A Patient-centered Communication Tool (UR-GOAL) for Older Patients With Acute Myeloid Leukemia, Their Caregivers, and Their Oncologists
Phase: NA
Conditions: Acute Myeloid Leukemia
Sponsor: University of Rochester

UNIVERSITY OF ROCHESTER MEDICAL CENTER 
 
WILMOT CANCER INSTITUTE 
 
A patient-centered communication tool (UR-GOAL) for older patients with acute myeloid 
leukemia, their caregivers, and their oncologists  
 
December 17, 2021 
 
 
Study Principal Investigator: 
Kah Poh (Melissa) Loh, MBBCh BAO 
Division of Hematology/Oncology 
University of Rochester Medical Center  
 
 
James P Wilmot Cancer Center  
 
 
601 Elmwood Ave, Box 704  
 
 
Rochester, NY 14642 
 
 
Email: Kahpoh_loh@URMC.Rochester.edu 
 
Study Co-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 
 
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 
 
 
 
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 
 
 
 
Jessica Bauer 
 
 
James P Wilmot Cancer Center  
 
 
601 Elmwood Ave, Box 704  
 
 
Rochester, NY 14642 
 
 
Phone: (585) 276-6562/ Fax: (585) 273-1042 
 
 
Email: Jessica_Bauer@URMC.Rochester.edu 

 
Biostatisticians: 
 
Eva Culakova, PhD 
Department of Surgery 
University of Rochester Medical Center  
 
 
James P Wilmot Cancer Center  
 
 
601 Elmwood Ave, Box 704  
 
 
Rochester, NY 14642 
 
 
Email: Eva_Culakova@URMC.rochester.edu 
 
 

 
Contents 
1.0 Background ............................................................................................................................. 4 
2.0 Aim and Hypothesis ................................................................................................................ 6 
3.0. Study Design and Population ................................................................................................ 7 
4.0 Recruitment and Consent..................................................................................................... 10 
5.0 Registration ........................................................................................................................... 14 
6.0. UR-GOAL Intervention Tool.............................................................................................. 16 
7.0. Treatment Protocol .............................................................................................................. 19 
8.0 Data Handling and Statistical Considerations ................................................................... 25 
9.0. Data Management ................................................................................................................ 27 
10.0 Risks/Benefits ...................................................................................................................... 32 
11.0 Data Safety and Monitoring ............................................................................................... 33 
12.0 References ............................................................................................................................ 35 
 
 
 

1.0 Background 
 
1.1. Acute myeloid leukemia is a disease of the aging 
 
Nearly 60% of acute myeloid leukemia (AML) diagnoses are in adults aged ≥ 60 years.1 For fit 
older patients with AML (i.e., without significant comorbidities or disabilities), the standard 
first-line treatment consists of intensive inpatient chemotherapy. Intensive chemotherapy 
provides the best chance for durable remission, but it is associated with a high treatment-related 
mortality (60-day mortality: 15-20%).2,3 Intensive therapy is utilized in <1% of older patients 
with AML seen in the community oncology setting, due to various reasons such as distance to 
tertiary centers and need for hospitalizations.6 In the last decade, low-intensity outpatient 
treatments (e.g., azacitidine, decitabine, venetoclax, ivosidenib, enasidenib) with reduced 
treatment-related mortality rates have become available.4-9 These treatments have permitted more 
older patients with AML, including those with comorbidities and disabilities, to receive 
leukemia-directed therapy.10 Despite these treatment options, 40-50% of diagnosed individuals 
do not undergo leukemia-directed therapies.11 
 
1.2. There is substantial heterogeneity in the health status of older patients, making treatment 
selection challenging 
 
In a prospective study of 74 older patients with AML receiving intensive induction therapy, up to 
69% had physical impairments, 42% had significant comorbidities, 29% had impaired cognition, 
and 40% were depressed.12 The effect these fitness-related factors have on disease progression, 
treatment tolerance, and response is not well understood, in part due to an underrepresentation of 
older patients in clinical trials. This is especially true regarding older patients with comorbidities 
and poor performance status.1 It is often challenging for oncologists to identify older patients 
with AML who are fit enough for intensive treatment, or fit enough to receive treatment at all. 
Practice patterns therefore vary. 
 
1.3. Older patients with AML often do not feel informed of their disease and treatment options.  
 
We have previously conducted a qualitative study of 15 older patients with AML and 15 
oncologists to better understand their experience during the initial AML diagnosis and treatment 
decision-making.13 Many older patients did not feel that they were adequately informed of their 
treatment options (Patient quote: “The only option I had was going through this. It’s do or 
die.”)14 Patients and oncologists perceived fitness-related factors such as physical function, 
comorbidities, psychological health, and cognition as important for initial treatment decision-
making.13 Therefore, incorporating patient preferences and fitness-related factors into AML 
treatment decisions may facilitate communication and shared decision-making, leading to 
increased patient satisfaction.15-18 
 
1.4. Best worst scaling to elicit patient preferences 
 
Best-worst scaling (BWS) is a technique that assesses the relative importance that patients place 
on different aspects or attributes of care. BWS consists of choice tasks, with a minimum of three 
attributes (e.g., daily activities, quality of life, location of treatment, survival), in which a patient 

is asked to indicate the best and worst options. The overall aim is to obtain a ranking of the 
attributes. This methodology is a reliable and valid technique that can help patients to consider 
the risks and benefits of treatment as well as to clarify and reveal their values to their 
oncologists, ultimately improving shared decision making.19,20 
 
1.5. Information preferences vary among patients, and accurate prognostic awareness is an 
important component of shared decision-making. 
 
In a multicenter prospective cohort study, we have found that older patients were less likely to 
prefer treatment success rates presented in percentages. We also found that over half of patients 
with hematologic malignancies overestimate their prognosis compared to their oncologists.21 
Among older adults with AML, >90% thought that they could be cured, compared to 30% of 
oncologists.22 Patients with poor prognostic awareness are more likely to opt for aggressive 
chemotherapy23,24 and less likely to utilize palliative and hospice services at the end-of-life.25,26 
Older patients have lower awareness of their prognosis than younger adults.27-29 Therefore, 
prognostic discussion with oncologists can facilitate accurate prognostic awareness among older 
patients with AML (who are often incurable). We have shown that among older adults with 
cancer referred to geriatric oncology clinics at our center, almost 60% stated that a frank 
conversation about their prognosis would be helpful to them.  
 
1.5. Caregivers play an essential role in decision-making 
 
Caregivers (generally family members or friends) play an integral role in the care of older 
adults,30, and many assist patients with treatment decision-making and participate in prognostic 
discussions and.31,32 Effective communication between older patients and caregivers is associated 
with patient and caregiver satisfaction with care, treatment adherence, and improved health 
outcomes.33,34 In addition, clear communication between patients and caregivers can ensure that 
the needs of both are met.35 Studies have shown that disagreements between patients and 
caregivers in the reporting of symptoms, description of treatment side effects and benefits, and 
estimates of prognosis are common.36-39 Disagreement between patient and caregiver is 
associated with negative outcomes such as increased patient depression36 as well increased 
caregiver anxiety, distress, depression, and burden (i.e., the latter refers to stress experienced by 
caregivers from providing care for patients).39-42 
 
1.6. Overall goal 
 
Older adults with AML may benefit from help and support in understanding their treatment 
options. This pilot study seeks to develop and adapt a patient-centered communication tool 
(University of Rochester-Geriatric Oncology Assessment for acute myeloid Leukemia or UR-
GOAL) and then evaluate the usability and feasibility of this tool. The UR-GOAL tool will 
incorporate BWS to elicit patient preferences as well as assessments of fitness and prognostic 
awareness. We hypothesize that this tool will be usable and feasible in this population. Once we 
have shown usability and feasibility, we will assess whether the UR-GOAL tool improves shared 
decision-making, communication, and prognostic awareness. Given that caregivers are closely 
involved in the care of older adults with cancer, we also seek to obtain feedback from caregivers. 
In addition, we will also obtain feedback from oncologists. 

2.0 Aim and Hypothesis 
 
2.1 Primary Aim 
 
Develop and adapt a communication tool (UR-GOAL) for 10 older patients with AML.  
 
2.2 Secondary Aim 
 
Evaluate the usability and feasibility of the UR-GOAL communication tool among 15 older 
patients with AML, their caregivers, and oncologists.  
 
2.3 Exploratory Aim 
 
To assess change in priorities longitudinally among 15 older patients with AML. 
 
2.4 Overall Hypothesis 
 
The UR-GOAL will be usable and feasible. 
 
2.5 Usability and feasibility metrics 
  
The usability and feasibility of the UR-GOAL communication tool will be evaluated based on 
the following:  
 
a) Recruitment rates (percentage of patients who are approached and agree to enroll) 
b) System Usability Scale (score on 10-item scale, ranging 0-100; higher score corresponds 
to greater usability) 
c) Semi-structured interviews (audio-recorded/transcribed interviews exploring perceived 
usefulness, barriers, and facilitators) 
 
 
 

3.0. Study Design and Population 
 
3.1. Study Settings  
Wilmot Cancer Institute (WCI), University of Rochester Medical Center (URMC) and its 
affiliated centers 
 
3.2. Study Type 
Aim 1: Qualitative study 
 
Aim 2 and Exploratory Aim: Single-arm pilot study 
 
3.3. Study Population 
Aim 1: We will gather feedback from 20 older patients with AML. We anticipate thematic 
saturation will be reached with this number of participants based on past similar research.43,44 We 
will consent up to 30 patients to account for screen fail or withdrawal.  
 
Aim 2 and Exploratory Aim: We will recruit 15 older patients with AML (and their caregivers if 
available) to evaluate the usability and feasibility. We will consent up to 20 patients to account 
for screen fail or withdrawal. We will also interview their oncologists. 
 
3.4. Inclusion and Exclusion Criteria for Patients 
 
Inclusion criteria: 
Aim 1 
 Age ≥60 years (conventional definition of older age in AML)  
 Established AML diagnosis (within 1 year) 
 Able to provide informed consent 
 English-speaking 
 
Aim 2 
 Age ≥60 years (conventional definition of older age in AML)  
 Newly diagnosed AML  
 Able to provide informed consent 
 English-speaking 
 
Exclusion criteria 
 None 
 
3.5. Inclusion and Exclusion Criteria for Caregivers (Aim 2 only) 
 
Inclusion criteria: 
 Selected by the patient when asked if there is a “family member, partner, friend or 
caregiver [age 21 or older] with whom you discuss or who can be helpful in health-
related matters;” patients who cannot identify such a person (“caregiver”) can be eligible 
for the study. A caregiver need not be someone who lives with the patient or provides 

direct hands-on care. A caregiver can be any person who provides support (in any way) to 
the patient. 
 Able to provide informed consent 
 English-speaking 
 
3.6. Inclusion and Exclusion Criteria for Oncologists (Aim 2 only) 
 
Inclusion criteria: 
 A practicing oncologist 
 At least one of their patients are recruited to the study 
 English-speaking 
 
Exclusion criteria 
 None 
 
3.7. Number of Subjects 
 
Aim 1: We plan to enroll 20 patients in 6 months. Two previous qualitative studies conducted in 
this population showed a recruitment of 75%-100%. Annually, from 2012-2018, WCI saw 60-70 
patients aged ≥60 years with AML.  
 
Aim 2 and Exploratory Aim: We plan to enroll 15 patients (and their caregivers if available) in 
12 months. We will be recruiting patients from WCI and WCI-affiliated sites. The WCI inpatient 
malignant hematology service will also be screened. We plan recruit at least 3 oncologists and up 
to 15 oncologists (assuming 1 patient per oncologist is enrolled). 
 
3.8. Gender of Subjects 
 
The gender ratio of enrolled patients will be similar to that of the gender ratio of AML in older 
adults (approximately 1.2:1 male to female ratio).45 
 
3.9. Age of Subjects 
 
We will recruit patients with AML aged 60 and above (from date of consent, confirmed on 
electronic medical record).  
 
3.10. Racial and Ethnic Origin 
 
The Caucasian to Non-Caucasian ratio of individuals with AML is 5:1. In Rochester, New York, 
Whites, African Americans, and Hispanics make up approximately 65%, 30%, and 5% of the 
population (Race and Ethnicity in Rochester, NY statistical atlas). As enrollment is limited to 
English-speaking patients, we predict a higher percentage of whites. The study does not restrict 
enrollment based on race or ethnicity.  
 
3.11. Vulnerable Subjects 
 

Recruitment will exclude vulnerable populations such as fetuses, neonates, children, pregnant 
woman, prisoners, and institutionalized individuals. We will also exclude adults who are deemed 
to not have decisional capacity and those who lost their consent capacity during the study period, 
as per their treating oncologist.  
 
 
 
 

4.0 Recruitment and Consent 
 
Subjects will be enrolled at the URMC WCI. 
 
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. 
 
4.1 Identification of Study Subjects, Recruitment, and Consent Procedures 
 
Patients will be identified by treating physicians at WCI and WCI-affiliated sites, nurses of these 
physicians, and the study coordinator. The study coordinator will work closely with physicians 
and nurses to identify patients who have an established AML diagnosis (Aim 1) or have been 
newly diagnosed with AML (Aim 2). Given permission from the oncologist, the study team will 
screen clinic schedules of these oncology providers. The study coordinator will contact the 
physician (or designee) and inform them of patient eligibility and ask permission to approach the 
patient.  The principal investigator will address any eligibility questions that may arise.   
 
For in-person consent with patients, below are the possible scenarios for obtaining 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 a 
potential candidate for 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. 
 
For verbal consent with patients, below are the possible scenarios for obtaining 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. An information sheet summarizing the study and patient' s 
involvement will be mailed /emailed to the patient for their records. 
 
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. An 
information sheet summarizing the study and patient's involvement will 
be mailed/emailed to the patient for their records. 
 
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. An information sheet summarizing the 
study and patient's involvement will be mailed/emailed to the patient for 
their records. 
 
For caregivers, we will obtain verbal consent. They will be provided with an information sheet. 
The patient will identify a caregiver and makes the initial contact. After confirming with the 

patient that a caregiver is willing to speak with the study coordinator about the study, the study 
staff then call the caregiver 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 caregiver 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. An information sheet summarizing the study and caregiver’s 
involvement will be provided/mailed/emailed to the caregiver for their records. 
 
For oncologists, we will obtain verbal consent and they will be provided with an information 
sheet. 
 
4.1.1. 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. Verbal consent 
documents with caregivers and oncologists will also be maintained in separate records with 
copies provided to caregivers and oncologists. 
 
Waiver of documentation of consent:  
We are requesting for waiver of documentation of consent as the research involves no more 
than minimal risk to the subjects and involves procedures for which written consent is 
normally not required outside the research context. The only record linking the subject and 
the research would be the consent document and the principal risk would be potential harm 
resulting from a breach of confidentiality. 
 
Alteration of HIPAA Authorization: 
We are requesting an alteration 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. 
 
We are requesting an alteration of HIPAA authorization for enrollment of caregivers and 
oncologists. We will provide an information sheet to these participants who provided 
verbal consent. Verbal consent will allow for reduction of in-person visits, thus maximizing 
the safety of both patients and study staff.  We are not collecting protected health 
information (PHI) from Oncologists or Caregivers. 

  
4.1.2. Human Subject Protection 
 
The University of Rochester Research Subject Review Board Investigator Guidance policy 
will be used to ensure that ethical standards for human subjects are upheld.  
 
4.1.3. 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.  
 
 
4.1.4. Duration 
 
Aim 1: The qualitative section of this study involves interviewing consented patients for 
30-60 minutes. They will watch an education video and use the UR-GOAL tool and 
feedback can be provided during the interview. Study participants will be interviewed by 
the study team either in-person (in a private space) or via phone/zoom. Interviews will be 
audio-recorded, uploaded to Box, and subsequently deleted from the audio-recorder.   
 
Aim 2 and Exploratory Aim: After completing baseline measures, watching an education 
video, and completing the UR-GOAL tool, study participants will participate in a semi-
structured interview with the study team for 30-60 minutes either in-person or via 
phone/zoom. The post-intervention measures will be completed within 1-2 weeks of the 
patient’s encounter with the primary oncologist either in-person or via phone/zoom. 
Caregivers will complete baseline measures and watch an education video. They will 
participate in a separate semi-structured interview with the study team for 30-60 minutes 
either in-person or via phone/zoom. The post-intervention measures will be completed 
within 1-2 weeks of the patient’s encounter with the primary oncologist either in-person 
or via phone/zoom. After the study is completed, participant data will be maintained for 7 
years at URMC and will be kept in a password-protected database.  
 
Oncologist will also complete the post-intervention assessments (surveys) within 1-2 
weeks of the patients encounter. Oncologists will participate in a semi-structured 
interview with the study team for 30-60 minutes either in-person or via phone/zoom., 
after at least one of their patients have completed the tool. The semi-structured interviews 
with oncologists will be conducted at any time during the study. After the study is 
completed, participant data will be maintained for 7 years at URMC and will be kept in a 
password-protected database.  
 

5.0 Registration 
 
If patients, caregivers, and oncologists meet eligibility criteria and have provided informed 
consent, the study personnel will enter the following information into the OnCore Database: 
 
5.1. Registration Information for Patients 
5.1.1 Site 
5.1.2 Most recent IRB approval date 
5.1.3 Name of person registering study participant 
5.1.4 Eligibility verification  
5.1.5 Verification that consent form has been signed and who signed by (patient and/or 
health care proxy) and date signed 
5.1.6 Treatment facility (WCI vs. Other) 
5.1.7 Participant’s identification 
 
5.1.7.a 
First and last names  
 
5.1.7.b Birth date (MM/DD/YEAR) 
 
5.1.7.c 
Gender 
 
5.1.7.d Race  
 
5.1.7.e 
Five-digit zip code 
 
5.1.7.f 
Medical Record Number 
 
5.1.7.g   Ethnicity 
 
5.1.7.h Patient’s preferred and alternate phone numbers (and email address if 
patients consent to be contacted via email) 
 
5.1.7.i 
Date of baseline visit 
 
5.2. Registration Information for Caregivers 
 
5.2.1 Participant’s identification 
 
5.2.1.a 
First and last names  
 
5.2.1.b Birth date (MM/DD/YEAR) 
 
5.2.1.c 
Gender 
 
5.2.1.d Race  
 
5.2.1.e 
Five-digit zip code 
 
5.2.1.f   Ethnicity 
 
5.2.1.g Caregiver’s preferred and alternate phone numbers (and email address if 
patients consent to be contacted via email) 
 
5.3. Registration Information for Oncologists 
 
5.3.1 Participant’s identification 
 
 
5.3.1.a 
First and last names  
 
 
5.3.1.b    Birth date (MM/DD/YEAR) 
 
 
5.3.1.c    Gender 
 
 
5.3.1.d    Race 
 
 
5.3.1.e    Five-digit zip code 
 
 
5.3.1.f    Ethnicity 

5.4. Initial Assessment 
 
In Aim 1, study patients will complete demographics and a 30-60 minutes interview in 
which they will watch an education video and complete the UR-GOAL tool and provide 
feedback. Patients in Aim 2 will complete baseline assessments with the study 
coordinator, watch an education video, and complete the UR-GOAL tool. Caregivers in 
Aim 2 will complete baseline assessments with the study coordinator and watch an 
education video. 
 
 
 

6.0. UR-GOAL Intervention Tool 
 
The proposed tool consists of three components: BWS to elicit patient preferences, fitness 
assessment, and prognostic awareness assessment (Figure 1). In addition, an education video will 
also be included. The education tool provides information on the diagnosis, epidemiology, 
symptoms, risk factors, and prognosis of AML, as well as goals of AML treatment and treatment 
approaches. 
 
Figure 1: Components of the UR-GOAL communication tool 
 
 
 
6.1.Best-worst scaling 
 
BWS consists of 10 choice tasks, with 4 attributes per task. Patients will be presented with 4 
attributes at a time, in which a patient is asked to rank the most and least important attribute 
when choosing a treatment (Figure 2). This process then repeats 10 times until all attributes are 
evaluated. Based on our qualitative study of older patients with AML and oncologists,43 we 
selected eight attributes that are important in treatment decision making. At completion, a 
summary containing the ranking of the attributes will be provided to the patient and oncologist. 
The patient summary also includes a question prompt list (based on their top four attributes).  
 
Figure 2: Best-Worst Scaling showing 4 options 
 

 
 
 
6.2. Fitness Assessment:  
 
We will include assessments (e.g., physical function, nutritional status; Table 1) that evaluate 
fitness and are important in decision-making for both patient and oncologist.13 At completion, a 
summary containing the patient’s fitness level will be provided to the oncologists. 
 
Table 1: Questionnaires that will be included in the tool 
Fitness domain 
Assessments 
Physical function 
Activities of daily living, instrumental 
activities of daily living, number of falls, 
Short Physical Performance Battery 
Nutritional status 
Weight loss in the prior 6 months 
 
Comorbidity 
Hearing and eyesight 
Psychological health 
Geriatric Depression scale 
Social support 
Patient’s social support 
Living situation 
Medications 
Number of medications 
Cognition 
Mini-Cog 
 
 
6.3. Prognostic Awareness Assessment:  
 

We will incorporate assessment of prognostic awareness (i.e., chance of cure and survival 
estimates, their information preference (i.e., do they prefer treatment success rate presented in 
percentages, words, fractions, or they wanted to hear about a previous patient that the physician 
treated), and whether conversation about prognosis would be helpful to them. At completion, a 
summary contacting this information will be provided to the oncologists. 
 
As described above, the generated summaries are tailored and intended to improve 
communication between the patient and oncologist during the decision-making process. 
 
 
6.4. Education Video 
 
As the overall goal of the study is to improve patient-physician communication, we created an 
education video for patients. The video contains basic information about the diagnosis, 
epidemiology, symptoms, risk factors, and prognosis of AML, as well as goals of AML 
treatment and treatment approaches. We created this video because of two main reasons: 1) Our 
preliminary data suggest that many older patients may not understand the AML diagnosis and 
treatment approaches given the acuity, 2) The video provides an overview of AML which will 
help patients complete the tool subsequently (e.g., the tool will ask patients if they are willing 
trade quality of life for higher remission, and the education video provides information on what 
remission means in the context of the different treatments). The video is not part of standard of 
care. We developed this video based on feedback from the leukemia and bone marrow transplant 
and geriatric oncology groups at WCI. 
The video is available for view using this link: 
https://rochester.box.com/s/m25aidirevgzaeumgvnpxmd3mck1lxhy  
 

7.0. Treatment Protocol 
 
7.1. Study Outline 
 
We will screen and consent eligible patients of treating physicians at WCI and WCI-affiliated 
centers.  
 
For Aim 1, the study team will conduct an in-person or zoom/phone interview for 30-60 minutes. 
First, we will explain the rationale of the study. Second, patients will use the communication 
tool. Third, we will conduct an interview to elicit feedback about the communication tool. This 
feedback will be used to adapt the tool for Aim 2.  
 
For Aim 2 and Exploratory Aim (Figure 3), the study subject will complete baseline measures 
and utilize the UR-GOAL communication tool either in-person or via zoom/phone. Following 
this, patients will complete the usability testing form. The patient (and caregiver if available) will 
have a visit with their primary oncologist and the clinical encounter will be audio-recorded. The 
study staff will provide an audio recorder to the physician for in-person or phone visits, and the 
zoom recording feature will be used for zoom visits. All parties present for recorded visits, 
including: enrolled patients, any accompanying caregivers, family or friends, the oncologist, and 
any other physicians or health care providers not participating in the study will be fully aware 
that the conversation is being audio-recorded before any recording begins, in addition to the prior 
written consent of enrolled patients. Patients, caregivers and oncology physicians may receive 
copies of these recordings at their request. 
 
The post-intervention measures, including the qualitative interviews, for patients and caregivers 
will be completed within 1-2 weeks of the patient’s encounter with the primary oncologist either 
in-person or via phone/zoom. The interviews will be conducted separately. Patients will 
participate in a semi-structured interview for 30-60 minutes during which feedback will be 
elicited. Enrolled caregivers will also participate in a separate semi-structured interview for 30-
60 minutes during which feedback will be elicited. Oncologist will also complete the post-
intervention assessments (surveys) within 1-2 weeks of the patients encounter. The semi-
structured interviews with oncologists will be conducted at any time during the study, after at 
least one of their patients have completed the study procedures. 
 
To assess priorities longitudinally, patients will complete the BWS on the tool at 1, 2, 3, and 6 
months. 
 

Figure 3: Study Procedures (Aim 2 and Exploratory Aim) 
 
 
7.2. Assessments of the Participants 
 
Demographic, clinical, and cancer characteristics will be collected.  
 
7.2.1. Demographics – Patient, Caregiver, and Oncologist 
 
Patient and caregiver’s age, date of birth, race, ethnicity, gender, highest level of education 
achieved, employment status, and marital status. This will only be collected at baseline. 
 
Oncologist’s name, date of birth, race, five-digit zip code, ethnicity, and gender will be collected. 
 
7.2.2. Clinical and Cancer Characteristics  - Patient 
 
ECOG performance status, diagnosis, prior hematologic malignancies, cytogenetic risk group 
and treatment regimen will be abstracted from the medical records. This information will only be 
collected at baseline. 
 
7.2.3. Measures  
 
Measures will be collected via the UR-GOAL tool, done in person, or mailed to the participants.  
 
 
7.2.2.1. Physical Function and Functional Status (Baseline Only - Patient) 
 
Short Physical Performance Battery (SPPB; baseline only): The SPPB is an objective 
physical assessment evaluating lower extremity physical function. It is comprised of a 
four-meter walk, repeated chair stands and a balance test. Impairment on SPPB testing 
has been shown to be predictive of short-term mortality and nursing home admission in 
community-dwelling older adults.46 If in-person SPPB cannot be performed, we will 

perform the virtual SPPB via the phone/zoom, which evaluates the participants’ 
perceived ability to perform above tests (walking, repeated chair stands, and balance).47  
 
Activities of daily living (ADL): ADLs are measures of self-care. ADL independence will 
be assessed using the Katz Index of Independence in Activities of Daily Living, 
commonly referred to as the Katz ADL. The Katz ADL is the most appropriate 
instrument to assess functional status as a measurement of the client’s ability to perform 
activities of daily living independently. Clinicians typically use the tool to detect 
problems in performing activities of daily living and to plan care accordingly. The Index 
ranks adequacy of performance in the six functions of bathing, dressing, toileting, 
transferring, continence, and feeding. Clients are scored yes/no for independence in each 
of the six functions. A score of 6 indicates full function, 4 indicates moderate 
impairment, and 2 or less indicates severe functional impairment.48 
 
Instrumental Activities of Daily Living (IADL): Self-reported functional status will be 
assessed using the IADL subscale of the Multidimensional Functional Assessment 
Questionnaire: Older American Resources and Services (OARS). The IADL subscale 
consists of seven questions rated on a three-point Likert scale. It measures the degree to 
which an activity can be performed independently.49 
 
Fall History: A self-reported history of falls in the past three months will be recorded. A 
history of a recent fall has been demonstrated to be independently predictive of increased 
risk for chemotherapy toxicity in older cancer patients.50 
 
 
7.2.2.2. Nutritional Status (Baseline Only - Patient) 
 
Screenings for nutritional deficit will be performed with body mass index (BMI) 
evaluation and self-reported weight loss.  
 
7.2.2.3. Comorbidity (Baseline Only - Patient and Caregiver) 
 
OARS Comorbidity: Patients and caregivers report coexisting illnesses and indicate the 
degree to which these comorbidities interfere with their daily activities.51 
  
Patients and caregivers also self-report their perceived levels of eyesight and hearing.  
 
7.2.2.4. Psychological Health (Baseline and Post-Intervention – Patient and Caregiver) 
 
General Anxiety Disorder-7: A 7-item screening tool for anxiety.52  
 
Geriatric Depression Scale-15: A 15-item valid and reliable screening tool for depression 
in older adults.53 This will be used for patients. 
 
Patient Health Questionnaire-2 (PHQ-2): A 2-item valid and reliable screening tool 
depression in the general population.54 This will be used for caregivers. 
 

7.2.2.5. Social Support (Baseline Only - Patient) 
 
OARS Medical Social Support: A 13-item questionnaire for patients regarding persons 
involved in medical social support as well as perception of overall support.51,55  
 
Patients also self-report their living situation and their main social support.  
 
7.2.2.6. Medications (Baseline Only - Patient) 
 
Medications: 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. 
 
7.2.2.7. Cognition (Baseline Only - Patient) 
 
Mini-Cog (baseline only): A 3-item screening tool for cognitive impairment in older 
adults.56  
 
7.2.2.8. Communication Self-Efficacy (Baseline and Post-intervention – Patient and 
Caregiver) 
 
Perceived Efficacy in Patient-Physician Interactions (PEPPI): A valid and reliable 
assessment of perceived self-efficacy of older patients interacting with physicians.57 
 
Perceived Efficacy in Caregiver-Physician Interactions (PECPI): A valid and reliable 
assessment of perceived self-efficacy of caregivers interacting with physicians.58  
 
7.2.2.9. Patient-Centered Communication (Post-Intervention Only – Patient and 
Caregiver) 
 
Patient-Centered Communication in Cancer Care (PCC-Ca-36): A questionnaire 
assessing patient-centered communication in six domains: exchanging information, 
making decisions, fostering healing relationships, enabling patient self-management, 
managing uncertainty, and responding to emotions.59We will adapt the PCC-Ca-6 for 
caregivers. 
 
7.2.2.10. Shared Decision-Making (Post-Intervention Only – Patient, Caregiver, and 
Physician) 
 
Shared Decision-Making Questionnaire (SDM-Q-9): A 9-item reliable questionnaire 
assessing patient satisfaction with the medical decision-making process.60 
 
Shared Decision-Making Questionnaire (SDM-Q-Doc): A 9-item reliable questionnaire 
assessing physician satisfaction with the medical decision-making process.61  
 
CollaboRATE Measure: A 3-item questionnaire assessing patient, caregiver, and 

physician shared decision-making.62 
 
 
Preparation for Decision Making Scale: A 10-item questionnaire assessing patients’ and 
caregivers’ perception of how useful the communication tool is in preparing them to 
communicate with their physician at a consultation focused on making a health 
decision.63 
 
7.2.2.11. Disease Knowledge (Baseline and Post-intervention – Patient and Caregiver) 
 
Disease Knowledge: A 14-item questionnaire assessing patients and caregivers’ 
understanding of AML.  
 
7.2.2.12. Information and Decision-Making Preferences (Baseline Only – Patient and 
Caregiver) 
 
Information Preferences: A questionnaire assessing patient and caregiver preferences 
regarding treatment information.  
 
Decision-Making Preferences: The Control Preference Scale assess patient and 
caregivers’ preferred roles in treatment decisions.64 
 
7.2.2.13. Disease Understanding (Patient, Caregiver, and Physician) 
 
Disease Understanding – Patient (baseline and post-intervention): A questionnaire 
assessing patient’s prognostic understanding of illness and preferences regarding life 
expectancy discussions.  
 
Disease Understanding – Caregiver (baseline and post-intervention): A questionnaire 
assessing caregiver’s prognostic understanding of illness and preferences regarding life 
expectancy discussions.  
 
Disease Understanding – Physician (post-intervention only): A physician-facing 
questionnaire assessing patient prognosis.  
 
7.2.2.14 Decisional conflict and regret (post-intervention for decisional conflict and 1, 2, 
3, and 6 month for decisional regret at) 
 
Decisional conflict scale – A questionnaires that measures personal perceptions of 
uncertainty in choosing options, modifiable factors contributing to uncertainty, and 
effective decision making.65 
 
Decisional regret scale – A questionnaire that measures distress or remorse after a 
healthcare decision.66 
 
Was it worth it questionnaire – A questionnaires that assesses satisfaction with decision 
made.67 

 
7.2.2.15 Health-related quality of life (Post-Intervention and 1, 2, 3, and 6 month) 
 
EQ-5D-5L: A health-related quality of life questionnaire that consists of five dimensions: 
mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each 
dimension has 5 levels: no problems, slight problems, moderate problems, severe 
problems and extreme problems. The patient is asked to indicate his/her health state by 
ticking the box next to the most appropriate statement in each of the five dimensions. 
This decision results in a 1-digit number that expresses the level selected for that 
dimension. The digits for the five dimensions can be combined into a 5-digit number that 
describes the patient’s health state.68 
 
7.2.2.16. Usability (Post-Intervention Only) 
 
Usability questions – Patient and Oncologist: Questions to assess usability of the tool 
and/or summary.  
  
7.2.2.17. Environmental Mastery (Baseline and Post-Intervention - Caregiver) 
 
Ryff’s Environmental Mastery: A 7-item questionnaire measuring whether the respondent 
makes effective use of opportunities and has a sense of mastery in managing 
environmental factors and activities, including managing everyday affairs and creating 
situations to benefit personal needs.70  
 
 

8.0 Data Handling and Statistical Considerations 
 
8.1. Data Handling 
 
8.1.1. The same protocols and procedures for data quality and control that are readily 
used for the NCI Community Oncology Research Program (NCORP) Research Base 
protocols currently being overseen by our office (which have accrued over 1,000 patients 
in the previous year) will be used for this study. Patients will fill out forms generated 
from RedCap and this information will be entered into RedCap (Section 9.5). Study 
personnel will perform SPPB and the scores will be entered into RedCap.    
 
8.1.2. It is anticipated that allowing for the appropriate number of evaluable participants 
and by checking self-report measures for completeness, we will have a full complement 
of data. Every effort will be made to encourage and facilitate participants’ completion of 
all questionnaires and all items on the questionnaires for each study assessment.  In the 
event that missing data occur, every effort will be made to contact participants via phone 
and obtain the data or to find out why the questionnaires or items are missing.  The 
reasons for missing data will be documented. Missing questionnaire items will be treated 
in accordance with the documented scoring procedures. Although it is very unlikely that 
missing values will not occur randomly, we will confirm their randomness.  Multiple 
imputation71 will be applied to (1) give more accurate statistical tests and standard errors 
for key treatment effect parameters and to (2) give some indication of the sensitivity of 
the analyses to missing data.  The causes and pattern of the missing data will be 
examined and taken into consideration in the design of future studies. 
 
8.1.3. Data collected via the UR-GOAL communication tool will only be accessed by the 
following: 1) The research team and 2) The treating physician and their designee.  
 
 
8.2. Data Analysis and Sample Size: 
 
8.2.1. Analysis Plan for Aim 1 
 
We anticipate thematic saturation will be reached with this number of participants (N=20) 
based on past similar research.43,44 We will conduct and audio-record all interviews, 
which will be transcribed by a professional transcription service. We will analyze the 
qualitative data using grounded theory and constant comparative methods, with coding to 
structure data into categories and create groups according to the broader issues or 
themes.72 An audit trail of the coding activity will be kept. We will critically examine the 
data collection and analysis process and reach consensus on key themes from patient 
feedback to be used to adapt the intervention in preparation for Aim 2.  
 
8.2.2. Analysis Plan for Aim 2 
 
We anticipate that our proposed sample size will be sufficient based on prior research73 
and also published guidance on usability study.74,75 The feasibility of the UR-GOAL tool 

will be evaluated based on the percentage of patients consented to the study ultimately 
completing all study components. 
 
Recruitment rate (percentage of patients who are approached and agree to enroll) will 
also be described. Other feasibility metrics include retention rate (percentage of patients 
who were enrolled and completed the intervention and assessments). The usability of the 
UR-GOAL tool will be evaluated using the SUS score. 
 
We will consider the UR-GOAL study feasible if >50% of consented patients ultimately 
complete all study components. We chose 50% based on our prior behavioral 
intervention study in this population and published studies that utilize similar tools (e.g., 
value elicitation tool).73,76,77 We will use descriptive statistics to describe the measures. If 
we do not meet our usability and feasibility goals, we will further adapt the study and 
tool. 
 
For other measures, these are being collected in preparation for a larger clinical trial in 
the future. As exploratory analyses, paired t-tests or McNemar’s test will be used to 
evaluate change in measures from baseline to post-intervention. Linear mixed models 
will be used to assess change in measures over several time points. 
 
 
Qualitative data from the semi-structured interviews will be analyzed as per Aim 1. 
Interviews will be conducted, audio-recorded, and transcribed. We will analyze the 
qualitative data using grounded theory and constant comparative methods, with coding to 
structure data into categories and create groups according to the broader issues or 
themes.72 An audit trail of the coding activity will be kept. We will critically examine the 
data collection and analysis process and reach consensus on key themes from patient 
feedback to be used to further adapt the tool. 
 
For audio-recorded clinic encounters, we will use published shared decision-making 
coding schemes to assess quality of shared decision making.78,79 Coders will undergo 
extensive training and supervision by study investigators.  
 

9.0. Data Management  
 
9.1. Data Collection Table  
 
9.1.1. Aim 1 
  
Eligibility 
and Consent 
Form 
Assessment  
Informed Consent 
X 
  
Demographics 
  
X 
Clinical and Cancer Characteristics 
 
X 
Qualitative Interview 
 
X 
Short Physical Performance 
Battery/Virtual Short Physical 
Performance Battery, Activities of Daily 
Living, Instrumental Activities of Daily 
Living, Fall History 
  
X 
Nutritional Status 
 
X 
Comorbidity 
 
X 
Geriatric Depression Scale-15 (GDS-15), 
Generalized Anxiety Disorder-7 (GAD-7) 
  
X 
Social Support 
 
X 
Medications 
 
X 
Mini-Cog 
 
X 
Information and Decision-Making 
Preferences 
 
X 
Disease Understanding - Patient 
 
X 
 
 
 

9.1.2. Aim 2 
a) Patients 
  
SCHEDULE OF DATA COLLECTION 
  
Eligibility and 
Consent Form 
Baseline 
Assessment 
(week 0) 
Post-intervention 
Assessment (week 1-
2) 
Month 1, 2, 3, and 
6 
Informed Consent 
X 
 
 
 
Demographics 
 
X 
 
 
Clinical and Cancer Characteristics 
 
X 
 
 
Qualitative Interview 
 
 
X 
 
Short Physical Performance 
Battery/Virtual Short Physical 
Performance Battery, Activities of 
Daily Living, Instrumental 
Activities of Daily Living, Fall 
History 
 
X 
 
 
Nutritional Status 
 
X 
 
 
Comorbidity 
 
X 
 
 
Geriatric Depression Scale-15 
(GDS-15), 
Generalized Anxiety Disorder-7 
(GAD-7) 
 
X 
X 
 
Social Support 
 
X 
 
 
Medications 
 
X 
 
 
Mini-Cog 
 
X 
 
 
Perceived Efficacy in Patient-
Physician Interactions (PEPPI) 
 
X 
X 
 
Patient-Centered Communication 
in Cancer Care (PCC-Ca-36) 
 
 
X 
 
Shared Decision-Making (SDM-Q-
9)a 
 
 
X 
 
CollaboRATE Measure 
 
 
X 
 
Preparation for Decision Making 
Scale 
 
 
X 
 
Patient Disease Knowledge 
 
X 
X 
 
Information and Decision-Making 
Preferences - Patient 
 
X 
 
 
Disease Understanding - Patient 
 
X 
X 
 
Decisional Conflict Scale 
 
 
X 
 
Decisional Regret Scale and Was it 
Worth It Questionnaire 
 
 
 
X 
BWS component only of the tool 
 
 
 
X 
EQ-5D-5L 
 
 
X 
X 
Usability (Usability questions) 
 
 
X 
 
 

b) Caregivers 
  
SCHEDULE OF DATA COLLECTION 
  
Eligibility 
and Consent 
Form 
Baseline 
Assessment 
(week 0) 
Post-
intervention 
Assessment 
(week 1-2) 
Informed Consent 
X 
  
  
Demographics 
  
X 
  
Qualitative Interview 
 
 
X 
Comorbidity 
 
X 
 
Patient Health Questionnaire-2 (PHQ-2), 
Generalized Anxiety Disorder-7 (GAD-7) 
  
X 
X 
Perceived Efficacy in Caregiver-Physician 
Interactions (PECPI) 
  
 X 
X 
Patient-Centered Communication in 
Cancer Care (PCC-Ca-6) – adapted 
caregiver version 
 
 
X 
Ryff’s Environmental Mastery 
 
X 
X 
CollaboRATE Measure 
 
 
X 
Preparation for Decision Making Scale 
 
 
X 
Caregiver Disease Knowledge 
 
X 
X 
Information and Decision-Making 
Preferences – Caregiver 
  
X 
 
Disease Understanding – Caregiver 
 
X 
X 
 
c) Oncologists 
  
SCHEDULE OF DATA COLLECTION 
  
Eligibility 
and Consent 
Form 
Baseline 
Assessment 
(week 0) 
Post-intervention 
Assessment (week 
1-2) 
Informed Consent 
X 
  
  
Demographics 
 
X 
 
Shared Decision-Making (SQM-Q-Doc, 
physician version) 
 
 
X 
Disease Understanding – Physician 
 
 
X 

Usability questions 
 
 
X 
Qualitative Interview 
 
 
After at least 1 
patient per 
oncologist 
completed study 
procedures, can be 
done at any point 
during the study 
 
9.2. 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. For audio-recordings, these will 
be uploaded to Box within a week of the interview and deleted from the audio-recorded. All 
study data will be kept for a period of 7 years after the study and all reports and publications are 
complete.  
 
9.3. 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. 
 
9.4. 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.   
 
9.5. Additionally, data on the socio-demographics, clinical, and cancer and treatment 
characteristics will be collected and managed by the research teams at URMC using REDCap 
electronic data capture tools hosted at URMC.80 We will also evaluate the medical records for 
clinical characteristics and outcomes, and utilize REDCap to collect and manage this 
information.  
 
9.5a. URMC provides the following information on the REDCap program: “Vanderbilt 
University, in collaboration with a consortium of institutional partners, has developed a 
software toolset and workflow methodology for electronic collection and management of 
research and clinical trial data, called REDCap (Research Electronic Data Capture). The 
REDCap system is a secure, web-based application that is flexible enough to be used for a 

variety of types of research. It provides an intuitive interface for users to enter data and real 
time validation rules (with automated data type and range checks) at the time of data entry. 
REDCap offers easy data manipulation with audit trails and functionality for reporting, 
monitoring and querying patient records, as well as an automated export mechanism to 
common statistical packages (SPSS, SAS, Stata, R/S-Plus). Through the REDCap 
Consortium, Vanderbilt has disseminated REDCap for use around the world. Currently, 
over 240 academic and non-profit consortium partners on six continents with over 26,000 
research end-users use REDCap.81  
 
9.5b. According to the Clinical and Translational Science Institute (CTSI), REDCap is 
supported with the following means. “The CTSI Informatics Core, a unit of the SMD 
Academic Information Technology (AIT) Group, will serve as a central facilitator for data 
processing and management.  REDCap data collection projects rely on a thorough study-
specific data dictionary defined in an iterative self-documenting process by all members of 
the research team, with planning assistance from the AIT-CTSI Informatics Core. The 
iterative development and testing process results in a well-planned data collection strategy 
for individual studies.”72  
 
9.5c. The CTSI states that regarding security, “REDCap servers are housed in a local 
data center at the University of Rochester and all web-based information transmission is 
encrypted. REDCap was developed in a manner consistent with HIPAA security 
requirements and is recommended to University of Rochester researchers by the URMC 
Research Privacy Officer and Office for Human Subject Protection.81  
 
 
 

10.0 Risks/Benefits  
 
10.1. Risks 
 
There is potential loss of confidentially associated with participation in the proposed study. In 
terms of loss of confidentiality, quantitative data from participants will need to be stored. Though 
rigorous and well-tested data safety and security guidelines will be observed, there is still a 
chance that confidentiality could be breached and sensitive medical information could become 
known to persons outside the research team. 
 
10.2. Benefits 
 
There are no anticipated benefits to the participants. 
 
10.3 Payments and Costs 
Patients participating in the first aim will be paid $30 and those participating in the second aim 
will be paid $50 for their participation in the form of gift cards. For Aim 1, participants will 
receive the gift cards immediately following the interviews. For Aim 2, participants will be paid 
for completion of the post-intervention assessment. Oncologists will not be reimbursed for their 
participation. 
 
 
 

11.0 Data Safety and Monitoring  
 
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. 
 
11.1. Adverse Event Reporting Requirements 
 
11.1.1. Adverse events will be reported using the URCC Adverse Event form and/or as 
required by the Cancer Center Clinical Trials Office.   
 
 
11.1.2. Adverse events will be reported in accordance with the following guidelines: 
 
11.1.3. Adverse event reports will be submitted in one of the following ways: 
(1) By email: (pdf) 
 
(2) By mail: 
(3) By fax: 
 
 
11.1.4. 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 both exercise and mobile app-driven interventions have been shown to improve 
outcomes in community-dwelling older adults.   
11.1.5. 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. 

11.1.6. 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.  
11.2. Data Safety Monitoring 
11.2.1. 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.   
11.2.2. 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. 
11.2.3. 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.   
 
 
 
 

 
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