comfortable with? 
• Do you think this information might help you make decisions about screening tests? 
• If a provider were to want to discuss your life expectancy, how might you like to hear or discuss this 
information? [can prompt about graphics, comparisons to other individuals, how it might help them 
with decisions, etc] 
 
Now I’d like you to take out and reference the communication tool we sent you in the mail or over 
email. If you don’t have it with you, I have provided additional copies here. Please break the seal on 
the envelope and open up the communication too. We want to review it with you now and get your 
thoughts about how it may or may not help you make decisions about getting mammograms. We 
would like you to be as honest as possible. 
 
Please read it and let me know what you think as you are reading it. You may need to read it more than 
once. 
1. Can you take a look at the benefits of mammography listed there? Let’s review them 
(interviewer reviews the list) Please explain in your own words what this means or how would 
you explain to a friend what you read?  

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2. Is anything unclear?  
3. [if participant stated they would be interested in hearing their life expectancy above, ask the 
following:] Based on your health from the questions you answered above…you have _[to be 
filled in by interviewer]____ chance of benefiting from mammography. How does it make you 
feel to hear that?  
a. How does this information affect your thoughts about getting a mammogram? 
b. How do you feel about seeing this information about life expectancy here? Helpful? Does 
it make you feel anxious? Does it make you uncomfortable? 
4. How clear was the information in the breast cancer risk communication aid? 
a. Anything you would change? 
5. Would you prefer this to be electronic and visible on your phone or computer? Or do you prefer 
the paper version? 
6. Was the length of the aid too short, just right, or too long? 
7. Would you find this useful to bring to your doctor’s office visit when discussing mammography? 
8. Do you find that your primary care doctor or nurse is aware of your follow up plan for your 
breast cancer?  
9. How would you describe communication between your primary care doctor and oncology team? 
10. Could this communication be better or does it work well (in your opinion)? 
11. Do you think having this communication aid could help with communication between your 
oncology and primary care doctors?  
12. Would you be willing take it with you to your provider visits to show the discussions you had?  
13. Any other suggestions on the communication tool? 
14. Any other comments or suggestions about anything else we have discussed today? 
 
PART D (5 minutes) 
BRIEF DEMOGRAPHIC QUESTIONNAIRE –provided on paper for focus group at the end of the 
discussion and on the phone for one-on-one interviews 
We would like to ask some questions about your background so that we have an idea of the 
characteristics of the women we interview. All of these answers will be confidential and will not be 
recorded along with any identifiable information (such as your name, etc.). Please answer the 
following questions to the best of your ability. While this information will be helpful to us, you do not 
have to answer any questions if you do not wish to.  
 
• What is the highest grade you finished in school? 
o < 6th grade 
o 6th grade 
o 7th grade 
o 8th grade 
o 9th grade 
o 10th grade 
o 11th grade 
o 12th grade 
o 1 year of college 
o 2 years of college or an Associate’s degree 
o 3 years of college 
o 4 years of college or a Bachelor’s degree 

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o Master’s degree 
o Doctoral degree or a law degree 
o Trade, vocational, or technical school 
o GED 
 
• How confident are you filling out medical forms by yourself? 
o Extremely confident 
o Quite a bit confident 
o Somewhat confident 
o A little confident 
o Not at all confident 
 
• How often do you have someone like a family member, friend, hospital, or clinic worker or 
caregiver, help you read hospital materials? 
o Always 
o Often  
o Sometimes 
 
 
o Rarely  
 
 
o Never 
 
• How often do you have problems learning about your medical condition because of difficulty 
understanding written information? 
o Always 
o Often  
o Sometimes 
 
 
o Rarely  
 
 
o Never 
 
• We would like to know how you prefer to receive health educational materials in general.  Do you 
prefer health education materials on: 
o Paper 
o Computer/internet 
o Web-based or mobile application 
o No preference 
o Other 
 
• Do you have a computer at home? 
o No 
o Yes 
 
• How would you describe your knowledge of computers? 
o Excellent  
o Very Good 
o Good 
o Fair 

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o Poor 
 
• Do you have internet access at home? 
o No 
o Yes  
 
• If so, which statement below best describes how comfortable you are using the internet? 
o I use the internet very comfortably 
o I use the internet somewhat comfortably 
o I use the internet but not comfortably 
o other 
 
• How frequently do you use the internet? 
o Daily 
o Once a week or less 
o Less than once a week but greater than once in a month 
o Once a month 
o Less than once a month 
 
• How would you describe your household’s financial situation right now? (please select one answer) 
o After paying the bills, you still have enough money for special things that you want. 
o You have enough money to pay the bills, but little spare money to buy extra or special things. 
o You have money to pay the bills, but only because you have cut back on things. 
o You are having difficulty paying the bills, no matter what you do. 
 
• Which of the following best describes your current marital situation? 
o Married 
o Living as married or domestic partner 
o Divorced or separated 
o Widowed 
o Never married 
 
• What race do you consider yourself to be? You may select one or more of the following. 
o American Indian or Alaskan Native (Native Person/Aboriginal). A person having origins in 
any of the original peoples of North, Central, or South America, who maintains tribal affiliation 
or community attachment. 
o Asian. A person having origins in any of the original peoples of the Far East, Southeast Asia, 
or the Indian subcontinent, including for example, Cambodia, China, India, Japan, Korea, 
Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam. 
o Black, Haitian, or African American. A person having origins in any of the black racial groups 
of Africa. 
o Native Hawaiian or other Pacific Islander. A person having origins in any of the original 
peoples of Hawaii, Guam, Samoa, or other Pacific Islands. 
o White. A person having origins in any of the original peoples of Europe, the Middle East, or 
North Africa. 

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o You prefer not to provide this information 
 
• Do you consider yourself to be Hispanic or Latina? (Spanish, Hispanic, or Latina is a person 
of Mexican, Puerto Rican, Cuban, South or Central American, or other Spanish culture of origin, 
regardless of race.) 
o Yes 
o No 
o Other______________ 
 
PART E (2 minutes) 
CLOSING 
We thank you so much for participating in this interview. We will be mailing you a $50 gift card in 
appreciation of your time and opinions. Where shall we mail this or email this?  
 
 
 

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APPENDIX D- SURVEYS FOR AIM 1.2 
 
References for survey questions from patient and provider are at the end of this appendix. Validated 
surveys were used whenever possible.  
All surveys will be provided to patients on REDCap but can be done on paper when patient requests and 
then later submitted to REDCap by the study team.  
 
**Baseline (‘Pre’) Patient Questionnaire**  
 
Thank you for agreeing to participate in this study.  
 
Study ID ________________________ (to be filled out by study team) 
 
Date:___________________________  
 
 
1. If your doctor or nurse asked you right now to make a choice about whether or not to get a mammogram, on a 
scale from 1-15 how certain are you about whether or not you would choose to get a mammogram in the next year? 
(1 means you are sure you would get a mammogram while 15 means you are sure you would not get a 
mammogram, if you are unsure please give a number between 1 to 15, 8 is the middle). 
 
(**If interview is being done over the phone because the in-person visit was missed, then ask patient: From 1-15, 
how likely are you to get a mammogram, 1 means you are certain I will get a mammogram and 15 means you are 
certain you will not get a mammogram. If you are not sure, please give a number between 1 and 15 that best 
describes how likely you are to get a mammogram)** 
 
 
     1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12  
13 
14 
15 
 
 
Will Get a 
 
 
  
              Unsure   
 
 
         
 
Will Not Get                  
 
Mammogram   
 
 
 
 
 
 
 
               
 Mammogram 
 
 
As women age, the benefits of routine (when no symptoms are present) mammography may get smaller. As 
we try to learn from you, we would appreciate your honest answers to the questions below. These questions 
are about how you feel about whether or not to get a mammogram.  Please say whether you Strongly Agree, 
Agree, are not sure, Disagree, or Strongly Disagree with the statements below.  
 
 
2. I know which options are available to me for getting tested for breast cancer. 
□ 
 
 □ 
       
□ 
   
□     
    
□ 
     
 Strongly 
 Agree     
Not sure   
Disagree  
Strongly 
        
        
Agree  
 
 
 
 
 
 
Disagree 
 
3. I know the benefits of getting a mammogram. 
□ 
 
 □ 
       
□ 
 
  □    
    
□ 
     Strongly 
  
Agree     
Not sure 
  Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 

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4. I know the downsides or risks of getting a mammogram. 
□ 
 
 □      
 
□ 
 
  □    
    
□ 
     Strongly 
  
Agree     
Not sure  
 Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
5. I am clear about which benefits of getting a mammogram matter most to me. 
□ 
 
 □ 
       
□ 
 
  □     
    
□ 
     Strongly 
  
Agree     
Not sure   
Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
 
 
 
6. I am clear about which downsides or risks of getting a mammogram matter  
       most to me. 
□ 
 
 □ 
       
□ 
 
  □     
    
□ 
     Strongly 
  
Agree     
Not sure 
  Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
7. I am clear about whether the benefits of getting a mammogram are more  
       important to me than the downsides or risks. 
□ 
 
 □ 
       
□ 
 
  □     
    
□ 
     Strongly 
  
Agree     
Not sure   
Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
8. I have enough support from others to make a choice whether or not to get a  
       mammogram. 
□ 
 
 □ 
       
□ 
 
  □     
    
□ 
     Strongly 
  
Agree     
Not sure   
Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
9. I am choosing without pressure from others about whether or not to get a  
      mammogram. 
□ 
 
 □ 
       
□ 
 
  □    
    
□ 
     Strongly 
  
Agree     
Not sure 
  Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
 
10. I have enough advice to make a choice about whether or not to get a mammogram. 
□ 
 
 □ 
       
□ 
 
  □     
    
□ 
     Strongly 
  
Agree     
Not sure   
  Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
11. I am clear about the best choice for me when it comes to getting a mammogram 
□ 
 
 □ 
      
□ 
 
  □     
    
□ 
     Strongly 
  
Agree     
Not sure   
Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 

PROTOCOL TITLE: 
 
Page 43 of 65 
 
 
12. I feel sure about what to choose in terms of whether or not to get a mammogram.  
□ 
 
 □ 
       
□ 
 
  □     
    
□ 
     Strongly 
  
Agree     
Not sure   
Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
13. The decision whether or not to get a mammogram  is easy for me to make. 
□ 
 
 □ 
       
□ 
 
  □    
    
□ 
     Strongly 
  
Agree     
Not sure 
  Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
14. I feel I have made an informed choice whether or not to get a mammogram. 
□ 
 
 □ 
       
□ 
 
  □     
    
□ 
     Strongly 
  
Agree     
Not sure 
  Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
15. My decision about whether or not to get a mammogram shows what is important to me  
□ 
 
 □ 
       
□ 
 
  □     
    
□ 
     Strongly 
  
Agree     
Not sure 
  Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
16. I expect to stick with my decision whether or not to get a mammogram 
□ 
 
 □ 
       
□ 
 
  □     
    
□ 
     Strongly 
  
Agree     
Not sure   
Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
17. I am satisfied with my decision whether or not to get a mammogram.  
□ 
 
 □ 
       
□ 
 
  □    
    
□ 
     Strongly 
  
Agree     
Not sure   
Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
 
The next set of questions are questions about mammograms in general.  Your best guess is fine. 
 
18. Among women aged 75 or older, who is more likely to die from breast cancer?  
□ 
Women who get mammograms  
□ 
Women who do NOT get mammograms  
□ 
There is almost no difference  
□ 
I don’t know 
 
19. The benefit of getting a mammogram is finding and treating a breast cancer when it is small and can be treated 
with only minor surgery. 
 
 
□   True 
 
□  False 
 
 
 
20. Getting a mammogram will prevent me from getting breast cancer. 
 
 
□   True 
 
□  False 
 
 
21. Most women who have an abnormal mammogram have breast cancer. 

PROTOCOL TITLE: 
 
Page 44 of 65 
 
 
 
□   True 
 
□   False 
 
 
 
 
22. Women aged 75 or older have a higher chance of getting breast cancer than younger women. 
 
 
□   True 
 
□   False 
 
 
 
 
23. More women aged 75 or older die of heart disease than breast cancer. 
 
 
□   True 
 
□   False 
 
 
 
24. Your other health problems should affect whether or not you get a mammogram. 
 
 
□   True 
 
□   False 
 
 
 
 
25.Some breast cancers found by a mammogram would never have shown up or caused problems in a woman’s 
lifetime. . 
 
 
□  True  
 
 
□   False 
 
 
 
 
26. Most women aged 75 or older with breast cancer are treated with chemotherapy. 
 
 
□   True 
 
□   False 
 
 
 
 
27. Some breast cancers are not detected by mammograms. 
 
 
□   True 
 
□   False 
 
 
 
 
28. What is your preferred role in decision-making around mammography?   
□ 
I prefer to make the final decision about whether or not to get a mammogram. 
□ 
I prefer to make the final decision about whether or not to get a mammogram after seriously 
considering my health care provider’s opinion. 
□ 
I prefer that my health care provider and I share responsibility for deciding whether or not to get a 
mammogram is best for me. 
□ 
I prefer that my health care provider make the final decision about whether or not I should get a 
mammogram, but seriously considers my opinion. 
□ 
I would prefer to leave all decisions regarding mammography to my health care provider.       
□ 
Don’t know 
 
We would like to get a sense of how much you worry about your cancer coming back. Please answer the next 
set of questions as honestly as possible. 
 
29. On a scale of 1 – 6, with 6 being the most worried and 1 being the least worried, how much do you worry 
about your cancer coming back? 
 
□ 
 
 
□ 
 
□ 
 
□ 
 
□ 
 
□ 
1 
 
 
2 
 
3 
 
4 
 
5 
 
6 
Not at all worried 
 
 
 
 
 
 
 
 
very worried 
 
 
30. On a scale of 1 – 6, with 6 being the most worried and 1 being the least worried, how much do you worry 
about needing more tests after you have a mammogram? 
 
□ 
 
 
□ 
 
□ 
 
□ 
 
□ 
 
□ 

PROTOCOL TITLE: 
 
Page 45 of 65 
 
1 
 
 
2 
 
3 
 
4 
 
5 
 
6 
Not at all worried 
 
 
 
 
 
 
 
 
very worried 
 
 
31. On a scale of 1 – 6, with 6 being the most worried and 1 being the least worried, how much do you worry 
about getting another cancer besides breast cancer? 
 
□ 
 
 
□ 
 
□ 
 
□ 
 
□ 
 
□ 
1 
 
 
2 
 
3 
 
4 
 
5 
 
6 
Not at all worried 
 
 
 
 
 
 
 
 
 
very worried 
 
 
We would like to know how you feel about hearing information regarding your life expectancy (or how 
many more years someone like you is expected to live).   
 
32. Have any your health care providers ever talked with you about how much time you have left to live? 
□ 
Yes 
□ 
No 
□ 
Don’t know 
 
33. If your health care provider could estimate how long you may have to live based on your current health status, 
would you want him or her to tell you? 
□ 
Yes 
□ 
No 
□ 
Don’t know 
 
 
34. We have no idea how long you will live. We would like to give you a made up example. Let’s say your health 
care provider thinks you have less than 5 years to live. Would you want to know this information? 
□ 
Yes 
□ 
No 
□ 
Don’t know 
 
 
 
35. We would like to give you another made up example. Let’s say your health care provider thinks you have less 
than 1 year to live. Would you want to know this information? 
□ 
Yes 
□ 
No 
□ 
Don’t know 
 
36. Would having this information help you make decisions about your health care? 
□ 
Yes 
□ 
No 
□ 
Don’t know 
 
We will now ask you some questions about you. 

PROTOCOL TITLE: 
 
Page 46 of 65 
 
 
37. How would you define your marital status?   
 
 
 
 
□ 
Single (never married)  
□ 
Currently married or living as married  
□ 
Divorced  
□ 
Separated  
□ 
Widowed  
□ 
Don’t know  
 
38. Do you live alone or with others?  
 
 
 
 
 
 
 
□ 
I live alone  
□ 
I live with others  
 
39. What is the highest level of school you have completed or the highest degree you have received?  
□ 
less than or equivalent to 8th grade 
□ 
GED or equivalent 
□ 
High school or less, no diploma 
□ 
High school graduate 
□ 
Some college or an Associate’s degree 
□ 
Bachelor’s degree (i.e., BA, AB, BS, BBA) 
□ 
Master’s degree (i.e., MA, MS, MEngineering, MEducation, MBA) 
□ 
Professional School degree (MD, DDS, DVM, JD) 
□ 
Nursing degree 
□ 
Doctoral degree (PhD, EdD, ScD) 
□ 
Don’t know 
 
□ 
Other 
 
40. Do you consider yourself to be Hispanic or Latino?   
 
 
 
□ 
No, I am not Hispanic or Latino  
□ 
Yes, I am Hispanic or Latino  
□ 
Don’t know  
 
41. Which of the following racial groups do you most identify with?  
□ 
White or Caucasian  
□ 
Black or African American  
□ 
Asian  
□ 
American Indian or Alaska Native  
□ 
Native Hawaiian or other Pacific Islander  
□ 
Other  
□ 
Don’t know  
 
• 
42. How would you describe your household’s financial situation right now? (please select one answer) 
□ 
After paying the bills, you still have enough money for special things that you want. 
□ 
You have enough money to pay the bills, but little spare money to buy extra or special things. 
□ 
You have money to pay the bills, but only because you have cut back on things. 

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Page 47 of 65 
 
□ 
You are having difficulty paying the bills, no matter what you do  
 
 
43. What type of health insurance do you have?   
 
 
 
□ 
Private health insurance plan  
□ 
Medicare A and B  
□ 
Medicare Advantage/Medicare Choice/Medicare HMO  
□ 
Medicaid  
□ 
Medicare +Federal  
□ 
Medicare +Private health insurance plan  
□ 
No Coverage 
□ 
Other  
 
44. How confident are you filling out medical forms by yourself? 
□ 
Extremely confident 
□ 
Quite a bit confident 
□ 
Somewhat confident 
□ 
A little confident 
□  
Not at all confident 
 
45. How often do you have someone like a family member, friend, hospital, or clinic worker or caregiver, help 
you read hospital materials? 
□ 
Always 
□ 
Often  
□ 
Sometimes 
 
 
□ 
Rarely  
 
 
□ 
Never 
 
46. How often do you have problems learning about your medical condition because of difficulty understanding 
written information? 
□ 
Always 
□ 
Often  
□ 
Sometimes 
 
 
□ 
Rarely  
 
 
□ 
Never 
 
47. We would like to know how you prefer to receive health educational materials in general.  Do you 
prefer health education materials on: 
□ 
Paper 
□ 
Computer/internet 
□ 
Web-based or mobile application 
□ 
No preference 
□ 
Other _______________________________ 
 
48. Do you have a computer at home? 
□ 
No 

PROTOCOL TITLE: 
 
Page 48 of 65 
 
□ 
Yes 
 
49. How would you describe your knowledge of computers? 
□ 
Excellent  
□ 
Very Good 
□ 
Good 
□ 
Fair 
□ 
Poor 
 
50. Do you use the internet? 
□ 
No 
□ 
Yes  
 
51. If yes, which statement below best describes how comfortable you are using the internet? 
□ 
I use the internet very comfortably 
□ 
I use the internet somewhat comfortably 
□ 
I use the internet but not comfortably 
□ 
Other _________________ 
 
52. How frequently do you use the internet? 
□ 
Daily 
□ 
Once a week or less 
□ 
Less than once a week but greater than once in a month 
□ 
Once a month 
□ 
Less than once a month 
 
 
53. How good are you at working with fractions? 
 
 
 
 
 
 
 □ 
 
  □ 
 
   □ 
 
□ 
    
□ 
 
   □ 
 
 
   Extremely 
          Very      Good          
Somewhat     
A little bit     
Not at all 
     Good 
         Good                                  Good            Good 
 
Good  
 
 
 
         
 
54. How good are you at working with percentages? 
 
 
 
 
 
 
□ 
 
  □ 
 
   □ 
 
□ 
    
□ 
 
   □ 
 
 
   Extremely 
          Very      Good          
Somewhat     
A little bit     
Not at all 
     Good 
         Good                                  Good            Good 
 
Good  
 
55. How good are you at calculating a 15% tip?  
 
 
 
 
 
 
□ 
 
  □ 
 
   □ 
 
□ 
    
□ 
 
   □ 
 
 
   Extremely 
          Very      Good          
Somewhat     
A little bit     
Not at all 
     Good 
         Good                                  Good            Good 
 
Good  
 
 
56. How good are you at figuring out how much a shirt will cost if it is 25% off? 
 
□ 
 
  □ 
 
   □ 
 
□ 
    
□ 
 
   □ 
 
 

PROTOCOL TITLE: 
 
Page 49 of 65 
 
    
Extremely 
 Very      
Good          
Somewhat     
A little bit     
Not at all 
      
Good           Good                                  Good            Good 
 
Good  
 
57. When reading the newspaper, how helpful do you find tables and graphs that are part of a story?  
 
□ 
 
   □ 
 
   □ 
 
   □ 
 
   □ 
 
   □ 
 
    Extremely 
 
Very             Quite        Somewhat 
A little        
Not at all 
 
     Helpful             
Helpful        Helpful          Helpful         Helpful        Helpful 
 
        
 
58.  When people tell you the chance of something happening, do you prefer that they use words (“it rarely 
happens”) or numbers (“there’s a 1% chance”)?  
      □ 
 
   
 □ 
 
      □ 
 
  
 
  □ 
 
   □ 
 
   □ 
     
     Always               Most of the          Sometimes              Sometimes        Most of the      Always                                          
prefer words            time prefer          prefer words           prefer numbers   time prefer       prefer  
 
 
                        words 
 
 
 
 
 
 
numbers      numbers 
 
59. When you hear a weather forecast, do you prefer predictions using percentages (“there will be a 20% chance 
of rain today”) or predictions using only words (“there is a small chance of rain today”)?   
 
□ 
 
□ 
 
       □  
   
 □ 
 
        □  
 
□ 
 
Always prefer   Most of the            Sometimes         
 Sometimes           
Most of the   
Always prefer 
 percentages time       prefer        
prefer percentages   
prefer words          
time prefer          words         
 
 
              percentages                                                                         
words 
 
60. How often do you find numerical information to be useful?  
 
 
 
□ 
 
   □ 
 
   □ 
 
   □ 
 
   □ 
 
   □ 
 
 
      Extremely   Very             Quite       Somewhat             A little        Never  
        Often              Often            Often               Often 
 
 
Thank you for completing the baseline questionnaire. 
We will find you after your appointment to complete the second survey. If we miss you, we will call you or email 
you in the next 1-7 days to complete the survey by phone, email, or mail. You will receive $40 after completing 
the next survey.  
 
 
 
 
 
**Post-visit Patient Questionnaire** 
 
 
Study ID: ___________ 
 
Date:_______________ 
 
Thank you for agreeing to participate in this study. Now that you have had your visit with your provider, there are 
a few more questions that we would like you to answer.  
 
If your health care provider asked you right now to make a choice about whether or not to get a mammogram, on 
a scale from 1-15 how certain are you about whether or not you would choose to get a mammogram in the next 

PROTOCOL TITLE: 
 
Page 50 of 65 
 
year? (1 means you are sure you would get a mammogram while 15 means you are sure you would not get a 
mammogram, if you are unsure please give a number between 1 to 15, 8 is the middle). 
 
      
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12  
13 
14 
15 
 
 
Will Get a 
 
 
  
              Unsure   
 
 
         
 
Will Not Get                  
 
Mammogram   
 
 
 
 
 
 
 
            
Mammogram 
 
(**If interview is being done over the phone because the in-person visit was missed, then ask patient: From 1-15, 
how likely are you to get a mammogram, 1 means you are certain I will get a mammogram and 15 means you are 
certain you will not get a mammogram. If you are not sure, please give a number between 1 and 15 that best 
describes how likely you are to get a mammogram)** 
 
2. When do you plan to get your next mammogram?  
 
□ 
Never   
□ 
In the next year  
□ 
More than 1 year from now but less than 2 years from now 
□ 
More than 2 years from now 
□ 
Other:____________________ 
 
 
The next set of questions are about how you feel about whether or not to get a mammogram and are the same 
questions we asked you before your visit today.  Please say whether you Strongly Agree, Agree, Neither, 
Disagree, or Strongly Disagree with the statements below. 
 
3. I know which options are available to me for getting tested for breast cancer. 
□ 
 
 □ 
       
□ 
   
□     
    
□ 
     
 Strongly 
 Agree     
Not sure   
Disagree  
Strongly 
        
        
Agree  
 
 
 
 
 
 
Disagree 
 
4. I know the benefits of getting a mammogram. 
□ 
 
 □ 
       
□ 
 
  □    
    
□ 
     Strongly 
  
Agree     
Not sure 
  Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
 
5. I know the downsides or risks of getting a mammogram. 
□ 
 
 □      
 
□ 
 
  □    
    
□ 
     Strongly 
  
Agree     
Not sure 
 Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
6. I am clear about which benefits of getting a mammogram matter most to me. 
□ 
 
 □ 
       
□ 
 
  □     
    
□ 
     Strongly 
  
Agree     
Not sure 
  Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
7. I am clear about which downsides or risks of getting a mammogram matter  

PROTOCOL TITLE: 
 
Page 51 of 65 
 
       most to me. 
□ 
 
 □ 
       
□ 
 
  □     
    
□ 
     Strongly 
  
Agree     
Not sure 
  Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
8. I am clear about whether the benefits of getting a mammogram are more  
       important to me than the downsides or risks. 
□ 
 
 □ 
       
□ 
 
  □     
    
□ 
     Strongly 
  
Agree     
Not sure 
  Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
9. I have enough support from others to make a choice whether or not to get a  
       mammogram. 
□ 
 
 □ 
       
□ 
 
  □     
    
□ 
     Strongly 
  
Agree     
Not sure 
  Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
10. I am choosing without pressure from others about whether or not to get a  
      mammogram. 
□ 
 
 □ 
       
□ 
 
  □    
    
□ 
     Strongly 
  
Agree     
Not sure 
  Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
 
11. I have enough advice to make a choice about whether or not to get a mammogram. 
□ 
 
 □ 
       
□ 
 
  □     
    
□ 
     Strongly 
  
Agree     
Not sure 
  Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
12. I am clear about the best choice for me when it comes to getting mammograms 
□ 
 
 □ 
      
□ 
 
  □     
    
□ 
     Strongly 
  
Agree     
Not sure 
  Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
13. I feel sure about what to choose in terms of whether or not to get a mammogram.  
□ 
 
 □ 
       
□ 
 
  □     
    
□ 
     Strongly 
  
Agree     
Not sure 
  Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
14. The decision whether or not to get a mammogram  is easy for me to make. 
□ 
 
 □ 
       
□ 
 
  □    
    
□ 
     Strongly 
  
Agree     
Not sure 
  Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
15. I feel I have made an informed choice whether or not to get a mammogram. 
□ 
 
 □ 
       
□ 
 
  □     
    
□ 
     Strongly 
  
Agree     
Not sure 
  Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 

PROTOCOL TITLE: 
 
Page 52 of 65 
 
 
16. My decision about whether or not to get a mammogram shows what is important to me  
□ 
 
 □ 
       
□ 
 
  □     
    
□ 
     Strongly 
  
Agree     
Not sure 
  Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
17. I expect to stick with my decision whether or not to get a mammogram 
□ 
 
 □ 
       
□ 
 
  □     
    
□ 
     Strongly 
  
Agree     
Not sure 
  Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
18. I am satisfied with my decision whether or not to get a mammogram.  
□ 
 
 □ 
       
□ 
 
  □    
    
□ 
     Strongly 
  
Agree     
Not sure 
  Disagree  
Strongly 
        
       Agree 
 
 
 
 
 
 
 
Disagree 
 
19. Did your health care provider discuss your life expectancy with you today? 
□ 
Yes 
□ 
No 
□ 
Don’t know 
 
20. If yes, how did this make you feel? You can check as many answers as you think apply: 
 
□ 
Comfortable 
 
□ 
Uncomfortable 
 
□ 
Informed 
□ 
Sad 
□ 
Content/Happy 
 
□ 
Scared 
 
□ 
Anxious 
 
□ 
Calm 
 
□ 
Interested 
 
□ 
Uninterested 
 
□ 
Other __________________________________ 
 
The next questions are questions and are the same questions we asked you on your baseline survey.  Please 
state whether each of the following statements is true or false (your best guess is fine). 
 
21. Among women aged 75 or older, who is more likely to die from breast cancer?  
□ 
Women who get mammograms  
□ 
Women who do NOT get mammograms  
□ 
There is almost no difference  
□ 
Don’t know 
 
 
22. The benefit of getting a mammogram is finding and treating a breast cancer when it is small and can be treated 
with only minor surgery. 

PROTOCOL TITLE: 
 
Page 53 of 65 
 
 
 
□   True 
 
□  False 
 
 
 
23. Getting a mammogram will prevent me from getting breast cancer. 
 
 
□   True 
 
□  False 
 
 
24. Most women who have an abnormal mammogram have breast cancer. 
 
 
□   True 
 
□   False 
 
 
 
 
25. Women aged 75 or older have a higher chance of getting breast cancer than younger women. 
 
 
□   True 
 
□   False 
 
 
 
 
26. More women aged 75 or older die of heart disease than breast cancer. 
 
 
□   True 
 
□   False 
 
 
 
27. Your other health problems should affect whether or not you get a mammogram. 
 
 
□   True 
 
□   False 
 
 
 
 
28. Some breast cancers found by a mammogram would never have shown up or caused problems in a woman’s 
lifetime. 
 
 
□  True  
 
 
□   False 
 
 
 
 
29. Most women aged 75 or older with breast cancer are treated with chemotherapy. 
 
 
□   True 
 
□   False 
 
 
 
 
30. Some breast cancers are not detected by mammograms. 
 
 
□   True 
 
□   False 
 
 
 
 
The next questions are about the communication tool that we provided you before your clinic visit 
 
Did it… 
 
31. Help you recognize that a decision needs to be made about whether or not to get a mammogram? 
        □ 
 
   □ 
 
      □ 
 
        □    
  
  □ 
          A great deal        Quite a bit          Somewhat         A little         Not at all 
 
32. Prepare you to make a better decision about whether or not to get a mammogram? 
        □  
   □ 
 
      □ 
 
        □     
  □ 
          A great deal        Quite a bit          Somewhat         A little         Not at all 
 
33. Help you think about the pros and cons of getting a mammogram? 
□ 
 
   □ 
 
      □ 
 
        □    
  
  □ 
          A great deal        Quite a bit          Somewhat         A little         Not at all 
 
34. Help you think about which pros and cons about getting a mammogram are most important to you? 
□ 
 
   □ 
 
      □ 
 
        □    
  
  □ 
          A great deal        Quite a bit          Somewhat         A little         Not at all 

PROTOCOL TITLE: 
 
Page 54 of 65 
 
 
35. Help you know that the decision whether or not to get a mammogram depends on what matters most to you?  
□ 
 
   □ 
 
      □ 
 
        □    
  
  □ 
          A great deal        Quite a bit          Somewhat         A little         Not at all 
 
36. Help you organize your own thoughts about the decision whether or not to get a mammogram? 
□ 
 
   □ 
 
      □ 
 
        □    
  
  □ 
          A great deal        Quite a bit          Somewhat         A little         Not at all 
 
37. Help you think about how involved you want to be in this decision? 
□ 
 
   □ 
 
      □ 
 
        □    
  
  □ 
          A great deal        Quite a bit          Somewhat         A little         Not at all 
 
38. Help you identify questions you want to ask your health care provider about mammography? 
        □ 
 
   □ 
 
      □ 
 
        □    
  
  □ 
          A great deal        Quite a bit          Somewhat         A little         Not at all 
 
39. Prepare you to talk to your health care provider about what matters most to you about whether or not to get a 
mammogram?  
□ 
 
   □ 
 
      □ 
 
        □    
  
  □ 
          A great deal        Quite a bit          Somewhat         A little         Not at all 
 
40. Prepare you for a follow-up visit with your doctor? 
        □ 
 
   □ 
 
      □ 
 
        □    
  
  □ 
          A great deal        Quite a bit          Somewhat         A little         Not at all 
 
41. At your follow-up visit, did you talk to your health care provider about getting a mammogram? 
 
 
□ 
YES 
 
 
 
□  NO 
 
42. Did your provider talk to you about the benefits of getting a mammogram? 
 □  YES  
 
 
□  NO 
 
43. Did your provider talk to you about any downsides of getting a mammogram? 
□ YES  
 
 
 
□  NO 
 
44. What did your provider recommend in terms of mammograms? 
□ 
Continue having mammograms 
□ 
Get another mammogram but consider stopping after that  
□ 
It is my choice 
□ 
To not get a mammogram now but reconsider later 
□ 
To stop getting mammograms 
□ 
Other:________________ 
 
 
45. The length of the communication sheet was  
 
 
 
 
 
      □ 
       
 
□ 
 
      □ 
 
    
 □     
                   
□ 

PROTOCOL TITLE: 
 
Page 55 of 65 
 
      Much too     A little too              Just right             A little too        
  
Much too  
      Long 
 
long 
 
 
 
 
short 
 
     
short 
 
 
46. The amount of information was 
 
 
 
 
 
 
      □ 
 
      
 
 □ 
 
      □ 
 
 □     
  
 
□ 
   Much less 
            A little less              Just right 
 
A little more           
Much more 
  than needed 
   
than needed 
 
 
 
 than needed 
         
than needed 
 
 
47. How clear was the information? 
□ 
 
   
□ 
 
   
□ 
 
        
□    
   
 Everything  
     
Most things  
    
Some things  
   
Many things  
    
 was clear 
     
were clear   
    
were clear          
were unclear 
 
48. I found the information 
 
 
 
 
 
 
 
 
□   
 
        
□  
 
 □  
 
□ 
 
                □ 
Clearly slanted  
 A little slanted    
Completely    
A little slanted               Clearly slanted                             
towards getting 
 towards getting          balanced      
towards NOT                towards NOT  
   a mammogram       
a mammogram                     
getting a mammogram  getting mammogram 
 
 
49. Reading the information made me feel: 
 
 
 
 
 
 
 
 
□  
 
 
□ 
 
          □  
             □   
Not anxious at all 
A little anxious        Very anxious       
 
As anxious as could be  
 
 
50. Please check the most accurate statement below:   
 
 
 
       
□ 
I understood none of the information 
□  
I understood a little of the information 
□   
I understood most of the information 
□   
I fully understood all of the information 
 
Any other Comments for us?? 
___________________________________________________________________________________________
___________________________________________________________________________  
 
 
51. How helpful was the communication tool in making a decision about mammography?  
 
□   
 
  
    □ 
 
 
 
 □  
 
         
 
□ 
  
   
Very helpful 
           Somewhat helpful    
   
A little helpful    
     
Not helpful 
 
52. Would you recommend the use of this communication tool? 
 
□   
 
        □ 
 
 
 
 □  
 
            
 □ 
 
 
 
   Definitely  
            Probably  
 
  
Probably not  
         
 
Definitely not   
 Recommend         
 Recommend              
  
Recommend 
           
Recommend 
 
 

PROTOCOL TITLE: 
 
Page 56 of 65 
 
It would be helpful to learn how you prefer to receive health educational materials such as the one you read today. 
 
53. What is your preferred format for health education materials: 
 
□ 
A pamphlet like the one you read for this study 
 
□ 
The computer/internet 
 
□ 
No preference 
 
□ 
Other 
 
54. Which would you prefer: 
 
□ 
To be mailed health educational materials that relate to me before a visit 
 
□ 
To be emailed health educational materials that relate to me before a visit 
 
□ 
To receive health educational materials in the waiting room before a visit 
 
□ 
To have your doctor or nurse give you health educational materials during the visit 
□ 
To have your doctor’s staff give you health educational materials after a visit to read at home. 
 
□ 
No preference 
 
□ 
Other 
 
Thank you so much for your help. You will receive $40 for participating in this study.  
 
 
 
 
 
 

PROTOCOL TITLE: 
 
Page 57 of 65 
 
**Post-visit Clinician Questionnaire** 
 
 
Thank you for agreeing to participate in this study. We are going to ask you some questions relating to this particular 
visit with the patient. All of your answers will be kept confidential, will not be linked to your name for future use, and 
are for informational purposes only as we try to understand how helpful this tool was in your discussions with patients. 
Please answer openly and honestly and you can skip any question you prefer not to answer 
 
Study ID ________________________ 
 
Date:___________________________  
 
 
 
Intentions for mammography 
 
1. What did you recommend in terms of mammograms for this patient? 
□ 
Continue having mammograms 
□ 
Get another mammogram but consider stopping after that  
□ 
It is the patient’s choice 
□ 
To not get a mammogram now but reconsider later 
□ 
To stop getting mammograms 
□ 
Did not discuss mammograms 
□ 
Other:________________ 
 
2. Before the visit, what did you think you would recommend?  
□ 
Continue having mammograms 
□ 
Get another mammogram but consider stopping after that  
□ 
It is the patient’s choice 
□ 
To not get a mammogram now but reconsider later 
□ 
To stop getting mammograms 
□ 
I did not think I would discuss mammograms 
□ 
Other:________________ 
 
3. During the visit today, did you discuss any of the following (circle each answer): 
 
• 
Pros of mammograms?   
 
Yes  
 
No 
 
Not sure 
 
• 
Cons of mammograms?  
 
Yes 
 
No 
 
Not sure 
 
 
• 
The patients individual risk of in-breast, pre-cancer or invasive cancer events? 
Yes 
 
No 
 
Not sure 
 
• 
Family history?  
 
 
 
Yes 
 
No 
 
Not sure 
 
• 
Life expectancy? 
 
 
 
Yes 
 
No 
 
Not sure 
 

PROTOCOL TITLE: 
 
Page 58 of 65 
 
• 
Any other relevant discussion points you discussed? 
 
__________________________________________________________________ 
 
 
3A. If yes to discussing life expectancy, how did this go? Check any that apply: 
 Helpful to patient 
 Helpful to me 
 It was uncomfortable 
 It was comfortable 
 Made decision-making easier for mammogram 
 Made decision-making harder for mammogram 
 Neutral effect on decision-making 
 Other ____________________________________________________ 
 
 
3B. If no to discussing life expectancy above, why not? Check any that apply 
 It didn’t come up 
 I was uncomfortable talking about it 
 Patient did not want to discuss it 
 Patient was anxious 
 Patient healthy so I didn’t think it was important 
 I didn’t have time 
 I didn’t think it was important for this discussion 
 
 
Questions about the Communication Sheet (with regard to its use during this visit with the patient) 
 
 
4.  The length of the communication sheet was  
 
 
 
 
 
      □ 
       
 
□ 
 
      □ 
 
    
 □     
                   
□ 
 
□ 
 
      Much too      
A little too              Just right              
A little too          
Much too  
I didn’t  
      Long 
 
long 
 
 
 
 
short 
 
     
short 
 
use it 
 
5. The amount of information was 
 
 
 
 
 
 
      □ 
 
      
□ 
 
      □ 
 
  
□     
  
 
□ 
 
□ 
   Much less 
            A little less            Just right 
 
A little more           
Much more 
I didn’t 
 than needed 
   
than needed 
 
 
 
than needed 
         
than needed 
use it 
 
6. How clear was the information? 
□ 
 
   
□ 
 
   
□ 
 
        
□    
 
□ I didn’t use it 
Everything  
     
Most things  
    
Some things  
   
Many things  
   was clear 
     
were clear   
    
were clear          
were unclear 
 
 
 
 
 

PROTOCOL TITLE: 
 
Page 59 of 65 
 
7. I found the information 
 
 
 
 
 
 
 
 
□   
 
        
□  
 
  
□  
 
□ 
 
                □ 
 
□ 
Clearly slanted   A little slanted    
Completely    
A little slanted               Clearly slanted    
I didn’t               
towards getting  towards getting          balanced      
towards NOT                towards NOT  
 
use it 
a mammogram      a mammogram 
                    
getting a mammogram  getting mammogram 
 
 
8.  How helpful was the communication tool in making a decision about mammography?  
 
□   
 
  
    □ 
 
 
 
 □  
 
         
□ 
 
 □ 
   
Very helpful 
           Somewhat helpful    
   
A little helpful    
Not helpful 
I didn’t 
 
 
 
 
 
 
 
 
 
 
 
 
 
use it 
 
9. Would you recommend the use of this communication tool? 
 
□   
 
        □ 
 
 
 
 □  
 
           □  
 
 
   Definitely  
            Probably  
 
  
Probably not  
         
Definitely not   
 Recommend          
Recommend              
  
Recommend 
          Recommend 
 
 
It would be helpful to learn how you prefer to use health educational materials such as the one you used today. 
 
10. What is your preferred format for health education materials: 
 
□ 
A pamphlet like the one you used for this study 
 
□ 
The computer/internet 
 
□ 
No preference 
 
□ 
Other ________ 
 
11. How did using this tool affect the length of the visit with your patient today? 
□ 
Made visit a lot longer 
□ 
Made visit a little longer 
□ 
No effect on visit time 
□ 
Made visit a little shorter 
□ 
Made visit a lot shorter 
□ 
Not sure 
□ 
Other 
□ 
I didn’t use it 
 
 
12. Please let us know about any other thoughts you have about using the tool in practice. Please be as honest as 
possible. 
 
________________________________ 
 
Thank you so much for your help. You will receive a one-time $40 at the end of this study for participating in 
these surveys.  
 
 
 

PROTOCOL TITLE: 
 
Page 60 of 65 
 
CITATIONS 
***All questionnaires are adapted and revised from validated surveys used in the following publications : 
Decision Aid evaluation for screening by Schonberg M.A. et al JAMA Intern Med 2014; 174(416-424), 
https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_ChoicePredisposition_Decision.pdf, 
https://decisionaid.ohri.ca/docs/develop/Tools/DCS_English.pdf, 
https://decisionaid.ohri.ca/docs/develop/Tools/Acceptability_osteoporosis.pdf) 
Gotay CC and Pagano. Assessment of Survivor Concerns: A newly proposed brief questionnaire. Health Qual Life Outcomes 2007; 5: 15. 
Chew LD, Griffin JM, Partin MR, et al. Validation of screening questions for limited health literacy in a large VA outpatient population. J 
Gen Intern Med 2008; 23:561-566 
Enzinger AC, Zhang B, Schrag D, et al. Outcomes of prognostic disclosure: associations with prognostic understanding, distress, and 
relationship with physician among patients with advanced cancer. J Clin Oncol 2015; 33:3809-3816. 
Ahalt C, Walter LC, Yourman L, et al: "Knowing is better": preferences of diverse older adults for discussing prognosis. J Gen Intern Med 
27:568-75, 2012 
 
 
 
 

PROTOCOL TITLE: 
 
Page 61 of 65 
 
 
 
APPENDIX E: VERBAL CONSENT FOR THE PATIENT PHONE INTERVIEWS 
AND FOCUS GROUPS 
 
Hi and thanks for participating in this interview today. I’m from Dana-Farber Cancer 
Institute and we’re doing a study on how we can better approach mammography in older 
breast cancer survivors. We’ve asked you to participate in this discussion because we’d like 
to hear your perspectives on your experiences and how you feel about this topic.  This 
project is funded by a grant from the National Cancer Institute.  
 
I’d like to start off by introducing myself. I’m [name of interviewer]. I’ll be conducting this 
interview and will be recording our discussion. As was mentioned to you when you were 
invited to participate, we will audiotape this session. We are doing this to make sure that 
we remember everything that you say. Your comments are really important to us. The tapes 
are confidential information. Your name or any other information that could identify you 
will not be linked to the tape recordings. The tapes will be listened to only by the research 
staff or by the professional transcriptionist (the person who will type what is on the tape). 
Once the recordings have been typed and the data analyzed, we will erase the tapes. All 
records of the discussions will be kept in a locked file. Only the researchers will have 
access to these records. Any results of your interview and those of other women (including 
the views of you and other women) will be reported or published as a group and will not be 
associated with any identifiers. 
 
Everything that you say is confidential and will not be shared with anyone other than the 
research staff. Therefore, I want to encourage you to speak openly about your ideas. There 
are no right or wrong answers. The goal is to hear your views and experiences to fully 
understand how you feel on the topics we will discuss. We expect that you will find the 
questions generally easy to answer, but if you find that any parts of the discussion are 
upsetting, you can ask the interviewers to move on. If you experience any distress during or 
after the discussion, please let us know and we will refer you to your doctor or nurse for 
follow-up care. 
 
This is a voluntary activity. Today’s discussion will last about 30-45 minutes. You may 
choose not to take part in this study. If you do decide to participate, you can stop at any 
time or choose not to answer any of the questions. Choosing not to take part or leaving the 
study will not affect any current or future medical care in any way. We will mail you a $50 
gift card after you complete the interview. Thank you so much for agreeing to participate. .  
 
Are you ready to begin? [Then start recording and begin interview] 
 
 
 
 
 
 

PROTOCOL TITLE: 
 
Page 62 of 65 
 
 
 
APPENDIX F: INFORMATION FOR MAILING AND VERBAL CONSENT FOR 
AIM 1.2 (PILOT INTERVENTION) 
 
Dear potential participant: 
 
I’m from Dana-Farber Cancer Institute and we’re working on a research study that looks to 
improve how we follow patients with breast cancer who are 75 and older. We’ve asked you 
to participate because we’d like to hear your perspectives on your experiences on this topic.  
This project is funded by a grant from the National Cancer Institute. We will be calling you 
in the next week or so to review the information provided here to see if you are interested 
in participating. Your participation is completely voluntary. We have also enclosed a phone 
number and email address in case you want to let us know ahead of time that you are 
interested or not interested in participating. If we do not hear back from you, we will call 
you to introduce you to this study and review this form again. 
 
Purpose: Our goal is to develop a communication tool that will provide recommendations 
for clinicians and patients for surveillance mammography and follow-up care for breast 
cancer survivors over the age of 75. Specifically, this tool will help prevent over screening 
breast cancer survivors by reducing unnecessary mammograms in follow-up care. With your 
permission, we will provide you with an information sheet about mammograms. We will 
then ask you to answer some questions about your breast cancer, your intentions for 
mammography before and after your next follow-up visit at Dana-Farber, and your decision-
making and your experiences.  
 
Procedures: This is a two-time survey that will occur before and after your upcoming Dana-
Farber follow-up appointment and will take approximately 20-30 minutes in total. You can 
take these surveys by email (through a link), by paper (in person or through mail), or by 
phone. You are free to skip any questions you do not wish to answer or end the survey at any 
time. At this time, we are also asking for your consent to review your medical record. The 
medical record review is an important part of this study because we can confirm information 
about your cancer, the treatments you may or may not have received, as well demographic 
data such as your age. Only members of the study team will have access to the information 
in medical records. When we finish the surveys, we will arrange for a $40 gift card to be sent 
to you. 
 
Benefits: There are no direct benefits to you. However, the information you provide us with 
will provide important information on follow-up care for survivors of breast cancer.  
 
Risks: The risks of participating in this interview are minimal. We expect that you will find 
the questions generally easy to answer, but if you find that any questions are upsetting, you 
can ask the interviewer to move on. If you experience any distress during our discussion, 
please let us know and we will refer you to your doctor or nurse for follow-up care.  
Another potential risk is a loss of confidentiality. We will take measures to protect the 

PROTOCOL TITLE: 
 
Page 63 of 65 
 
privacy and security of all your personal information, but we cannot guarantee complete 
confidentiality of study data. 
 
Confidentiality: All the information you give us will be kept confidential. Your name and 
address will not be linked directly to your interview responses. We will keep all our study 
notes in locked files and secured computers. To protect your confidentiality, your signature 
will not be required in this or other documents.  Your verbal agreement to participate in the 
survey will serve as your consent. We will destroy the file containing your name and address 
information as soon as we have completed the study.  
 
Future Research: Your personal information collected during this study may be retained 
and used for future research. Any personal identifiers will be removed, before the 
information is shared, so that the information cannot be linked back to you. As a result, we 
will no longer be able to identify and destroy them. Investigators, including investigators 
from collaborating institutions, can request these data for new research. Your information 
may also be shared with outside non-profit academic investigators as well as with for-profit 
pharmaceutical investigators or commercial entities, with whom we collaborate. You will 
not be asked to provide additional informed consent for the use of your de-identified 
information in future research. 
 
It is YOUR choice!  Your participation is important but voluntary. You may choose not to 
take part at all, or to stop at any time after you begin.  You can refuse or quit at any time 
without penalties of any kind or loss of any benefits you are otherwise entitled. Also, if you 
experience distress during the surveys and would like to speak to the Principal Investigator 
of this study, you are welcome to do so and Dr. Freedman’s information is below. 
 
If you would like to opt in or out of this study, feel free to let us know by calling the 
study coordinator, Haley Gagnon, at 617-632-6257 or email: 
haleyc_gagnon@dfci.harvard.edu. If we don’t hear from you, we will try to contact 
you soon and look forward to chatting with you.  
 
Questions? If you have any questions or comments about this study, or to report a study-
related problem or injury, you are also welcome to contact Dr. Rachel Freedman from Dana-
Farber Cancer Institute at 617-632-3800 or by mail at Dana-Farber Cancer Institute, 450 
Brookline Avenue, Boston, MA.  If you have any questions or comments about your rights 
as a research participant; or to report problems, concerns, or complaints, please contact the 
Office of Human Research Services at 617-632-3029, extension #6. 
 
If you decide to participate in the study: This document will be reviewed with you and 
considered verbal consent. Our team will be sure you have a copy of this paper. 
 
 

PROTOCOL TITLE: 
 
Page 64 of 65 
 
APPENDIX G – INFORMATIONAL EMAIL/FLYER FOR POTENTIAL 
PATIENTS FOR FOCUS GROUPS AND INTERVIEWS (Aim 1.1) 
 
Are mammograms still right for me? 
 
Goal of the Project 
Breast cancer is a disease of aging. With our aging U.S. population, 
we will see more breast cancers in older patients. However, older 
patients are often not included in clinical trials that guide our care. This 
is part of the reason why there are still many unanswered questions 
about how we should follow older breast cancer survivors over time.  
The goal of this study is to better understand when it may be the right 
time to stop mammograms in breast cancer survivors over time –as 
patients age–and how to have these conversations with them. The 
benefits of mammograms become less as people age, while the risks 
of the test, such as false alarms, may increase.  
 
What We are Asking from You 
We have created an information tool to help women decide on whether 
having a mammogram is still right for them. We have also crafted a set 
of recommendations regarding getting a mammogram test. Now we 
would like to share this information with you to get your opinion. 
Would you be available to discuss the tool and our recommendations 
with us? This would take about 45 minutes over the phone, for a one-
on-one interview. You could also attend one of our focus group 
sessions in which a group of 6 to 8 people would get together to review 
all the information and tell us what they think.  
In appreciation of your time, we would provide a $50 gift card at the 
end of the interview.   
If you are interested, please let us know. We hope to hear from you! 
 
Rachel Freedman, MD, MPH 
Dana-Farber Cancer Institute 
Boston, MA 
617-632-xxxx or rafreedman@partners.org 
 
 

PROTOCOL TITLE: 
 
Page 65 of 65 
 
Appendix H: Draft email to providers for patients potentially eligible for the pilot 
intervention (Aim 1.2) 
 
From: Freedman, Rachel A., M.D., M.P.H. [or appropriate site PI] 
Sent: Tuesday, August 07, 2020 3:29 PM 
To: xx 
Subject: potential patient for protocol 19-001, Individualizing Mammography in the Older Breast 
Cancer Survivor 
 
Dear MD/NP/PA team: 
I am writing about your patient, (insert name), regarding Protocol 19-001, which is study 
evaluating an information sheet for older breast cancer surivovors on the pros and cons for 
surveillance mammography (PI: Rachel Freedman, MD, MPH [Dana-Farber]; co-investigators 
Meredith Faggen, MD [South Shore], and Philip Poorvu, MD [St. Elizabeth’s]). 
 
Per our medical record review, it seems that Ms. XX is aged 75 or older, had breast conservation, 
and is in long-term follow-up care for her breast cancer. She is likely eligible for protocol 19-001. 
As you may know, this is survey-based study where patients will be given an information tool to 
discuss mammography with you that can be used as you like and per your discretion. Patients will 
be surveyed before and after your visit on their mammography decisions and how the information 
tool may have helped/not helped them make decisions.  Participants will receive $40 for their time. 
This cohort is purely survey-based and there is no therapeutic component to the study. 
 
If we do not hear from you within 2 business days, we will assume permission to initiate contact 
with the patient. We will mail your patient an introduction to the study and then call them a week 
later to assess their interest. If this patient is interested in participating, we will be responsible for 
consenting her and for all study procedures. We will survey you at the end of the patient 
encounter via email and at the end of the study, you will receive a $40 amazon gift card in 
appreciation of your time.  
 
Thank you for your assistance and support of this study.  Please feel free to contact us if you have 
any questions. 
 
Sincerely, 
 
Rachel Freedman, MD, MPH