An Inpatient Advance Care Planning Intervention for Older Patients With Hematologic Malignancies
Phase: NA
Conditions: Hematologic Malignancies
Sponsor: University of Rochester

 
Cover Page for ClinicalTrials.gov 
 
Study Official Title: 
An Inpatient Advance Care Planning Intervention for Older Patients With Hematologic 
Malignancies 
NCT number: 
NCT05433090 
Document Type: 
Study Protocol with Statistical Analysis Plan 
Document Date: 
May 10, 2023 

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UNIVERSITY OF ROCHESTER MEDICAL CENTER
WILMOT CANCER INSTITUTE
An inpatient advance care planning intervention for older patients with hematologic malignancies
May 10th, 2023
Study Principal Investigator:
Kah Poh (Melissa) Loh, MBBCh BAO, MS
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-PI:
Jason Mendler, MD, PhD
Department of Hematology/Oncology 
University of Rochester Medical Center 
601 Elmwood Ave, Box 704
Rochester, NY 14642
Email: Jason_mendler@URMC.Rochester.edu
Study Co-Investigator:
Danielle Kindron, PA
Department of Hematology/Oncology 
University of Rochester Medical Center 
601 Elmwood Ave, Box 704
Rochester, NY 14642
Email: Danielle_kindron@URMC.Rochester.edu
Thomas Carroll, MD, PhD
Department of Medicine, Division of Palliative care 
University of Rochester Medical Center
601 Elmwood Ave
Rochester, NY 14642
Email: Thomas_caroll@urmc.rochester.edu

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  Andrea Baran, MS
Department of Biostatistics
University of Rochester Medical Center 
601 Elmwood Ave, Box 630
Rochester, NY 14642
Email: Andrea_baran@URMC.Rochester.edu
Marissa LoCastro, BS
School of Medicine and Dentistry 
University of Rochester Medical Center 
601 Elmwood Ave
Rochester, NY 14642
Email: Marissa_locastro@URMC.Rochester.edu
Biostatisticians:
Andrea Baran, MS 
Department of Biostatistics
University of Rochester Medical Center 
601 Elmwood Ave, Box 630
Rochester, NY 14642
Email: Andrea_baran@URMC.Rochester.edu
Funding source:
University of Rochester Quality Institute Dissemination 
and Implementation Grant 

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Background
1.1. Many hematologic malignancies are diseases of aging.
Many hematologic malignancies are diseases of aging.1,2 For example, the median age at time of 
diagnosis for patients with acute myeloid leukemia (AML), non-Hodgkin lymphomas (NHL), 
and multiple myeloma (MM) are 68, 67, and 69 years, respectively.1 Recently, there have been 
advances in treatment options for older adults with hematologic malignancies. For example, in 
the last decade, lower-intensity outpatient treatments with reduced treatment-related mortality 
rates and potentially similar efficacy to standard first-line intensive inpatient chemotherapy have 
become available to patients with AML.4-6  Despite hematologic malignancies being more 
common in older populations and recent treatment advances, survival rates for older adults with 
hematologic malignancies remain poorer than their younger counterparts.1 In older patients with 
AML, for example, the median overall survival rates range from 6-12 months. In addition, 
hospitalizations due to treatment- and disease- related adverse events are common. 
1.2. Patients with hematologic malignancies receive more aggressive care at the end-of-life 
(EOL) compared to those with solid tumors.
Previous studies have established quality indicators to guide optimal care at the EOL.8,9 These 
quality indicators include healthcare utilization [emergency department (ED) visits, 
hospitalizations, intensive care unit (ICU) admission, life-sustaining treatments (LSTs), 
chemotherapy administration, and receipt of transfusion] at EOL, completion of Medical or 
Physician Orders for Life Sustaining Treatment (MOLST/POLST) forms, utilization of palliative 
care and hospice services, and place of death. Compared to patients with solid tumors, patients 
with hematologic malignancies are more likely to visit the ED, be hospitalized, be admitted to 
ICU, and to receive LSTs, transfusions, and chemotherapy at the EOL.3,10,11 They are also less 
likely to complete MOLST/POLST forms in a timely fashion, less likely to receive palliative 
care and hospice services, and more likely to die in the hospital.3,10 Therefore, interventions are 
needed to improve EOL care in patients with hematologic malignancies.
1.3. Advance care planning (ACP) may improve EOL care for older patients with 
hematologic malignancies.
ACP is a process that supports adults in understanding and sharing their personal values, life 
goals, and preferences regarding medical care. These decisions can then be recorded in 
MOLST/POLST forms to guide surrogate decisions makers if the patient loses decision making 
capacity. Our preliminary data demonstrates that among adults with AML and myelodysplastic 
syndrome (MDS) seen at the Wilmot Cancer Institute (WCI) and its affiliated community 
centers, most MOLST forms were completed late in the disease course.12 Compared to patients 
who completed MOLST 
30 days prior to death or never completed MOLST, those who 
≤

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completed MOLST >30 days prior to death were less likely receive inpatient care and more 
likely to utilize hospice at the EOL, indicating early MOLST completion is associated with better 
EOL care. Interventions to improve access to ACP and MOLST/POLST completion can 
therefore be expected to improve EOL care.
1.4. Evidence-based interventions can improve access to ACP but are not tailored to older adults 
with hematologic malignancies.
The Serious Illness Care Program (SICP) is an evidence-based intervention to enhance EOL 
conversations between physicians and patients with advanced cancer in the outpatient setting.13 It 
consists of the Serious Illness Conversation Guide (SICG) as well as training and system-level 
support for physicians to conduct conversations about ACP. In a phase III randomized trial, 
compared to the control arm, more patients and physicians in the intervention arm had serious 
illness conversations (96% vs. 79%) and these conversations occurred 2.4 months earlier and 
were more comprehensive and patient centered. However, less than 10% had hematologic 
malignancies. Therefore, we have adapted the SICP for older patients with hematologic 
malignancies based on feedback from clinicians [oncologists, palliative care physicians, 
advanced practice providers (APP), and nurses)], older patients with these diseases, and their 
caregivers.
1.5. Previous research has shown that advanced practice providers-initiated ACP discussions 
improve ACP engagement.
APPs play an important role in the care of patients, especially in the inpatient setting at the 
Wilmot Cancer Institute, alongside the attending physician and hematology/oncology trainee 
physician. APP-initiated ACP discussions have been shown to improve patient understanding of 
ACP and completion of advance directives for patients with cancer.14 Furthermore, 
implementation of APP roles in inpatient settings, including critical care, have been shown to 
improve patient satisfaction and cost of care.15 Therefore, an inpatient APP-delivered ACP 
intervention for patients with hematologic malignancies may improve care for this patient 
population.
1.6. Overall goal
The long-term goal of this proposal is to improve ACP access and EOL care in older patients 
with hematologic malignancies via an inpatient ACP intervention delivered by APPs and 
hematology/oncology trainee physicians (hereby referred to as fellows).
The objective of this two-year project is to create training materials and processes for an 
inpatient ACP intervention and to assess its preliminary efficacy in older patients with 
hematologic malignancies in a single arm study (comparing data to historical control).13

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2.0. Aim and Hypothesis
2.1 Primary Aim
To adapt training materials and processes for an inpatient ACP intervention delivered by 
APPs and hematology/oncology fellows (completed). 
2.2. Secondary Aim
To assess the feasibility of an inpatient ACP intervention, as well as the preliminary efficacy of 
the intervention on completion of advance directives (e.g., MOLST form, healthcare proxy 
form) and on EOL care (e.g., intensive care unit admissions, life-sustaining treatments, 
readmission rates, hospice enrollment, inpatient death).
2.3. Hypothesis
An inpatient ACP intervention delivered by APPs and hematology/oncology fellows will improve 
completion of advance directives and EOL care.
3.0. Study Design and Population
3.1. Study Setting
Wilmot Cancer Institute (WCI), University of Rochester Medical Center (URMC) 
3.2. Study Type
Aim 1: Qualitative study (phase 1) - completed
Aim 2: Single-arm pilot study (phase 2) 
3.3. Study Population
Aim 1 (completed): We will discuss the study at APP meetings and solicit interest in 
participation. Ms. Danielle Kindron will serve as the APP lead and has preliminarily solicited 
support from APPs on the inpatient hematology service. We will approach APPs in person or via 
email communications. We will conduct focus group interviews to obtain feedback on training 
materials (e.g., prerecorded vs. interactive sessions, duration of training) and processes (e.g., 
workflow, template to document ACP visit in the electronic medical record) in the inpatient 
setting. Interviews will be audio-recorded by study personnel and then transcribed. Two trained 
personnel (“coders”) will extract and highlight themes from the transcripts. We anticipate up to 
15 APPs will participate in this aim.

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Results from Aim 1 will be used to adapt the inpatient APP-delivered ACP intervention for use 
in Aim 2 (these will be shared with APPs via email prior to Aim 2 so they can review how their 
feedback was used to adapt the intervention). In other words, Aim 2 will occur after Aim 1 has 
been completed.
Aim 2: We will conduct a single arm study of 50 older patients, their caregivers (up to 2 
caregivers per patient), and APPs/hematology/oncology fellows. We will approach all APPs on 
the inpatient hematologic malignancy service for Aim 2, with a goal of between 10-15 APPs 
participating. We will discuss the study at hematology/oncology fellow meetings and PIs (Dr. 
Kah Poh Loh and Dr. Jason Mendler) will lead efforts to solicit support and involvement from 
fellows. We will approach all hematology/oncology fellows at Wilmot Cancer Institute for Aim 
2, with a goal of between 10-12 fellows participating. We will consent up to 252 participants (75 
patients, 150 caregivers, 15 APPs, 12 fellows) to account for screen fail or withdrawal with the 
target number being 50 patients and 100 caregivers.
3.4. Inclusion and Exclusion Criteria for Clinicians (Aim 1 and Aim 2)
Inclusion criteria:
Aim 1 (completed)

APP on the inpatient malignant hematology service [including both physician assistants (PA) 
and nurse practitioners (NP)]
Aim 2

APP on the inpatient malignant hematology service [including both physician 
assistants (PA) and nurse practitioners (NP)]

Hematology/Oncology fellows at the Wilmot Cancer Institute
Exclusion criteria

None
3.5 Inclusion and Exclusion Criteria for Patients (Aim 2)
Inclusion criteria:

Age ≥60 years

A diagnosis of hematologic malignancy [including but not limited to acute leukemia, myeloid 
malignancies (e.g., atypical CML, MDS/MPN overlap syndromes, CMML), multiple myeloma, 
lymphoma, or any other hematologic malignancies based on the primary oncologist’s judgment]

Able to provide informed consent

Being managed in the inpatient setting

English-speaking

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Exclusion criteria

None
3.6 Inclusion and Exclusion Criteria for Caregivers (Aim 2)
Inclusion criteria:

Age ≥18 years

Selected by patient when asked if there is a “family member, partner, friend, or caregiver 
with whom you discuss or who can be helpful in health-related matters”

Able to provide informed consent

English-speaking
Exclusion criteria

None
3.7. Number of Subjects
Aim 1: We plan to enroll APPs on the inpatient malignant hematology service. This phase will 
consist of focus group interviews with APPs. We plan to enroll up to 15 APPs. We will conduct 
at least two and up to four focus groups. We anticipate thematic saturation will be reached with 
this number of participants based on previous studies (i.e., the point at which no new data 
emerge).17,18
Aim 2: We plan to enroll 50 patients total and their caregivers (up to 2 caregivers per patient if 
available) in 18 months. On average, 2-4 patients with hematologic malignancies are admitted to 
Wilmot Cancer Institute every day (and on average, the inpatient malignant hematology service 
cares for 15-25 patients daily). Our team has a proven track record in recruiting older patients 
with hematologic malignancies to supportive care and quality improvement studies (65-75% 
consent rate).17,18 Therefore, recruiting 50 patients and their caregivers [approximately 150 
participants (50 patients; 100 caregivers), but can consent up to 225 patients/caregivers to account 
for screen fail/withdrawal; 75 patients and 150 caregivers] over 18 months is feasible. Patients 
and caregivers participation in this study will last approximately 4 weeks.
APPs who consent to the study in Aim 1 will also be consented to participate in Aim 2. APPs can 
also consent and join the study in Aim 2, after Aim 1 has been completed. Therefore, participation 
in Aim 1 of this study will last for 1 day for APPs and participation in Aim 2 of the study will last 
approximately 18 months for APPs. We plan to consent hematology/oncology fellows to 
participate in this study for Aim 2 only, since Aim 1 of this study has already been completed. 
Therefore, fellows will not participate in the focus group interviews. Participation in this study 
will last approximately 18 months for hematology/oncology fellows participating in Aim 2.

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3.8. Gender of Subjects
The gender ratio of enrolled patients will be similar to the gender ratio of each hematologic 
malignancy in older adults (e.g., approximately 1.2:1 to 1.5:1 male to female ratio for AML 
patients).19,20
3.9. Age of Subjects
We will recruit patients with hematologic malignancies aged 60 and above (from date of 
consent, confirmed on electronic medical record).
3.10. Racial and Ethnic Origin
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). We expect 
participants to be similar to these statistics. Certain hematologic malignancies are more common 
in Caucasian individuals, including leukemia and lymphoma, while hematologic malignancies 
such as multiple myeloma are more common in African American individuals. We expect our 
participants will be similar to this epidemiology. As enrollment is limited to English-speaking 
patients, we predict a higher percentage of Caucasian individuals. The study does not restrict 
enrollment based on race or ethnicity. Because our intervention materials are written in English, 
we will only enroll English-speaking patients.
3.11. Vulnerable Subjects
Recruitment will exclude vulnerable populations such as fetuses, neonates, children, pregnant 
women, 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 (APPs, hematology/oncology fellows, patients, and caregivers) 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.

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4.1. Identification of Study Subjects, Recruitment, and Consent Procedures
We will discuss the study at APP/hematology/oncology fellow meetings and solicit interest in 
participation. Ms. Danielle Kindron will serve as the APP lead and has preliminarily solicited 
support from APPs on the inpatient hematology service. Dr. Kah Poh Loh and Dr. Jason 
Mendler will lead efforts to solicit support and participation from hematology/oncology 
fellows. We will approach APPs/hematology/oncology fellows in person or via email 
communications.
For clinicians, email communications will be used for the following purposes: to complete 
baseline and post-intervention surveys, notify clinicians of enrolled patients, schedule study 
visits, and schedule end-of-study interview. For patients and caregivers, email 
communications may be used for administering baseline and post-intervention surveys. Due 
to the setting of this study being inpatient, study coordinators will prioritize administering 
surveys and communications in person with patients and caregivers. In the event this is not 
possible, such as a patient is discharged or a caregiver is participating in the study remotely, 
then email communications will be used.
4.1.1 APPs/Hematology/Oncology Fellows
For in-person consent with APPs, study staff will contact APPs to formally consent to the study 
after the study has been discussed at staff meetings and/or the APP has been made aware of the 
study by Ms. Kindron. For in-person consent with hematology/oncology fellows, study staff will 
contact hematology/oncology fellows to formally consent to the study after the study has been 
discussed at hematology/oncology fellow meetings and/or they have been made aware of the 
study by Dr. Kah Poh Loh and/or Dr. Jason Mendler. Therefore, we will also discuss the study at 
staff/hematology/oncology fellow meetings and solicit interest in participation. Following the 
staff meeting, all APPs/hematology/oncology fellows who attended will be contacted via email. 
The study staff will offer to call or meet the APP/hematology/oncology fellow in person, if 
requested by the APP/hematology/oncology fellow, for consent. Otherwise, the 
APP/hematology/oncology fellow will consent via email through implied consent. We will 
obtain APP or hematology/oncology fellow email addresses from Ms. Kindron or Dr. Loh and 
Dr. Mendler, respectively. When appropriate, they will set up time to come meet the 
APP/hematology/oncology fellow to go over every detail of the study. If the 
APP/hematology/oncology fellow agrees, they will sign the consent with the study staff during 
this in-person encounter.
For implied consent with APPs/hematology/oncology fellows, study staff will contact 
APPs/hematology/oncology fellows via email. In the email, study staff will include a link to a 

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REDCap survey for APPs/hematology/oncology fellows. The survey will include the same 
information that can be found on the RSRB approved APP/hematology/oncology fellow 
information sheet. Therefore, when APPs/hematology/oncology fellows click the REDCap link, 
they will see the APP/hematology/oncology fellow information sheet. APPs/ 
hematology/oncology fellows will review the information sheet and click “I agree” at the end of 
the study if they would like to consent and enroll. If the APP/hematology/oncology fellow does 
not want to participate in the study, there will be an option for “I do not agree” at the bottom of 
the REDCap survey.
4.1.2 Patients
Patients will be identified by treating physicians, APPs, hematology/oncology fellows, and 
nurses of these physicians, and the study coordinators. The study coordinators will work closely 
with APPs/hematology/oncology fellows to identify patients who are admitted to the hospital 
with a hematologic malignancy (Aim 2). 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/APP/Hematology/Oncology Fellow/Study Investigator makes the initial 
contact and provides consent form, and patient signs consent 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/APP/hematology/oncology fellow/study investigator so he/she can provide it to 
the patient during an in-person hospital admission. The 
physician/APP/hematology/oncology fellow/study investigator will go over every detail 
of the study during the hospital admission with patient. If the patient agrees, the patient 
will sign the consent form with the physician/APP/hematology/oncology fellow/study 
investigator during the same in-person visit. If the patient wants more information or 
wants to think about the study, the physician/study investigator (or their designee) will 
provide the patient with the “info only- do not sign” version of the consent document for 
the patient review.
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 while admitted to the WCI. The study 
staff will introduce the study to the patients and go over every detail of the study. If the 
patient agrees, the patient will sign the consent form with the study staff during the same 
hospital admission with the study staff. If the patient wants more information or wants to 
think about the study, the physician/study investigator (or their designee) will provide 
the patient with the “info only- do not sign” version of the consent document for the 

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patient review.
4.1.3 Caregivers
For in-person consent with caregivers, patients will make 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 will approach the caregiver in-person in the hospital. The study coordinator will 
go over every detail of the study during the hospital admission with the caregiver. If the 
caregiver agrees, the caregiver will sign the consent with the study coordinator during the same 
in-person visit. If the caregiver wants more information or wants to think about the study, the 
study staff will provide the patient with the “info only- do not sign” version of the consent 
document for the patient review.
Consent for study procedures can be conducted remotely therefore in-person visits are not 
necessary if caregivers are not actively in the hospital with their respective patient. For verbal 
consent with caregivers, patient will make 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 
will 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 
caregiver 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.
4.1.4  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. Verbal consent documents with caregivers and 
APPs/hematology/oncology fellows will also be maintained in separate records with copies 
provided to caregivers and APPs/hematology/oncology fellows.
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 (APPs/fellows via implied consent and caregiver via verbal consent) 
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 
caregivers who provided verbal consent and APPs/hematology/oncology fellows who provide 
implied consent. Verbal and implied consent will allow for reduction of in-person visits, thus 

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maximizing the safety of both participants 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.
4.1.5 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.
4.2  Participation
Regulations at the state, federal, and institutional level will be adhered to in regard 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.
4.3  Duration
Aim 1: The qualitative section of this study involves focus group interviews with APPs for 30-60 
minutes. Participating APPs will be interviewed by the study team either in-person (in a private 
space) or via zoom. Interviews will be audio-recorded, uploaded to Box, and subsequently 
deleted from the audio-recorder.
Aim 2: At study initiation, APPs/hematology/oncology fellows will undergo a skill-based 
training session of the SICG (3 hours). APPs and hematology/oncology fellows will undergo the 
same skill-based training session. The SICG training session is a 2.5 to 3-hour training session 
that will be conducted via zoom or in-person and led by Dr. Thomas Carroll (palliative care 
physician). This training session will include standardized patient encounters for 
APPs/hematology/oncology fellows to practice using the SICG under the direct supervision of 
Dr. Carroll with real time feedback.
At baseline, study patients and consented caregivers will complete demographics and baseline 
measures. We will also collect demographic information from APPs/hematology/oncology 
fellows. We will perform a geriatric assessment that assesses the patient’s overall health status 

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prior to ACP intervention. Following this, we will schedule an ACP visit with an 
APP/hematology/oncology fellow on the inpatient malignant hematology service during the 
same hospital admission. Their caregivers can join via in person, zoom, or phone (depending on 
COVID restrictions). During the ACP visit, the APP/hematology/oncology fellow will discuss 
ACP and EOL care and may facilitate completion of advance directives and a MOLST form if 
appropriate. This visit will be recorded. After the visit, they will complete post-intervention 
measures. Within 4 weeks of the ACP visit, we will conduct a semi-structured interview with the 
patient and caregiver (if available) either via video, phone, or in-person to elicit their experience 
with the visit and feedback on the ACP intervention. We will also conduct a semi-structured 
interview with APPs/hematology/oncology fellows who enrolled patients at the end of the study.
All audio-recordings will be uploaded to Box, transcribed by a professional transcription service, 
and subsequently deleted from the audio-recorder. After the study is completed, all participant 
data will be maintained for 7 years at URMC and will be kept in a password-protected database.
5.0. Registration
For Aim 1 (qualitative), registration information for APPs/hematology/oncology fellows 
will be collected and entered into REDCap.
For Aim 2, registration information for patients, caregivers, and 
APPs/hematology/oncology fellows will be collected and entered into the OnCore 
Database:
5.0. Registration Information for APPs/hematology/oncology fellows
5.0.1 Participant’s identification
5.0.1.a
First and last names
5.0.1.b
Birth date (MM/DD/YEAR)
5.0.1.c
Gender
5.0.1.d
Race
5.0.1.e
Five-digit zip code
5.0.1.f
Ethnicity
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 date signed

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5.1.6
Treatment facility (WCI)
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
Medical Record Number
5.1.7.f
Ethnicity
5.1.7.g
Date of baseline visit 
5.3. Registration Information for Caregivers
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
5.3.1.g
Caregiver’s preferred and alternate phone numbers (and email address if 
patients consent to be contacted via email)
6.0. Intervention
The original SICP intervention included clinical tools, training, and system changes (Table 1). 
The primary clinician tool was a structured communication guide called the Serious Illness 
Conversation Guide (SICG; https://www.ariadnelabs.org/wp-content/uploads/sites/2/2017/05/SI- 
CG-2017-04-21_FINAL.pdf). We conducted 45 qualitative interviews with oncology clinicians, 
palliative care clinicians, patients with hematologic malignancies, and their caregivers to adapt 
the original SICG. Our adapted SICG is designed to meet the unique needs of older patients with 
hematologic malignancies. The adapted SICG was further refined based on feedback gathered 
through APP focus group interviews (Aim 1).

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Table 1 SICP intervention components and description
                

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Table 2 Adapted SICG for patients with hematologic malignancies. 

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7.0. Treatment Protocol
7.1. Study Outline
For Aim 1, we will identify all inpatient APPs. We will email the intervention materials to them 
before the focus group meetings. Following this, the study team will conduct in-person or 
zoom/phone focus group interviews with APPs for 30-60 minutes. First, we will explain the 
rationale of the study. Second, we elicit preferences and feedback regarding the inpatient APP- 
delivered ACP intervention. This will include preferences on SICG training (i.e., length of 
training, in-person vs. virtual, live vs. prerecorded) and on SICG implementation (i.e., 
organization and content of the SICG including language that should be added, removed, or 
changed, workflow).
For Aim 2, we will screen and consent eligible patients of treating physicians at WCI. After 
consent, the study subject and caregiver (if applicable) will complete demographics and baseline 
measures. The patient will be provided with the “Patient Preparation Letter” following completion 
of baseline measures and prior to the inpatient ACP visit. This will allow the patient to review the 
document and prepare for their discussion with the APP/hematology/oncology fellow. Following 
this and during the same hospital admission, an inpatient ACP visit will be scheduled with an 
APP/hematology/oncology fellow on the inpatient malignant hematology service. The 
APP/hematology/oncology fellow will use the “Serious Illness Care Guide” during this visit with 
the patient. The APPs who participated in Aim 1 of this study have already completed training on 
how to use this guide. For additional APPs who may join in Aim 2 and hematology/oncology 
fellows who will join in Aim 2, they will complete the same training session as the original group 
of APPs on how to use this guide. Finally, at the end of the visit, the patient will be provided with 
the “Family Guide” (either from the APP/hematology/oncology fellow or the study coordinator). 
The patient can use this guide to help communicate with their family about the visit that they had 
with the APP/hematology/oncology fellow. The APP/hematology/oncology fellow will be able to 
access with the Epic Serious Illness Conversation Template on Epic and will document their 
conversation with the patient using the template in the electronic medical record.
During the ACP visit, the APP/hematology/oncology fellow will discuss ACP and EOL care. This 
visit will be recorded. After the visit, the study subject and caregiver (if applicable) will complete 
post-intervention measures. Within 4 weeks of the in-patient visit, we will conduct an interview 
with the patient and caregiver (if applicable) either in-person or via zoom/phone for 30-60 
minutes. We will also conduct an interview with the APPs/hematology/oncology fellows who 
participated in the ACP visits with the patients at the end of the study. All parties present for the 
recorded visit, including enrolled patients, any accompanying caregivers, family or friends, the 
APP/hematology/oncology fellow, 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 APPs/hematology/oncology fellows may request access to the audio recording or 
the written transcript.

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In order to collect data from the EMR regarding EOL metrics, patients in this study will be 
followed until death or up to 5 years following their participation.
7.2. Assessments of the Participants
Demographic, clinical, and cancer characteristics will be collected on paper or via RedCap.
7.2.1. Demographics (APPs, Fellows, Patient, and Caregivers)
APPs/hematology/oncology fellows age, race, ethnicity gender, and years in practice 
since completion of training will be collected. For hematology/oncology fellows, years 
in fellowship will be collected.
Patient and caregiver’s age, race, ethnicity, gender, highest level of education achieved, 
employment status, and marital status. Caregiver’s relationship to the patient will also be 
inquired. This will only be collected at baseline.
7.2.2. Clinical and Cancer Characteristics (Patient)
ECOG performance status, comorbidities, medications, weight, height, BMI, diagnosis 
and date of diagnosis, prior hematologic malignancies, stage/risk group, and treatment 
regimen will be abstracted from the medical records. This information will only be 
collected at baseline.
In addition, we will collect the following from the medical records (up to 5 years 
following their participation in the study or death) which will provide end of life quality 
indicators. We have previously collected this information in a retrospective fashion and 
will use similar procedures to extract this information prospectively from the medical 
records.

Hospice enrollment (and timing relative to death)

Palliative care referral (and timing relative to diagnosis)

Chemotherapy administration within the last 2 weeks of life

Completion of advance directives which include MOLST forms, living will, 
durable power of attorney for healthcare, and healthcare proxy forms (and timing 
related to diagnosis and death)

Do not resuscitate order /Do not intubate order (and timing related to diagnosis 
and death)

Emergency department visits in the last 30 days of life

ICU admissions in the last 30 days of life

Hospitalization in the last 30 days of life (number of hospitalizations, reasons for 
hospitalizations)

Use of life-sustaining treatments (e.g., mechanical ventilation, vasopressors, 

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tracheostomy, dialysis for acute kidney injury, percutaneous endoscopic 
gastrostomy) in the last 30 days of life

Transfusion in the last 7 days of life

Place of death (home, hospital, facility, etc.)

Inpatient mortality rate
7.2.3. Measures
Measures will be collected via in-person, done via email on redcap as a survey option, or 
from mailings sent to the participants.
7.2.3.1. Functional Status (Patient) – baseline only – Aim 2
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.22
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.23
Fall History: A self-reported history of falls in the past year 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.24
7.2.3.2. Nutritional status (Patient) – baseline only – Aim 2
Self-reported weight loss in the past 6 months.
7.2.3.3. Social Support (Patient) – baseline only – Aim 2
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 7.2.3.4. Psychological Health (Patient and Caregiver) – baseline only – Aim 2
Geriatric Depression Scale-15: A 15-item screening instrument for depressive 
symptoms in older adults.25
7.2.3.5. Cognition (Patient) – baseline only – Aim 2
Mini-Cog (baseline only): Brief, cognitive screening test that is used to evaluate 
cognition in older adults.26
7.2.3.6. Health Literacy (Patient) – baseline only – Aim 2
Cancer health literacy (CHLT-6): A brief instrument to determine whether an 
individual has limited cancer health literacy.27
7.2.3.7. Disease Understanding (Patient) – baseline and post-intervention – Aim 2
Disease Understanding – Patient: A questionnaire assessing patient’s prognostic 
understanding of illness. They will also be asked if prognostic information was 
provided.
7.2.3.8. ACP Engagement Survey (Patient) – baseline and post-intervention – 
Aim 2
ACP Engagement Survey: 15-item engagement survey that assess patient self- 
efficacy and readiness for identification of a medical decision maker, 
identification of personal values, and flexibility in decision making and 
communication with their physician.
7.2.3.9. ACP Documentation – baseline and post intervention – Aim 2
Data on ACP documentation will be collected through the electronic medical 
record. This will include explicit statement of the patient’s medical preferences 
for EOL care in a note, scanned MOLST form that was completed with their 
clinician, and/or scanned healthcare proxy form that was completed with their 
clinician.
7.2.3.10. Acceptability Questionnaire (Patient and APP/Fellow) – post-intervention only
– Aim 2
Patient Acceptability Questionnaire (Aim 2): A questionnaire used in the original 

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evaluation of the SICP implementation to assess the impact of the serious illness 
conversation on the patient’s understanding and perception of their diagnosis.28
Clinician Confidence Questionnaire (Aim 2): A questionnaire used in the original 
study evaluating the SICP implementation to assess clinician’s self-perceived 
ability to implement the SICP in real practice. This will be used in Aim 2 at 3 time 
points: before the SICP training (led by Dr. Thomas Carroll), after the SICP 
training, and at completion of the study (APPs and hematology/oncology fellows 
will complete the same training).27
Clinician Acceptability Questionnaire (Aim 2): A questionnaire used in the 
original study evaluating the SICP implementation to assess the clinicians 
experience in using the SICP with patients.27
7.2.3.11. Feasibility metrics
Feasibility metrics will be collected:

Retention rate (percentage of patients consented to the study ultimately 
completing all study components) – primary metric

Recruitment rate (percentage of patients who are approached and agree to 
enroll) will also be described.
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). They may also complete 
RedCap survey directly. Study personnel will perform Mini-Cog 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 imputation29 will be 

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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. For audio-recordings, these will be uploaded to Box within a week of the 
interview/clinic visits and deleted from the digital audio recorder (Sony). The recordings will 
be transcribed by a professional transcription service, and the transcripts will be used for data 
analysis.
8.1.4. Data collected (both assessments and transcripts) will only be accessed by the 
following: 1) The research team and 2) The treating physician (only if the patient consents for 
research information to be shared or if their treating physician is a study co- investigator).
8.2 Data Analysis and Sample Size:
8.2.1 Analysis Plan for Aim 1
Qualitative analyses: We anticipate thematic saturation will be reached with this number 
(N=approximately 10-15) of participants based on previous studies (i.e., the point at which no 
new data emerge).16,17 All interviews will be conducted and audio-recorded by study personnel 
and then transcribed by a professional transcription service. Two trained personnel (“coders”) will 
extract and highlight themes from the transcripts. 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.31 The themes will focus on feedback 
on training materials (e.g., prerecorded vs. interactive sessions, duration of training) and processes 
(e.g., workflow, template to document ACP visit in the electronic medical record) in the inpatient 
setting. These interviews will be audio-recorded by study personnel and then transcribed. We will 
keep an audit trail to establish trustworthiness. We will critically examine the data collection and 
analysis process, discuss emerging codes, and reach consensus on principal themes. These themes 
will be used to adapt the inpatient APP/fellow-delivered ACP intervention.
8.2.2 Analysis Plan for Aim 2
Quantitative analyses: We will use descriptive statistics to summarize feasibility metrics and all 
measures. Feasibility will be defined based on the retention rate (% of patients approached who 
consented and complete the ACP visit); >70% will be considered a successful benchmark for 
feasibility. Rates will be presented with associated two-sided 95% exact binomial confidence 

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intervals. A sample size of 50 patients produces a confidence interval with a maximum width of 
0.29 (limits 0.36-0.65), when the observed feasibility rate is 0.50. We anticipate a higher 
feasibility rate, which will result in a narrower confidence interval. If the observed feasibility rate 
is 0.70, the width of the confidence interval is reduced to 0.24 (limits 0.55-0.82). If more than 50 
patients are approached, then the confidence intervals will become narrower. Recruitment rate 
will be the % of patients approached who agree to participate (i.e., consent), and will be described 
similarly.
Models for comparison with historical control: For AML and MDS specifically, we will 
compare outcomes (EOL quality indicators) to a historical control cohort, which we have 
previously collected and published.12 Rates of EOL outcomes in the historical cohort are 
shown in Figure 4, and range from <20% (chemotherapy in the last 14 days of life) to >80% 
(hospitalization in the last 30 days of life). Rates of EOL outcomes in this study population 
will be graphically summarized in a similar fashion. We aim to compare EOL outcome 
measures in this study population to EOL outcomes seen in the historical cohort referenced 
above. 
Figure 1: End of life quality indicators (2014-2019)

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Qualitative analyses: All inpatient ACP visits and interviews will be audio-recorded by 
study personnel and then transcribed by a professional transcription service. Inpatient 
ACP visit transcript themes will focus on the APPs/hematology/oncology fellows ability 
to assess EOL concerns brought up by the patient and caregiver, as well as advance 
directive completion. Post-intervention interview themes will focus on participant 
experience during the inpatient ACP visit and feedback which will be used to further 
optimize the study procedures and intervention.
9.0 Data Management
9.1. Data Collection Table
9.1.1. Aim 1
a) APP
Eligibility and 
consent form
Baseline 
Assessment
Post-
Interview 
Assessment
Informed Consent
X
Demographics
X
Focus Group 
Interview
X
9.1.2. Aim 2
a) APP/Hematology/Oncology Fellow
Eligibility and consent 
form
Baseline 
Assessment
Post-Intervention 
Assessment
Informed Consent
X
Demographics
X
Qualitative Interview
X (at the end of 
the study)
Clinician 
Acceptability 
Questionnaire
X
Clinician Confidence 
Questionnaire
X (before and after 
SICP training)
X (at the end of 
the study)
b) Patient

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Eligibility and consent 
form
Baseline 
Assessment
Post- 
Intervention 
Assessment
Informed Consent
X
Demographics
X
Clinical and Cancer 
Characteristics
X
Cancer Health Literacy 
(CHLT-6)
X
Disease Understanding
X
X
Activities of Daily 
Living (ADL), 
Instrumental Activities 
of Daily Living 
(IADL), Fall History
X
Nutritional Status
X
Geriatric Depression 
Scale-15
X
Mini-Cog
X
ACP Engagement 
Survey
X
X
Qualitative Interview
X
Patient Acceptability 
Questionnaire
X
End-of-Life Quality 
Indicators
X (up to 5 years 
or death; EMR)
c) Caregiver (if applicable)
Eligibility and consent 
form
Baseline 
Assessment
Post- 
Intervention 
Assessment
Informed Consent
X
Demographics
X
Qualitative Interview
X
Acceptability 
Questionnaire
X
9.2. All hardcopy research records will be stored onsite in the URMC, in locked research files at 
the Wilmot Cancer Institute (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 

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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 recorder. 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.32 We will also evaluate the medical records for 
clinical characteristics and outcomes, and utilize REDCap to collect and manage this 
information.
9.5.a. 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.33
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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.31
9.5.c. 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.33

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10.0 Risks/Benefit
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.
Advarra will be used as the direct payment system for study payments. During registration or account 
creation on the site, Advarra may collect any or all of the following subject information, (i) name, (ii) 
home or business address, (iii) professional information, including specialty or nature of concern, (iv) 
organization with whom they are affiliated and its address, and (v) email address. When they visit the site 
using their personal smart device, the site may automatically record information that their browser sends 
like, the name of the domain and host from which they access the Internet; the Internet Protocol (IP) 
address of the computer or smart device they are using; the date and time they access the site or make 
uploads or post to the site; and the Internet address of the website from which they linked directly to the 
site. This information does not include any Personally Identifiable Information and we refer to this 
information as non-identifiable information.
There is still a risk that a third party could gain access to any Information provided to or 
collected through this site. To mitigate these risks, any data breaches and, potential identification 
of the subjects, Advarra has security measures in place to protect electronically transmitted 
information. They are frequently reviewing and consistently trying to improve the security of the site. 
They do not collect and subjects will not be asked to submit any “protected health information” as defined 
in HIPAA. 
10.2. Benefits
There are no anticipated benefits to the participants.
10.3 Payments and Costs
Patients and caregivers participating will be paid $10 for their participation in the form 
of gift cards following their inpatient APP/hematology/oncology fellow-delivered 
ACP visit. APPs/hematology/oncology fellows will not be reimbursed for their 
participation. However, for APPs, if we have to schedule the training on how to 
deliver the ACP intervention outside of the APP working hours, they will be paid for 
those working hours by the APP leadership (confirmation with APP leadership 
through email communication). There are no additional costs to patients and caregivers 
for participating in this study.

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For this study we will use a subject payment system called Advarra Participant Payments. The 
system allows three ways to provide payment. Subjects can choose: a reloadable debit card; direct 
deposit; or mailed paper checks. The study team will help create a “subject profile” in the system. In order 
to provide payment, the subject will need to enter their name and date of birth into their subject profile. 
Depending on which payment method they choose, they may also need to enter their email address and 
banking information. If the subject already has an Advarra account (because of another study that uses 
this system), the existing profile will be used to provide payment.
10.4 Future Work
Results of this study can be expanded to guide ACP interventions for other types of 
cancers. It can also be translated to other languages.

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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. If study bone marrow biopsy is collected, 
this would be a greater than minimal risk study.

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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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References:
1.
Krok-Schoen JL, Fisher JL, Stephens JA, et al. Incidence and survival of hematological cancers 
among adults ages ≥75 years. Cancer Med. Jul 2018;7(7):3425-3433. doi:10.1002/cam4.1461
2.
SEER Cancer Statistics Factsheets: Acute Myeloid Leukemia. National Cancer Institute. 
Bethesda M, http://seer.cancer.gov/statfacts/html/amyl.html. 
3.
Ma X, Does M, Raza A, Mayne ST. Myelodysplastic syndromes: incidence and survival in the 
United States. Cancer. Apr 15 2007;109(8):1536-42. doi:10.1002/cncr.22570
4.
DiNardo CD, Jonas BA, Pullarkat V, et al. Azacitidine and Venetoclax in Previously Untreated 
Acute Myeloid Leukemia. N Engl J Med. Aug 13 2020;383(7):617-629. doi:10.1056/NEJMoa2012971
5.
DiNardo CD, Pratz K, Pullarkat V, et al. Venetoclax combined with decitabine or azacitidine in 
treatment-naive, elderly patients with acute myeloid leukemia. Blood. Jan 3 2019;133(1):7-17. 
doi:10.1182/blood-2018-08-868752
6.
Stein EM, DiNardo CD, Pollyea DA, et al. Enasidenib in mutant IDH2 relapsed or refractory 
acute myeloid leukemia. Blood. Aug 10 2017;130(6):722-731. doi:10.1182/blood-2017-04-779405
7.
Mederios BC S-HS, Momin F, Parisi M. Real-World Treatment Patterns and Comparative 
Effectiveness Among a Population of Elderly Patients with Acute Myeloid Leukemia (AML).132(Supp 
1):835
8.
Earle CC, Park ER, Lai B, Weeks JC, Ayanian JZ, Block S. Identifying potential indicators of the 
quality of end-of-life cancer care from administrative data. J Clin Oncol. Mar 15 2003;21(6):1133-8. 
doi:10.1200/jco.2003.03.059
9.
Odejide OO, Cronin AM, Condron NB, et al. Barriers to Quality End-of-Life Care for Patients 
With Blood Cancers. J Clin Oncol. Sep 10 2016;34(26):3126-32. doi:10.1200/jco.2016.67.8177
10.
Fletcher SA, Cronin AM, Zeidan AM, et al. Intensity of end-of-life care for patients with 
myelodysplastic syndromes: Findings from a large national database. Cancer. Apr 15 2016;122(8):1209-
15. doi:10.1002/cncr.29913
11.
Hui D, Didwaniya N, Vidal M, et al. Quality of end-of-life care in patients with hematologic 
malignancies: a retrospective cohort study. Cancer. May 15 2014;120(10):1572-8. 
doi:10.1002/cncr.28614
12.
Earle CC, Landrum MB, Souza JM, Neville BA, Weeks JC, Ayanian JZ. Aggressiveness of 
cancer care near the end of life: is it a quality-of-care issue? J Clin Oncol. Aug 10 2008;26(23):3860-6. 
doi:10.1200/jco.2007.15.8253
13.
LoCastro M, Baran AM, Liesveld JL, et al. Portable medical orders and end-of-life measures in 
acute myeloid leukemia and myelodysplastic syndromes. Blood Adv. Dec 28 2021;5(24):5554-5564. 
doi:10.1182/bloodadvances.2021004775
14.
Bernacki R, Paladino J, Neville BA, et al. Effect of the Serious Illness Care Program in 
Outpatient Oncology: A Cluster Randomized Clinical Trial. JAMA Intern Med. Jun 1 2019;179(6):751-
759. doi:10.1001/jamainternmed.2019.0077
15.
Goswami P, Mistric M, Diane Barber F. Advance Care Planning: Advanced Practice Provider-
Initiated Discussions and Their Effects on Patient-Centered End-of-Life Care. Clin J Oncol Nurs. Feb 1 
2020;24(1):81-87. doi:10.1188/20.Cjon.81-87
16.
Woo BFY, Lee JXY, Tam WWS. The impact of the advanced practice nursing role on quality of 
care, clinical outcomes, patient satisfaction, and cost in the emergency and critical care settings: a 
systematic review. Hum Resour Health. Sep 11 2017;15(1):63. doi:10.1186/s12960-017-0237-9

Version Date: 5/10/23
PRMC#: UOCPC22039
Study Protocol
ClickIRB #: STUDY00007403
Page 34 of 34
17.
Loh KP, Abdallah M, Kadambi S, et al. Treatment decision-making in acute myeloid leukemia: a 
qualitative study of older adults and community oncologists. Leuk Lymphoma. Feb 2021;62(2):387-398. 
doi:10.1080/10428194.2020.1832662
18.
Loh KP, Sanapala C, Di Giovanni G, et al. Developing and adapting a mobile health exercise 
intervention for older patients with myeloid neoplasms: A qualitative study. J Geriatr Oncol. Jul 
2021;12(6):909-914. doi:10.1016/j.jgo.2021.02.023
19.
Loh KP, Ramsdale E, Culakova E, et al. Novel mHealth App to Deliver Geriatric Assessment-
Driven Interventions for Older Adults With Cancer: Pilot Feasibility and Usability Study. JMIR Cancer. 
Oct 29 2018;4(2):e10296. doi:10.2196/10296
20.
Acharya UH, Halpern AB, Wu QV, et al. Impact of region of diagnosis, ethnicity, age, and 
gender on survival in acute myeloid leukemia (AML). J Drug Assess. 2018;7(1):51-53. 
doi:10.1080/21556660.2018.1492925
21.
Cartwright RA, Gurney KA, Moorman AV. Sex ratios and the risks of haematological 
malignancies. Br J Haematol. Sep 2002;118(4):1071-7. doi:10.1046/j.1365-2141.2002.03750.x
22.
Shelkey M, Wallace M. Katz Index of Independence in Activities of Daily Living. J Gerontol 
Nurs. Mar 1999;25(3):8-9. doi:10.3928/0098-9134-19990301-05
23.
Graf C. The Lawton instrumental activities of daily living scale. Am J Nurs. Apr 2008;108(4):52-
62; quiz 62-3. doi:10.1097/01.Naj.0000314810.46029.74
24.
Hurria A, Togawa K, Mohile SG, et al. Predicting chemotherapy toxicity in older adults with 
cancer: a prospective multicenter study. J Clin Oncol. Sep 1 2011;29(25):3457-65. 
doi:10.1200/jco.2011.34.7625
25.
Shin C, Park MH, Lee SH, et al. Usefulness of the 15-item geriatric depression scale (GDS-15) 
for classifying minor and major depressive disorders among community-dwelling elders. J Affect Disord. 
Dec 1 2019;259:370-375. doi:10.1016/j.jad.2019.08.053
26.
Borson S, Scanlan JM, Chen P, Ganguli M. The Mini-Cog as a screen for dementia: validation in 
a population-based sample. J Am Geriatr Soc. Oct 2003;51(10):1451-4. doi:10.1046/j.1532-
5415.2003.51465.x
27.
Dumenci L, Matsuyama R, Riddle DL, et al. Measurement of cancer health literacy and 
identification of patients with limited cancer health literacy. J Health Commun. 2014;19 Suppl 2(0 
2):205-24. doi:10.1080/10810730.2014.943377
28.
Paladino J, Bernacki R, Neville BA, et al. Evaluating an Intervention to Improve Communication 
Between Oncology Clinicians and Patients With Life-Limiting Cancer: A Cluster Randomized Clinical 
Trial of the Serious Illness Care Program. JAMA Oncol. Jun 1 2019;5(6):801-809. 
doi:10.1001/jamaoncol.2019.0292
29.
Little R, Yau L. Intent-to-treat analysis for longitudinal studies with drop-outs. Biometrics. Dec 
1996;52(4):1324-33. 
30.
Loh KP, Abdallah M, Kadambi S, et al. Treatment decision-making in acute myeloid leukemia: a 
qualitative study of older adults and community oncologists. Leuk Lymphoma. Oct 11 2020:1-12. 
doi:10.1080/10428194.2020.1832662
31.
Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. Nov 
2005;15(9):1277-88. doi:10.1177/1049732305276687
32.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data 
capture (REDCap)--a metadata-driven methodology and workflow process for providing translational 
research informatics support. J Biomed Inform. Apr 2009;42(2):377-81. doi:10.1016/j.jbi.2008.08.010
33.
 Clinical & Translational Science Institute. REDCap. REDCap at the University of Rochester.
Available at: Https://www.urmc.rochester.edu/ctsi/research-help/REDCap.cfm.