Feasibility Study of the Head and Neck Survivorship Tool: Assessment and Recommendations (HN-STAR)
Conditions: Head and Neck Cancer
Sponsor: Memorial Sloan Kettering Cancer Center

Memorial Sloan Kettering Cancer Center 
IRB Number: 15-245 A(7) 
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OneMSK Sites 
Approval date: 15-Feb-2018 
Feasibility Study of the Head and Neck Survivorship Tool: Assessment and 
(HN-STAR) 
PROTOCOL FACE PAGE FOR 
MSK NON THERAPEUTIC PROTOCOL 
Principal Investigator/Department: 
Talya Salz, PhD 
Recommendations 
Epidemiolgy & 
Biostatisitcs 
Co-Principal  Investigator(s)/Department: 
Elena Elkin, PhD 
Epidemiology & 
Biostatistics 
Investigator(s)/Department: 
Kevin Oeffinger, MD 
Stacie Corcoran, NP 
Andrew Vickers, PhD 
Daniel Sjoberg, MA 
Janet McKiernan, NP 
Elizabeth Fortier, MPH 
Medicine 
Nursing 
Epidemiology & 
Biostatistics 
Epidemiology & 
Biostatistics 
Nursing 
Epidemiology & 
Biostatistics 
Consenting  Professional(s)/Department: 
Elizabeth Fortier, MPH 
Talya Salz, PhD 
Epidemiology & 
Biostatistics 
Epidemiolgy & 
Biostatisitcs 
 
 
Please Note: A Consenting Professional must have completed the mandatory Human 
Subjects Education and Certification Program. 
 
 
 
Manhattan 
MSK Alliance Clinical Trials Sites 
PI's Name 
Site's Role 
Hartford Healthcare 
Andrew Salner, MD 
Data Collection 
 
 
 
Participating Institutions – If multicenter 
study coordinated by MSK: 
PI's Name 
Site's Role 
Columbia University 
Rebecca Schnall, PhD 
Data Analysis 
 
 
Memorial Sloan Kettering Cancer Center 
1275 York Avenue 

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Memorial Sloan Kettering Cancer Center 
IRB Number: 15-245 A(7) 
Approval date: 15-Feb-2018 
 
 
 
 
New York, New York 10065 

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Memorial Sloan Kettering Cancer Center 
IRB Number: 15-245 A(7) 
Approval date: 15-Feb-2018 
 
 
 
 
Table of Contents 
1.0 
PROTOCOL SUMMARY AND/OR SCHEMA ....................................................................... 4 
2.0 
OBJECTIVES AND SCIENTIFIC AIMS ................................................................................ 6 
3.0 
BACKGROUND AND RATIONALE ..................................................................................... 6 
4.0 
OVERVIEW OF STUDY DESIGN/INTERVENTION ................................................................... 8 
4.1 
Design...................................................................................................................................8 
4.2 
Intervention ................................................................................................................................ 9 
5.0 
CRITERIA FOR SUBJECT ELIGIBILITY ............................................................................... 13 
5.1 
Subject Inclusion Criteria ..................................................................................................... 13 
5.2 
Subject Exclusion Criteria ................................................................................................... 14 
6.0 
RECRUITMENT PLAN .................................................................................................................... 14 
7.0 
ASSESSMENT/EVALUATION PLAN ................................................................................. 16 
8.0 
TOXICITIES/SIDE EFFECTS .................................................................................................... 20 
9.0 
PRIMARY OUTCOMES ..................................................................................................... 20 
10.0 
CRITERIA FOR REMOVAL FROM STUDY ....................................................................... 21 
11.0 
BIOSTATISTICS ............................................................................................................... 22 
12.0 
RESEARCH PARTICIPANT REGISTRATION AND RANDOMIZATION PROCEDURES 
24 
12.1 
Research Participant Registration ....................................................................................... 24 
Confirm eligibility as defined in the section entitled Criteria for Patient/Subject Eligibility .............. 24 
12.2 
Randomization .................................................................................................................... 25 
13.0 
DAT A M ANAGEMENT ISSUES ........................................................................................ 25 
13.1 
Quality Assurance............................................................................................................... 26 
13.2 
Data and Safety Monitoring .................................................................................................... 26 
14.0 
PROTECTION OF HUMAN SUBJECTS ............................................................................ 28 
14.1 
Privacy ................................................................................................................................ 29 
14.2 
Serious Adverse Event (SAE) Reporting ................................................................................ 29 
14.2.1  ........................................................................................................................................  32 
15.0 
INFORMED CONSENT PROCEDURES................................................................................... 32 
16.0 
REFERENCES ....................................................................................................................... 33 
17.0 
APPENDICES ................................................................................................................... 39 

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Memorial Sloan Kettering Cancer Center 
IRB Number: 15-245 A(7) 
Approval date: 15-Feb-2018 
 
 
 
 
 
 
1.0 
PROTOCOL SUMMARY AND/OR SCHEMA 
 
Title 
Feasibility Study of the Head and Neck Survivorship Tool: 
Assessment and Recommendations (HN-STAR) 
Objective 
Assess the feasibility of implementing HN-STAR in clinical 
practice to prepare for a future evaluation trial. 
Study Aims 
1. Determine the usability and feasibility of HN-STAR. 
2. Assess preliminary metrics  of HN-STAR use in 
preparation for a multi-site randomized controlled trial. 
Patient Population 
Patients who have completed treatment for head and neck cancer 
at least one year prior and are eligible, scheduled, or due for a 
routine follow-up at a survivorship clinic at MSK or Hartford 
Healthcare (HH). 
Treatment Plan 
None 
Intervention 
Patients visiting a head and neck cancer survivorship clinic and 
their nurse practitioner will use HN-STAR‟s web-based interfaces 
to provide patient information that will first create a discussion 
guide for the clinic visit and then create a survivorship care plan 
for the patient and the primary care provider. 
Study Design 
Aim 1: Part 1. Component Pilot Testing: Patients at MSK and their 
nurse practitioner will complete usability testing for all parts of the 
HN-STAR process. 
Aim 1: Part 2. After incorporating changes to HN-STAR resulting 
from feedback in Aim 1: Part 1, patients visiting the MSK or HH 
head and neck cancer survivorship clinic will use HN-STAR for a 
routine clinic visit. Patients and their primary care providers will 
provide feasibility feedback. 
Assessment 
Usability outcomes will come from patient surveys and interviews, 
and a nurse practitioner interview in Aim 1: Part 1. In Aim 1: Part 
2, patients and their primary care providers will complete online 
surveys regarding feasibility. Nurse practioners will be interviewed 
at the end of Aim 1: Part 2. Health outcomes and data regarding 
health care actions will be collected from HN-STAR and the clinic 
note will be collected to assess feasibility of collecting these 
metrics in a future trial. 
 
 
Survivors of head and neck cancer have a complex set of ongoing health needs. People 
who have completed treatment for head and neck cancer commonly experience severe 
long-term toxicities, late-occurring symptoms, and significant risks of second primary 
malignancy and comorbid illnesses. With multiple simultaneous health issues, health care 
providers often fail to comprehensively address the needs of these complex cancer 
survivors. 
 
This study evaluates the use of a new, secure, web-based tool in the head and neck 
cancer survivorship clinic at MSK and adult survivorship clinic at HH. The Head and Neck 
Survivorship Tool: Assessment and Recommendations (HN-STAR) uses electronically 
collected data from patients and nurse practitioners (NPs) to create a discussion guide for 

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Memorial Sloan Kettering Cancer Center 
IRB Number: 15-245 A(7) 
Approval date: 15-Feb-2018 
 
 
 
 
a routine clinic visit and a survivorship care plan. Figure 1 shows how HN-STAR integrates 
patient-reported outcomes from the Survivor Self-Assessment (1) and medical record data 
from the Treatment Checklist (2) to create an Interactive Discussion Guide (3) that the NP 
can use to structure the clinic visit. Lastly, HN-STAR creates a survivorship care plan 
based on the clinic visit, and it is given to the survivor (4) and the primary care provider (5). 
 
 
Figure 1: Study Summary 
 
 
 
 
This study evaluates the usability and feasibility of HN-STAR from the perspective of key 
stakeholders, so that we can study its effectiveness in a future multi-center trial. We will 
enroll 55 head and neck cancer survivors who are seen in an NP-led survivorship clinic and 
implement HN-STAR for their routine survivorship visits. The study will take place in two parts. In 
Aim 1: Part 1, we will assess usability and feasibility outcomes of HN-STAR from the perspective 
of key stakeholders, and in Aim 1: Part 2 we will assess the planned outcomes intended for the 
larger trial. We will collect usability and feasibility data from online surveys of survivors and their 
providers. In Aim 2, we will collect preliminary data on relevant health actions to inform the 
feasibility of collecting these data in a future trial. 
 
Figure 2. Study Schema 
 
 

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Memorial Sloan Kettering Cancer Center 
IRB Number: 15-245 A(7) 
Approval date: 15-Feb-2018 
 
 
 
 
 
 
2.0 
OBJECTIVES AND SCIENTIFIC AIMS 
 
Aim 1. Determine the usability and feasibility of HN-STAR. 
 
We will evaluate the components of HN-STAR in two parts. In Aim 1: Part 1, survivors at MSK 
(N=10) and their nurse practitioner (N=1) will provide in-depth feedback on the usability of HN- 
STAR. 
 
After refining HN-STAR, Aim 1: Part 2 will elicit feedback from survivors at MSK (N=30) and 
Hartford HealthCare (N=15) and the survivors‟ primary care providers (N=45) regarding feasibility 
of HN-STAR in clinical practice. The nurse practitioners (N=2) will provide in-depth feedback on 
the usability of HN-STAR. 
 
Aim 2. Assess preliminary metrics  of HN-STAR use in preparation for a multi-site randomized 
controlled trial. 
 
Using data from survivors in Aim 1: Part 2 (N=45), we will abstract data on health care actions 
from both the medical record and HN-STAR. Such data include receipt of appropriate oncologic 
surveillance, identification and management of symptoms, and appropriate preventive health 
services, as indicated by referrals, prescriptions, and recommendations in both clinic notes and 
the HN-STAR Survivor Self-Assessment. This Aim will determine the feasibility of data collection, 
establish baseline health status measures, and contribute to power calculations for the future trial. 
 
3.0 
BACKGROUND AND RATIONALE 
 
After cancer treatment is complete, cancer survivors need a new approach to their ongoing care. 
Comprehensive survivorship care involves routine surveillance for recurrence and new cancers, 
detection and management of chronic and late-developing toxicity (together called late effects), 
and management of comorbid conditions. For some survivors, the risks of recurrence and late 
effects are low, and a primary care provider can effectively oversee comprehensive survivorship 
care with minimal involvement of oncology providers. Other groups of cancer survivors, however, 
have more complex needs and require continued follow-up with their oncology providers.1 
 
Head and neck cancer patients are one such group of complex cancer survivors who confront 
numerous and serious health challenges beyond the risk of local recurrence. Advances in 
treatment, specifically concurrent radiation and chemotherapy, have improved survival in head 
and neck cancer but have also led to an increase in chronic and late-developing toxicity.2-7  Some 
common late effects include hearing loss, dry mouth, decreased taste, neck fibrosis, and 
lymphedema in the neck and face.8-11  More debilitating late effects include destruction of the jaw, 
inability to speak, difficulty swallowing, and difficulty opening the mouth.
12 -16  Up to half of head 
and neck cancer survivors are diagnosed with psychological distress.17-19 
 
Because many head and neck cancers arise in the setting of chronic tobacco or alcohol exposure, 
these patients also often have other tobacco-related comorbid illnesses, such as other cancers, 
pulmonary disease, and cardiovascular disease and can have multiple non-cancer health care 
providers.
20-26
 

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Memorial Sloan Kettering Cancer Center 
IRB Number: 15-245 A(7) 
Approval date: 15-Feb-2018 
 
 
 
 
 
Recently, there has been a dramatic rise in the incidence of head and neck cancer due to human 
papillomavirus (HPV).
27,28  Patients with HPV-related disease differ in that they have excellent 3- 
year tumor control rates, are on average younger at diagnosis, and have lower rates of comorbid 
illnesses.
29,30  As a result, HPV-positive survivors are likely to live years or decades beyond 
diagnosis. Longer survival translates to more years at risk for late-developing serious toxicities of 
treatment, such as radiation-related carotid artery stenosis and second malignancies – both of 
which develop many years after primary treatment.25,31,32  Taken together, then, head and neck 
cancer survivors are a heterogeneous population with the potential to develop multiple, serious 
health issues. 
 
With such complex needs, comprehensive survivorship care may be difficult to deliver. The 
central focus of survivorship care in head and neck cancer is early identification of recurrent and 
second head and neck cancers.1  Although surveillance by oncology providers also includes the 
identification and management of late effects, there is no central clearinghouse for guidelines or 
standards in head and neck cancer, suggesting that methods for addressing late effects are likely 
ad hoc. Beyond oncologic surveillance, coordinated primary care is necessary to improve 
survival. Primary care should include aggressive management of comorbid illnesses, risk 
modification (e.g. tobacco-cessation), completion of recommended cancer screening, vaccination, 
and receipt of general preventive care.
21,33  Unfortunately, in one study, only half of head and neck 
cancer survivors reported even seeing a primary care provider.34 
 
Addressing multiple medical issues simultaneously, and identifying which provider is responsible 
for management, can complicate a cancer survivor‟s ongoing care. In its landmark report, From 
Cancer Patient to Cancer Survivor: Lost in Transition, the Institute of Medicine ( IOM) 
recommended the use of survivorship care plans to facilitate coordination of survivorship care 
between oncology and primary care providers.35  A survivorship care plan is a document given to 
the patient by oncology providers at the end of treatment that includes 1) a treatment summary 
and 2) a plan of care describing late effects and recommendations for interventions and self- 
management.35  The survivorship care plan, which is shared with the primary care provider, 
includes explicit plans for who is responsible for each aspect of care. Survivorship experts have 
widely endorsed the use of survivorship care plans, and multiple professional societies have 
encouraged their use.36- 43  In their 2012 accreditation standards, the Commission on Cancer called 
for the implementation of a “process to disseminate a comprehensive care summary and follow- 
up plan” to all patients who have completed cancer treatment.44  However, the development and 
consistent implementation of survivorship care plans in clinical practice have been challenging.45- 
51 The major barriers to the use of survivorship care plans are the time and personnel required to 
create them and the difficulty reviewing their content during routine visits.45-49,51  These barriers 
may be particularly problematic for complex cancer survivors, like head and neck cancer 
survivors, who may have multi-modality treatment histories, have treatment-based surveillance 
recommendations, experience numerous persistent toxicities, be at risk for late effects, require 
management of comorbidities, and need modification of multiple risk factors – all of which should 
to be noted in survivorship care plans. 
 
We developed a web-based, algorithm-driven platform called the Head and Neck Survivorship 
Tool: Assessment and Recommendations (HN-STAR) to address the most salient issues in 
providing comprehensive survivorship care to head and neck cancer survivors. First, HN-STAR 
ensures the identification of all late effects by collecting symptom data directly from patients. It 
then synthesizes patient-reported outcomes, treatment data, and current evidence about 
survivorship care into a tailored Interactive Discussion Guide. The oncology provider uses the 
Interactive Discussion Guide in a routine oncology follow-up visit to address all elements of 

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Memorial Sloan Kettering Cancer Center 
IRB Number: 15-245 A(7) 
Approval date: 15-Feb-2018 
 
 
 
 
comprehensive survivorship care. Finally, HN-STAR automatically creates the Survivorship Care 
Plan based on the clinic visit, which minimizes burden for oncology providers. This Survivorship 
Care Plan is updated at each visit to incorporate symptom changes, modified management plans, 
and more current evidence regarding survivorship care. 
 
The goal of our proposal is to evaluate the feasibility of HN-STAR in the setting of 
survivorship clinics, in preparation for a future multi-site randomized controlled trial. The 
future trial will randomize clinics at multiple centers to use HN-STAR or usual care, and the 
primary outcomes will be changes in 1) the number of late effects identified and 2) the number of 
late effects managed in clinic. We will also investigate adherence to recommended care and any 
changes in health outcomes. The current protocol is a necessary feasibility study to inform 
preliminary outcomes, design, and sample size for the future trial. 
 
 
4.1 
OVERVIEW OF STUDY DESIGN/INTERVENTION 
 
4.2 
Design 
 
This is a pilot study of HN-STAR for routine follow-up visits in two survivorship clinics – the Head 
and Neck Survivorship Clinic at MSK and the Survivorship Clinic of the Gray Cancer Center. 
 
Patient Survivorship Program at HH. Each clinic is led by a single NP, Ms. Janet McKiernan at 
MSK (co-Investigator) and an NP at HH, Ms. Deborah Walker, who is a co-investigator on the HH 
study team. Each hospital has determined patient eligibility for the clinic. The head and neck 
survivors seen in each clinic have completed treatment for head and neck cancer at least one 
year prior and have no evidence of disease. In standard care, the NP provides oncologic follow- 
up, creates and delivers a survivorship care plan, addresses healthy behaviors, and ensures that 
the survivor has a primary care provider who will manage general preventive care. 
 
For this pilot study, we will incorporate HN-STAR into a routine NP-led survivorship visit, in order 
to assess feasibility of HN-STAR in clinical practice. For a single routine visit, each patient will 
report his or her medical history, preventive care, and symptoms online, and this information (as 
well as other medical history information) will populate an Interactive Discussion Guide for the NP 
to use in the clinic visit. In Aim 1: Part 2 of the study, each patient and his or her primary care 
provider (PCP) will receive the automatically generated Survivorship Care Plan. This study will 
use surveys at multiple time points during this process to elicit usability and feasibility data from 
patients, NPs, and PCPs regarding the use of this system (Aim 1). 
 
This study also includes non-survey outcomes assessments. HN-STAR will automatically collect 
patient reports about symptoms, preventive care, and medical history. Other oncology-related 
outcomes (such as referrals, medications, and other treatment decisions) will appear in the clinic 
note for each visit. Both data sources will be used to establish baseline measures and inform 
feasibility of collecting data for a future trial (Aim 2). In addition, as part of Aim 2, the oncology- 
related metrics from the clinic visit will enable us to gain preliminary insight into changes after HN- 
STAR, using a pretest-posttest design. 
 
Data collection will take place in two parts. Aim 1: Part 1 will enroll 10 patients at MSK to 
participate in component pilot testing and usability testing of HN-STAR and the associated 
surveys. We will also elicit feedback from the NP. After incorporating any changes to HN-STAR or 
the surveys based on findings from Aim 1: Part 1, Aim 1: Part 2 will enroll 30 additional patients 

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Memorial Sloan Kettering Cancer Center 
IRB Number: 15-245 A(7) 
Approval date: 15-Feb-2018 
 
 
 
 
from MSK and 15 from HH to provide feedback on usability. We will also survey each patient‟s 
PCP in Aim 1: Part 2. We will also elicit feedback from the NPs. 
 
 
4.3 
Intervention 
 
We have created HN-STAR in consultation with the Web Survey Core Facility (Web Core) at 
MSK, which develops web-based platforms that integrate data from online patient self- 
assessments and MSK records.52  HN-STAR has four components, described below. 
4.2.1 First, the HN-STAR Survivor Self-Assessment elicits the presence and burden of toxicities 
using relevant items from the National Cancer Institute‟s Patient-Reported Outcomes version of 
the Common Terminology Criteria for Adverse Events (PRO-CTCAE).53  (Survivor Self- 
Assessment, Appendix A) For symptoms that are specific to head and neck cancer but not 
included in existing PRO-CTCAE measures, we have created items using the same format and 
symptom attributes as existing items. In addition, the Survivor Self-Assessment includes items 
regarding medical history and preventive health. Items from validated screening instruments are 
used to screen for alcohol misuse, tobacco use, physical activity, sexual function, and depression, 
as shown in Table 1.
54-58  For other health behaviors, ad hoc assessments are based upon 
guidelines and institutional consensus at MSK.59-66 For Aim 1: Part 1, participants will fill out the 
Survivor Self-Assessment online in a designated room in the clinic as part of the usability testing. 
For Aim 1: Part 2, patients fill out the Survivor Self-Assessment online before the visit, either at 
home or in the clinic waiting room. 

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Memorial Sloan Kettering Cancer Center 
IRB Number: 15-245 A(7) 
Approval date: 15-Feb-2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 1.Standardized Items in Survivor Self-Assessment 
H&N 
Source 
Symptom: memory, insomnia, fatigue, tiredness, or lack of 
energy, numbness or tingling in your hands or feet, 
shortness of breath, cough, ringing in your ears, dry 
mouth, voice changes, nosebleeds, mouth or throat 
sores, pain (general), difficulty swallowing, dizziness 
PRO-CTCAE53 
Symptom: difficulty hearing, neck or shoulder stiffness, neck 
pain, jaw pain, pain in your mouth, pain in your throat, 
frequency of pain (general), difficulty with  opening your 
mouth, bad breath, bleeding from your mouth 
Based on PRO-CTCAE 
Symptom: Sexual function 
EORTC QLQ – H&N3567 
Symptom: Depression 
PHQ-255 
Physical Activity: Frequency 
Godin Leisure-Time Exercise 
Questionnaire56 
Physical Activity: Average exercise time 
Current MSK Survivorship Patient 
Assessment 
(Based on the Godin Leisure-Time 
Exercise Questionnaire) 
Smoking Status: At least 100 cigarettes in entire life 
National Health Interview Survey68 
Smoking Status: Years as a smoker 
Lung Cancer Screening Decision Tool
69
 
Smoking Status: Current smoking 
Current MSK Survivorship Patient 
Assessment 
(Based on the National Health Interview 
Survey) 
Cigarettes per day 
Current MSK Survivorship Patient 
Assessment 
Alcohol use 
The CAGE questionnaire54  

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Memorial Sloan Kettering Cancer Center 
IRB Number: 15-245 A(7) 
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4.2.2 The Treatment Checklist (Appendix B) collects claims data about the head and neck 
cancer diagnosis and treatment, which will then be translated into lay language. This will be done 
differently at the two participating sites. At MSK, HN-STAR generates an Automated Treatment 
Checklist, which presents an organized list of diagnosis, staging and treatment received at MSK 
using claims data from billing codes in the MSK record. The NP is prompted to verify the accuracy 
of the presented list and make necessary corrections. At HH, where claims data will not be 
automatically ported to HN-STAR, there is a Manual Treatment Checklist, in which all possible 
diagnosis and treatment options are presented as an organized checklist. The NP must manually 
complete the Manual Treatment Checklist by referring to the patients‟ medical records. At either 
institution, once a patient has agreed to participate in the study, prior to the participant‟s 
survivorship clinic visit, the NP will verify or complete the checklist. The checklist will result in the 
generation of a lay language treatment summary that will appear in the Survivorship Care Plan 
(described below in section 4.2.4). The NPs at both sites will be trained on how to use the 
Treatment Checklist. 
 
4.2.3 The Interactive Discussion Guide (Appendix M) integrates data from the Survivor Self- 
Assessment, data from the Treatment Checklist, and data regarding evidence-based survivorship 
care. Three algorithms will then use these data to generate the Interactive Discussion Guide that 
the NP can use during the routine visit. 
 
1. Treatment algorithms use Current Procedural Terminology (CPT) codes and National 
Comprehensive Cancer Network (NCCN) guidelines to generate personalized surveillance 
recommendations (e.g., annual thyroid studies for survivors who received radiation to 
neck).1 
 
2. Symptom algorithms use PRO-CTCAE responses to identify toxicities of treatment and 
other relevant issues to address. In the Interactive Discussion Guide, seen only by the NP, 
these symptoms populate an evidence-based list of common diagnosis to consider 
evaluation and management options. We have developed these recommendations based 
on existing evidence when available and institutional consensus within MSK and approval 
from HH otherwise. We will refine these guidelines as new evidence emerges.
38,70-81
 
 
3. Prevention algorithms use patient responses and demographic information to generate a 
list of personalized prevention recommendations, based on guidelines from the United 
States Preventive Service Task Force and the NCCN survivorship guidelines.
1,59-66,82- 85 
Using the Interactive Discussion Guide, the NP will discuss ongoing care and select 
management plans with the survivor. Selected symptom management plans are entered 
into HN-STAR and populate the Survivorship Care Plan (described below). 
 
None of the patients will see the Interactive Discussion Guide, which is intended only for the NP 
to use during the clinic visit. An example of content of Interactive Discussion Guide is shown 
below in Figure 3. The NP at each site will be trained on how to use the Interactive Discussion 
Guide. 

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Memorial Sloan Kettering Cancer Center 
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Figure 3. Excerpt of Interactive Discussion Guide for Insomnia 
 
 
 
SYMPTOM: INSOMNIA 
Frequency: Occasional Severity: Moderate Interference with usual activities: Very Much 
Common diagnoses to consider (Check any diagnoses or ongoing work-up below.) 
□ Medications 
□ Anxiety/Depression 
□ Sleep Apnea 
□ Insomnia 
□ Pain 
□ Other 
□ Work-up is ongoing. 
Focused Evaluation 
History 
• 
Onset, duration, change over time, alleviating/aggravating factors 
• 
Nature of the sleep problem – sleeping at night, daytime sleepiness 
• 
Assess for sleep apnea 
• 
Medication and alcohol use review 
• 
Sleep hygiene – total sleep time, sleep latency, daytime napping, circadian rhythm, sleep 
environment 
Physical exam 
• 
Assess for increased neck size or obesity indicating possible causes of sleep apnea 
Recommendations for evaluation and management (Check all that apply.) 
□ Referral to primary care provider 
□ Sleep log 
□ Sleep hygiene review (routine of bed time and awakening, light exposure, avoiding naps, and 
only being in bed to sleep) 
□ Consider discontinuing or reducing use of steroids, opioids, anti-depressants. 
□ Physical activity (moderate aerobic exercise for 2.5 hours a week and strength training 2-3 days 
a week) 
□ Referral to psychology (MSK) 
□ Referral to psychology (outside) 
□ Referral to integrative medicine (MSK) 
□ Prescription for sleep aide 
□ Patient education material on sleep 
□ Video on sleep 
□ Not discussed because chronic and previously addressed 
□ Other (Note names of providers or other details not described above) 

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4.2.4 Finally, the Survivorship Care Plan will present a treatment summary and plan of care. 
HN-STAR generates a Survivorship Care Plan after each visit (See template in Appendix C). The 
treatment summary contains a plain-language cancer history. The plan of care contains 
personalized recommendations for cancer surveillance, management of late effects, and 
preventive care. It also reports a list of non-cancer conditions reported by the patient. Each 
recommendation includes a schedule and clear delineation of who is responsible. The plan of 
care also contains generic survivorship information, with a description of signs and symptoms to 
report to the oncology provider, contact information for the oncology provider, and 
recommendations to visit a primary care provider. 
 
4.2.5 Clinical flow using HN-STAR 
 
1. Before the survivorship visit: At MSK, the institutional database of CPT codes will automatically 
populate the Automated Treatment Checklist in HN-STAR, and the NP will verify its accuracy. 
At HH, the NP will complete the Manual Treatment Checklist. At both sites, the Treatment 
Checklist will inform treatment-based recommendations in the Interactive Discussion Guide 
and generate a plain-language treatment summary for the Survivorship Care Plan. 
 
2. Before the survivorship visit, survivors will complete the online Survivor Self-Assessment. 
Using the Survivor Self-Assessment and Treatment Checklist data, HN-STAR will create the 
Interactive Discussion Guide for the clinic visit that presents 1) an oncologic surveillance 
schedule, 2) a list of severity-based symptom management options, and 3) personalized 
preventive care and screening recommendations. 
 
3. During the visit, the NP will use the Interactive Discussion Guide to facilitate conversation. 
Specifically, the NP and survivor will discuss ongoing care, select plans for symptom 
management, and identify who is responsible for each action (NP, survivor, or primary care 
provider). 
 
4. At the end of the visit, the Treatment Checklist will be combined with the selected plan of care 
from the visit in the Survivorship Care Plan. At the end of the visit, the Survivorship Care Plan 
will be given to the survivor and discussed with the survivor.For Aim 1: Part 2, after the visit, the 
Survivorship Care Plan will be sent to each survivor‟s primary care provider. 
 
5.0 
CRITERIA FOR SUBJECT ELIGIBILITY 
 
 
5.1 
Subject Inclusion Criteria 
Aim 1: Part 1 
 
Patients must: 
• 
Have completed treatment for head and neck cancer at least 1 year prior to 
survivorship visit and have no evidence of disease 
• 
Be able to provide informed consent 
• 
Be able to speak and read English 
• 
Be at least 18 years old 
 
Aim 1: Part 2 
 
Patients must: 

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• 
Have completed treatment for head and neck cancer at least 1 year prior to 
survivorship visit and have no evidence of disease 
• 
Have a primary care provider 
• 
Be able to provide informed consent 
• 
Be able to speak and read English 
• 
Be at least 18 years old 
 
 
5.2 
Subject Exclusion Criteria 
 
Subject exclusion criteria for patients recruited to Aim 1: Parts 1 and 2 is the same. 
 
• 
Patients or providers who cannot speak or read English 
• 
Patients with cognitive, visual, or motor impairment such that they cannot 
complete the Survivor Self-Assessment as assessed by the research team. 
 
 
6.0 
RECRUITMENT PLAN 
 
Recruitment Plan (with Limited waiver of Authorization) 
Potential research subjects will be identified by a member of the patient‟s treatment team, the 
protocol investigator, or research team at Memorial Sloan Kettering Cancer Center (MSKCC). 
 
The principal investigator may also screen the medical records of patients with whom they do not 
have a treatment relationship for the limited purpose of identifying patients who would be eligible 
to enroll in the study and to record appropriate contact information in order to approach these 
patients regarding the possibility of enrolling in the study. 
 
During the initial conversation between the investigator/research staff and the patient, the patient 
may be asked to provide certain health information that is necessary to the recruitment and 
enrollment process. The investigator/research staff may also review portions of their medical 
records at MSKCC in order to further assess eligibility. They will use the information provided by 
the patient and/or medical record to confirm that the patient is eligible and to contact the patient 
regarding study enrollment. If the patient turns out to be ineligible for the research study, the 
research staff will destroy all information collected on the patient during the initial conversation 
and medical records review, except for any information that must be maintained for screening log 
purposes. 
 
In most cases, the initial contact with the prospective subject will be conducted either by the 
treatment team, investigator or the research staff working in consultation with the treatment team. 
The recruitment process outlined presents no more than minimal risk to the privacy of the patients 
who are screened and minimal PHI will be maintained as part of a screening log. For these 
reasons, we seek a (partial) limited waiver of authorization for the purposes of (1) reviewing 
medical records to identify potential research subjects and obtain information relevant to the 
enrollment process; (2) conversing with patients regarding possible enrollment; (3) handling of PHI 
contained within those records and provided by the potential subjects; and (4) maintaining 
information in a screening log of patients approached (if applicable). 
 
This limited waiver applies only to MSK.  HH will obtain a limited waiver of authorization for their 
site. 

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Aim 1: Part 1: Component pilot testing 
 
Head and neck cancer survivors. Aim 1: Part 1 will be completed at MSK. We will recruit 10 
patients (meeting eligibility criteria described in Section 5.0, above) to participate in end-user 
testing with a Research Study Assistant (RSA) before and after an HN-STAR-guided routine 
clinic visit. Patients scheduled to be seen at the Head and Neck Cancer Survivorship Clinic at 
MSK will be screened for eligibility Two weeks before each patient‟s scheduled survivorship 
clinic visit, eligible head and neck cancer survivors will be invited by mail to participate in the 
HN-STAR study. A consenting professional will follow-up with a phone call. At least three 
attempts will be made to reach the patient by phone. When the consenting professional 
reaches the patient by phone, she will describe the study and invite interested and eligible 
patients to participate. During the phone call, the consenting professional will follow a 
standard consent script that describes the study and confirms eligibility.  Interested and 
eligible participants will be asked to provide consent.  Participants who are not interested in 
participating will not be contacted again.  As part of the verbal consenting process, reasons for 
non-participation may be asked in order to identify whether the study recruitment strategy is 
adequate. Patients will be consented over the phone before arriving to the clinic for their visit. 
 
Because we want to sample a range of responses representing a diverse group of survivors, 
we will enrich for minorities in this group by enrolling no more than 7 white non-Hispanic 
patients. After enrolling 7 white non-Hispanic patients, if we have not yet enrolled 10 total 
patients, we will only invite non-white or Hispanic patients to participate until 10 patients enroll. 
With over 20 new survivors seen in the Head and Neck Cancer Survivorship Clinic at MSK 
clinic each month, this will not hinder enrollment. 
 
Patients who participate in Aim 1: Part 1 of the study, will receive $100 to provide thanks for 
their time and effort and a voucher to cover their parking fee, for those participants who drive. 
 
NP. We will be asking the MSK NP to provide feedback (via survey and interview) about her 
experience using HN-STAR. Through the consent process, participants will understand that 
their NP will be surveyed and interviewed about HN-STAR as part of the study. The NP 
responsible for head and neck cancer survivors will be asked to provide written consent to 
participate. 
 
Aim 1: Part 2: Feasibility in clinical practice 
There is a designated RSA at MSK and HH who will be responsible for recruitment, 
enrollment, data collection and study management at their respective site. 
 
Head and neck cancer survivors. We will recruit an additional 45 survivors (30 from MSK and 
15 from HH) to participate in Aim 1: Part 2 for feasibility testing. Patients who are eligible, 
scheduled, or due to be seen at the survivorship clinic at MSK and HH will be invited by mail 
to participate in the HN-STAR study. The patient will be able to opt out of the study by 
contacting the RSA. If the patient does not opt out, research staff at MSK or HH will follow-up 
with a phone call. At least three attempts will be made to reach the patient by phone. When 
the consenting professional at the respective site reaches the patient by phone, she will 
describe the study and invite interested and eligible patients to participate. The consenting 
professional will follow a standard consent script as described above.  Patients will be 
consented over the phone with the RSA from their respective study site before completing the 

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Survivor Self-Assessment before the clinic visit. However, unlike Aim 1: Part 1, participants 
can complete the Survivor Self-Assessment online at home or in the waiting room before the 
clinic appointment. 
 
Similar to Aim 1: Part 1, we will enrich for minorities in the MSK clinic by enrolling no more 
than 20 white non-Hispanic patients at MSK. After enrolling 20 white non-Hispanic patients 
from MSK, if we have not yet enrolled 30 total patients from MSK, we will only invite non-white 
or Hispanic patients to participate until 30 patients enroll. With over 20 new survivors seen in 
this clinic each month, this will not hinder enrollment. 
 
At each study site, each study participant will receive $50 from the RSA at their study site to 
provide thanks for their time and effort immediately following completion of the final study 
survey.  This is less than the $100 incentive for patients in Aim 1: Part 1 because the time and 
effort will be less for these participants. 
 
NP. We will be asking the MSK and HH NP to provide feedback (via survey and interview) 
about their experience using HN-STAR. Through the consent process, participants will 
understand that their NP will be surveyed and interviewed about HN-STAR as part of the 
study. The NPs responsible for head and neck cancer survivors will be asked to provide 
written consent to participate. 
 
Primary care providers. After a participant has attended the survivorship clinic visit and 
received the Survivorship Care Plan, their identified PCP will be mailed the Survivorship Care 
Plan, consistent with current practice. One week later, at each site, the RSA will contact the 
primary care provider associated with the participant by mail and follow up by telephone to 
invite them to complete an online survey. Through the consent process, patient participants 
will understand that their PCPs will be contacted and surveyed as part of the study. The RSA 
at each site will attempt to recruit all 45 primary care providers by trying to reach them by 
phone for at least one month but no more than 6 weeks after the initial call. We will not 
explicitly consent the PCP‟s, because they will not provide any PHI, and the study is minimal 
risk. Their participation is optional, and we will consider completion of the survey as 
agreement to participate. We anticipate that not all 45 PCP‟s will complete the survey; this is 
one of the feasibility benchmarks of our study. 
 
PCP‟s may complete the survey over the phone with the RSA, by paper form and return by 
mail, or  log in to the survey. After completing the online survey, each participating primary 
care provider will receive a $100 electronic gift card via email to provide thanks for their time 
and effort. This anonymous payment procedure has been used successfully in the past as 
part of protocol (#X09-007, Practice-Based Research Networks (PBRN) Primary Care 
Providers Survey, PI: Salz). 
 
We anticipate that we will complete recruitment for both Aim 1: Part 1 and Aim 2: Part 2 within 
18 months of opening the protocol. 
 
 
7.0 
ASSESSMENT/EVALUATION PLAN 
 
Data collection will take place at both MSK and HH by trained RSAs. Patients will be assigned a 
unique study identification number independent of the patients‟ medical record number.  Data will 
be stored on the secure MSK network drive housed in the Department of Epidemiology and 

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Biostatistics at MSK. Interview data will be analyzed jointly with Columbia University, a Data 
Analysis site. 
 
7.1 Usability Assessments 
 
Aim 1: Part 1: Component pilot testing. Usability testing will evaluate how easily and appropriately 
users interact with each component of HN-STAR. We will recruit 10 patients from MSK‟s Head 
and Neck Cancer Survivorship Clinic to participate in end-user testing of the self-assessment and 
the Survivorship Care Plan. 
 
7.1.1 Survivor Self-Assessment (Appendix A): Each survivor will arrive 1 hour before their 
scheduled routine visit at the clinic. He or she will complete the Survivor Self-Assessment 
with a RSA in a private room in the Survivorship Clinic before a routine visit. 
 
7.1.2 Survivor Post-Assessment Survey (Appendix D): Participants will then complete the 
Survivor Post-Assessment Survey regarding perceptions of information quality, system 
quality, and usefulness of the Survivor Self-Assessment.88,89  Feedback from 10 survivors 
should identify most usability issues with HN-STAR.90 
7.1.3 Survivor Post-Assessment Interview (Appendix N): After the survivor completes the 
Survivor Self-Assessment and the Survivor Post-Assessment Survey, the RSA will 
interview the survivor, asking whether items were clearly presented, whether any 
symptoms were missed, and whether response options made sense. This conversation 
will supplement the Survivor Post-Assessment Survey by providing in-depth information 
when needed. This interview will be audio-recorded. 
 
7.1.4 Survivorship Care Plan (Appendix C). After thePost Assessment Interview, the 
patient will proceed to the clinic visit room for the routine follow-up visit. The NP will use 
the Interactive Discussion Guide during the clinic visit, and the survivor will receive the 
automatically generated Survivorship Care Plan at the end of the visit. 
7.1.5 Survivor Post-Visit Survey (Appendix E): Following thevisit , the participant will return 
to the private room with the RSA  to complete the Survivor Post-Visit Survey. The Survivor 
Post-Visit Survey elicits participant opinion on the role of the Survivor Self-Assessment in 
the clinic visit and the ease of use of, satisfaction with, and perceived usefulness of the 
Survivorship Care Plan.88,89,91,92 
 
7.1.6 Survivor Post-Visit Interview (Appendix O): After the survivor completes the Post- 
Visit Survey, the RSA will interview the survivor, asking about the ease of use of, 
satisfaction with, and perceived usefulness of the visit and Survivorship Care Plan. This 
conversation will supplement the Survivor Post-Visit Survey by providing in-depth 
information when needed. This interview will be audio-recorded. 
 
 
7.1.7 Nurse Practitioner Post-Visit Survey.(Appendix F): Directly after each clinic visit, the 
NP will complete one brief online survey for each participant. The Nurse Practitioner Post- 
Visit Survey focuses on the experience using the Interactive Discussion Guide during the 
visit. Specifically, it will assess whether the Interactive Discussion Guide presented a 
complete list of issues for the patient, whether it contained irrelevant information, and the 
length of the visit.
93-95  Survey responses will be recorded and stored electronically with 
Web Core. 

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7.1.8 Nurse Practitioner Interview: After all 10 participants have completed usability  
testing, the RSA will conduct a qualitative interview with the NP (Ms. McKiernan) to 
evaluate any problems with, or strengths of, the Interactive Discussion Guide and whether 
the usefulness or usability of the Interactive Discussion Guide varied by type of patient 
seen in clinic. This interview will take place with the RSA and the NP in a private office and 
will be audio recorded. The interview guide is included as Appendix K. 
 
7.2 Feasibility Assessments 
 
Aim 1: Part 2: Feasibility in clinical practice 
 
Feasibility testing involves evaluating whether HN-STAR can move forward to evaluation in a 
clinical trial setting. Before beginning Aim 1: Part 2, we will address findings from Aim 1: Part 1 by 
making changes to HN-STAR and the accompanying surveys. This will be done once, after the 
completion of Aim 1: Part 1. 
 
7.2.1 Survivor Post-Assessment Survey.(Appendix D)  After integrating feedback from Aim 
1: Part 1 into HN-STAR and the accompanying surveys, an additional 45 survivors (30 
from MSK and 15 from HH) will be recruited and will provide informed consent over the 
phone (see section 6.0). The participants will complete the Survivor Self-Assessment 
online (on a computer or tablet, at home or in the clinic waiting room) within two weeks of a 
routine scheduled visit. The Survivor Post-Assessment Survey (adapted, if needed, from 
Aim 1: Part 1) will immediately follow the Survivor Self-Assessment.
88,89  Survey responses 
will be recorded and stored electronically with Web Core. 
 
7.2.2 Survivor Post-Visit Survey. (Appendix E) When the patient comes for the visit, the 
RSA will be at the clinic and available to answer questions about the study and direct the 
integration of study flow in clinical practice as needed. Each patient will see the NP (who 
will use the Interactive Discussion Guide during the visit) and receive the Survivorship 
Care Plan. The RSA will then bring the patient to the waiting room to complete the 
Survivor Post-Visit Survey (adapted from Aim 1: Part 1) on a computer or IPad.96.88,89,91,92 
Survey responses will be recorded and stored electronically with Web Core. The RSA will 
then provide the patient incentive when the survey is complete. 
 
7.2.3 Primary Care Provider Survey. (Appendix G) Two weeks after the visit (when the 
Survivorship Care Plan is mailed to the PCP), each patients‟ PCP will be invited to 
complete a brief online survey regarding whether they received and reviewed the 
Survivorship Care Plan, as well as the ease of use of, satisfaction with, and perceived 
usefulness of the Survivorship Care Plan.93,95,97  Survey responses will be recorded and 
stored electronically by Web Core. The PCP may complete the survey at any time within 
two months following enrollment. 
 
7.2.4 Nurse Practitioner Post-Visit Survey.(Appendix F): Directly after each clinic visit, the 
NP will complete one brief online survey for each participant. The Nurse Practitioner Post- 
Visit Survey focuses on the experience using the Interactive Discussion Guide during the 
visit. Specifically, it will assess whether the Interactive Discussion Guide presented a 
complete list of issues for the patient, whether it contained irrelevant information, and the 
length of the visit.
93-95  Survey responses will be recorded and stored electronically with 
Web Core. 

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7.2.5 Nurse Practitioner Interview: After all  participants in Part 2 have completed usability 
testing, the RSA will conduct a qualitative interview with the NPs (Ms. McKiernan and Ms. 
Walker) to evaluate any problems with, or strengths of, the Interactive Discussion Guide 
and whether the usefulness or usability of the Interactive Discussion Guide varied by type 
of patient seen in clinic. This interview will take place with the RSA and the NP in a private 
office and will be audio recorded. The interview guide is included as Appendix K. 
 
7.2.6. Survivor Follow-up Interview: Six months after the visit, the RSA will conduct a brief 
interview with the patient to determine adherence to the recommendations in the 
Survivoship Care Plan. Using the Survivorship Care Plan as a guide, the RSA will ask 
about whether the patient completed each task that was recommended and whether other 
providers were involved. 
 
 
7.3 Passively Collected Data 
 
In addition to surveys, patient and nurse practitioner data will be recorded through the web 
interfaces of HN-STAR. In addition, NPs will document clinic notes as part of routine care. These 
data will be used to inform feasibility of HN-STAR and contribute to power calculations for the 
future multi-site randomized controlled trial. 
 
7.3.1 For all visits at MSK, preceding the patient visit, the NP will verify the Automated 
Treatment Checklist. When the NP makes any changes to imported data and verifies the 
final Treatment Checklist, these data will be collected. These data will inform the accuracy 
of the automatically generated treatment summary and the time required to verify the 
information. 
 
7.3.2 For all visits at HH, preceding the patient visit, the NP will complete the Manual 
Treatment Checklist. Data will be collected regarding the time required to complete the 
checklist. 
 
7.3.3 All patients will complete the Survivor Self-Assessment before their clinic visit. HN- 
STAR will record the amount of time taken, the items skipped, and the proportion of the 
Self-Assessment completed. 
 
7.3.4 As part of routine care, the NP will record topics addressed and actions taken in the 
clinic note for each visit. Clinic notes regarding the identification and management of late 
effects will be abstracted. 
 
7.4 Preliminary metrics for future trial 
 
Abstracted clinic note data and HN-STAR data will inform feasibility of data collection and assess 
preliminary outcomes for Aim 2. 
 
7.4.1 Clinic note data will be used as part of a pretest-posttest design, described in further 
detail in the Biostatistics section 11.3. At each clinic visit, the NP will record actions from 
the visit, including referrals, prescriptions, and other management plans in the clinic note 
as part of routine care. The RSA at each site will retrieve data regarding late effects 
identified and addressed in the year preceding the study visit and during the study visit, to 
assess changes before and after the HN-STAR intervention. The RSA will also assess 

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oncologic surveillance occurring in the year preceding the study visit and during the study 
visit from the medical record. RSAs will use the Medical Record Data Abstraction Form 
(Appendix H). 
 
7.4.2 The receipt of routine preventive care, including cancer screening tobacco cessation, 
immunizations, and routine general testing, is not routinely collected in the clinic note and 
will instead by collected from HN-STAR. We will only collect these outcomes once (before 
the HN-STAR visit), and they will not serve as outcomes for the pretest-posttest study. 
 
7.5 Columbia University as data analysis site 
 
All survey data collected via WebCore will be analyzed at MSK, as will the NP interview data. 
Usability data and interview data with patients and the NP from Aim 1: Part 1 in the MSK 
survivorship clinic will be analyzed by Dr. Rebecca Schnall at Columbia University. All of the data 
will be identified by a unique participant identifier and the date of assessment. Data will be stored 
at MSK and shared with Dr. Schnall using the MSK secure file-transfer system, ShareBox. 
 
8.0 
TOXICITIES/SIDE EFFECTS 
 
We do not anticipate any toxicities or side effects from participating in this study. Although 
unlikely, there is a chance patients may experience emotional distress while discussing their 
symptoms or health condition. In any case of participant distress, we will encourage the patient to 
discuss his or her concerns with the NP, or other members of the clinical team. Referral to 
appropriate staff will be facilitated if necessary including social work, psychology or psychiatry. 
 
 
9.0 
PRIMARY OUTCOMES 
 
The following table shows the timing of each assessment in the study. The content and sources 
for each assessment are described in Section 7.1, 7.2, 7.3, and 7.4 above. 
 
Figure 4. Outcome collection 
 
Assessment 
Source 
Timing (including end of data 
collection window) 
Aim 1: Part 1: Component pilot testing 
Survivor Post-Assessment Survey 
Patient 
Upon completion of Survivor Self- 
Assessment 
Survivor Post-Assessment 
Interview 
Patient 
Upon completion of Survivor Post- 
Assessment Survey 
Survivor Post-Visit Survey 
Patient 
After clinic visit, and after receiving 
Survivorship Care Plan 
Survivor Post-Visit Interview 
Patient 
Upon completion of Survivor Post-Visit 
Survey 
Nurse Practitioner Post-Visit 
Survey 
NP 
Following each clinic visit, within 2 
days of clinic visit 
Nurse Practitioner Interview 
NP 
After 10 patients have completed Aim 
1: Part 1, within 1 month of last patient 
completing Aim 1: Part 1 
Aim 1: Part 2: Feasibility in Clinical Practice 

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Assessment 
Source 
Timing (including end of data 
collection window) 
Survivor Post-Assessment Survey 
Patient 
Upon completion of Survivor Self- 
Assessment, before the clinic visit 
 
 
 
 
 
 
Figure 4 continued. Outcome collection 
 
Assessment 
Source 
Timing (including end of data 
collection window) 
Survivor Post-Visit Survey 
Patient 
Following clinic visit, before leaving 
clinic 
Primary Care Provider Survey 
PCP 
At least one week after being mailed 
Survivorship Care Plan, within a month 
of enrollment into study 
Passively collected feasibility 
metrics 
HN-STAR 
Immediate concurrent data collection 
via Webcore 
Nurse Practitioner Interview 
NP 
After 30 patients have completed Aim 
1: Part 2 at MSK and 15 patients have 
completed Aim 1: Part 2 at HH, within 
1 month of last patient completing Aim 
1: Part 2 at the respective site 
Survivor Follow-up Interview 
Patient 
Six months after the clinic visit 
Preliminary metrics for future trial (Aim 2) 
Oncologic metrics: Late effects 
identified and addressed, receipt 
of head and neck surveillance and 
appropriate follow-up (e.g. dental 
exam for those who underwent 
radiation therapy) 
Clinic notes, 
prescriptions 
or referrals 
Abstracted from any time in the year 
before the visit (pretest) and in the 
note pertaining to the clinic visit 
(posttest) 
Non-oncologic metrics: Receipt of 
routine preventive care (e.g., 
cancer screening, tobacco 
cessation) 
Survivor 
Self- 
Assessment 
After completion of the Survivor Self- 
Assessment 
 
 
 
 
10.0 
CRITERIA FOR REMOVAL FROM STUDY 
 
In the unlikely event that researchers or the NP observe acute individual distress during the 
interviews or clinic visit, they will ask participants whether they wish to continue. Researchers will 
conclude the interview upon participant request. The patient may voluntarily discontinue 
participation in the study at any time. 

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11.0 
BIOSTATISTICS 
 
11.1 Sample size. This feasibility study is not powered to test formal hypotheses. Instead, it will 
provide feedback regarding the HN-STAR process. We will enroll 10 patients in Aim 1: Part 1. In 
Aim 1: Part 2, we will enroll 45 additional patients: 30 from MSK and 15 from HH. The MSK clinic 
sees over 20 patients per month, ensuring that enrollment is attainable. The HH clinic sees 
approximately 8 patients per month. We anticipate that enrolling 45 patients will not take longer 
than 6 months. Enrolling PCPs may be more difficult; we anticipate that not all 45 PCPs will 
complete the Primary Care Provider Survey. Part of our feasibility study is to test whether this 
method of recruitment and level of incentives will be adequate to recruit PCPs in a future study, 
and the level of participation will inform this feasibility outcome. Both NPs are integrally involved in 
implementing HN-STAR in their clinics. 
 
11.2 Analysis Aim 1: Parts 1 and 2 
 
The structured survey questions (asked of survivors, NPs, and PCPs in Aim 1: Parts 1 and 2) will 
be summarized using descriptive statistics. Quantitative outcomes will include survivors‟ rates of 
completion of the self-assessment, survey completion rates for survivor, NP, and Primary Care 
Provider Surveys in the feasibility study.
98 The number of questions to answer is different between 
surveys and even between respondents, based on skip patterns built into the electronic survey 
platform. Each survey will be considered complete if at least 75% of questions that are asked are 
answered. WebCore will automatically capture the percentage of questions that are answered for 
each survey administered. We will also look at survivor responses by race and ethnicity. Other 
quantitative outcomes include the median time survivors required to complete the self- 
assessment, the accuracy of the automated treatment summary (verified against the EMR), the 
time required for NP verification of the treatment summary, and the length of HN-STAR visits. 
 
Each component of HN-STAR will be evaluated individually for feasibility. We will consider the 
Survivor Self-Assessment feasible for subsequent effectiveness testing if the following criteria are 
met: 
• 
>75% survivors completed >75% of self-assessment. The survivor self-assessment has 
multiple components that include a total of 47 items for men and 49 items for women. We 
will only include items that are asked of every participant (i.e. no sub questions) for this 
metric. We will consider 75% of the self-assessment complete if 36 items (for men) and 37 
items (for women) are completed. 
• 
The mean proportion of assessment completed >75%. 
• 
The median time to complete self-assessment <15 minutes. 
• 
>50% of survivors rate the Self-Assessment visit positively on the Survivor Post 
Assessment Survey (Appendix D). For items #13, a response of “No” is positive, for item 
#14, a response of “yes” is positive, for item #15, a response of ”Just right” is positive, and 
for items 16-18, a response of “Agree” or “Strongly agree” is positive. We will consider a 
positive overall rating if >50% of responses are positive. 
 
We will consider the Automated Treatment Checklist feasible if the following criteria are met: 
• 
>90% of the treatment summaries were deemed accurate . 
• 
The median time to verify the summary <20 minutes. 
We will consider the Manual Treatment Checklist feasible if the following criteria are met: 

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• 
The median time to complete <30 minutes. (In practice, survivorship care plans typically 
take an hour or more to complete.
46) 
The Interactive Discussion Guide will be considered feasible if the following criteria are met: 
• 
>75% of discussion guides did not miss relevant information. We will determine whether 
relevant information was covered using item #6 from the Nurse Practitioner Survey 
(Appendix F) for this metric. Responses of ”Agree” or “Strongly agree” to the item, “the 
discussion guide missed important information about the patient will be measured as 
missing relevant information. 
• 
>50% of survivors rate the survivorship visit positively on the Survivor Post Assessment 
Survey (Appendix E). For items #1-8, a response of “Agree” or “Strongly agree” is 
positive. We will consider a positive overall rating if >50% of responses are positive. 
• 
The median visit time <50 minutes (current visit time average is 40 minutes). 
The Survivorship Care Plan will be deemed feasible if the following criteria are met: 
• 
>50% of survivors rate the Survivorship Care Plan positively. For survivors, item response 
will be defined as positive if they report that they strongly agree or agree with the items 
#25-29 on the Survivor Post-Visit Survey (Appendix E). A survivor will be considered as 
having a positive overall rating of the Survivorship Care Plan if at least 3 of the five 
responses are positive.>50% of primary care providers rate the Survivorship Care Plan 
positively. For primary care providers, item response will be defined as positive if they 
report that they strongly agree or agree on items #2, 4-6, 8-14. Because of the wording, 
for items #3 and 7 responses of disagree or strongly disagree will defined as positive on 
the Primary Care Provider Survey (Appendix G). If at least 7 of 13 items are positive, we 
will consider this a positive overall rating to the survivorship care plan. 
• 
If any component does not meet all criteria, we will consider further adapting the 
component as needed and testing them further in a future protocol. 
 
We will use qualitative data from study interviews to supplement our understanding of usability 
issues for both the NP and survivors in Aim 1: Part 1. We will use grounded theory to identify 
salient themes regarding the usability of the Survivor Self-Assessment, the Automated Treatment 
Checklist, the Interactive Discussion Guide, and the Survivorship Care Plan from the perspectives 
of both the survivors and the NP. 
 
11.3 Analysis Aim 2: Collection of preliminary metrics of health care actions. As described 
in Section 9.0, relevant metrics for Aim 2 are both oncologic and non-oncologic. We will collect 
oncologic metrics from any clinic notes that appear in the patient‟s chart in the year preceding the 
HN-STAR visit and for the HN-STAR visit itself. Non-oncologic metrics will be collected only from 
the HN-STAR patient assessment completed before the HN-STAR visit. We will use descriptive 
statistics to report receipt of oncologic and non-oncologic care. 
 
Also as described in Section 9.0 and listed completely in Appendix H, oncologic outcomes include 
late effects (symptoms) identified and addressed, receipt of head and neck surveillance and 
appropriate follow-up (e.g. dental exam for those who underwent radiation therapy). Non- 
oncologic outcomes include receipt of recommended routine preventive care (e.g., cancer 
screening, tobacco cessation). 
 
11.3.1 Oncologic outcomes. We will only investigate late effects that we assess in HN- 
STAR. (If usability testing identifies additional late effects we did not target in our Survivor 
Self-Assessment, we will add them to the Survivor Self-Assessment for Aim 1: Part 2 and 
include them in Appendix H.) For each late effect, we will consider it identified if it was 
mentioned in a clinic note, and we will consider it addressed if there was a referral, 

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recommendation, education, or explicit acknowledgement of inaction. (Inaction may be 
appropriate, because in some cases, when symptoms are persistent and intractable, no 
intervention may be recommended.) For each patient, we will first count the number of 
late effects identified. We will then calculate the proportion of identified late effects that 
are addressed. 
 
We will use descriptive statistics to report each element of oncologic care listed in 
Appendix H (i.e. smoking cessation, dental exam, blood work for thyroid studies, 
endoscopic exam, and head and neck physical exam). Each patient may not require 
every element of follow-up, depending on their primary tumor site or treatment received. 
We will use the number of recommended elements of care as the denominator, and we 
will calculate the proportion of these elements that are performed. 
 
11.3.2 Non-oncologic outcomes. The non-oncologic outcomes in HN-STAR are 
collected only once. They include cancer screening, vaccination, and other preventive 
care elements that are explicitly collected in the Survivor Self-Assessment. Only some of 
these elements will be recommended for each patient, depending on their age, sex, and 
behaviors. We will calculate the proportion of recommended elements of non-oncologic 
care that are performed per patient. In addition, for each element of non-oncologic care, 
we will calculate the proportion of patients who receive it as recommended. 
 
Findings from Aim 2 will inform whether these metrics can be collected from the EMR and HN- 
STAR. In addition, they will inform the statistical analysis for the future trial. For oncologic metrics 
only (Section 9.0, Figure 4), we will calculate the difference before HN-STAR use and after. 
Differences in oncologic metrics will be used in the power calculation for the proposed 
randomized trial. Non-oncologic metrics will be reported descriptively to inform the feasibility of 
collecting these data from self-report. 
 
11.4 Adaptation of and advance of HN-STAR. If HN-STAR is deemed feasible for further 
effectiveness testing, we will use our findings to adapt the content of HN-STAR. We will then 
advance HN-STAR to a randomized clinical trial to assess its effectiveness in improving the 
health outcomes assessed in Aim 2. 
 
12.1 
RESEARCH PARTICIPANT REGISTRATION AND RANDOMIZATION PROCEDURES 
 
12.2 
Research Participant Registration 
 
Confirm eligibility as defined in the section entitled Criteria for Patient/Subject Eligibility. 
 
 
 
Obtain informed consent, by following procedures defined in section entitled Informed 
Consent Procedures. 
 
 
During the registration process registering individuals will be required to complete a 
protocol specific Eligibility Checklist. 

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The individual signing the Eligibility Checklist is confirming whether or not the participant is 
eligible to enroll in the study. Study staff are responsible for ensuring that all institutional 
requirements necessary to enroll a participant to the study have been completed. See 
related Clinical Research Policy and Procedure #401 (Protocol Participant Registration). 
 
 
12.3 
Randomization 
 
Participants in this study will not be randomized. 
 
13.1 
DAT A M ANAGEMENT ISSUES 
 
13.1.1 Data and Source Documentation 
 
The participating site(s) will enter data remotely into an electronic database using the internet 
based systems, HN-STAR, which operates using Web Core. Data entry guidelines have been 
generated for this study and site staff will receive database training prior to enrolling its first 
participant. The participating site PI is responsible for ensuring these forms are completed 
accurately and in a timely manner. A schedule of required forms is shown in section 13.0.3. In 
addition, research staff at MSK will maintain a minimal CRDB dataset for both sites. 
 
An RSA will be assigned to the study at each site.  The responsibilities of the RSA include project 
compliance, data collection, abstraction and entry, data reporting, regulatory monitoring, problem 
resolution and prioritization, and coordinate the activities of the protocol study team. 
 
Online data collected using the following study assessments at MSK and HH will be stored with 
Web Core as described in sections 7.1, and 7.2: 
 
o Survivor Self-Assessment (Appendix A) 
o Treatment Checklist (Appendix B) 
o Survivor Post-Assessment Survey (Appendix D) 
o Survivor Post-Visit Survey (Appendix E) 
o Nurse Practitioner Post-Visit Survey (Appendix F) 
o Primary Care Provider Survey (Appendix G) 
 
 
Similarly, data collected during the NP Interview, the Survivor Post-Assessment Interview, and the 
Post-Visit Interview will be stored in a secure folder in the Department of Epidemiology & 
Biostatistics at MSK. Only study investigators and research staff at MSK will have access to the 
folder. All of the data will be identified by a unique participant identifier and the date of 
assessment. 
 
Passively collected data described in section 7.3 will be recorded through the web interfaces of 
HN-STAR and in clinic notes. Some data from the following components will be collected 
passively: 
 
o Treatment Checklist (Appendix B) (e.g., time required to complete or verify) 
o Survivor Self- Assessment (Appendix A) (e.g., time required to complete, proportion 
completed) 
o Clinic notes regarding late effects will be abstracted. 

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As described in section 7.4, the Medical Record Data Abstraction Form (Appendix H) will be 
completed by the RSAs at MSK and HH after each participant has completed participation. This 
Word document will be stored on secure folders at MSK and HH. Only investigators and research 
staff will have access to these folders. The completed Medical Record Data Abstraction Word 
document will be sent to MSK from HH using Sharebox. 
 
13.1 
Quality Assurance 
 
Registration reports will be generated to monitor patient accruals and completeness of registration 
data. The RSA will conduct monthly data quality scans to check the accuracy and completeness  
of data entry in HN-STAR and Medical Record Data Abstraction Forms. The principal investigator 
will regularly review registration report and data quality scans with the RSA. 
 
In addition to registration reports and data quality scans, elements of the data process will be 
designed to minimize inaccuracies and inconsistencies and to maximize completeness. The 
databases created by HN-STAR will also be designed to automatically notify the person entering 
data when fields have been left blank or if the entry is out of a designated range. 
 
Random-sample data quality and protocol compliance audits will be conducted by the study team 
on an annual basis. 
 
 
13.2 
Data and Safety Monitoring 
 
The Data Safety and Monitoring (DSM) Plans at Memorial Sloan Kettering Cancer Center were 
approved by the National Cancer Institute in September 2001. The plans address the new policies 
set forth by the NCI in a document entitled “Policy of the National Cancer Institute for Data and 
Safety Monitoring of Clinical Trials.” The DSM Plans at MSK were established and are monitored 
by the Office of Clinical Research. The MSK Data and Safety Monitoring Plans can be found on 
the MSK Intranet at  
https://one.mskcc.org/sites/pub/clinresearch/Documents/MSKCC%20Data%20and%20Safety%20   
Monitoring%20Plans.pdf. 
 
There are several different mechanisms by which clinical trials are monitored for data, safety and 
quality. There are institutional processes in place for quality assurance (e.g., protocol monitoring, 
compliance and data verification audits, therapeutic response, and staff education on clinical 
research quality assurance) and departmental procedures for quality controls, as well as two 
institutional committees that are responsible for monitoring the activities of our clinical trials 
programs. The committees – Data and Safety Monitoring Committee (DSMC) for Phase I and II 
clinical trials, and the Data and Safety Monitoring Board (DSMB) for Phase III clinical trials – 
report to the Center‟s Research Council and Institutional Review Board. During the protocol 
development review process, each protocol will be assessed for its level of risk and degree of 
monitoring required. Every type of protocol (e.g., NIH sponsored, in-house sponsored, industrial 
sponsored, NCI cooperative group, etc.) will be addressed and the monitoring procedures will be 
established at the time of protocol activation. 
 
The Principal Investigator at MSK and site investigators will provide oversight and monitoring of 
all data collection. Forms will be kept in a secured location and will be available only to study 
members. The study team will have access to participants‟ PHI. 

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13.3 Regulatory Documentation 
 
Prior to implementing this protocol at MSK, the protocol, informed consent form, HIPAA 
authorization and any other information pertaining to participants must be approved by the 
MSK Institutional Review Board/Privacy Board (IRB/PB). 
 
MSK Alliance sites will rely on the MSK IRB. Prior to implementing this protocol at a 
participating MSK Alliance site, all internal site approvals (e.g., HSP training and conflict of 
interest review) must be on file at MSK, and the MSK IRB must have granted approval for 
the site to open. Alliance site‟s compliance to Health Insurance Portability and 
Accountability Act (HIPAA) will be ensured by the Alliance site‟s privacy board. 
 
Upon receipt of the required documents, MSK will formally contact the MSK Alliance site 
and grant permission to proceed with enrollment. 
Amendments 
 
Each change to the protocol document must be organized and approved by the MSK 
IRB/PB before changes can be implemented at the Alliance site..  Upon receipt of MSK 
IRB/PB approval, MSK will notify the MSK Alliance site. 
 
Continuing Review Approval 
 
The MSK IRB will review the study at least annually. The MSK primary site is responsible 
for submitting continuing review reports to the MSK IRB/PB. 
 
Deviations and Violations 
A protocol deviation on this study is defined as any incident involving noncompliance with 
an IRB approved protocol. Deviations typically do not have a significant effect on the 
rights, safety, or welfare of research participants or on the integrity of the resultant data. 
Deviations may be intentional or unintentional and they may be identified before or after 
they occur (prospective or retrospective). 
 
A prospective deviation is any event that impacts eligibility, informed consent, or the 
intervention. IFor MSK sponsored multicenter studies, prospective deviations at the 
participating sites must be approved by the MSK IRB prior to implementation at the site; 
and reported to the site IRB according to site guidelines. 
 
Retrospective deviations are all other deviations that do not adversely affect the rights, 
safety, or welfare of participants and do not result in a complete modification to the IRB 
approved protocol. 
Retrospective deviations that represent non-compliance, unanticipated problems involving 
risks to participants or others, or serious adverse events will be reviewed in accordance 
with their respective policies and procedures. For MSK sponsored multicenter studies, 
retrospective deviations at the participating sites should be reported to the MSK IRB per 
the guidelines in this document and reported to the site IRB according to site guidelines. 
 
Document maintenance 

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The MSK PI and the MSK Alliance Site PI will maintain adequate and accurate records to 
enable the implementation of the protocol to be fully documented and the data to be 
subsequently verified. 
 
A regulatory binder for each MSK Alliance site will be maintained onsite at the MSK 
Alliance site.  An electronic regulatory binder will also be maintained at MSK. 
After study closure, the participating site will maintain all source documents, study related 
documents and CRFs for 3 years. 
Noncompliance 
 
If a MSK Alliance site is noncompliant with the protocol document, accrual privileges may 
be suspended and/or contract payments may be withheld (if applicable), until the 
outstanding issues have been resolved. 
 
 
 
14.1 
PROTECTION OF HUMAN SUBJECTS 
 
We aim to protect the rights of the participants with a comprehensive informed consent 
procedure. A printed consent form and letter of invitation will be provided to all participants 
(including primary care providers). The PIs and RSA will be available to respond to questions or 
concerns of the participants. Individuals will be informed that participati on is voluntary. The 
purpose of the study and potential risks and benefits will be explained during the informed 
consent process. All potential patients will be informed as to their rights as volunteers in a 
research study. The right to refuse or withdraw at any point during the study, without 
compromising medical and other care will be explained. The purpose of the study and potential 
risks and benefits associated with it will be stated. 
 
Risks for this study are minimal, and we will aim to protect participants from risk. Participants will 
complete the consent form and respond to the study surveys and interviews. The information 
presented to survivors about their symptoms may cause psychological distress. We have taken 
steps to minimize the risk of distress attributable to study participation. All study personnel will be 
trained and supervised to implement study procedures. All assessments will be conducted by 
research staff skilled in interviewing participants in a sensible manner with the utmost respect for 
human subjects‟ issues. In the unlikely event of psychological distress observed or expressed by 
participants, appropriate referrals will be made. Participants will be treated with respect and 
sensitivity. 
 
There are no anticipated toxicities or side effects from this nontherapeutic study. We do not 
anticipate any serious adverse events needing to be reported. However, a patient could 
experience severe anxiety, for example, when reporting any current symptoms. If such an SAE 
occurs, we will report it as described in section 14.2 below. 
 
As an alternative to participation, any patient may choose not to participate or to terminate 
participation at any time. The patient would then receive usual care in the survivorship clinic. 
Participation is completely voluntary. We will inform patients of this during the informed consent 
process. 

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Participants may benefit from this study. The NP will receive an Interactive Discussion Guide 
summarizing medical history, relevant symptoms, and recommendations for care (including 
symptom management, routine oncologic follow-up, and recommended preventive care). This  
may help the NP and survivor focus on the most salient issues while promoting the survivor‟s 
involvement in his or her care. This may also serve to ensure adherence to current guidelines and 
promote standardized care for survivors. After the visit, the cancer survivors will receive a 
Survivorship Care Plan with a plain-language treatment summary and personalized 
recommendations for ongoing care, which may help the survivors, their primary care providers, 
and oncology providers plan ongoing management strategies. In Aim 1: Part 2, participants‟ 
primary care providers will also receive a Survivorship Care Plan. In addition, survivors will have 
the opportunity to report their symptoms, engaging the patient in their survivorship care. Further, 
for the NP who is tasked with providing Survivorship Care Plans as part of routine care in the 
survivorship clinic, HN-STAR alleviates or minimizes the burden of manual data entry. For primary 
care providers, they will receive personalized information to help guide the ongoing care of their 
patients who completed treatment for head and neck cancer. 
 
Another benefit is the knowledge gained from the study. Following curative therapy, head and 
neck cancer survivors can face significant challenges that impact both quality of life and overall 
survival. HN-STAR may improve our ability to address oncologic and non-oncologic issues – 
including surveillance for recurrence, management of late effects of therapy, screening for second 
cancer, and prevention and treatment of co-morbid illness – during routine survivorship care. This 
study will evaluate if HN-STAR is feasible in actual practice, if it improves the care provided  
during the clinical encounter, and if the resulting Survivorship Care Plan is useful to stakeholders. 
Results from this study will provide critical feedback for modifying HN-STAR and implementing 
and evaluating it as an intervention in a future multi-center trial. 
 
There will be no financial costs or burdens to the participants. For those participants in Aim 1: Part 
1, who are asked to arrive for their clinic visit one hour early and stay 30 minutes after, and who 
drive to their visit will receive payment for parking as an incentive to participate. 
Confidentiality will be maintained at all times during the study administration. The WebCore 
platform has been reviewed by the MSKCC Information Security Department and conforms to 
current MSK and HIPAA standards for the protection of PHI. Participant interviews will take place 
in a private clinic room. Participants will be informed that information collected during their 
participation in this study is considered confidential. All data gathered will be kept in a secured 
location. Confidentiality of each participant‟s data will be protected with utmost care. Participants 
will specifically not be identified in manuscripts or public presentations. 
14.2 
Privacy 
 
MSK‟s Privacy Office may allow the use and disclosure of protected health information 
pursuant to a completed and signed Research Authorization form. The use and disclosure 
of protected health information will be limited to the individuals described in the Research 
Authorization form. A Research Authorization form must be completed by the Principal 
Investigator and approved by the IRB and Privacy Board (IRB/PB). 
14.3 
Serious Adverse Event (SAE) Reporting 
 
It is not anticipated that any SAEs will result from the processes described in this protocol (i.e., 
related to completing online assessments and interviews). A hypothetical example, albeit unlikely, 

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might be severe anxiety or distress as a result of the completing the surveys. Although it will be 
the responsibility of the investigators to report any such SAE resulting from processes described 
in this protocol, it will not be their responsibility to report serious adverse events related to 
treatments or underlying disease in patients who are participating in this study. Patients enrolled 
in this study may be receiving treatments for cancer late effects or other conditions, but these 
treatments are not directed or provided by the research described in this protocol, and are at the 
discretion of clinical staff separate from the investigators on this study. Adverse events related to 
those interventions should be managed by the clinical staff as a part of standard care, via routine 
approaches. 
An adverse event is considered serious if it results in ANY of the following outcomes: 
• 
Death 
• 
A life-threatening adverse event 
• 
An adverse event that results in inpatient hospitalization or prolongation of existing 
hospitalization 
• 
A persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions 
• 
A congenital anomaly/birth defect 
• 
Important Medical Events (IME) that may not result in death, be life threatening, or 
require hospitalization may be considered serious when, based upon medical 
judgment, they may jeopardize the patient or subject and may require medical or 
surgical intervention to prevent one of the outcomes listed in this definition 
Note: Hospital admission for a planned procedure/disease treatment is not considered an 
SAE. 
 
SAE reporting is required as soon as the participant signs consent.  SAE reporting is 
required for 30-days after the participant‟s last investigational treatment or intervention. 
Any events that occur after the 30-day period and that are at least possibly related to 
protocol treatment must be reported. 
 
If an SAE requires submission to the IRB office per IRB SOP RR-408 „Reporting of Serious 
Adverse Events‟, the SAE report must be sent to the IRB within 5 calendar days of          
the event. The IRB requires a Clinical Research Database (CRDB) SAE report be 
submitted electronically to the SAE Office as follows: 
 
For IND/IDE trials: Reports that include a Grade 5 SAE should be sent to  
saegrade5@mskcc.org.  All other reports should be sent to saemskind@mskcc.org. 
 
For all other trials: Reports that include a Grade 5 SAE should be sent to  
saegrade5@mskcc.org.  All other reports should be sent to sae@mskcc.org. 
 
The report should contain the following information: 
Fields populated from CRDB: 
• 
Subject‟s initials 
• 
Medical record number 

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• 
Disease/histology (if applicable) 
• 
Protocol number and title 
Data needing to be entered: 
• 
The date the adverse event occurred 
• 
The adverse event 
• 
The grade of the event 
• 
Relationship of the adverse event to the treatment (drug, device, or intervention) 
• 
If the AE was expected 
• 
The severity of the AE 
• 
The intervention 
• 
Detailed text that includes the following 
o A explanation of how the AE was handled 
o A description of the subject‟s condition 
o Indication if the subject remains on the study 
• 
If an amendment will need to be made to the protocol and/or consent form 
• 
If the SAE is an Unanticipated Problem 
 
The PI‟s signature and the date it was signed are required on the completed report. 
 
 
 
 
SAE Reporting for MSK Alliance Sites 
 
• MSK Alliance sites must adhere to the SAE reporting requirements under the MSK 
IRB.  Sites should use the SAE Report Form found in MSK‟s internet-based Clinical 
Research Database, CRDBi-Multicenter to report SAEs to MSK as detailed above. 
• MSK Alliance sites are responsible for reporting all SAEs to the MSK PI via e-mail 
within 3 calendar days of learning of the event. 
• When a death is unforeseen and indicates participants or others are at increased risk 
of harm, the MSK Alliance sites should notify the MSK PI as soon as possible but 
within 24 hours of the time the site becomes aware of the event. 
• MSK Alliance sites should also report SAEs to their own IRB per local guidelines. 
• Local IRB SAE approvals/acknowledgments must be sent to the MSK Alliance 
Program Manager upon receipt. 
 
Responsibilities of MSK 
• The MSK PI is responsible for informing all MSK Alliance sites about unexpected 
SAEs that are either possibly, probably, or definitely related to the study intervention 
within 30 days of receiving the stamped SAE from the MSK IRB/PB. 
The MSK PI is responsible for informing all sites within 24 hours or on the next 
business day about a death that is unforeseen and indicates participants or others are 
at increased risk of harm. 

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Safety Reports 
 
MSK must submit outside safety reports to the MSK IRB/PB according to institutional 
guidelines. The MSK PI will notify the MSK Alliance site PIs of any safety report 
requiring a protocol amendment as soon as possible. All outside safety reports will be 
made available to the MSK Alliance sites. 
 
 
14.2.1 
 
Not applicable 
 
 
 
15.1 
INFORMED CONSENT PROCEDURES 
 
Before protocol-specified procedures are carried out, consenting professionals will explain 
full details of the protocol and study procedures as well as the risks involved to  
participants prior to their inclusion in the study. Participants will also be informed that they 
are free to withdraw from the study at any time. All participants must sign an IRB/PB- 
approved consent form indicating their consent to participate. This consent form meets the 
requirements of the Code of Federal Regulations and the Institutional Review 
Board/Privacy Board of this Center. The consent form will include the following: 
1. The nature and objectives, potential risks and benefits of the intended study. 
2. The length of study and the likely follow-up required. 
3. Alternatives to the proposed study. (This will include available standard and 
investigational therapies. In addition, patients will be offered an option of 
supportive care for therapeutic studies.) 
4. The name of the investigator(s) responsible for the protocol. 
5. The right of the participant to accept or refuse study interventions/interactions and 
to withdraw from participation at any time. 
 
Before any protocol-specific procedures can be carried out, the consenting professional 
will fully explain the aspects of patient privacy concerning research specific information.  In 
addition to providing verbal consent, all participants must agree to the Research 
Authorization component of the informed consent form. 
 
Each participant will provide verbal consent prior to participation and the consenting 
professional will sign the verbal script. The participant will receive a written copy of the 
informed consent. 
In following the Code of Federal Regulations Title 45, Part 46, Subpart A, whichstates that an 
IRB maywaive the requirement for an investigator to obtain a signed consent form for some or 
all subjects if it finds that the research presents no more than minimal risk of harm to subjects 

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and involves no procedures for which written consent is normally required outside of the 
research context, a signed consent may not be required for this study. 
As described in Section 6.0, we will obtain informed consent for the NP, but not for the 
PCP‟s. 
 
For MSK Alliance sites, the investigators will be listed on the site-specific Alliance face 
sheet and approved by the MSK IRB. 
 
A copy of the verbal consent, signed by the consenting professional, should be maintained 
on file at MSK. Another copy will be confidentially maintained by the MSK Alliance site. 
A note will be placed in the medical record documenting that informed consent was 
obtained for this study, and that the participant acknowledges the risk of participation. 
 
 
16.0 
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17.0 
APPENDICES 
 
Appendix A: Survivor Self-Assessment 
Appendix B: Treatment Checklist 
Appendix C: Survivorship Care Plan (Template) 
Appendix D: Survivor Post-Assessment Survey 
Appendix E: Survivor Post-Visit Survey  
Appendix F: Nurse Practitioner Post Visit-Survey 
Appendix G: Primary Care Provider Survey 
Appendix H: Medical Record Data Abstraction Form 
Appendix I: Sample Recruitment LetterPart 1 
Appendix J: Sample Recruitment LetterPart 2 
Appendix K: Nurse Practitioner Interview Guide 
Appendix L: Sample Primary Care Provider Letter 
Appendix M: Interactive Discussion Guide 
Appendix N: Survivor Post-Assessment Interview 
Appendix O: Survivor Post-Visit Interview 
Appendix P: Voicemail Script 

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Appendix Q: Survivor Self-Assessment Follow-up Part 2