Joint Oncology Collaboration for Proactive Symptom Assessments by a Lay Health Worker
Conditions: Cancer
Sponsor: Stanford University

Joint Oncology Collaboration for Proactive 
Symptom Assessments by a Lay Health Worker 
NCT03737058 
March 31, 2018 
1. 
PURPOSE OF THE STUDY 
a. 
Brief Summary 
The purpose of the LEAPS program is to understand how a trained lay health worker who 
engages with newly diagnosed patients after a diagnosis of an advanced stage of cancer 
can help to improve patient satisfaction with their decision-making, activation, quality of 
life, and healthcare resource utilization. 
b. 
Objectives 
We hope to better understand how to help improve patients' careafter a diagnosis of 
advanced cancer. We want to better understand the influence of a local lay health coach 
on improving patient's efficacy, quality of life, and satisfaction. We also want to know 
the impact of the program on healthcare resource utilization (emergency department, 
hospitalization, hospice utilization). 
c. 
Rationale for Research in Humans 
Because this is a novel program focused on helping patients better understand their goals 
of care, human subjects must be used for this project. 
2. 
STUDY PROCEDURES 
a. 
Procedures 
Unite Here Health will institute a novel program focused on providing patients with a lay 
health coach who will engage patients with goals of care after a diagnosis of cancer. 
Unite Here Health will enroll patients into the study after a new diagnosis of cancer or 
after a diagnosis of cancer that has progressed to a worsening stage. Unite Here Health 
staff will identify patients for the program through primary care physicians, oncologist 
referrals, and hospitalization daily notice of admissions and emergency department 
reports which Unite Here Health routinely receives as part of usual care. Patients without 
capacity to consent verbally will not be eligible for the study. 
 
The Unite Here Health staff will contact eligible patients by telephone to introduce the 
study. If the patient is interested, he/she will be randomized into the usual oncology care 
arm versus the lay health worker intervention arm. Patients randomized into the 
intervention will be assigned a lay health worker who will contact the patient to begin the 
intervention. The intervention includes: education on early advance care planning, 

March 31, 2024 
 
Page 2 of 8 
documenting goals of care, assessing symptoms, and coordinating community services 
(such as home health, home visits, and home hospice). 
 
The Unite Here Health staff, as part of their usual assessments, will conduct the following 
assessments for patients enrolled in the intervention and the usual oncology care arm at 
time of randomization and at 6 and 12 months after enrollment: a satisfaction with 
decision-making survey to compare changes in satisfaction, a patient activation measure 
survey (PAM survey), and the Functional Assessment of Cancer Therapy - General 
quality of life survey. At these time points, additional data collected as part of usual care 
will also be assessed for each patient. This includes: healthcare utilization (total number 
of emergency department visits and hospitalizations, referral to palliative care, and 
hospice receipt). This data will be abstracted from the patients' claims data that Unite 
Here Health routinely reviews and collects. 
b. 
Procedure Risks 
The risks to subjects will be minimized as this is a study that provides usual oncology 
care. As part of the study intervention, additional support services will be provided to 
patients. Usual care procedures at the local site ensure sound procedures to minimize data 
sharing risk. There are no identifiers that will be collected or shared with the Stanford PI. 
c. 
Use of Deception in the Study 
No deception will be used. 
d. 
Use of Audio and Video Recordings 
No recordings will occur. 
e. 
Alternative Procedures or Courses of Treatment 
The study could improve documentation of patients' overall goals of care and could lead 
to a reduction in unwanted healthcare utilization. No standard of treatment will be 
withheld from patients. There are no potential risks to the patients involved in the study 
other than breach of confidentiality however no identifiers will be collected or shared 
with Stanford PI in the analysis of the data. 
f. 
Will it be possible to continue the more (most) appropriate therapy for the 
participant(s) after the conclusion of the study? 
Yes 
g. 
Study Endpoint(s) 
The primary endpoint is the Edmonton Symptom Assessment System (ESAS) at 12 
months.  

March 31, 2024 
 
Page 3 of 8 
3. 
BACKGROUND  
a. 
Past Experimental and/or Clinical Findings 
We implemented a trial at the VA Palo Alto Health Care System that assigned a lay 
health worker to patients with advanced cancer. In this study, we found improvements in 
patient satisfaction and reduction in healthcare utilization at the end of life. However, it is 
unclear if such an effort will improve quality of life and improve satisfaction and reduce 
healthcare utilization outside of the VA system. 
b. 
Findings from Past Animal Experiments 
None 
4. 
PARTICIPANT POPULATION 
a. 
Planned Enrollment 
At the local site, Unite Here Health will enroll a total of 180 patients into the study. 
Inclusion criteria are as follows: 
 
1. Newly diagnosed patients with a cancer diagnosis. 
2. Patients with any relapse or progressive disease (any cancer diagnosis) as identified by 
imaging or biopsy and confirmed by physician. 
3. The patients must be 18 years or older. 
4. Patients must have the capacity to verbally consent. 
 
The total number of patients with cancer who are members of Unite Here Health are 200 
per year. Therefore we anticipate that we will feasibly be able to enroll 180 patients into 
the study during the first 18 months. 
b. 
Age, Gender, and Ethnic Background 
The age range is > 18, gender is both male and female, and ethnic population is Hispanic, 
Asian/Pacific Islander, Non-Hispanic White, Non-Hispanic Black, American Indian, and 
Alaskan Native. 
c. 
Vulnerable Populations 
We will not enroll children or pregnant women. The study will be offered to all patients 
regardless of economic status. Patients who are unable to consent to participation will not 
be included. 
d. 
Rationale for Exclusion of Certain Populations 
Children are not included because the study is focused on adult patients with cancer. 
Additionally, Unite Here Health does not have any members less than the age of 18. 
e. 
Recruitment Details 
All eligible patients at Unite Here Health will be identified and referred into the study by 
the primary oncologist, primary care physician, or through daily inpatient and emergency 

March 31, 2024 
 
Page 4 of 8 
department reports which are routinely sent to the Unite Here Health staff as part of usual 
care. 
f. 
Eligibility Criteria 
i. 
Inclusion Criteria 
1. Newly diagnosed patients with a cancer diagnosis. 
2. Patients with any relapse or progressive disease (any cancer diagnosis) as 
identified by imaging or biopsy and confirmed by physician. 
3. The patients must be 18 years or older. 
4. Patients must have the capacity to verbally consent. 
ii. 
Exclusion Criteria 
Inability to consent to the study due to lack of capacity as documented by the 
referring physician. 
 
Patients without a newly diagnosed malignancy or patients without relapse of 
disease. 
g. 
Screening Procedures 
There are no screening procedures for enrollment in the study. 
h. 
Participation in Multiple Protocols 
There are no other studies ongoing at Unite Here Health that may lead to dual enrollment 
in studies. 
i. 
Payments to Participants 
No payment will be provided. 
j. 
Costs to Participants 
No costs will be charged to the participant. 
k. 
Planned Duration of the Study 
Patients will be enrolled in the study for a total of 12 months from the date of 
enrollment.Analysis of participant data in aggregate is estimated to take 8 months. 
5. 
RISKS 
a. 
Potential Risks 
As part of the study, patients will receive either usual care or will be assigned into the 
intervention. Patients assigned to the intervention will receive a lay health coach assigned 
to educate patients in goals of care, assist with symptom assessments, and coordinate 
community care (such as home hospice, home health services). All patients in the study 
will receive 3 surveys at baseline, 6 and 12 months after study enrollment: satisfaction 
with decision, patient activation, and quality of life assessment. receive satisfaction 

March 31, 2024 
 
Page 5 of 8 
surveys with their care (CAPHS-G). These will be anonymous surveys and will not be 
linked to the patient. 
b. 
Procedures to Minimize Risk 
We will not obtain identifiable records. For analysis purposes, all patients enrolled into 
the study will be assigned a unique identifier number. Data will be provided to the 
Stanford PI in aggregate. Patients will be coded and no direct identifiers will be linked to 
the patient. All data will be kept in a secure REDCAP database without any patient 
identifiers other than a unique identifier code. 
6. 
BENEFITS 
The benefit from this study will help to inform whether a lay health coach can improve patient 
satisfaction, quality of life, and reduce healthcare utilization for patients diagnosed with advanced 
cancer. 
7. 
PRIVACY AND CONFIDENTIALITY 
All participant information and specimens are handled in compliance with the Health Insurance 
Portability and Accountability Act (HIPAA) and privacy policies of Stanford University, Stanford 
Health Care, and Stanford Children’s Health. 
 

Stanford –CareMore-Oncology Institute of Hope and Innovation- Lay Health Worker Symptom 
Assessment Quality Improvement Pilot 
Identifying Patients 
! All patients with newly diagnosed cancer Stage 3 or 4 or hematologic malignancies requiring Medical
Oncology will be included in the program.
1)
Patients will be categorized as either "High Risk" or "Low-Risk" based on the following criteria:
1)
High Risk: All metastatic cancer patients as well as all patients on active chemotherapy, all patients
with symptom scores 4 or above, or any change in symptom of greater than 2 points from prior
assessment
2)
Low Risk: Patients who are not on chemotherapy and are undergoing routine follow-up/surveillance,
who have no symptom scores of 4 or above, and no change in symptom scores
3)
Three months after a non-metastatic patient has completed adjuvant chemotherapy or treatment,
he/she will be transitioned to low-risk status unless trigger event occurs as above.
Patient Engagement 
"
LHW will contact all patients via telephone who meet the criteria prior to their first oncology
appointment
"
LHW will schedule an initial oncology consultation appointment with the patient within 5 days of
initial contact
"
LHW will discuss program
"
LHW will prepare the patient for their upcoming initial consultation with an oncologist
"
LHW will invite and encourage the patient to include anyone in the conversation such as
family/caregiver and encourage the patient to include anyone who may potentially be attending
future oncology appointments with the patient.
"
If necessary, the LHW will offer to reschedule the call to accommodate patient’s request
for others to be present during conversation.
#
LHW will provide contact information for patients to use in the event of any future triggers and
provide a list of all the appropriate triggers to the patient and the care circle.
o
Triggers Include:
"
Disease progression
"
Unexpected side effects
"
Potential change of treatment
"
ED visit or hospital use
"
If for any reason patient does not feel comfortable
"
Life situation changes in a manner that potentially impacts symptoms
"
Oncologist refers patient back to the LHW
"
Patient family members need education/clarification/support
Introduction of HVCCP 
! Explain the purpose is to help patients maintain symptom relief.
"
The LHW is here to support the patient throughout this process
! Identify symptom control resources, which the oncologist may later prescribe as appropriate
(including palliative care resources).
Appendix 1: Patient Procedures

" Note: Here is a good place to address palliative care and begin the intake/ESAS. In 
addition, connect the patient with individual and group-based opportunities (support 
groups at the Cancer Institute) for emotional support involving interaction with trained 
professionals and other people undergoing similar health challenges 
 
! Invite and encourage the patient to include anyone in the conversation such as 
family/caregiver and encourage the patient to include anyone who may potentially be 
attending future oncology appointments with the patient.  Ask patient “are there any 
members of your family that you think will be part of your care?’  
# 
 Note: If necessary, offer to reschedule the call to accommodate patient’s request. 
! Provide ESAS for baseline assessment  
 
Prior to each patient’s first oncologist appointment:   
 
Educational Materials 
! LHW will discuss educational materials such as videos/handouts with patients 
! All cancer patients will be educated on the general topics of chemotherapy, radiation, and surgical 
approaches to treating cancer and potential side effects.   
" LHW will discuss available handouts and reading materials with patients during the initial phone 
conversation 
" Front office staff will provide patients with handouts for their specific diagnosis, 
chemotherapy and symptom management (constipation, diarrhea, nausea, etc.) upon 
check out 
 
Edmonton Symptom Assessment System (ESAS) 
1) During the initial phone conversation the LHW will screen patients for symptom management using 
Edmonton Symptom Assessment System (ESAS) tool (attached) 
2) After the initial consultation, LHW will review patient list with Physician Assistant to determine 
patient risk stratification and will contact and screen all high-risk patients via telephone on a weekly 
basis and all low risk patients on a monthly basis  
3) LHW will input data into Rabbit EHR via ESAS/PHQ-9 template 
4) Physician Assistant will review findings of ESAS results through EHR and if patient scores 4 or higher 
PA will notify the treating oncology practitioner and initiate usual care process for identified 
symptom management 
5) Treating oncology practitioner must review/treat and agree with appropriate orders for any positive 
findings noted on the ESAS 
6) PA will place necessary orders for referrals and notify the treating oncology practitioner via Rabbit e-
mail 
 
! Referrals will be requested via the CareMore Utilization Management Provider Portal 
 
Patient Symptom Complaints/Triages 
o When LHW pilot patients contact staff with a symptom related complaint, staff will create 
and assign a triage message to the appropriate provider per the most up to date Mid-Level 
Triage schedule 

o The oncology PA will then assess and treat the patient's symptoms per the symptom 
management algorithms provided to them 
o PA will follow each triage message to ensure that the treating oncology practitioner is 
following all LHW protocols 
 
After Hour Calls 
" When a patient contacts exchange after hours (between 5pm-8:30am Monday-Friday and all day 
Saturday/Sunday), the on-call treating oncology provider will be paged per the standing protocol.  
" All patients will be instructed to identify themselves as pilot program patients to both the exchange 
service as well as to the treating oncology provider who takes the call.  
" The treating oncology provider will assess and treat the patient's symptoms per the symptom 
management algorithms 
" If the treating oncology provider feels that patient requires urgent evaluation which cannot wait 
until business hours, patient will be referred to the nearest emergency department.  
" The treating oncology provider is required to notify the PA about the call on the next business day.  
The message to the PA will include the reason for call, recommended treatment and outcome.  
" PA will ensure that the treating oncology provider has followed symptom management algorithms  
" PA will recommend more aggressive symptom management to the treating oncology practitioner if 
applicable.  
 
Patient Satisfaction, Mental and Emotional Health  
" All Surveys are to be done by research team and will be conducted when patients enroll and again 5-
months post enrollment 
 
No Shows  
" If a patient is a no show to his/her office visit appointment LHW will contact the patient 
3 times (1 time  per week) in an effort to reschedule patient's appointment 
" In the event the LHW is unable to reach patient/reschedule patient's appointment, LHW 
will send an Outlook e-mail to PA/Hilda Agajanian/Dr. Richy Agajanian/Caremore 
Exit Criteria 
! Patient Preference 
" If patient notifies staff of the Oncology Institute he/she does not wish to continue care, staff 
must place a triage the reason patient does not want to continue care at the practice and must 
notify LHW/PA/Hilda Agajanian/Dr. Agajanian and the treating oncology practitioner via Rabbit 
e-mail  
" Death 
" Staff must follow standard office policy for documenting and marking the chart whenever a 
patient expires  
! Staff must notify the LHW and site leader as well as the treating oncology practitioner 
! LHW will ensure that chart has been appropriately documented in EHR 
! Disqualification 
! If at any point during the staging/screening process a patient is noted to not have invasive 
cancer, he/she will be removed from the study list 
! Date and reason of exit will be documented in EHR