St. Judes-Stanford Comprehensive Support Initiative
Phase: NA
Conditions: Acute Myeloid Leukemia, Brain Glioblastoma, Estrogen Receptor Negative, Extensive Stage Small Cell Lung Carcinoma, Head and Neck Carcinoma, HER2/Neu Negative, Hormone-Resistant Prostate Cancer, Limited Stage Small Cell Lung Carcinoma, Myelodysplastic Syndrome, Progesterone Receptor Negative, Progressive Disease, Recurrent Carcinoma, Stage II Pancreatic Cancer, Stage II Rectal Cancer, Stage IIA Pancreatic Cancer, Stage IIA Rectal Cancer, Stage IIB Pancreatic Cancer, Stage IIB Rectal Cancer, Stage IIC Rectal Cancer, Stage III Colon Cancer, Stage III Esophageal Cancer, Stage III Gastric Cancer, Stage III Non-Small Cell Lung Cancer, Stage III Ovarian Cancer, Stage III Pancreatic Cancer, Stage III Rectal Cancer, Stage III Skin Melanoma, Stage IIIA Colon Cancer, Stage IIIA Esophageal Cancer, Stage IIIA Gastric Cancer, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIA Ovarian Cancer, Stage IIIA Rectal Cancer, Stage IIIA Skin Melanoma, Stage IIIB Colon Cancer, Stage IIIB Esophageal Cancer, Stage IIIB Gastric Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IIIB Ovarian Cancer, Stage IIIB Rectal Cancer, Stage IIIB Skin Melanoma, Stage IIIC Colon Cancer, Stage IIIC Esophageal Cancer, Stage IIIC Gastric Cancer, Stage IIIC Ovarian Cancer, Stage IIIC Rectal Cancer, Stage IIIC Skin Melanoma, Stage IV Bladder Cancer, Stage IV Bone Sarcoma, Stage IV Breast Cancer, Stage IV Colon Cancer, Stage IV Esophageal Cancer, Stage IV Gastric Cancer, Stage IV Non-Small Cell Lung Cancer, Stage IV Ovarian Cancer, Stage IV Pancreatic Cancer, Stage IV Rectal Cancer, Stage IV Renal Cell Cancer, Stage IV Skin Melanoma, Stage IV Soft Tissue Sarcoma, Stage IVA Bone Sarcoma, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Bone Sarcoma, Stage IVB Colon Cancer, Stage IVB Rectal Cancer, Triple-Negative Breast Carcinoma
Sponsor: Stanford University

 
 
 
 
St. Jude’s-Stanford Comprehensive Support 
Initiative 
   
Study Protocol and Statistical Analysis Plan 
NCT03154190 
May 18, 2016 

eProtocol. Health Coach Study Protocol 
Health Coach Study 
 
at 
 
St. Jude Crosson Cancer Institute 
 
 
 
Coordinating Center 
Stanford  University  
875 Blake Wilbur Drive 
Stanford, CA 94305 
 
 
Site Principal Investigator 
David Park MD 
2151 N. Harbor Boulevard 
Fullerton, CA 92835 
david.park@stjoe.org 
 
 
Protocol Director 
Manali Indravadan Patel, M.D. 
75 Alta Road 
Stanford, CA 94305 
650-724-0611 
manalip@stanford.edu 
 
 
Biostatistician 
Manisha Desai PhD 
Kris Kapphahn  
 
 
Version Date (5-18-2016) 
 
 
 

Table of Contents 
1.0 SPECIFIC STUDY AIMS .............................................................................................. 3 
2.0 BACKGROUND AND RATIONALE ............................................................................ 4 
3.0 STUDY ENROLLMENT AND PARTICIPANT ELIGIBILITY .............................................. 5 
3.1 Study Enrollment .................................................................................................. 5 
3.2 Participant Criteria .............................................................................................. 5 
3.3 Enrollment ............................................................................................................. 6 
4.0 MATERIALS AND METHODS ..................................................................................... 7 
5.0 STATISTICAL CONSIDERATIONS ............................................................................... 9 
5.1 Outcome Measurements ................................................................................... 9 
5.2 Analysis Plan ......................................................................................................... 9 
5.3 Sample Size ........................................................................................................ 10 
6.0 DATA MANAGEMENT CONSIDERATIONS ............................................................. 11 
6.1 Data Management ........................................................................................... 11 
6.3 Confidentiality ................................................................................................... 11 
6.4 Protocol Review and Amendments ................................................................ 11 
REFERENCES ................................................................................................................. 12 
APPENDIX A: PARTICIPANT ELIGIBILITY CHECKLIST.................................................... 14 
 
 
 
 
 
 
 

1.0 SPECIFIC STUDY AIMS 
Aims 
The primary aim is to reduce acute care utilization and cost for advanced cancer patients by 
training and deploying health care coaches who help patients and families discuss care goals, virtual 
modalities, engage in shared-decision-making, and participate in educational activities.  
The secondary aims are to improve patients’ experience of their care including overall health and 
emotional and mental health status, improve patient satisfaction with care and decision-making and 
advance care planning. 
Hypothesis 
Compared to patients who receive usual advanced cancer care, patients who partner with lay 
health care coaches are hypothesized to experience lower rates of acute care utilization, lower 
numbers of emergency room visits and hospital stays within 6-months post-enrollment. Secondarily, 
we will explore the effect of the intervention on satisfaction with care, overall health and emotional 
and mental health status, from time to enrollment to 6 months post-enrollment, advance care 
planning documentation, and acute care use at 12-months post-enrollment and within 30 days prior 
to death among those who died during the 12-month follow-up period.  
 
 
 

2.0 BACKGROUND AND RATIONALE 
Advanced cancer is an incurable condition, the second leading cause of death in the United States, 
and incidence rates are expected to increase and costs are expected to double over the next 
seven years. Many patients and families currently describe a poor quality of life with difficult 
decisions, little understanding of the disease context, unnecessary pain and suffering, and treatment 
options that are often provided far from their residence. Care delivery is often fragmented with poor 
care coordination and lack of resource utilization closer to patient and family needs.  
Often quality of life, especially at the end of life, is improved when care is coordinated, components 
of proactive health and well-being are adopted and elements of patient-centered care help 
establish the Goals of Care Plan with appropriate documentation, and when special attention is 
provided to allowing care delivery to be received closer to patient’s neighborhood. We recognize 
that in any situation, goals of care may change with the delivery of care for patients with advanced 
cancer; however, establishing improved care coordination, care goals that provide guidance and 
reassurance and develop with the patient and his/her support network, and providing care in a 
patient-centered approach can result in significant improvements in patient experience and may 
ultimately help to contain health care spending. 
 
The key elements address three major challenges: 1) patients with cancer and their families face 
confusing choices and difficult decisions and 2) Patients at the end of life may suffer pain or 
uncontrolled symptoms along with poor care coordination associated with their cancer diagnoses.  
The proposed patient-centered care program addresses these three critical care elements by 
training and deploying health care coaches who help patients and families discuss goals for life 
virtual modalities, engage in shared-decision-making, and participate in educational activities.  
Cancer related symptom management is addressed through the establishment of a nurse-supervised 
protocol-driven proactive symptom relief for patients with cancer. The desired outcomes include: 1) 
Identify and engage patients with advanced or newly diagnosed cancer, and to include their family 
members and support network in decisions about their health care plans; 2) Ensure patients and 
families understand prognosis and document goals for life, and link patients to health care coaches 
to make optimal life decisions 3) Implement established protocols and operations to improve timely 
symptom control and oncology care coordination. 
 
 
 
 

3.0 STUDY ENROLLMENT AND PARTICIPANT ELIGIBILITY 
3.1 Study Enrollment 
Location 
Patients will be recruited from the oncology clinics at St. Jude Hospital in Fullerton, CA.  
Enrollment Procedures 
Each week, the site PI and study staff will receive a list of potential patients. After the site PI and study 
staff conduct proper screening (see below section titled “Screening Procedures” for specific details), 
the staff will create a list of eligible patients and their primary oncology appointment times. At the 
patient’s oncology appointment, the oncologist will present the study and initiate the consent 
procedure (see below section titled “Consent Procedures” for specific consent details). 
Screening Procedures 
The Site PI and staff will utilize the following documents and procedures to screen for patients who fit 
the inclusion criteria listed in 3.2 
- 
Diagnosis (ICD-9) codes 
- 
Provider Referrals (request for oncology consultation) 
- 
Pathology results (must be positive for malignancy) 
- 
Biopsy requests 
- 
Abnormal test results (mammograms, colonoscopies, imaging results) 
Screen failures will not be included in the study data. The PI will keep a record of history and reasons 
for screen failures; however, any patient information gathered during this process will be destroyed. 
Consent Procedures 
The oncologist will refer eligible patients to the program. The program manager or the primary 
oncologist will introduce will obtain consent from eligible patients at the patient’s primary oncology 
appointment following advanced cancer diagnosis. The program manager or the oncologist will 
introduce the research project and provide a consent form document describing the project with 
sufficient information to potential participants.  Patients will be provided adequate time to make an 
informed decision regarding their participation. Participants must sign an IRB approved informed 
consent document prior to participation in any study specific procedure. The participant will receive 
a copy of the signed and dated consent form document. The original signed informed consent 
document will be retained in the research file. Patients who refuse participation or have no capacity 
for decision-making will not be included in the study. 
If a patient consents, patients will be provided a welcome letter with basic information and contact 
phone numbers for the project. 
For all patients assigned to the health care coach, the program manager will provide the coach with 
the patient’s phone number and the coach will contact the patient by phone to begin the 
intervention procedures that include: assisting patients with their goals of care, documenting goals of 
care, and assisting with symptom assessment. The intervention will be provided in addition to the 
usual care processes.  
 
  

3.2 Participant Criteria 
Inclusion criteria 
1. Newly diagnosed patients for the following conditions.  
 
Colon cancer stage III and IV 
 
Rectal cancer stage II, III, IV 
 
Glioblastoma multiforme (brain) -- no stage 
 
Non-small cell lung cancer stage IIIA, IIIB, IV  
 
Small cell lung cancer, limited stage and extensive stage 
 
Castration-resistant prostate cancer 
 
Head and neck cancer stage III and IV 
 
Gastric cancer stage III and IV 
 
Esophageal cancer stage III and IV 
 
Pancreatic cancer stage II,III, IV 
 
Renal cell carcinoma, stage IV  
 
Breast cancer, stage IV, if triple negative ER/PR/H2N negative or on systemic chemotherapy 
 
Sarcoma, stage IV 
 
Bladder carcinoma, stage IV 
 
Acute myeloid leukemia 
 
Melanoma, stage III and IV 
 
Ovarian cancer, stage III and IV 
 
High Grade MDS 
Eligibility also includes patients with recurrent cancer of any diagnosis.  
2. The patients must be 18 years or older. 
3. Patients must have the ability to understand and willingness to sign a written informed consent 
document. 
4. Patient must have ongoing oncologic needs and plan to receive all care at the study institution 
and not already be in hospice or home-care. 
Exclusion Criteria 
The disease must be newly diagnosed or patients with recurrent disease of any cancer diagnosis. 
Patients must not already receive hospice services and palliative care.  
Criteria for Removal from Study 
Any patients or families of patients in the intervention arm who withdraw consent will be removed 
from the study.  Upon removal, usual care will be restored for these patients. 
3.3 Enrollment 
The target number of subjects at the site is 128.  Patient enrollment is anticipated to begin upon study 
approval and continue until 128 participants have enrolled.  
 
 
 

4.0 MATERIALS AND METHODS 
After a patient consents, the patient will be registered and entered into the project database and 
assigned an identification number. The subject’s identification number will be used on all subject-
specific documents and research-related forms. 
During registration, patients will be randomized to two arms (Arm A: Usual Care Arm B: Health Care 
Coach Intervention). Specifically, the patients will be randomized into two arms by cancer type.  
All patients will be surveyed over the course of the study regarding patient experience with care, 
patient satisfaction and overall health status and emotional and mental health status (using the CG-
CAHPS: Clinician and Group Consumer Assessment of Healthcare Providers and Systems), advanced 
care planning, and symptom assessments (using the ESAS: Edmonton Symptom Assessment Scale) 
and healthcare use.  A member of the project team, excluding the Health Care Coach, will 
administer the assessments and conduct an electronic health record review of all health care use at 
baseline, 3, 6, 9 and 12 months post-enrollment.  Participants will provide consent for health record 
review at external facilities by signing a health release authorization form at each of the outcome 
assessment time periods. The symptom assessments will be administered at baseline for each patient 
in the intervention and control. Participant information should be entered into the local databases 
within 7 calendar days. 
 
Arm A: Usual Care (Control) / No Intervention 
Patients in this arm receive “usual” care from their care team. 
 
 
Arm B: Health Care Coach Arm / Intervention Group 
The intervention will be comprised of a health care coach assignment with a baseline 
introduction (either telephonic or in-person) of the program followed by a visit (telephonic or 
in-person) with the health care coach within 1 week after the first oncology appointment or 
after a patient has recurrent disease to discuss goals of care.  The health care coach is trained 
in engaging patients and families in goals discussion and in symptom management 
algorithms. The health care coach will use standardized educational information to inform 
contacts with the patient including PREPARE for your care and other educational content as 
determined by the study team. The health care coach will contact patient based on patients’ 
ongoing needs (i.e. weekly to monthly) and will conduct symptom assessments based on 
patients’ treatment plans and symptoms for 6-months post-enrollment. All symptoms that are 
scored 4 or above and/or change by 2 points from a prior assessment will be reviewed with 
the supervising nurse who will conduct standard  usual care processes as determined by the 
facility.  Health care coach will also conduct meetings with patient’s family and caregivers at 
the same time intervals as needed and upon request. All health care coach interactions will 
be logged and will include date of the interaction, details of the interaction, and the duration 
of the interaction.  
Choosing the Health Coach: 
Possible health coaches are identified by Dr. Park, the site PI.  Candidate health coaches are 
educated fully about the project and the workflow. Health coaches who are interested in engaging 
in this study are appointed. Health coaches do not need to have a clinical background to engage in 
this study.  
Training the Health Coach: 

The oncology care team of a triage RN, APN/PA, or PI will train the health care coaches and provide 
standardized training manuals. The manuals include a highly detailed workflow of the project, from 
enrollment to completion. Coaches will learn about what to say during patient contact, advanced 
care planning conversations, the administration of various psychosocial questionnaires, the study 
calendar, data management, and key contact information.  
Supervising the Health Coach: 
The health care coach will be supervised by the triage RN or APN/PA who provides oncology 
treatment support and also training. The triage RN or APN/PA will ensure that the protocol is carried 
out correctly and address any issues that may arise in the health care coach’s workflow. The health 
care coach will participate in weekly meetings with the health coach in addition to daily supervision 
and will participate in monthly meetings with the rest of the project members (at both Stanford and 
St. Jude) to review study accrual and program goals. At these meetings, the health care coach will 
be responsible for providing a report on project progress and project issues.  
Psychometric Measures 
1. The Consumer Clinician and Group Consumer Assessment of Healthcare Providers and Systems 
(CG-CAHPS) will be used to assess patient satisfaction, overall health status, and overall emotional 
and mental health status. Information about the measure can be found here: 
https://cahps.ahrq.gov/Surveys-Guidance/CG/index.html 
2. The Edmonton Symptom Assessment Scale (ESAS) will be used to measure the presence and 
degree of pain symptoms. The ESAS will be administered to the control group (at 0 months of 
diagnosis) and intervention group (every 2 weeks). The health care coach will embed the ESAS results 
for the control and intervention groups into Allscripts and alert the patient’s provider that the results 
are available and if an issue exists. 
Dr. Patel has used both of these measures with success before with a similar project completed at the 
Palo Alto Veterans Hospital (Palo Alto, CA). Information about this measure can be found here: 
http://www.npcrc.org/files/news/edmonton_symptom_assessment_scale.pdf 
If patients feel discomfort while conducting their surveys they may choose to not complete them.  If 
there are any psychological events that occur during the study, these will be reported to the NPOD 
and MOD via the site PI. 
Site PI: Dr. Park 
Dr. Park is responsible for site study supervision as well as the following: conducting biweekly meetings 
with all study members, troubleshooting recruitment and follow-up challenges, training the health 
care coaches, ensuring proper data collection, and general upkeep.  The site PI is also responsible 
for interacting with the protocol director at Stanford, Dr. Patel. As this is Dr. Patel’s conception, and 
she piloted at another site, she will be able to provide Dr. Park with specific advice and 
recommendations should challenges arise. 
Protocol Director: Dr. Patel 
Dr. Patel is responsible for the overall study, submitting IRB and protocol amendments, corresponding 
with the site PI to help him troubleshoot any challenges in data collection or follow-up. Dr. Patel is also 
responsible for overseeing data analysis and manuscript publication. 

5.0 STATISTICAL CONSIDERATIONS 
Biostatistician: Manisha Desai PhD and Kris Kapphahn (Stanford University) 
5.1 Outcome Measurements 
None of the listed outcomes relate to safety: 
Primary Outcome Measure 
The specific key measurement used to measure the effect of the intervention corresponding to the 
primary outcome is acute care utilization. Utilization will be measured evaluating comparisons of 
hospitalizations, emergency department visits, referrals to hospice and palliative care, time to first 
contact with care coach, duration of care coach contacts, frequency of care coach contacts, and 
symptom assessment changes throughout the study and time to intervention. Electronic health 
record review at the facility, review of health records at external facilities, and patient-report will be 
utilized to assess dates and utilization of all acute care use, hospice and palliative care use at each 
of the specified assessment time periods.  
Secondary Outcome Measures 
The specific key measurements corresponding to the secondary objective are several patient-
reported outcome tools:  
Satisfaction with Care and decision making and overall health and emotional and mental health 
status: CAPHS-G will be used to assess satisfaction with care, overall health status, and overall 
emotional and mental health status among patients at each of the specified time periods after 
enrollment. A 6 question satisfaction with decision making scale will also be administered at these 
time points.  
Qualitative data regarding implementation will be assessed through 2 focus groups during the study. 
This may include patients, caregivers, providers, and staff at the site of implementation. PI and study 
team from Stanford will provide oversight on analysis and data collection.  
5.2 Analysis Plan (see Detailed Statistical Analysis Plan Attached) 
All patients will be included in the analysis based on their randomization assignment at time of 
enrollment. The unit analysis will be completed at the participant-level. We will conduct descriptive 
statistics to evaluate balance between demographic (i.e., sex, age, race/ethnicity) and clinical 
variables (i.e., stage of cancer, diagnosis of cancer) between both the randomized and control 
groups. To assess our primary outcome of the effect of the intervention on acute care use within 6-
months post-enrollment we will assess % of patients with acute care use. We will create a (composite 
measure for acute care use that includes both ED visits and hospitalizations. To compare risk of acute 
care use (composite measure) and individual ED and hospital use within 6 months post-enrollment, we 
will use Cox regression models.    We will also compare counts of total ED visits and hospitalization 
(composite measure of acute care use) within the first 6 months, using General Estimating Equation 
with Poisson family, log link, and independent correlation.  
For secondary outcomes of ED and hospital use within 12 months, we will compare use using 
GEE models.  We will compare counts of total ED visits and hospitalization (composite measure of acute 
care use) within 12 months, using General Estimating Equation (Poisson) with an offset term for length 
of follow-up. To compare goals of care discussion and documentation, Advance Directive 

documentation, Physician Order for Life Sustaining Treatment documentation, Chemotherapy, 
Radiation, Surgery, hospice, and palliative care within 12 months, we will use GEE models to compare 
odds of documentation or use across groups.  For end-of-life health care use, we, we will compare any 
ED use and hospital use prior to death (30 days prior) and proportion of participants with palliative care 
and hospice use using the models described above among participants who died during the 12-month 
study. 
For secondary outcomes, we will assess change in patient-reported outcome scores from 
baseline (at time of enrollment) to 6-months (post-enrollment). For satisfaction variables with responses 
“never”, “sometimes,” “usually,” or “always” we will report results as the proportion of participants who 
respond “always” at 6-months post-enrollment compared to all other responses. For satisfaction 
variables with responses, “strongly disagree,” “disagree,” “neither agree nor disagree,” “agree,” or 
“strongly agree, we will report results as the proportion of participants who respond, “strongly agree.” 
For overall health and overall mental and emotional health variables, responses are scores that range 
from 0 to 5, with lower scores indicating “very good” or “excellent” health and higher scores indicate 
poorer overall health. We will report results as the proportion of participants who respond, “very good” 
or “excellent.” Missing data will not be imputed in any case. We will utilize GEE to compare changes 
between groups overtime from baseline (time of enrollment) to 6-months post-enrollment using GEE 
models with a term for an interaction between the treatment group and time (month) and clustered 
within person.  
We will compare survival using Kaplan Meier methods and the risk of death for both groups after 
randomization using Cox proportional hazards regression models. All analyses will be adjusted for 
covariates that are found to be imbalanced between study groups, such as age, race/ethnicity, 
cancer stage and cancer diagnosis.   
Relevant subsets of the above metrics may be measured on patients by cancer diagnosis and stage. 
Sample Size Considerations 
 
The sample size of 128 participants (64 randomized to the intervention group and 64 randomized 
to the control group) provides greater than 90% power to detect a 55% or greater difference in acute 
care use risk at 6-months follow-up. The anticipated effect size was based on our prior studies [11, 13, 
18] and feedback by the oncology clinicians at St. Jude’s Crosson Cancer Institute.  Power calculations 
will not be generated for our secondary outcomes as these are considered exploratory. Statistical 
significance of secondary outcomes is for trends only and not represented in this sample size 
calculation. 
Interim analyses every 6 months will evaluate point estimates and trends to inform refinements to the 
protocol. Descriptive statistics and exploratory data analyses will be conducted as needed to 
evaluate protocol process measures with key outcomes identified. 
5.3 Sample Size 
The goal is to reduce acute care use.  Based on data from St. Jude Hospital, the mean number of 
acute care visits per member per year is 1.45. Local site oncologist in the pre-review assessment 
anticipated at least a 55% difference in risk of acute care use among participants in the intervention 
group as compared to the control group. For this trial, we estimated that a sample size of 128 
participants would have at least 90% power with a 2-sided type I error rate of 0.05 to detect at least a 

55% difference in risk of acute care use in the intervention group compared with the control group 
based on effect sizes from our ongoing VA pilot and other pilot studies. For this trial, we expect to 
obtain point estimates with an understanding that we may not reach significance in this study.  
6.0 DATA MANAGEMENT CONSIDERATIONS 
6.1 Data Management 
The Protocol Director and participating site investigators will maintain adequate and accurate 
participant case histories with observations and other data pertinent to the study. Original source 
documents will be transcribed to data collection tools and used to communicate study data to the 
lead site.  
Participating site PI will be responsible for maintaining the clinical protocol and subjects’ study charts, 
reporting adverse events, assuring that written, informed consent is obtained and documented, and 
reporting the status of the trial in continuing renewals submitted to their IRB and trial monitoring 
group(s) as per their facility protocol. 
6.3 Confidentiality 
Members of the local team will be responsible for database records of patient data. The data will be 
kept in the central online database, under password protection with access limited to specific areas 
of the database. A chart with all of the relevant research patient information will be maintained for 
each patient at each institution by the local team for that specific institution. Stanford PI and Study 
Coordinator may review patient charts for yearly audits. 
6.4 Protocol Review and Amendments 
The protocol, the proposed informed consent and all forms of participant information related to the 
study (e.g. advertisements used to recruit participants) will be reviewed and approved by the 
Stanford IRB and Stanford Cancer Center Scientific Review Committee (SRC).  Any changes made to 
the protocol will be submitted as a modification and will be approved by the IRB prior to 
implementation.  The Protocol Director will disseminate the protocol amendment information to all 
participating investigators.” 
 
 
 
 
 
 
 

REFERENCES 
 
1  
National Cancer Institute Cancer Prevalence and Cost Projections. http://costprojections.cancer.gov. 
 
2  
Mariotto AB, Yabroff KR, Shao Y, et al. (2011) Projections of the cost of cancer care in the United States: 
2010-2020. J Natl Cancer Inst 103:117–128.  
 
3  
Wagner-Johnston ND, Carson KA, Grossman SA (2010) High outpatient pain intensity scores predict 
impending hospital admissions in patients with cancer. J Pain Symptom Manage 39:180–185.  
 
4  
Blayney DW (2006) Defining quality: QOPI is a start. J Oncol Pract 2:203.  
 
5  
Institute of Medicine Delivering affordable cancer care in the 21st century. 
www.iom.edu/Reports/2013/Delivering-Affordable-Cancer-Care-in-the-21st-Century.aspx.  
 
6  
Hoover DR, Crystal S, Kumar R, et al. (2002) Medical expenditures during the last year of life: Findings 
from the 1992-1996 Medicare current beneficiary survey. Health Serv Res 37:1625–1642.  
 
7  
Chastek B, Harley C, Kallich J, et al. (2012) Health care costs for patients with cancer at the end of life. J 
Oncol Pract 8:75s–80s.  
 
8  
Leak A, Mayer DK, Wyss A, et al. (2013) Why do cancer patients die in the emergency department? An 
analysis of 283 deaths in NC EDs. Am J Hosp Palliat Care 30:178–182.  
 
9  
Mayer DK, Travers D, Wyss A, et al. (2011) Why do patients with cancer visit emergency departments? 
Results of a 2008 population study in North Carolina. J Clin Oncol 29:2683–2688.  
 
10 
Patel JD, Krilov L, Adams S, et al. (2014) Clinical cancer advances 2013: Annual report on progress 
against cancer from the American Society of Clinical Oncology. J Clin Oncol 32:129–160.  
 
11 
Jacobson M, O'Malley AJ, Earle CC, et al. (2006) Does reimbursement influence chemotherapy 
treatment for cancer patients? Health Aff (Millwood) 25:437–443.  
 
12 
Bakitas M, Kryworuchko J, Matlock DD, et al. (2011) Palliative medicine and decision science: The critical 
need for a shared agenda to foster informed patient choice in serious illness. J Palliat Med 14:1109–1116.  
 
13 
Balogh EP, Ganz PA, Murphy SB, et al. (2011) Patient-centered cancer treatment planning: Improving 
the quality of oncology care—Summary of an Institute of Medicine workshop. Oncologist 16:1800–1805.  
 
14 
Barnato AE, Anthony DL, Skinner J, et al. (2009) Racial and ethnic differences in preferences for end-of-
life treatment. J Gen Intern Med 24:695–701.  
 
15 
Bradley EH, Prigerson H, Carlson MD, et al. (2004) Depression among surviving caregivers: Does length of 
hospice enrollment matter? Am J Psychiatry 161:2257–2262.  
 
16 
Dodd MJ, Dibble SL, Thomas ML (2007) Outpatient chemotherapy: Patients' and family members' 
concerns and coping strategies. Public Health Nurs 9:37–44.  
 
17 
Earle CC, Neville BA, Landrum MB, et al. (2004) Trends in the aggressiveness of cancer care near the 
end of life. J Clin Oncol 22:315–321.  
 
18 
Given BA, Given CW, Stommel M (1994) Family and out-of-pocket costs for women with breast cancer. 
Cancer Pract 2:187–193.  
 
19 
Gustafson DH, Taylor JO, Thompson S, et al. (1993) Assessing the needs of breast cancer patients and 
their families. Qual Manag Health Care 2:6–17.  
 
20 
Zhang B, Wright AA, Huskamp HA, et al. (2009) Health care costs in the last week of life: Associations with 

end-of-life conversations. Arch Intern Med 169:480–488.  
 
21 
Mayer DK, Reiner A (2009) The costs of cancer. Clin J Oncol Nurs 13:255–256.  
 
 

APPENDIX A: PARTICIPANT ELIGIBILITY CHECKLIST 
 
A Participant Eligibility Checklist is completed and signed by an Investigator prior to obtaining signed informed 
consent.  The eligibility checklist is filed in the subject’s research chart.   
 
Existing medical information in the patient’s medical record will be used as supporting documentation of 
eligibility.  
Protocol Title: 
Pilot Test Health Care Coach Program 
Protocol Number: 
35626 
Principal Investigator: 
Manali Patel MD MPH 
 
II. Subject Information: 
Subject Name/ID: 
 
Gender:    
 Male     
 Female 
III. Study Information: 
SRC Approved 
 IRB Approved 
 Contract signed 
 
IV. Inclusion/Exclusion Criteria 
 
Inclusion Criteria 
(From IRB approved protocol) 
Yes 
No 
Supporting Documentation* 
1. Patient has been newly diagnosed 
with cancer, except non-melanoma 
skin cancer, non-metatastic thyroid 
cancer, and prostate cancer not 
requiring Medical Oncology as 
described above in the protocol 
with stages of disease as outlined in 
protocol. 
 
 
      
2. Patient is age 18 or older 
 
 
      
3. Patient will receive all future care at 
local site 
 
 
      
4. Ability to consent 
 
 
      
Exclusion Criteria 
(From IRB approved protocol) 
 
1. Inability to consent 
 
 
      
2. Cancer diagnosis does not require 
Medical Oncology 
 
 
      
3. Patient is pregnant  
 
 
      

4. Patient is already receiving home 
care or palliative care 
 
 
      
5. Patient is younger than 18 years 
 
 
      
6. Patient will not receive subsequent 
care at local site 
 
 
      
*All subject files must include supporting documentation to confirm subject eligibility.  The method of 
confirmation can include, but is not limited to, laboratory test results, radiology test results, subject self-
report, and medical record review.   
IV.  Statement of Eligibility 
By signing this form of this trial I verify that this subject is [
 eligible / 
 ineligible] for participation in the study. 
This study is approved by the Stanford Cancer Institute Scientific Review Committee, the Stanford IRB, and has 
finalized financial and contractual agreements as required by Stanford School of Medicine’s Research 
Management Group.   
 
Treating Physician Signature: 
Date: 
Printed Name: 
 
Secondary Reviewer Signature: 
Date: 
Printed Name: 
 
Study Coordinator Signature: 
Date: 
Printed Name: