A Telehealth Advance Care Planning Intervention for Older Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
Phase: NA
Conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes
Sponsor: University of Rochester

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UNIVERSITY OF ROCHESTER MEDICAL CENTER
WILMOT CANCER INSTITUTE
A telehealth advance care planning intervention for older patients with acute myeloid 
leukemia and myelodysplastic syndrome
July 11th, 2022
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:
Benzi Kluger, MD
Department of Neurology
University of Rochester Medical Center 
601 Elmwood Ave, Box 704 
Rochester, NY 14642
Email: Benzi_Kluger@URMC.rochester.edu
Sally Norton, PhD, RN
School of Nursing
University of Rochester Medical Center 
601 Elmwood Ave, Box 704 
Rochester, NY 14642
Email: Sally_Norton@URMC.rochester.edu
Thomas Carroll, MD, PhD
Department Medicine
University of Rochester Medical Center 
601 Elmwood Ave, Box MED 
Rochester, NY 14642
Email: thomas_carroll@URMC.rochester.edu
Marissa LoCastro
James P Wilmot Cancer Center 
601 Elmwood Ave, Box 704 
Rochester, NY 14642
Email: Marissa_LoCastro@URMC.Rochester.edu

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Study Personnel: 
Terri Lloyd 
James P Wilmot Cancer Center 
601 Elmwood Ave, Box 704 
Rochester, NY 14642
Phone: (585) 276-5652/ Fax: (585) 273-1042
Email: Terri1_Lloyd@URMC.Rochester.edu
Jessica Bauer
James P Wilmot Cancer Center 
601 Elmwood Ave, Box 704 
Rochester, NY 14642
Phone: (585) 276-6562/ Fax: (585) 273-1042
Email: Jessica_Bauer@URMC.Rochester.edu

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1.0 Background
1.1. Acute Myeloid Leukemia (AML) and Myelodysplastic syndrome (MDS) are a disease of the 
aging
Approximately 20,000 and 10,000 people are diagnosed with AML and MDS each year. Over 
60% of AML and MDS cases are diagnosed in adults aged ≥60 years.1,2 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%).3,4 Intensive therapy is utilized in <1% of older patients with AML seen in 
the community oncology setting due to the need for hospitalizations.6 In the last decade, lower-
intensity outpatient treatments with reduced treatment-related mortality rates and potentially 
similar efficacy have become available.5-10 These treatments have permitted more older patients 
with AML, including those with comorbidities and disabilities, to receive leukemia-directed 
therapy.11 Management of MDS may consist of observation, growth factors, transfusion, or 
chemotherapy in the outpatient setting. AML and MDS are generally incurable except with the 
use of hematopoietic stem cell transplantation, for which many older adults are not candidates 
due to advanced age and comorbidities. In older patients with AML or high-risk MDS, outcomes 
are poor, with median overall survivals ranging from 6-12 months. 
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 end of life 
(EOL).12,13 These quality indicators include healthcare utilization [emergency department (ED) 
visits, hospitalizations, intensive care unit (ICU) admissions, 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 (including AML and MDS) are more likely to visit the ED, be 
hospitalized, be admitted to ICU, and to receive LSTs, transfusions, and chemotherapy at the 
EOL.14-16 In addition, they are 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.14,16 Therefore, interventions are needed to improve EOL care for patients with 
hematologic malignancies.
1.3. Advance care planning (ACP) may improve EOL care for older patients with AML and 
MDS
Advance care planning (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 suggest that among adults aged ≥70 years with 
AML and MDS seen at the Wilmot Cancer Institute (WCI) and its affiliated community centers, 
most MOLST forms were completed late in the disease course; median times from MOLST 
completion to death were 18 days and 75 days, respectively, for AML and MDS. Approximately 

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42% completed MOLST >30 days prior to death. Compared to patients who completed MOLST 
30 days prior to death or never completed MOLST, those who completed MOLST >30 days 
prior to death were less likely to be admitted to the ICU and to utilize LSTs at the EOL, 
indicating that early MOLST completion may be 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 they are not tailored to older 
adults with AML and MDS.
The Serious Illness Care Program is an evidence-based intervention to enhance EOL 
conversations between physicians and patients with advanced cancer.17 It consists of the Serious 
Illness Conversation Guide as well as training and system-level support for physicians to conduct 
ACP conversations. 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.17 
However, <10% of patients had hematologic malignancies.
1.5. Telehealth may improve access to ACP.
Telehealth refers to the practice of caring for patients remotely when the provider and patient are 
not physically present with each other. Telehealth allows for improved patient access, but its 
adoption has been slow due to barriers such as lack of insurance coverage and patient/provider 
unfamiliarity.18 The coronavirus pandemic has stimulated rapid increase in the use of telehealth 
visits in cancer care. Infrastructure and regulatory changes to facilitate telehealth visits have been 
implemented, including insurance reimbursement and education/support to assist older adults 
and providers. Therefore, telehealth provides an attractive modality improve access to ACP 
among older adults with AML and MDS.
1.6. Overall goal
The long-term goal of this proposal is to improve ACP access, patient-reported outcomes, and 
EOL care in older patients with AML and MDS via a telehealth-delivered ACP intervention. The 
objective of this one-year project is to adapt and assess the feasibility and usability of a 
telehealth-delivered ACP intervention for older patients with AML and MDS. The optimization 
of the ACP intervention will be guided by the Center for eHealth and Wellbeing Research 
(CeHRes) Roadmap that emphasizes structural stakeholder involvement.

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2.0 Aim and Hypothesis
2.1. Primary Aim
To incorporate telehealth into an evidence-based ACP intervention that is adapted for older 
patients suffering from AML and MDS utilizing qualitative interviews with patients, their 
caregivers, and oncology and palliative care providers
Findings from Aim 1 will be used to inform Aim 2. Aim 2 will be done following completion of 
Aim 1.
2.2. Secondary Aim
To assess the feasibility and usability of the adapted telehealth-delivered ACP intervention in a 
single-arm pilot study of 20 older patients with AML and MDS.
2.3. Hypothesis
The telehealth ACP intervention will be feasible and usable. 
2.3.1 Feasibility and usability metrics
The usability and feasibility of the adapted telehealth-delivered ACP intervention will be 
evaluated based on the following: 
a) Retention rate (percentage of patients who consented and completed the visit)
b) Telehealth Usability Questionnaire (total average of >5 will be considered usable)

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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 (phase 1)
Aim 2: Single-arm pilot study (phase 2)
3.3. Study Population
Aim 1: We will gather feedback from older patients with AML/MDS (N=5-10), caregivers 
(N=up to 2 caregivers per patient and therefore up to a total of 20 caregivers), oncology 
physicians (N=5-10), oncology APP and nurses (N=5-10), palliative care physicians (N=5-10), 
as well as palliative care APP and nurses (N=5-10). Therefore, the total number of participants 
will be between 25 and 70.We anticipate thematic saturation will be reached with this number of 
participants based on past similar research.19,20 For patients, we will consent up to 15 patients to 
account for screen fail or withdrawal. 
Results from Aim 1 will be used to adapt the telehealth intervention for use in Aim 2. In other 
words, Aim 2 will occur after Aim 1 has been completed.
Aim 2: We will recruit 20 patients, their caregivers (up to 2 caregivers per patient), and oncology 
providers. We will consent up to 30 patients to account for screen fail or withdrawal. 
3.4. Inclusion and Exclusion Criteria for Patients
Inclusion criteria:
Aim 1 

Age ≥60 years 

Have an AML or MDS diagnosis 

Able to provide informed consent

English-speaking
Aim 2 

Age ≥60 years (conventional definition of older age in AML/MDS) 

AML or MDS diagnosis

Being managed in the outpatient settings 

Able to provide informed consent

English-speaking

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Exclusion criteria

None
3.5. Inclusion and Exclusion Criteria for Caregivers (Aims 1 and 2)
Inclusion criteria:

Age ≥21 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
3.6. Inclusion and Exclusion Criteria for Oncology Providers
Inclusion criteria:
Aim 1

Oncologists, advanced care practitioners (APPs), and nurses who cared for at least 
one patient age ≥60 years with AML/MDS in the past year. 
Aim 2

Oncologists, advanced care practitioners (APPs), and/or nurses who will be 
conducting the telehealth-delivered ACP visit
Exclusion criteria

None
3.7. Inclusion and Exclusion Criteria for Palliative Care Providers (Aim 1 only)
Inclusion criteria:
Aim 1

Palliative care physicians, APPs, and nurses who cared for at least one patient age 
≥60 years with AML/MDS in the past year. 
Exclusion criteria

None
3.8. Number of Subjects
Aim 1: We plan to enroll the following groups: older patients with AML/MDS (N=5-10), 
caregivers N=(up to 20), oncology (N=5-10) and palliative care physicians (N=5-10) as well as 

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oncology (N=5-10) and palliative care APPs and nurses (5-10). In prior qualitative studies of 
older patients, caregivers, and oncologists, we were able to successfully enroll similar numbers 
of participants in 3-6 months.20,21 In addition to enrolling at WCI, we will also be recruiting 
patients and oncologists from WCI-affiliated community practices (e.g., Interlakes Oncology, 
Dansville, Pluta, Olean, Wellsville), to obtain feedback from community oncology settings. 
Aim 2: We plan to enroll 20 patients total and their caregivers (up to 2 caregivers per patient if 
available) in 9 months. From 2012-2019, 4-7 oncologists saw >100 patients with AML or MDS 
aged ≥60 annually at WCI and its affiliated centers. In prior studies of similar populations, the 
recruitment rate was 65-75%.20,22 Therefore, recruiting 20 patients and their caregivers over 9 
months is feasible.
3.9. 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 to 1.5:1 male to female ratio).23,24
3.10. Age of Subjects
We will recruit patients with AML and MDS aged 60 and above (from date of consent, 
confirmed on electronic medical record). 
3.11. 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). We expect these to be similar 
in MDS although data were not available. 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. 
3.12. 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.

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4.0. Recruitment and Consent
Subjects will be enrolled at the URMC WCI, as well as WCI-affiliated sites, including Interlakes 
Oncology, Dansville, Pluta, Olean, and Wellsville. 
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 AML or MDS diagnosis. 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. All 
study procedures can be conducted remotely therefore in-person visits are not necessary if 
patients are not returning for in-person visits or to minimize in-person contacts. 
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 will confirm that the patient 

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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.
For caregivers of alive patients, 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 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.
For providers, we will discuss the study at research or staff meetings and solicit interest in 
participation. In addition, we will approach providers via email communications. An 
informational sheet will be emailed to the providers. We will obtain verbal consent if they 
agree to participate. 
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 oncology/palliative care providers 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 (patients, caregivers, and oncology providers) 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, caregivers, and oncology providers 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.

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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.
 
4.1.2. 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 and 
caregivers for 30-60 minutes. We will also interview oncology and palliative care providers. 
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: At baseline, study patients and consented caregivers will complete demographics and 
baseline measures. We will also collect demographic information from oncology providers. After 
the oncology providers undergo a skill-based training session of SICG (2-4 hours; duration to be 
determined based on feedback obtained from aim 1), a telehealth visit will be scheduled with the 
study participants, caregivers, and oncologist providers within 1-2 months of enrollment. 
Following the visit, all participants will complete post-intervention measures. Within 1-2 weeks 
after the telehealth visit, the study team will separately interview the patient, caregiver (if 
available), and oncology provider present at the telehealth visit via Zoom/phone or in-person. 
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. 

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5.0. Registration
For Aim 1 (qualitative), registration information for patients, caregivers, and providers will be 
collected and entered into REDCap.
For Aim 2, registration information for patients, caregivers, and oncology providers will be 
collected and entered 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 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
Medical Record Number
5.1.7.f  Ethnicity
5.1.7.g
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 Oncology and Palliative Care Providers
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

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5.4. Initial Assessment
In Aim 1, study patients will complete demographics and a 30-60 minutes interview. 
Patients and caregivers in Aim 2 will complete baseline assessments with the study 
coordinator and then schedule a telehealth visit.

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6.0 Intervention
The original SICG 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). Patient tools included a preconversation letter given to the patient 
at study enrollment, which introduced the SICG, and a “Family Guide,” outlining an approach 
for continuing the conversation with their family after the patient-clinician discussion. The 
clinician training included a 2.5-hour, skills-based training session on the SICG led by palliative 
care faculty. System changes included the following systematic components: (1) clinicians were 
asked the “surprise question,” “would you be surprised if this patient died in the next year?”; (2) 
clinicians were sent email reminders and given the SICG by study staff the day before an 
outpatient visit; (3) an accessible, structured, EMR documentation template mirroring the SICG 
was provided, and clinicians were trained on its use; and (4) in-person, email-based, or 
telephonic clinician coaching on the SICG was provided by palliative care faculty. 
Table 1 SICG intervention components and description

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The intervention will be adapted based on feedback from stakeholders in Aim 1 and the protocol 
will be amended to include details of the intervention to be delivered in Aim 2.

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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, we will conduct an interview to elicit 
preferences and information regarding the ACP intervention.
For Aim 2, the study subject and caregiver (if applicable) will complete demographics and 
baseline measures. Following this, a telehealth visit will be scheduled with their oncology 
provider within 1-2 months of enrollment. If the patient does not have access to an electronic 
device, the study team will provide them with a tablet that is preloaded with the zoom 
application and internet access (if needed). Instructions on how to use zoom on the tablet will be 
provided. The sole purpose of the tablet is to allow for a zoom visit to occur and no data will be 
obtained and stored. If the tablet is lost or broken, we will provide a replacement tablet (and the 
broken tablet will be collected). We will work with the University IT to restrict the use of the 
tablets to zoom only.
During the ACP visit, their oncology provider will discuss ACP and EOL care. This visit will be 
recorded. Prior to the visit, providers will be provided with a checklist of items to discuss and 
summary of aging-related vulnerabilities. After the visit, the study subject and caregiver (if 
applicable) will complete post-intervention measures. They will be asked to mail back the tablet 
or return the tablet in the next in-person visit.
Within 4 weeks (up to 12 weeks if needed) of the telehealth 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 oncology provider who enrolled the patient 
on the study. All parties present for the recorded visit, 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 providers may receive copies of these recordings at 
their request. Participants will complete post-intervention measures within 4 weeks of the visit 
(up to 12 weeks if needed).
7.2. Assessments of the Participants 
Demographic, clinical, and cancer characteristics will be collected on paper or via RedCap. 
7.2.1. Demographics (Patient, Caregivers, and Providers)
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.

17
Provider’s age, race, ethnicity gender, years in practice since completion of training, and 
disciplines (e.g., oncology physician, palliative care physician, APP, nurse) will be 
collected.
7.2.2. Clinical and Cancer Characteristics (Patient)
ECOG performance status, comorbidity, medications, weight, height, BMI, diagnosis and 
date of 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.
In addition, we will collect the following from the medical records. We have previously 
collected this information in a retrospective fashion and will use similar procedures to 
extract this information prospectively from the medical records.

Rate of hospice enrollment (and timing relative to death) 

Rate of palliative care referral (and timing relative to diagnosis)

Rate of 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. 
Documentation of ACP conversation in the electronic medical record will also be 
collected.

Do no resuscitation order (and timing related to diagnosis and death)

Percentage of patients who died from cancer with more than one emergency 
department visit in the last 30 days of life

Percentage of patients who died from cancer admitted to the ICU 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, 
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, or mailed to the participants. 
7.2.3.1. Functional Status (Patient) – baseline only
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 

18
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.25
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.26
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.27
7.2.3.2. Psychological Health (Patient and Caregiver) – baseline and post-
intervention 
General Anxiety Disorder-7: A 7-item screening tool for anxiety.28 
Patient Health Questionnaire-9 (PHQ-2): A 9-item valid and reliable screening 
tool depression in the general population.29 
Distress: A self-reported tool to screen for symptoms of distress, using a 0-10 
rating scale.30
7.2.3.3. Social Support (Patient) – baseline only
OARS Medical Social Support: A 13-item questionnaire for patients regarding 
persons involved in medical social support as well as perception of overall 
support.31,32 
Patients also self-report their living situation and their main social support. 
7.2.3.4. Nutritional status (Patient) – baseline only
Self-reported weight loss in the past 6 months
7.2.3.5. Cognition (Patient) – baseline only
BLESSED (baseline only): A screening tool for cognitive impairment in older 
adults.33 
7.2.3.6. Satisfaction with Communication (Patient and caregiver) – post-
intervention only
Health Care Climate Questionnaire (HCCQ): A questionnaire assessing patients’ 
and caregivers’ satisfaction with patient-oncologist communication.34,35 

19
Heard and understood question: A self-report measure for seriously ill patients 
and their caregivers to report how well they feel heard and understand.36
7.2.3.7. Therapeutic alliance (Patient) – post-intervention only
Modified Human Connection Scale: A survey to measure the extent to which 
patients and caregivers feel a sense of mutual understanding, caring, and trust 
with their physicians.37 
7.2.3.8. Goal-Concordant care (Patient) – post-intervention only
SUPPORT Survey: The Study to Understand Prognoses and Preferences for
Outcomes and Risk of Treatments (SUPPORT) survey to assess if patient values
 align with current medical care.38
7.2.3.9. Usability (Patient and caregiver) – post-intervention only
Telehealth Usability Questionnaire: A questionnaire assessing the usability of 
telehealth implementation.39
7.2.3.10 Peaceful Acceptance of Illness (Patient) – post-intervention only
PEACE Questionnaire: Peace, Equanimity, and Acceptance in the Cancer 
Experience (PEACE) questionnaire to measure the extent to which patients with 
advanced cancer have a sense of peaceful acceptance of their terminal illness.40
7.2.3.11. Acceptability (Patient and clinician) – post-intervention only
Patient Acceptability Questionnaire: A questionnaire used to assess the impact of 
the serious illness conversation on the patient’s understanding and perception of 
their diagnosis.41
Clinician Acceptability Questionnaire: A questionnaire used implementation to 
assess the clinicians experience in using the SICP with patients.41
7.2.3.12 Confidence (Provider) – baseline and post-intervention
Clinician Confidence Questionnaire: A questionnaire used to assess clinician’s 
self-perceived ability to implement the SICP in real practice.41 
7.2.3.13. Health Literacy (Patient and caregiver) – baseline only
Cancer health literacy (CHLT-6): A brief instrument to determine whether an 
individual has limited cancer health literacy.42
7.2.3.14 Quality of Life (Patient and caregiver) – baseline and post-intervention
Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu): The FACT-
Leu scale was created by combining the Functional Assessment of Cancer 
Therapy-General module (FACT-G) and a sub-scale made up of 17 leukemia-
specific items.43 It been tested and determined to be a valid, reliable, and efficient 

20
instrument for evaluating leukemia-specific health-related QoL. This will be used 
for patients.
Caregiver Quality of Life Index-Cancer: The instrument self-reported health-
related QoL.44 This will be used for caregivers.
7.2.2.15. Disease Understanding (Patient, caregiver, and clinician) – baseline and 
post intervention
Disease Understanding – Patient (baseline and post-intervention): A 
questionnaire assessing patient’s prognostic understanding of illness. They will 
also be asked if prognostic information was provided.
Disease Understanding – Caregiver (baseline and post-intervention): A 
questionnaire assessing caregiver’s prognostic understanding of illness. They will 
also be asked if prognostic information was provided.
Disease Understanding – Provider (post-intervention only): A physician-facing 
questionnaire assessing patient prognosis. They will also be asked if prognostic 
information was provided.
7.2.2.16. 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.
7.2.2.17. 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

21
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 BLESSED 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 
imputation45 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.
8.1.2. 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 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 based 
on past similar research (i.e., the point at which no new data emerge).19,20 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.46 The themes will 
focus on EOL care as it relates to older patients with AML and MDS, barriers and 
challenges to ACP and MOLST completion, potential solutions and ideas, experience 

22
with telehealth interventions, added values of the intervention, support and concerns for 
the proposed intervention, components of the intervention that are important to them, and 
their opinions about the intervention (e.g., delivery, format). 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 telehealth-delivered ACP intervention.
8.2.2. Analysis Plan for Aim 2
Quantitative analyses: We anticipate that our proposed sample size will be sufficient 
based on prior research22 and also published guidance on usability study.47,48 We will 
employ descriptive statistics to summarize the data. Feasibility will be defined based on 
the retention rate (percentage of patients consented to the study ultimately completing all 
study components); >80% will be considered feasible. Recruitment rate (percentage of 
patients who are approached and agree to enroll) will also be described. Usability will be 
defined based on the Telehealth Usability Questionnaire completed by patients; total 
average of >5 will be considered usable.49,50 We anticipate that about 20% of the 
participants will withdraw before post-intervention assessment due to death.51 With 20 
patients enrolled, we anticipate at least 16 patients to be evaluable. When we estimate 
retention rate and usability, a 95% CI will span approximately +/- 25%. For example, if 
we observe 12/16 (75%) patients complete the tasks, the CI will be 51-90%. 
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. 
Qualitative analyses will be per Aim 1. All audio-recorded interviews and clinic visits 
will audio-recorded by study personnel and then transcribed by a professional 
transcription service. The themes will focus on participant experience during the 
telehealth ACP visit and feedback which will be used to further optimize the study 
procedures and intervention.
For audio-recorded clinic encounters, we will assess EOL care concerns brought up by 
patients and caregivers. We will assess how the physician addresses these concerns. 
Quantitative analysis of the communication processes, including number of questions 
asked and topics discussed will be analyzed. We have previously used the same study 
procedures and coders will undergo extensive training and supervision by study 
investigators. 

23
9.0 Data Management
9.1. Data Collection Table
9.1.1. Aim 1
a) Patient
Eligibility 
and consent 
form
Assessment
Informed Consent
X
Demographics
X
Clinical and 
Cancer 
Characteristics
X
Cancer Health 
Literacy (CHLT-
6)
X
Qualitative 
Interview
X
Disease 
Understanding
X
b) Caregiver (if applicable)
Eligibility and 
consent form
Assessment
Informed Consent
X
Demographics
X
Cancer Health Literacy 
(CHLT-6)
X
Qualitative Interview
X
Disease Understanding
X
c) Oncology and Palliative Provider
Eligibility and 
consent form
Assessment
Informed Consent
X
Demographics
X
Qualitative Interview
X
9.1.2. Aim 2 
a)
Patient

24
Eligibility and consent 
form
Baseline Assessment
Post-Intervention 
Assessment 
(within 4 weeks of 
the telehealth visit 
and up to 12 
weeks)
Informed Consent
X
Demographics
X
Clinical and Cancer 
Characteristics
X
Qualitative Interview
X
Activities of Daily Living 
(ADL), Instrumental 
Activities of Daily Living 
(IADL), Fall History
X
Patient Health 
Questionnaire (PHQ-9), 
General Anxiety 
Disorder-7 (GAD-7), 
Distress
X
X
Nutritional Status
X
OARS Medical Social 
Support
X
Cognition (BLESSED)
X
Health Care 
Communication 
Questionnaire (HCCQ), 
Heard and understood 
question
X
Therapeutic alliance 
Human Connection 
Survey
X
Cancer Health Literacy 
(CHLT-6)
X
Telehealth Usability 
Questionnaire (TUQ)
X
Acceptability
X
ACP engagement survey
X
X
Peaceful acceptance of 
illness
X
Goal concordant care
X
Functional Assessment of 
Cancer Therapy-
Leukemia (FACT-Leu)
X
X
Disease Understanding
X
X
b)
Caregiver (if applicable)

25
Eligibility and consent 
form
Baseline Assessment
Post-Intervention 
Assessment 
(within 4 weeks 
of the telehealth 
visit and up to 12 
weeks)
Informed Consent
X
Demographics
X
Patient Health 
Questionnaire (PHQ-9), 
General Anxiety 
Disorder-7 (GAD-7), 
Distress
X
X
Qualitative Interview
X
Cancer Health Literacy 
(CHLT-6)
X
Health Care Climate 
Questionnaire (HCCQ), 
Heard and understood 
question
X
Telehealth Usability 
Questionnaire (TUQ)
X
Caregiver Quality of Life 
Index-Cancer
X
X
Disease Understanding
X
X
c)
Oncology provider
Eligibility and consent 
form
Baseline Assessment
Post-Intervention
Assessment 
(within 4 weeks of 
the telehealth visit 
and up to 12 
weeks)
Informed Consent
X
Demographics
X
Qualitative Interview
X
Disease Understanding
X
Acceptability
X
Provider confidence 
survey
X
X
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 recorder. All study 

26
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.52 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.53 
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 

27
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.”46 
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.53 
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 and caregivers participating will be paid $10 Wegmans gift cards. For Aim 1, 
participants will receive the Wegmans gift cards immediately following the interviews. For Aim 
2, participants will be paid for completion of the post-intervention assessment. Oncology 
providers will not be reimbursed for their participation.
10.4 Funding Source
The study is funded by the Cancer and Aging Research Group and National Institute of Aging.

28
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