A Study in Development of a Personalized Discussion Prioritization Tool for Older Adults Considering Adjuvant Chemotherapy for Breast Cancer
Phase: NA
Conditions: Breast Cancer
Sponsor: University of Rochester

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UNIVERSITY OF ROCHESTER MEDICAL CENTER
WILMOT CANCER INSTITUTE
Development of a Personalized Discussion Prioritization Tool for Older Adults 
Considering Adjuvant Chemotherapy for Breast Cancer
November 11th, 2021
Study Principal Investigator:
Allison Magnuson, DO
James P Wilmot Cancer Center 
601 Elmwood Ave, Box 704
Rochester, NY 14642
Phone: (585) 275-7246/ Fax: 273-1042
Email: Allison_Magnuson@URMC.Rochester.edu
Study Sub-Investigator:
Supriya G. Mohile, MD, MS
Division of Hematology/Oncology 
University of Rochester Medical Center 
James P Wilmot Cancer Center
601 Elmwood Ave, Box 704
Rochester, NY 14642
Email: Supriya_Mohile@URMC.rochester.edu
Mina S. Sedrak, MD, MS
City of Hope National Medical Center 
1500 E. Duarte Road
Duarte, CA 91010
Email: Msedrak@coh.org
Jessica Gooch, MD
University of Rochester Medical Center 
Department of Surgery
601 Elmwood Avenue, Box SURG 
Rochester, NY 14642
Email: Jessica_Gooch@URMC.Rochester.edu
Study Personnel:
Terri Lloyd
James P Wilmot Cancer Center 
601 Elmwood Ave, Box 704
Rochester, NY 14642
Phone: (585) 276-5652/ Fax: (585) 273-1042
Email: Terri1_Lloyd@URMC.Rochester.edu
Jessica Bauer
James P Wilmot Cancer Center 
601 Elmwood Ave, Box 704
Rochester, NY 14642
Phone: (585) 276-6562/ Fax: (585) 273-1042
Email: JessicaC_Bauer@URMC.Rochester.edu

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Chandrika Sanapala
James P Wilmot Cancer Center 
601 Elmwood Ave, Box 704
Rochester, NY 14642
Phone: (585) 275-4391/ Fax: (585) 273-1042
Email: Chandrika_Sanapala@URMC.Rochester.edu

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TABLE OF CONTENTS:
1.0 Purpose of study…..........................................................................................pg.4
2.0 Background……………………………………………………………………..…..pg.4-6
3.0 Administrative Organization…………………………………………………….....pg.6 
4.0 Study Design……………………………………………………………………..…pg.6 
5.0 Subject Population………………………………………………………………....pg.6-7
6.0 Inclusion and Exclusion Criteria…………………………………………………. pg.7 
7.0 Recruitment and Consent………………………………………………………….pg.7-10
8.0 Registration………………………………………………………………………….pg.10-11
9.0 Discussion Prioritization Tool………………………………………………..…….pg.11-14 
10.0 Study Procedures ……………………………………………………………...…pg.14-17 
11.0 Audio/Video Recordings………………………………………………………….pg.17-18 
12.0 Risks and Benefits………………………………………………………………...pg.18 
13.0 Costs to Subjects……………………………………………………………….…pg.18 
14.0 Payment……………………………………………………………………………pg.18
15.0 Data and Sample Storage for Future Use………………………………….. …pg.19
16.0 Data and Safety Monitoring Plan……………………………………………..…pg.19-21 
17.0 Data Analysis Plan……………………………………………………………..…pg.21 
18.0 References…………………………………………………………………...……pg.21-22 
19.0 Tables…………………………………………………….………………………..pg.23-24

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1.
PURPOSE OF STUDY
1.1. Overall Goal:
We have developed a Discussion Prioritization Tool (DPT) for older adults 
considering adjuvant chemotherapy. The DPT utilizes Conjoint Analysis (CA) 
methodology and the objective of the current study is to assess usability of this DPT 
in our target population, older adults with breast cancer and to adapt the tool to 
optimize usability for our target population.
1.2. Study objectives and Hypothesis:
1.2.1. Primary objective:
To evaluate the usability of the DPT in ten older adults considering adjuvant chemotherapy or 
has made a decision about receiving adjuvant chemotherapy for breast cancer within the past 
12 months.
1.2.2. Secondary objective:
To adapt the DPT using “talk aloud” method to optimize usability for our target population.
1.2.3. Hypothesis:
The DPT tool will demonstrate adequate usability in older adults considering adjuvant 
chemotherapy or has made a decision about receiving adjuvant chemotherapy for 
breast cancer within the past 12 months.
1.2.4 Usability and feasibility metrics:
The usability and feasibility of the DPT will be evaluated based on the following:
Primary Usability Assessment Measures: System Usability Scale (SUS) (score on 10-item 
scale, total score ranging 0-100; higher score corresponds to greater usability). We will deem 
the tool usable if our mean SUS score among the 10 patients enrolled is >68.
Secondary Usability Assessment Measures:
a)
Recruitment rates (percentage of patients who are approached and agree to enroll)
b)
Talk Aloud Method (recordings of patients feedback while using the DPT)
2.
BACKGROUND AND RATIONALE
2.1 Breast Cancer is a disease of aging. Among other elements, age is a crucial risk factor in 
developing cancers. In breast cancer specifically, incidence has been shown to rise with age, 
resulting in the majority of deaths related to breast cancer occurring in women aged 65 years 
and older [1]. In 2016, it was found that the prevalence of breast cancer among women aged 65 
and over was 436.9 per 100,000 per year [2]. In patients with breast cancer, many are 
considered for adjuvant systemic therapy (e.g. chemotherapy). This is particularly relevant for 
older adults with higher risk breast cancer subtypes. For example, nearly 15% of older patients 
have triple negative breast cancers, which represent the most aggressive breast cancers with 
the majority of recurrences occurring within the first several years after treatment [1].

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2.2 Patient goals and preferences are an important component in developing treatment 
plans for localized breast cancer. Providing patient-centered care that incorporates patient 
goals and values in the oncology treatment decision making process is important [1]. When it 
comes to healthcare decisions, each patient has their own individual goals, beliefs, preferences, 
life experiences and values that influence their treatment preferences [1]. Identifying what is 
important to patients with breast cancer can ultimately tailor conversations for each patient 
when discussing cancer treatment options. In addition, evaluating the patient’s overall health 
and potential risks and benefits of various treatment option is also critical, particularly for older 
adults. The geriatric assessment (GA) is a validated tool to assess the overall health status of 
older adults and is superior to other measures of “fitness” in oncology (e.g. performance status 
assessment) [3]. The GA is a multidimensional tool that assesses domains relevant for older 
adults, including comorbidities, psychological status, functional status, physical performance, 
cognition, nutritional status, social support and polypharmacy and is recommended by national 
guidelines in the care of older adults with cancer [3]. Awareness of potential deficits or 
vulnerabilities in these areas (through the completion of the GA) could ultimately assist in 
decision making or can be used to identify patients who would benefit from interventions that 
would improve their health for treatment [3].
2.3 Information preferences vary amongst older adults with breast cancer. When deciding 
about treatment options, patients were shown to have three different styles such as physician 
based, patient based, or shared. Patients who made decisions based on their physicians, did so 
in fear of making the wrong choice. Other patients were satisfied making their own choices, 
while others relied on support from their physician to help make a shared decision about 
treatment [4]. Some patients elect to decline adjuvant therapy, and studies suggest a variety of 
reasons for this including prior family experience, not wanting to burden to others, clinical 
comorbidities that could increase their chance of adverse effects, and prior negative 
experiences [4]. Overall, there are multiple key elements that a patient considers when making 
decisions about treatment.
2.4. The aging process is heterogeneous and older adults of a similar chronologic age do 
not necessarily have similar health status. A geriatric assessment (GA) can be utilized to 
better understand the overall health status of an older adult. GA has been shown to be feasible 
in oncology[5] and also improves communication about aging-related issues between older 
adults with cancer and their oncologists.[6] Elements of the GA are associated with 
chemotherapy toxicity and other adverse outcomes such as hospitalization and early 
termination of chemotherapy. Recently, a risk model was developed and validated for older 
adults receiving adjuvant therapy for breast cancer (the Cancer and Aging Research Group- 
Breast Cancer [CARG-BC]) to estimate the risk of chemotherapy toxicity and other adverse 
events.[7] The CARG-BC includes clinical variables (e.g. cancer stage), laboratory results (e.g. 
liver function test), as well as GA elements (e.g. fall history) and a total sum score is calculated. 
The total CARG-BC score correlates with a risk of chemotherapy toxicity. Providing the results 
of a patients GA, their CARG-BC score, and their preferences about treatment options may 
facilitate a more personalized discussion about the benefits and risks of adjuvant treatment 
options for older adults with breast cancer.
2.5. Conjoint analysis is a method for eliciting patient preferences. Given the complexity of 
adjuvant chemotherapy decision making for older adults with breast cancer, enhancing support 
and promoting treatment discussions in the context of patient’s goals and preferences is an 
important need. With this need in mind, our group has completed interviews with patients with 
cancer patients who are considering adjuvant therapy. As a result of these interviews, our group 
has developed a common list of attributes (variables found to be important in decision making)

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that were used to create the Discussion Prioritization Tool (DPT) using Conjoint Analysis (CA) 
methodology. CA which is a method that can assess the relative importance that patients place 
on different aspects of care by asking patients to make a series of trade-offs between competing 
options. Attributes that were identified were quality of life, fatigue, activities of daily living, 
falls/balance, cognition, distress/worry, risk of treatment toxicity, risk of hospitalization, burden 
on support system, and outcome (recurrence risk/survival) [8].
Other decisional support tools have been developed and tested in oncology and demonstrated 
promising utility. For example, CONNECT, a computer-based communication aid, was 
developed to improve communication between patients with advanced cancer and their 
oncologists.[9] CONNECT included assessment of patient values, goals, and communication 
preferences and was tested in a 3-arm, prospective, randomized clinical trial. Patients who 
engaged with the CONNECT tool felt that it made treatment decisions easier to reach and 
helped them to be more satisfied with these decisions. Patients in the intervention arms also 
reported higher levels of satisfaction with communication. Other decision aids have also shown 
potential benefit, but the majority of these focused on patients with advanced cancer[10-13] or 
were not specific for the older adult population.[14, 15] To our knowledge, this is the first 
discussion prioritization tool developed for older adults with breast cancer considering adjuvant 
chemotherapy that incorporates GA and aging-specific preferences and relates patient 
preferences to validated risk tool results (the CARG-BC).
3.
ADMINISTRATIVE ORGANIZATION
3.1. Research location and participating site:
The study will be conducted through the Wilmot Cancer Institute at the University of Rochester 
Medical Center and will enroll patients through the Comprehensive Breast Care Center (located 
at Pluta Cancer Center)
Dr. Mina Sedrak, of the City of Hope is a co-investigator on the protocol. However, we will not 
be enrolling patients from the City of Hope. Dr. Sedrak will only have access to de-identified 
data and will be participating in data analysis for this study.
4.
STUDY DESIGN
4.1 Study Design:
This is a single arm pilot study to determine usability.
5.
SUBJECT POPULATION
5.1 Subject Population:
The eligibility criteria is aimed at identifying older patients diagnosed with localized breast 
cancer who are being considered for adjuvant chemotherapy or has made a decision about 
receiving adjuvant chemotherapy for breast cancer within the past 12 months. Since our study 
team is developing a tool that incorporates geriatric specific factors, we will recruit patients who 
are aged 65 or older. The study will have no restrictions on race or gender. However due to the 
disease, we anticipate that most, if not all participants will be female.
5.2 Number of subjects:

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Our study team expects 10 subjects to participate in the study. The majority of usability studies 
demonstrate that usability can be optimized in a small number of subjects (e.g. 10). We 
anticipate being able to enroll the targeted number of patients in <1 year duration.
5.3 Vulnerable Subjects:
Recruitment will exclude vulnerable populations such as fetuses, neonates, children, pregnant 
woman, prisoners, adults with decisional impairment, and institutionalized individuals.
6.
INCLUSION AND EXCLUSION CRITERIA
6.1 Inclusion Criteria.

Age ≥65

Diagnosis of stage I-III BC

Being considered for adjuvant chemotherapy or has made a decision about receiving adjuvant 
chemotherapy for breast cancer within the past 12 months.

Able to speak and read English

Able to participate in study procedures.
6.2 Exclusion Criteria.

Lacking medical decision-making capacity as determined by their oncologist

Evidence of metastatic disease
7.
RECRUITMENT AND CONSENT
Subjects will be identified and enrolled at the University of Rochester Comprehensive Breast 
Cancer Center at Pluta Cancer Center. The clinic schedules of breast oncologists and their 
advanced practice providers (APPs) will be screened for eligible patients.
To ensure appropriate safety precautions when conducting in-person study procedures, the 
process for conducting in-person visits outlined in the Guidance for Human Subject Research 
will be followed.
7.1 Identification of Study Subjects, Recruitment, and Consent Procedures
Potential patients will be identified in multiple ways. First, study participants will be identified by 
their treating physician, the nurses that work with the physicians, and the study coordinator.
The study coordinator works closely with the physicians and nurses to monitor patients and 
identify those patients who are being considered for adjuvant chemotherapy or has made a 
decision about receiving adjuvant chemotherapy for breast cancer within the past 12 months. 
With permission from oncology providers, we will screen for eligible patients from clinic 
schedules. The study coordinator contacts the physician (or their designee) and lets them know 
that a patient may be eligible for the study. The physician (or their designee) then confirms if the 
patient is a good study candidate or not and affirms that the patient has decision making 
capacity. If there is a question about eligibility, the principal investigator will be contacted and 
will meet with the patient and/or health care proxies, review the medical records, and perform 
an assessment of eligibility if necessary.  After meeting with the physician (or their designee), 
the study coordinator will meet with the patient either in person or via phone, and explain the 
details of the study. Study staff will introduce the study to the patients and provide adequate 

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time to read the consent.

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Our study group anticipates two different types of scenarios for the recruitment and consent 
process. Potential study subjects may be consented either in person or verbally during a virtual 
visit. Study participants will also have the ability to complete the study in person or virtually.
Potential scenarios for in-person consent:
1)
Physician/Study Investigator makes the initial contact and provides consent form, and 
patient signs consent with the physician on the same day: After confirming with the 
physician (or their designee) that a patient is a potential candidate for the study, the 
study staff will provide a consent form to the treating physician/study investigator so 
he/she can provide it to the patient during an in-person clinic visit. The physician/study 
investigator will go over every detail of the study during the clinic visit with patient. If 
agrees, the patient will sign the consent form with the physician/study investigator during 
the same in-person visit.
2)
Study staff makes the initial contact and provides consent form, and patient signs 
consent with the study staff on the same day: After confirming with the physician (or their 
designee) that a patient is willing to speak with the study coordinator about the study, the 
patient will be provided with an informed consent form by the study staff when they come 
in for an in-person clinic visit. The study staff will introduce the study to the patients and 
go over every detail of the study. If agrees, the patient will sign the consent form with the 
study staff during the same in-person visit with the study staff.
Potential scenarios for verbal consent:
1)
Physician/Study Investigator makes the initial contact, study staff follows up with the 
patient on the phone, and patient provides verbal consent on the phone: After confirming 
with the physician (or their designee) that a patient is a potential candidate for the study, 
the physician/study investigator confirms with the patient that he/she is willing to speak 
with the study staff about the study. The study staff will then call the patient via phone. 
The study coordinator will use the verbal consent script as a written aid and will go over 
every detail of the study with the patient to recruit them for the study. Study staff will sign 
and date it to confirm that he/she followed the script and the patient agrees to participate 
in the study. Following the completion of verbal consent with the subject, the coordinator 
will mail or email the subject a study information sheet that summarizes what the study 
entails and the subject’s involvement in it.
2)
Physician/Study Investigator makes the initial contact and provides consent form, study 
staff follows up with the patient on the phone, and patient provides verbal consent on the 
phone: After confirming with the physician (or their designee) that a patient is a potential 
candidate for the study, the study staff will provide a consent form to the treating 
physician/study investigator so he/she can provide it to the patient during an in-person 
clinic visit. If the patient is interested but does not want to consent on the same day, the 
patient will bring the consent form home. The study staff will then call the patient via 
phone. The study coordinator will use the verbal consent script as a written aid and will 
go over every detail of the study with the patient to recruit them for the study. Study staff 
will sign and date it to confirm that he/she followed the script and the patient agrees to 
participate in the study. Following the completion of verbal consent with the subject, the

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coordinator will mail or email the subject a study information sheet that summarizes what 
the study entails and the subject’s involvement in it.
3)
Study staff makes the initial contact and provides consent form, study staff follows up 
with the patient on the phone, and patient provides verbal consent on the phone: After 
confirming with the physician (or their designee) that a patient is willing to speak with the 
study coordinator about the study, the patient will be provided with an informed consent 
form by the study staff when they come in for an in-person clinic visit. If the patient is 
interested but does not want to consent on the same day, the patient will bring the 
consent form home. The study staff will then call the patient via phone. The study 
coordinator will use the verbal consent script as a written aid and will go over every 
detail of the study with the patient to recruit them for the study. Study staff will sign and 
date it to confirm that he/she followed the script and the patient agrees to participate in 
the study. Following the completion of verbal consent with the subject, the coordinator 
will mail or email the subject a study information sheet that summarizes what the study 
entails and the subject’s involvement in it.
7.1.1. Informed Consent
Informed consent will be obtained from the patient by the study investigators or 
coordinators. Consent documents will be signed by the patient and maintained in the 
patient record with copies provided to the patient. For verbal consent, documents will be 
maintained in the patient record with copies provided to the patient. Justification for waiver 
of documentation of written consent: If the patient cannot meet in person with the study 
coordinator to sign the informed consent, the study coordinator will verbally consent the 
subject. The study coordinator will use the verbal consent script, then sign and date it to 
confirm that s/he followed the script and the subject agreed to participate in the study.
Following the completion of verbal consent with the subject, the coordinator will mail or 
email the subject a study information sheet that summarizes what the study entails and the 
subject’s involvement in it.
Alteration of HIPAA Authorization:
We are requesting an altering of HIPAA authorization. We will provide an information 
sheet to patients who provided verbal consent. Verbal consent will allow for reduction of 
in-person visits, thus maximizing the safety of both patients and study staff. Nonetheless,
when possible and if we are able to coordinate study and clinic visits, we will obtain written 
informed consent.
The study cannot be conducted without the use of protected health information (PHI) as 
we have to link patient reported data with medical history collected on electronic medical 
record. We have adequate plans to protect the PHI from improper use and disclosure. We 
will destroy identifiers after completion of the study for 7 years. We will not reuse or 
disclose the PHI to another person or entity other than the study investigators. The waiver 
will not adversely affect the privacy rights of the individual and the research cannot be 
practicably done without access to the use of the PHI.
7.1.2. Human Subject Protection
The University of Rochester Research Subject Review Board Investigator Guidance policy

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will be used to ensure that ethical standards for human subjects are upheld.
7.1.3. Participation
Regulations at the state, federal, and institutional level will be adhered to in regards to 
informed consent. Study participation is completely voluntary. After consenting, 
participants may withdraw from the study at any time for any reason, and they may do so 
without any repercussions. Participants may also be withdrawn by study personnel if it is 
determined that it is not favorable for the patient. All information regarding consent and 
withdrawal will be kept confidential.
7.1.4. Duration
Participation in the study will last approximately 60-90 minutes during a one time in- 
person or virtual visit. If needed, our study team may follow up with the participant for 
further information for up to 2 months after the initial completion of the study procedures. 
After the study is completed, participant data will be maintained for 7 years at URMC 
and will be kept in a password-protected database.
7.1.5 Subject Capacity
We will ensure through the patient’s primary oncologists that the patient has capacity to 
consent and participate in the study by confirming the patient’s medical decision-making 
capacity with the oncologist.
7.1.6 Subject/Representative Comprehension
The study subject’s capacity to participate in the study will be confirmed by their primary 
oncologist prior to approaching the patient to discuss the study. During the consent process, 
the subject must be able understand and report the purpose of the study, its procedures, 
risks, and benefits in order to demonstrate full comprehension of the study.
8.
REGISTRATION
If a patient meets eligibility criteria and has provided informed consent, the study personnel will 
enter the following information into the OnCore Database:
8.1. Registration Information
8.1.1
Site
8.1.2
Most recent IRB approval date
8.1.3
Name of person registering study participant
8.1.4
Eligibility verification

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8.1.5
Verification that consent form has been signed and date signed. If verbal consent 
obtained, verification that verbal consent form has been signed and dated by the 
consenting individual.
8.1.6
Treatment facility (Pluta)
8.1.7
Participant’s identification
8.1.7.a
First and last names
8.1.7.b
Birth date (MM/DD/STREAM)
8.1.7.c
Gender
8.1.7.d
Race
8.1.7.e
Five-digit zip code
8.1.7.f
Medical Record Number
8.1.7.g
Ethnicity
8.1.7.h
Patient’s preferred and alternate phone numbers (and email address if 
patients consent to be contacted via email)
8.1.7.i
Date of baseline visit
9.0. DISCUSSION PRIORITIZATION TOOL
The proposed tool consists of three components:
1)
A survey tool consisting of demographic questions and selected patient-reported 
Geriatric Assessment measures;
2)
Selected coordinator-administered geriatric assessment measures; and
3)
The Conjoint analysis to elicit patient preferences, (see Figure 1 for depiction of conjoint 
analysis question).
9.1 Demographic measures (see table 1.a)
9.2 Patient-reported GA measures (see table 1.b)
9.3 Coordinator-administered GA measures (see table 1.c) 
9.4Conjoint Analysis
There are two main components of a conjoint analysis i.e., attributes (characteristics or factors 
that influence decision-making) and levels (degree of the characteristics). These attributes are 
categorized into 3 separate groups: benefits of treatment, potential risks of treatment, and 
quality of life during treatment. Scenarios are then drawn up for each of the attributes and levels 
(Figure 1). Patients will be presented with scenarios and asked to select one that is consistent 
with their preferences. This process then repeats until all attributes are evaluated. At 
completion, a summary containing a ranking of factors will be provided to the oncologists. A 
summary with patient concerns (i.e., factors that are important to them) and question prompt list 
will be provided to patients.
Table 1 outlines the attributes that are included in the conjoint analysis. Attributes are organized 
by Meta-Attributes (global descriptors of how attributes are organized). The software presents 
one attribute in each of the 4 meta-attributes for each hypothetical scenario (see figure 1 for 
layout of how met-attributes are presented; see table 1 for attributes in each meta-attribute).

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Table 1: List of Meta-Attributes and Attributes included in the conjoint analysis.
Meta-Attribute
Attribute
Recurrence Risk
Survival
Benefit of Therapy
Worry/distress
Fatigue
Falls/Balance
Cognition
Side Effects of Therapy
Risk of treatment Toxicity
Risk of hospitalization
Hardship
Burden on support system
Relatively unchanged
Quality of life
Significantly worse than it is right now
Figure 1 below is a representation of how the conjoint scenarios are displayed. This is an 
iterative process, whereby participants select one hypothetical scenario from the first set of 
options. They subsequently are presented with a second set of options and are asked to again 
select a preferred hypothetical scenario. Figure 1 is an image of how the scenarios appear to 
participants when using the online tool.
Figure 1:

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When participants have completed the exercise, the tool provides output ranking of the meta- 
attributes and three attributes (benefit of therapy, side effects of therapy, hardship). Figure 2 is an 
example image of how the output of patient preferences can appear for the meta-attribute and 
side effects of therapy.

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Figure 2: Conjoint analysis output example of meta-attribute and attribute ranking.
As described below in study procedures, results of the conjoint analysis as well as geriatric 
assessment results are provided to participants. For oncologists, the results provided include the 
conjoint analysis output, geriatric assessment results, and CARG-BC score.
10. STUDY PROCEDURES
10.1 Methods and Procedures:
We will screen and consent eligible patients of treating physicians at University of Rochester 
Comprehensive Breast Cancer Center at Pluta Cancer Center.
Consented study subjects will have the option of giving permission for use of their email address 
in order to send a link to their virtual visit (if subject is not completing the tool in person) or to 
receive the output from the tool via email.
Participants will complete GA measures (Table 1) and the DPT during a single 30-60 minute 
study visit either in-person or via virtual visit. In lieu of a post-study interview, our team will 
utilize the Talk Aloud method with participants while they complete the study assessments and 
ask the subject follow-up questions after completion of study assessments and the DPT. The 
Talk Aloud method is designed to identify points of patterns of cognitive thinking, decision 
making, and problems related to function and language that occur while the participant is 
engaging with the DPT. Participants will have the option of completing the study during an in- 
person or virtual visit – this approach is being taken due to COVID precautions to enhance 
social distancing where able. Slight variations in procedures will be implemented to 
accommodate an in-person study visit or a virtual study visit. Both scenarios will include the 
same procedures of completing the GA and the DPT using the Talk Aloud method.
Results that are generated from the Discussion Prioritization Tool will be emailed to the study 
subject as well as their oncologist. Obtaining permission to send results via email is included 
during the in-person and verbal consent process.
As for study subjects who complete the DPT virtually, their results will be emailed and screen 
shared with them via Zoom in order to help them respond to the post study follow-up questions.

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10.1.2 In-Person visit:
The study coordinator will familiarize eligible patients to the study by using the following script 
when approaching for consent.
Coordinator Recruitment Script: The goal of this study is to design a tool that helps patients 
and oncologists have more personalized discussions about the treatment options for breast 
cancer. Our hope is that this tool will help make you and your oncologist aware of factors that 
are important to you when discussing the different treatment options. This tool is not intended to 
make any decisions for you or to replace discussions that you have with your oncologist 
regarding your treatment. The online tool will ask questions about your overall health and also 
will present hypothetical situations about different treatment options. The different treatment 
options presented are not specific for you or your breast cancer, and are only meant to better 
understand how you consider the different characteristics between the options.
Once informed consent is obtained in person, patients will meet with a study coordinator either 
during the same visit or at another time and place based on the patient’s preference. When the 
coordinator meets with the study participant, they will be provided with a tablet to complete the 
baseline GA measures (table 1).
The following measures are administered to the patient by the study coordinator.
1.
Blessed cognitive test
2.
Nutritional assessment
The following GA measures are self-reported by the patient:
1.
Demographics
2.
IADL
3.
Falls history
4.
OARS physical health
5.
Comorbidity
6.
Polypharmacy
7.
GDS
8.
GAD-7
9.
OARS social functioning
Measures administered by the study coordinator will be completed first, then followed by the 
patient reported measures which will be completed as a component of the tool.
After completing the baseline GA measures, participants will then complete the DPT on the 
tablet provided by the study staff. Patients will be presented with several scenarios at once 
(similar to figure 1 above) and asked to select one that is consistent with their preferences. This 
process will repeat until all attributes are evaluated in the tool. While the subject is completing 
the DPT, they will be audio recorded in order to collect data for the Talk Aloud method.
After completing the GA and DPT, the summary of the results will be sent to the study email at 
GeriOncConjointTool@URMC.Rochester.edu. Once the results are emailed, the study 
coordinator will then show the participant their results on the IPad and will evaluate the patient’s 
impression while they look over their results. We will ask participants to continue with the talk 
aloud method as they are reviewing the results provided by the conjoint analysis.

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The summary of the results that contain a ranking of factors will be provided to the patient’s 
oncologist and the participant will also be provided with their results either in the form of an 
email sent to their personal email address or in the form of a hard copy print out.
Once results have been provided to the patient, the study patient will then complete a 
quantitative measure (SUS) evaluating the usability of the tool (Table 2).
The SUS will be administered verbally and the coordinator will have the questions visually 
available on the IPad for the patient as we go over the questions with them. The study 
coordinator will record the patient’s responses on a hard copy of the SUS form.
Lastly, we will ask additional questions to assess the usability of the tool at the end of the study.
1.
Do you have any feedback about the tool?
2.
What is your impression of the results in terms of format and understanding?
3.
Do you feel that the results accurately reflect your preferences?
10.1.3 Virtual Visit:
The study coordinator will familiarize eligible patients to the study by using the following script 
when approaching for consent.
Coordinator Recruitment Script: The goal of this study is to design a tool that helps patients 
and oncologists have more personalized discussions about the treatment options for breast 
cancer. Our hope is that this tool will help make you and your oncologist aware of factors that 
are important to you when discussing the different treatment options. This tool is not intended to 
make any decisions for you or to replace discussions that you have with your oncologist 
regarding your treatment. The online tool will ask questions about your overall health and also 
will present hypothetical situations about different treatment options. The different treatment 
options presented are not specific for you or your breast cancer, and are only meant to better 
understand how you consider the different characteristics between the options.
Once informed consent is obtained verbally, patients will provide the study coordinator with their 
email address so that the study team will have the ability to email and provide a link to the GA 
measures as well as a link enter a Zoom meeting to complete the study procedures. The study 
coordinator will organize a day and time that works best for the subject to complete the tool.
The following measures are administered to the patient by the study coordinator.
1.
Blessed cognitive test
2.
Nutritional assessment
The following GA measures are self-reported by the patient:
1.
Demographics
2.
IADL
3.
Falls history
4.
OARS physical health
5.
Comorbidity
6.
Polypharmacy

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7.
GDS
8.
GAD-7
9.
OARS social functioning
Measures administered by the study coordinator will be completed first, then followed by the 
patient reported measures which will be completed as a component of the tool.
Following the baseline GA measures, participants will then complete the DPT during a study 
visit with the coordinator that is conducted through telehealth platform (e.g. University of 
Rochester Zoom platform). The link to the DPT will be emailed to the patient so they can open 
and complete it during the study visit Zoom meeting.
When completing the DPT, patients will be presented with several scenarios at once (similar to 
figure 1 above) and asked to select one that is consistent with their preferences. This process 
will repeat until all attributes are evaluated in the tool. Participants will use the talk aloud method 
while completing the DPT. Feedback given through the Talk Aloud method will be recorded 
using the secure Zoom record feature during the study visit.
After completing the GA and DPT, the summary of the results will be sent to the study email at 
GeriOncConjointTool@URMC.Rochester.edu. Once the results are emailed, the study 
coordinator will then share the results with the participant by using the screen-share feature on 
Zoom. The study coordinator will evaluate the patient’s impression while they look over their 
results. We will ask participants to continue with the talk aloud method as they are reviewing the 
results provided by the conjoint analysis.
The summary of the results that contain a ranking of factors will be provided to the patient’s 
oncologist and the participant will also be provided with their results either in the form of an 
email sent to their personal email address or in the form of a hard copy print out.
Once results have been provided to the patient, the study patient will then complete a 
quantitative measure (SUS) evaluating the usability of the tool (Table 2).
The SUS will be administered to the patient verbally while displaying the questions by using the 
screen-share feature on Zoom while we go over the questions with them. The study coordinator 
will record the patient’s responses on a hard copy of the SUS form.
Lastly, we will ask additional questions to assess the usability of the tool at the end of the study.
4.
Do you have any feedback about the tool?
5.
What is your impression of the results in terms of format and understanding?
6.
Do you feel that the results accurately reflect your preferences?
11. AUDIO/VIDEO RECORDINGS
11.1 In Person: Audio Recordings
Audio recordings will be used during in-person study visits in order to collect Talk Aloud data 
while the study subject completes the conjoint decision-making tool. A secure, handheld 
recorder will be used to record the subject’s feedback. All audio recordings will be uploaded 
and stored by the research coordinator in a password protected file in Box.
11.2 Virtual: Video Recordings
Video recordings will be used during virtual study visits in order to collect Talk Aloud data 
while the study subject completes the conjoint decision-making tool. Video recordings will be

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made during a secure virtual visit by using the record function on Zoom to record the subject’s 
feedback. All video recordings will be uploaded and stored by the research coordinator in a 
password protected file in Box.
12. RISKS/BENEFITS TO SUBJECTS
12.1 Potential Risk.
This is a minimal risk study. However, a participant may experience psychological stress while 
participating in the study. While this is unlikely to provoke significant problems, the PI (Dr.
Magnuson) will be available for evaluation and referral to appropriate behavioral care if needed. 
Risks to privacy using telehealth and telecommunications are also potential concern. We 
recognize that while encryption of videoconferencing makes breeches of private information 
unlikely, not all risks to privacy can be completely eliminated. We will inform all participants 
using the telehealth equipment of this.
12.2 Protection Against Risks.
There is the risk of loss of confidentiality but this is minimal due to safeguards in place. All of the 
participant’s information will be kept password protected and encrypted with access restricted to 
the Principal Investigator and designated senior staff.
12.3 Potential Benefits to the Subjects.
There may be no direct benefits to participating in this study. However, the study may help to 
assist older patients when making decisions about treatment options.
12.4 Alternatives to Participation.
Taking part in this study is voluntary. Participants are free not to take part or to withdraw at any 
time, for whatever reason without consequence.
13. COSTS FOR PARTICIPATION
There will not be any cost incurred to the participants during this study. Materials to complete the 
study procedures, such as an IPad, will be provided by the study team. These will be returned to 
the study team upon completion of the procedures.
14. PAYMENT FOR PARTICIPATION
Subjects will be given a $30 gift card at the time of completion for their participation in the study 
to compensate for the time spent on study procedures.

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15. DATA / SAMPLE STORAGE FOR FUTURE USE
15.1. All hardcopy research records will be stored onsite in the URMC, in locked research files 
at the WCI. The Cancer Center is secured with electronic key cards. Offices within the Cancer 
Center are again secured by key and data is kept in locked file cabinets. Electronic research 
records are stored on the URMC’s password secured and firewall protected networks. These 
are the same methods of security used for patient medical records. All study data will be kept for 
a period of 7 years after the study and all reports and publications are complete.
15.3. All data collected for the current study will be used in post hoc analyses as appropriate. 
Data will not be used for future studies without prior consent of the patient. The patient’s 
individual research record will not be shared with their treating physician, unless they provide 
consent or the patient’s treating physician is a study physician, in which case they will have 
access to study data as a study co-investigator. Overall study results will be presented to 
participants, faculty and staff at the URMC after completion of the study. Study results will be 
presented at professional meetings and published.
15.4. The study coordinator will assign a numerical study ID to each participant once they have 
signed the consent form (chronologically based on the data they signed consent i.e., 001, 002, 
003…). All study forms and questionnaires will use this number and the participant’s first, 
middle, and last initials as identifiers, to ensure data integrity. Other identifying information will 
not exist on these forms. A complete list of study participants with study ID, name, and contact 
information will be maintained separately. This linkage information will only be accessible to the 
study coordinator, study investigators, and the individuals responsible for maintaining the 
database.
15.5. Additionally, data on the socio-demographics, clinical, and cancer and treatment 
characteristics will be collected and managed by the research teams at URMC using secure 
REDCap electronic data capture tools hosted at URMC. We will also evaluate the medical 
records for clinical characteristics and outcomes, and utilize REDCap to collect and manage this 
information.
16. DATA AND SAFETY MONITORING PLAN
Only adverse events (AEs) related to the study intervention or procedures will be reported. In 
other words, AEs related to cancer treatment will not be reported.
16.1. Adverse Event Reporting Requirements
16.1.1. Adverse events will be reported using the URCC Adverse Event form and/or as 
required by the Cancer Center Clinical Trials Office.
Adverse events will only be recorded for the time that the study subject is taking part in 
study procedures during their one time visit with the study coordinator.
16.1.2. Adverse events will be reported in accordance with the following guidelines:

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16.1.3. Adverse event reports will be submitted in one of the following ways:
(1) By email: (pdf)
(2) By mail:
(3) By fax:
16.1.4. An unexpected adverse event is defined as any adverse experience, the 
specificity or severity of which is not consistent with the risk information. This is a 
minimal risk study as detailed above.
16.1.5. A serious event refers to any event in which the outcome results in any of the 
following: death, a life-threatening adverse experience, inpatient hospitalization or 
prolongation of existing hospitalization, a persistent or significant disability, incapacity, or 
a congenital anomaly/birth defect. Important medical events that may not result in death, 
be life-threatening, or require hospitalization may be considered a serious adverse drug 
experience when, based upon appropriate medical judgment, they may jeopardize the 
participant and may require medical or surgical intervention to prevent one of the 
outcomes listed in this definition. We anticipate that any serious events will be related to 
standard of care cancer treatments and not due to the intervention. We will not collect 
adverse events related to cancer treatments.
16.1.6. Adverse events will be reported in accordance with institutional policies 
(University of Rochester, Research Subject Review Board, local IRB, URCC CCOP, 
CTO, and DSMB) as per their requirements.

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16.2. Data Safety Monitoring
16.2.1. All adverse events requiring reporting will be submitted to the current Project 
Coordinator as described in Section 11.1. Serious adverse event reports will be 
forwarded to the study chair and the Data Safety and Monitoring Committee (DSMC). 
Adverse events are entered into a protocol-specific spreadsheet.
16.2.2. Adverse event rates are monitored utilizing the spreadsheet. If a serious adverse 
event is reported frequently, the study chair will conduct a detailed review. The DSMC 
Committee Chair will be notified and will determine if further action is required.
16.2.3. The Data Safety Monitoring Committee (DSMC) will review study progress and 
cumulative reports of adverse events every year and as needed. An overall assessment 
of accrual and adverse events will enable the committee members to assess whether 
significant benefits or risks are occurring that would warrant study closure.
17. DATA ANALYSIS PLAN
Sawtooth software will be utilized for the conjoint analyses to determine prioritization of 
participant preferences [16, 17].
Usability testing is the evaluation of a program through the analysis of typical end user 
interactions, with iterative modifications [18]. The majority of usability problems can be identified 
in a small set of subjects (e.g. 8-10) [18].
Quantitative Analysis: The SUS ranges 0-100; a score >68 is above average [19]. Our goal will 
be to achieve a mean SUS score >68 amongst the 10 patients enrolled.
Qualitative Analysis: Audio-recordings capturing the “talk aloud” feedback will be transcribed 
and a Process Coding framework will be utilized to analyze the transcripts. Responses to the 
three feedback questions will also be transcribed and a Content Analysis framework will be 
utilized to analyze responses. Together, this qualitative data will be evaluated for themes to 
optimize usability of the tool for a planned subsequent RCT to evaluate the effect of the DPT on 
content of conversations between patients and their oncologists.
18.REFERENCES
1.
Jolly, T.A., et al., Adjuvant Treatment for Older Women with Invasive Breast Cancer.
Womens Health, 2016. 12(1): p. 129-146.
2.
Varghese, F. and J. Wong, Breast Cancer in the Elderly. Surg Clin North Am, 2018.
98(4): p. 819-833.
3.
Rodin, M.B. and S.G. Mohile, A Practical Approach to Geriatric Assessment in 
Oncology. Journal of Clinical Oncology, 2007. 25(14): p. 1936-1944.

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4.
Angarita, F.A., et al., Patient-reported factors influencing the treatment decision-making 
process of older women with non-metastatic breast cancer: a systematic review of 
qualitative evidence. Breast Cancer Res Treat, 2018. 171(3): p. 545-564.
5.
Hurria, A., et al., Developing a cancer-specific geriatric assessment: a feasibility study.
Cancer, 2005. 104(9): p. 1998-2005.
6.
Mohile, S.G., et al., Communication with older patients with cancer using geriatric 
assessment: a cluster-randomized clinical trial from the National Cancer Institute 
Community Oncology Research Program. JAMA oncology, 2020. 6(2): p. 196-204.
7.
Magnuson, A., et al., Development and Validation of a Risk Tool for Predicting Severe 
Toxicity in Older Adults Receiving Chemotherapy for Early-Stage Breast Cancer. J Clin 
Oncol, 2021. 39(6): p. 608-618.
8.
Magnuson, A., Zittel, J. Gilles, M., Wittink, M., Wells, M.,. The role of self-perception of 
age in decisions about adjuvant chemotherapy for older adults with cancer. in SIOG. 
2018.
9.
Meropol, N.J., et al., A web‐based communication aid for patients with cancer: the 
CONNECT study. Cancer, 2013. 119(7): p. 1437-1445.
10.
Chiew, K.S., et al., Development and evaluation of a decision aid for patients 
considering first‐line chemotherapy for metastatic breast cancer. Health expectations, 
2008. 11(1): p. 35-45.
11.
Smith, T.J., et al., A pilot trial of decision aids to give truthful prognostic and treatment 
information to chemotherapy patients with advanced cancer. The journal of supportive 
oncology, 2011. 9(2): p. 79.
12.
Sepucha, K.R., et al., Is there a role for decision aids in advanced breast cancer?
Medical Decision Making, 2009. 29(4): p. 475-482.
13.
Oostendorp, L.J., et al., Decision aids for second-line palliative chemotherapy: a 
randomised phase II multicentre trial. BMC medical informatics and decision making, 
2017. 17(1): p. 1-14.
14.
Zdenkowski, N., et al., Single-arm longitudinal study to evaluate a decision aid for 
women offered neoadjuvant systemic therapy for operable breast cancer. Journal of the 
National Comprehensive Cancer Network, 2018. 16(4): p. 378-385.
15.
Hawley, S.T., et al., Improving breast cancer surgical treatment decision making: the 
iCanDecide randomized clinical trial. Journal of Clinical Oncology, 2018. 36(7): p. 659.
16.
Wittink, M.N., et al., Towards Patient-Centered Care for Depression: Conjoint Methods 
to Tailor Treatment Based on Preferences. Patient, 2010. 3(3): p. 145-157.
17.
Fraenkel, L., S. Bodardus, and D.R. Wittnik, Understanding patient preferences for the 
treatment of lupus nephritis with adaptive conjoint analysis. Med Care, 2001. 39(11): p. 
1203-16.
18.
Kushniruk, A., Evaluation in the design of health information systems: application of 
approaches emerging from usability engineering. Comput Biol Med, 2002. 32(3): p. 141- 
9.
19.
Schnall, R., H. Cho, and J. Liu, Health Information Technology Usability Evaluation 
Scale (Health-ITUES) for Usability Assessment of Mobile Health Technology: Validation 
Study. JMIR Mhealth Uhealth, 2018. 6(1): p. e4.

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19.Table 1. Measures.
Discussion Prioritization Tool – Measures Included
1.a Patient Demographics
Demographics
•
Gender
•
Age
•
Health status
•
Race/Ethnicity
•
Education
•
Who do you live with
•
Describe living situation
1.b Patient Reported GA Measures
Functional 
Status
•
IADL
o
Instrumental Activities of Daily Living (IADL): Self-reported 
functional status will be assessed using the IADL subscale of the 
Multidimensional Functional Assessment
•
Falls History
o
A self-reported history of falls in the past three months will be 
recorded.
•
OARS Physical Health
o
A survey that asks about the people involved in the patient’s 
medical and social support.
Comorbidity
•
OARS Comorbidity
o
A self-report of any existing comorbidities and their effect on the 
patient’s daily life.
•
Polypharmacy
o
We will record all prescription and non-prescription medications, 
dosage and frequencies from the medical records. Polypharmacy is 
defined as the use of 5 or more medications.
Psychological
•
GDS
o
A screening tool for depression
•
GAD-7
o
A screening tool for anxiety
Social 
Functioning
•
OARS Medical Social Support
o
A survey that asks about the people involved in the patient’s 
medical and social support.
1.c Coordinator Administered Assessments
Cognition
•
Mini-Cog (in person)
o
An assessment consisting of memory questions and a drawing to 
help determine the current cognitive status of the patient.
•
Blessed (virtual)
o
A 6 question assessment to help determine the current cognitive 
status of the patient.
Nutrition
•
Nutritional Status
o
Nutritional status of the patient will be determined by their current 
height, current weight, and weight 6mo. ago.

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19.1 Table 2. System Usability Form (SUS).