Randomized Study of Early Palliative Care Integrated With Standard Oncology Care Versus Standard Oncology Care Alone in Patients With Incurable Lung or Non-Colorectal Gastrointestinal Malignancies
Phase: PHASE3
Conditions: Liver Cancer, Anxiety Disorder, Depression, Small Cell Lung Cancer, Extrahepatic Bile Duct Cancer, Malignant Mesothelioma, Pancreatic Cancer, Esophageal Cancer, Gastric Cancer, Non-small Cell Lung Cancer
Sponsor: Alliance for Clinical Trials in Oncology

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ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY 
ALLIANCE A221303 
RANDOMIZED STUDY OF EARLY PALLIATIVE CARE INTEGRATED WITH STANDARD ONCOLOGY 
CARE VERSUS STANDARD ONCOLOGY CARE ALONE IN PATIENTS WITH INCURABLE LUNG OR NON-
COLORECTAL GASTROINTESTINAL MALIGNANCIES 
A Limited Access Study 
Study Chair 
Jennifer Temel, MD 
Massachusetts General Hospital Cancer Center 
 
 
Community Oncology Co-chair 
 
  
 
Symptom Intervention Committee Chair 
 
 
Palliative Care Co-chair 
 
 
Quality-of-life Co-chair 
 
 
 
Primary Statistician 
 
 
Secondary Statistician 
 
 
Data Manager 
 
 
Protocol Coordinator 
 
 
 
Participating NCTN Organization 
Alliance/Alliance for Clinical Trials in Oncology—Limited to the following institutions: 
Columbia University Medical Center (NY024) 
Altru Cancer Center Grand Forks (ND028) 
Dartmouth Hitchcock Medical Center (NH012) 
Gunderson Lutheran Medical Center (WI029) 
Duke University Medical Center (NC010) 
Regions Hospital (MN001) 
Massachusetts General Hospital (MA034) 
Marshfield Clinic (WI031) 
Mayo Clinic Cancer Center (MN026) 
Mercy Health Saint Mary’s (MI047) 
Medical College of Wisconsin (WI013) 
North Shore University Health System-Evanston (IL018) 
UC San Diego Moores Cancer Center (CA249) 
North Shore University Health System-Glenbrook (IL113) 
The University of Chicago Medicine (IL057) 
North Shore University Health System-Highland Park (IL004) 
University of Iowa Hospitals and Clinics (IA018) 
Queen’s Medical Center (HI005) 
University of Oklahoma Health Sciences Center (OK003) 
Park Nicollet Clinic - Saint Louis Park (MN014) 
North Shore University Hospital (NY064) 
Hennepin County Medical Center (MN013) 
North Shore-LIJ Health System (NY387) 
Virginia Commonwealth University (VA010) 
Oncare Hawaii-POBII (HI022) 
Oncare Hawaii-Kuakini (HI023) 
Oncare Liliha (HI041) 
Oncare Hawaii-POBI (HI046) 

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Study Resources: 
Medidata Rave iMedidata portal 
https://login.imedidata.com 
OPEN (Oncology Patient Enrollment Network) 
https://open.ctsu.org 
Protocol Contacts: 
Alliance Central Protocol Operations 
 Program Office 
 
 
Alliance Statistics and Data Center 
Mayo Clinic 
 
A221303 Nursing Contacts 
 
 
 
  
  
 
 
 
A221303 Other Contact(s) 
 
 
 
Protocol-related questions may be directed as follows: 
Questions 
Contact (via email) 
Questions regarding patient eligibility, treatment, 
and dose modification: 
Study Chair, Nursing Contact(s), Protocol 
Coordinator, and (where applicable) Data Manager 
Questions related to data submission, RAVE or 
patient follow-up: 
Data Manager 
Questions regarding the protocol document and 
model informed consent: 
Protocol Coordinator 
Questions related to IRB review: 
Alliance Regulatory Inbox 
 
Questions regarding CTEP-AERS reporting: 
Regulatory Affairs Manager 
 
Document History 
Effective Date: 
Document History 
Activation 
Update #01 
05/15/2015 
05/15/2015 
Update #05 
Update #06 
Effective Date: 
06/01/2016 
08/01/2016 
Update #02 
07/01/2015 
Update #03 
08/01/2015 
Update #04 
10/01/2015 

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RANDOMIZED STUDY OF EARLY PALLIATIVE CARE INTEGRATED WITH STANDARD ONCOLOGY CARE 
VERSUS STANDARD ONCOLOGY CARE ALONE IN PATIENTS WITH INCURABLE LUNG AND NON-
COLORECTAL GASTROINTESTINAL MALIGNANCIES 
Study Patient Participant Eligibility Criteria (see Section 3.2) 
Required Initial 
Laboratory Values 
 
None 
• 
Confirmed incurable lung cancer (NSCLC, small cell lung cancer, or mesothelioma) 
or non-colorectal GI cancer (esophageal, gastric, hepatic, biliary,  pancreatic or GI 
unknown primary) not being treated with curative intent 
• 
Informed of diagnosis of incurable disease within the previous 8 weeks. 
• 
Age ≥ 18 years 
• 
ECOG Performance Status 0-2 
• 
Ability to read and respond to questions in English or able to complete questions with minimal assistance required 
from an interpreter or family member. 
• 
Planning to receive medical care for cancer at the enrolling institution 
• 
Participants must be under the care of an oncologists (who does not practice as a palliative care physician for that 
patient), but their current plan may or may not include chemotherapy or other forms of tumor-directed therapies. 
 
Study Family Caregiver Participant Eligibility Criteria (see Section 3.3) 
• 
Relative or friend who is identified by the patient participant who plans to regularly accompany the patient to the 
majority of their clinic visits. 
• 
Family caregiver must live with the patient or have in-person contact with him or her at least twice per week. 
• 
Ability to read and respond to questions in English or able to complete questions with minimal assistance required 
from an interpreter or family member. 
• 
Age ≥ 18 years 
Note: An eligible patient may participate in this trial without an eligible family caregiver being registered.  
Schema 
R
A
N
D
O
M 
I 
Z
E
D 
 
ARM 1 (Early Palliative Care) 
 
• 
Baseline visit  
• 
Palliative care visits/calls at least every 4 
weeks throughout life 
 
 
 
ARM 2 (Standard Oncology Care) 
• 
Baseline visit 
• 
Palliative care visit only upon request from 
attending oncologist(s) or patient/family 
 
 
 
Patients: Complete questionnaires at baseline, 6, 12 and 24 weeks 
Family caregivers: Complete questionnaires at baseline, 6, 12 and 24 weeks 
 
Please refer to the full protocol text for a complete description of the eligibility criteria and 
intervention plan. 
 
The outpatient palliative care (PC) clinic must be either (1) located within the Cancer Center or (2) the 
palliative care clinicians have the ability to see patients at the Cancer Center, and the palliative care clinic 
(or PC team) must be led by a board certified PC physician. At least the lead PC staff at each participating 
institution (ideally, as many as possible at each institution) must complete two 1-hour web-based training 
courses. 
  
 

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Table of Contents 
 
Section 
Page 
1.0 
Background ........................................................................................................................................ 6 
1.1 
Introduction ................................................................................................................................... 6 
1.2 
Rationale and Significance............................................................................................................ 6 
1.3 
Hypotheses .................................................................................................................................... 8 
1.4 
Study Design ................................................................................................................................. 8 
1.5 
Description of Intervention ........................................................................................................... 9 
2.0 
Objectives ........................................................................................................................................... 9 
2.1 
Primary objectives ........................................................................................................................ 9 
2.2 
Secondary objectives .................................................................................................................... 9 
3.0 
Patient Selection .............................................................................................................................. 10 
3.1 
On-Study Guidelines ................................................................................................................... 10 
3.2 
Study Patient Participant Eligibility Requirements ..................................................................... 10 
3.3 
Study Family Caregiver Participant Eligibility Requirements .................................................... 10 
4.0 
Patient Registration ........................................................................................................................ 11 
4.1 
CTEP Investigator Registration Procedures................................................................................ 11 
4.2 
CTEP Associate Registration Procedures / CTEP-IAM Account ............................................... 11 
4.3 
CTSU Site Registration Procedures ............................................................................................ 11 
4.4 
Registration Requirements .......................................................................................................... 12 
4.5 
Patient Registration/Randomization ........................................................................................... 13 
4.6 
Stratification Factors ................................................................................................................... 13 
4.7 
Study Arm Assignments ............................................................................................................. 13 
5.0 
Study Implementation .................................................................................................................... 14 
5.1 
Palliative Care Clinic Requirements ........................................................................................... 14 
5.2 
Palliative Care Physician and Advanced Practice Nurse Requirements ..................................... 14 
5.3 
Palliative Care Manual and Training Requirements ................................................................... 14 
5.4 
Patient Recruitment ..................................................................................................................... 15 
6.0 
Data Submission .............................................................................................................................. 15 
6.1 
Data collection and submission ................................................................................................... 15 
6.2 
Patient Reported Measures.......................................................................................................... 16 
6.3 
Family Caregiver Reported Measures ......................................................................................... 17 
6.4 
Chart Abstraction ........................................................................................................................ 17 
7.0 
Intervention ..................................................................................................................................... 18 
7.1 
Early Palliative Care Arm ........................................................................................................... 18 
7.2 
Standard Oncology Arm ............................................................................................................. 19 
7.3 
Duration of Intervention.............................................................................................................. 19 
7.4 
Duration of Follow-Up................................................................................................................ 19 
8.0 
Adverse Events ................................................................................................................................ 19 
9.0 
Measures .......................................................................................................................................... 19 
10.0 End of Intervention ......................................................................................................................... 20 
10.1 
Duration of Intervention.............................................................................................................. 20 
10.2 
Early Withdrawal ........................................................................................................................ 20 
11.0 Statistical Considerations ............................................................................................................... 21 
11.1 
Study Overview .......................................................................................................................... 21 

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11.2 
Sample Size, Accrual Time, and Study Duration ....................................................................... 21 
11.3 
Statistical Design and Analysis for the Primary Endpoint .......................................................... 21 
11.4 
Supplementary Analysis Plans .................................................................................................... 22 
11.5 
Study Monitoring ........................................................................................................................ 24 
11.6 
Study Reporting .......................................................................................................................... 24 
11.7 
Descriptive Factors ..................................................................................................................... 24 
11.8 
Inclusion of Women and Minorities ........................................................................................... 24 
12.0 General Regulatory Considerations and Credentialing .............................................................. 25 
12.1 
Institutional Palliative Care Requirements.................................................................................. 25 
12.2 
Individual Palliative Care Credentialing ..................................................................................... 25 
13.0 References ........................................................................................................................................ 26 
14.0 Model Consent Forms ..................................................................................................................... 30 
APPENDIX I:  Early Integration of Palliative & Oncology Care:  a Treatment Manual ................. 36 
APPENDIX II: Patient and Caregiver Information Sheets .................................................................. 44 
Appendix III: Patient Reported Measures ............................................................................................. 53 
APPENDIX IV: Family Caregiver Reported Measures ........................................................................ 60 
APPENDIX V: Patient Recruitment ....................................................................................................... 71 
APPENDIX VI: PC Web-Based Training Instructions ......................................................................... 72 
 

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1.0 
BACKGROUND 
1.1 
Introduction 
Despite improvements in cancer therapy, the prognosis of incurable lung and non-colorectal 
gastrointestinal cancers remains poor with median survivals of less than one year.1 During the 
course of illness, these patients often experience marked physical suffering, psychological  
distress and resource-intensive care at the end-of-life (EOL).2,3 While cancer treatment may 
extend survival, the improvement on quality-of-life (QOL) and distress is minimal for these 
patients.4 Moreover, anti-cancer therapy delivered at the EOL may negatively impact quality of 
death, family caregiver bereavement, the cost of health care delivery in the U.S., and survival.3,5,6 
Studies to date demonstrate a compelling need for interventions that not only diminish suffering 
but also improve the quality and delivery of care for patients who have both a short-life 
expectancy and high symptom burden.7 
Palliative care focuses on providing expert symptom management and psychosocial support for 
patients and families with serious illnesses.8 However, traditionally palliative care clinicians do 
not provide longitudinal care in the outpatient setting and are often consulted to see patients only 
near the EOL.9,10 We completed a randomized study of early, integrated palliative and oncology 
care versus standard oncology care alone in patients with newly diagnosed metastatic non-small 
cell lung cancer to assess whether early involvement of palliative care is beneficial.11 The 
palliative care model in this trial entailed board-certified palliative care physicians and advanced 
practice nurses who conducted their clinic visits in the Cancer Center and on the same day as 
the patients’ oncology visit.  Patients were scheduled for visits with the palliative care team at a 
minimum of every three weeks, although more frequent visits were permitted.  If patients were 
admitted to the hospital, they were also followed by the hospital-based inpatient palliative care 
team throughout their admission. We observed significant improvements in patient reported 
outcomes (QOL, mood and illness understanding) and several key measures of quality EOL care 
and resource utilization (chemotherapy near death, documentation of EOL care preferences, and 
length of stay in hospice).11-14 Despite less chemotherapy at the EOL and greater hospice 
utilization, patients assigned to early palliative care (PC) had prolonged survival of over two 
months, compared with patients receiving standard care. While these results are exciting, this 
study was a single institution study and it is unclear if these findings will be reproduced in a 
multi-site trial. 
Recently, the American Society of Clinical Oncology (ASCO) published a Provisional Clinical 
Opinion that early palliative should be considered for any patients with metastatic cancer.15 
Therefore, an urgent need exists to evaluate the early, integrated palliative care model in a larger 
number of cancer populations and across multiple care settings. No palliative care studies have 
been conducted through the cooperative group mechanism to date. 
A multi-site cooperative group study will be the most effective way to determine if the early 
palliative care model can be disseminated and if the findings are reproducible. We have 
assembled a team with significant experience in conducting early palliative care trials (Temel, 
Jackson, Greer) and in completing supportive care interventions in the cooperative group 
(Loprinzi). 
1.2 
Rationale and Significance 
Symptom burden in patients with incurable lung and gastrointestinal cancer and their families: 
Patients with incurable solid tumors experience high rates of both physical and psychological 
distress.16,17 Symptoms such as pain, fatigue, dyspnea, and nausea lead to a poor QOL and are 
associated with high rates of depression and anxiety.18 The family members of these patients 
also frequently experience emotional, physical and financial distress when caring for loved ones 
with incurable cancers.19,20 Despite advances in cancer care, life expectancy remains limited for 

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patients with incurable malignancies, such as lung and non-colorectal gastrointestinal (GI) 
cancer, which account for more than half of cancer-related deaths in men and one-third in 
women.21-24 These patients have a median survival of less than one year and often receive limited 
benefit from chemotherapy, usually with progression of disease after only a few months of 
treatment.25 While chemotherapy may improve symptoms, the impact on QOL is less clear as 
patients also experience marked side effects and toxicities from anti-cancer therapies, causing 
physical and emotional suffering.4  Impairments in QOL and mood not only compromise the 
wellbeing of patients with incurable cancer and their families, but also predict lower rates of 
survival.26-28 Typically, patients with incurable lung and non-colorectal GI cancers experience a 
high symptom burden, which begins at the time of diagnosis, persists throughout the course of 
disease, and intensifies near the end-of-life.29 Interventions should occur early in the course of 
incurable disease and demonstrate a meaningful impact on the suffering of patients with poor 
prognosis cancers and their family caregivers. 
Aggressive cancer care at the end-of-life: Oncology care for patients with incurable cancer is 
becoming increasingly aggressive with greater use of multiple anti-cancer regimens and 
administration of chemotherapy near the EOL.30 Over the last decade, rates of admission to the 
hospital, emergency department, and intensive care unit during the final month of life have 
increased as well.31,32 Unfortunately, aggressive medical treatment at the EOL fails to improve 
survival in patients with incurable cancer and correlates negatively with family caregivers’ 
perceptions of the quality of EOL care.3,33,34 Such care also places family caregivers at increased 
risk of major depression and complicated bereavement.3 Since U.S. hospice agencies generally 
lack the financial resources to provide anti-cancer therapy, administration of chemotherapy and 
inpatient stays at the EOL often interrupt or delay referrals  to hospice services.3,35,36 Late referral 
to hospice prevents patients from accessing comprehensive EOL services that benefit the entire 
family.37 Specifically, family members of patients who receive hospice services not only report 
greater satisfaction with care and higher quality of death for the patient, but also experience 
improved psychological and physical health outcomes, compared with those caring for patients 
who do not receive hospice.38 Thus, the American Society of Clinical Oncology Quality 
Oncology Practice Initiative (ASCO QOPI) has recognized several key metrics for determining 
high quality EOL care including: no chemotherapy in the last 14 days of life, referral to hospice 
and length of stay in hospice > 3 days.39 
End-of-life decision-making in advanced cancer: The majority of patients with advanced cancer 
and their families report a desire to receive timely and realistic prognostic information.40-45 Data 
demonstrate that patients with incurable cancer and their families often fail to understand the 
goals of therapy and maintain inaccurate illness perceptions. A recent study revealed that only 
half of patients with a new lung cancer diagnosis accurately recalled information about the goal 
of treatment 1-3 days after their oncology visit.46 However, a recent study demonstrated that 
patients who received early palliative care retained or developed an accurate assessment of their 
prognosis compared to those patients receiving standard oncology care (82% compared to 59%, 
respectively).47 Importantly, patients’ understanding of their illness and prognosis strongly 
predicts treatment decision-making at the EOL.48-50 While patients with advanced cancer who 
view themselves as terminally ill are more likely to prefer and receive symptom directed care, 
those who overestimate their prognosis are more likely to choose an aggressive course of 
therapy.33,51 
Impact of early palliative care on symptom burden, quality-of-life and end-of-life care: The 
benefits of palliative care in the inpatient setting are well established in the literature.9,52 
However, examining the impact of palliative care in the outpatient care setting represents a 
relatively newer focus of research.53 Several previous investigations have evaluated the utility 
of intermittent or telephone-based palliative care interventions in the outpatient care setting, 
demonstrating positive effects on some salient patient-reported outcomes.54,55 We have studied 

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a more clinically based integrated service model in which palliative and oncology care provide 
simultaneous care throughout the course of illness. After completing a pilot feasibility study of 
this integrated care model, we performed a randomized controlled trial in patients with incurable 
lung cancer, observing significant improvements in QOL and quality of care at the end-of-
life.11,53 We are currently performing a similar study in a broader population of patients with 
advanced thoracic and gastrointestinal cancers. In addition to assessing many patient-reported 
and health care utilization measures, we are collecting abundant qualitative and quantitative data 
on the nature of the palliative care service in the outpatient care setting. This information will 
allow us to study the early palliative care model in a multi-site trial. 
1.3 
Hypotheses 
Aim 1: To determine the efficacy of early, integrated palliative care (PC) on patient and family 
caregiver reported outcomes in those with newly diagnosed incurable lung or non-colorectal 
gastrointestinal cancer. 
• 
Hypotheses 1: Compared to patients receiving standard care (SC), patients receiving early 
PC will (1) experience improved QOL and fewer depressive symptoms; and (2) report a 
more accurate understanding of their terminal illness and the goals of care. 
• 
Hypotheses 2: Compared to family caregivers in the SC arm, family caregivers of patients 
receiving early PC will (1) experience improved QOL and fewer depressive symptoms 
throughout the course of the patient’s illness; and (2) report a more accurate understanding 
of the patient’s terminal illness and the goals of care. 
Aim 2: To assess the impact of early, integrated PC on quality of EOL care and resource 
utilization in patients with newly diagnosed incurable lung or non-colorectal gastrointestinal 
cancer 
• 
Hypotheses: Compared to patients receiving SC, patients receiving early PC will (1) receive 
higher quality EOL care (i.e., less chemotherapy in the last 14 days of life, greater utilization 
of hospice services, and/or length of stay in hospice > 3 days); (2) experience less hospital 
and ICU days and (3) have at least the same survival as patients receiving standard care 
1.4 
Study Design 
This study will be a randomized, controlled trial of early PC integrated with standard oncology 
care versus standard oncology care alone. Patients will be randomized in a 1:1 fashion between 
study arms. The dynamic allocation procedure was adopted to balance the marginal distributions 
of stratification: tumor type (lung vs. esophageal/gastric vs. hepatic/biliary/pancreatic/ unknown 
primary), and family caregiver participation (yes vs. no).56 We modeled this study design to be 
identical to the completed and ongoing trial at the Massachusetts General Hospital (MGH) 
Cancer Center. We are not randomizing by site (i.e. cluster-randomized design) due to several 
reasons: (1) Although such a design would reduce contamination effects, it introduces site 
effects that could also impact outcomes; (2) In both of our prior trials, there was minimal 
contamination with few patients in the standard care arm referred for PC in the outpatient care 
setting; and (3) Within Alliance, ensuring equivalent sites across geographical regions with the 
same PC resources would be challenging. We have also decided not to include an attention 
control group as the logistical and sample size requirements for a third study arm would be 
substantial. Additionally, the observed clinical benefits of PC in our previous investigation did 
not appear to be merely due to increased clinician time with patients and families but related to 
the expertise of PC clinicians. We anticipate including approximately 20 Alliance sites with a 
minimum of 10 community sites with an enrollment goal of at least 15 patients per site.  

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1.5 
Description of Intervention 
The study intervention consists of the early integration of palliative care services into standard 
oncology care in an outpatient setting for patients with advanced lung and non-colorectal 
gastrointestinal malignancies who are not being treated with curative intent. The palliative care 
services provided to patients randomized to the intervention will be provided by board-certified 
physicians and/or advanced practice nurses and will focus on the following areas: (1) developing 
and maintaining the therapeutic relationship with the patients and family caregivers; (2) 
assessing and treating patient symptoms; (3) providing support and reinforcement of coping with 
advanced cancer in patients and family caregivers; (4) assessing and enhancing prognostic 
awareness and illness understanding in patients and family caregivers; (5) assisting with 
treatment decision-making; and (6) end-of-life care planning. 
Palliative care services in the community are likely to be highly variable and there are no 
standard practices for outpatient palliative care at this time. Thus, to promote the use of more 
uniform palliative care practices for patients at the differing study sites, the PC service from 
each participating institution will be required to meet specific eligibility requirements and at a 
minimum, the lead PC member will be required to complete two web-based training courses on 
providing palliative care services to patients.  
We have included minimum requirements for participating palliative care services in Section 
12.1 under ‘Institutional credentialing’ to be as inclusive as possible. Also, to ensure 
reproducible and measurable intervention, study sites will be provided with guidelines for the 
palliative care visits in the form of a manual, which is based on our previous studies. The data 
used to generate this manual, revealed six key elements of PC visits (relationship and rapport 
building, addressing symptoms, addressing coping, establishing illness understanding, 
discussing cancer treatments, end-of-life planning and engagement family members).57 
2.0 
OBJECTIVES  
2.1 
Primary objectives  
To determine the efficacy of early integrated palliative care (PC) on patient reported QOL at 12 
weeks using the FACT in patients with newly diagnosed incurable lung or non-colorectal 
gastrointestinal cancer. 
2.2 
Secondary objectives 
2.2.1 To determine the efficacy of early integrated palliative care (PC) on other patient reported 
outcomes in patients with newly diagnosed incurable lung or non-colorectal gastrointestinal 
cancer, by assessing the endpoints detailed in Section 11.4.1.1. 
2.2.2 To determine the efficacy of early integrated palliative care (PC) on family caregiver 
reported outcomes in those with newly diagnosed incurable lung or non-colorectal 
gastrointestinal cancer, by assessing the endpoints detailed in Section 11.4.1.2. 
2.2.3 To assess the impact of early, integrated PC on quality of EOL care and resource utilization 
in patients with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer by 
assessing the endpoints detailed in Section 11.4.1.3. 
2.2.4 To determine concordance between patient and family caregiver report of 
prognosis/curability. 

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3.0 
PATIENT SELECTION 
For questions regarding eligibility criteria, see the Contact Information page. Please note that the 
Study Chair cannot grant waivers to eligibility requirements. 
3.1 
On-Study Guidelines 
This clinical trial can fulfill its objectives only if patients appropriate for this trial are enrolled. 
All relevant medical and other considerations should be taken into account when deciding 
whether this protocol is appropriate for a particular patient. Physicians should consider the risks 
and benefits of any therapy, and therefore only enroll patients for whom this intervention is 
appropriate.  
Although they will not be considered formal eligibility (exclusion) criteria, physicians should 
recognize that the following may seriously increase the risk to the patient entering this protocol: 
• 
Psychiatric illness which would prevent the patient from giving informed consent. 
3.2 
Study Patient Participant Eligibility Requirements 
Use the spaces provided to confirm a patient’s eligibility by indicating Yes or No as appropriate.  
___ 
3.2.1 Documentation of Disease:  
___ 
Confirmed incurable lung cancer (NSCLC, small cell lung cancer, or mesothelioma) 
or non-colorectal GI cancer (esophageal, gastric, hepatic, biliary,  pancreatic or GI 
unknown primary) not being treated with curative intent. 
___ 
3.2.2 Informed of diagnosis of incurable disease within the previous 8 weeks. 
___ 
3.2.3 Age ≥ 18 years 
___ 
3.2.4 ECOG Performance Status 0-2 
___ 
3.2.5 Ability to read and respond to questions in English or able to complete questions 
with minimal assistance required from an interpreter or family member. 
___ 
3.2.6 Planning to receive all medical care for cancer at the enrolling institution. 
___ 
3.2.7 Participants must be under the care of an oncologist (who does not practice as 
a palliative care physician for that patient), but their current plan may or may not 
include chemotherapy or other forms of tumor-directed therapies. 
3.3 
Study Family Caregiver Participant Eligibility Requirements 
Use the spaces provided to confirm one family caregiver’s eligibility by indicating Yes or No as 
appropriate.  
___     3.3.1 Relative or friend who is identified by the patient participant who plans to 
regularly accompany the patient to the majority of their clinic visits. 
___     3.3.2 Family caregiver must live with the patient or have in-person contact with him 
or her at least twice per week. 
___     3.3.3 Ability to read and respond to questions in English or able to complete questions 
with minimal assistance required from an interpreter or family member. 
___     3.3.4 Age ≥ 18 years 
 

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Note: An eligible patient may participate in this trial without an eligible family caregiver being 
registered.  
4.0 
PATIENT REGISTRATION 
4.1 
CTEP Investigator Registration Procedures 
Food and Drug Administration (FDA) regulations and National Cancer Institute (NCI) policy 
require all investigators participating in any NCI-sponsored clinical trial to register and to renew 
their registration annually. 
Registration requires the submission of: 
• 
a completed Statement of Investigator Form (FDA Form 1572) with an original signature 
• 
a current Curriculum Vitae (CV) 
• 
a completed and signed Supplemental Investigator Data Form (IDF) 
• 
a completed Financial Disclosure Form (FDF) with an original signature 
Fillable PDF forms and additional information can be found on the CTEP website at 
<http://ctep.cancer.gov/investigatorResources/investigator_registration.htm>.  For questions, 
please 
contact 
the 
CTEP 
Investigator 
Registration 
Help 
Desk 
by 
email 
at 
. 
4.2 
CTEP Associate Registration Procedures / CTEP-IAM Account 
The Cancer Therapy Evaluation Program (CTEP) Identity and Access Management (IAM) 
application is a web-based application intended for use by both Investigators (i.e., all physicians 
involved in the conduct of NCI-sponsored clinical trials) and Associates (i.e., all staff involved 
in the conduct of NCI-sponsored clinical trials). 
Associates will use the CTEP-IAM application to register (both initial registration and annual 
re-registration) with CTEP and to obtain a user account. 
Investigators will use the CTEP-IAM application to obtain a user account only. (See CTEP 
Investigator Registration Procedures above for information on registering with CTEP as an 
Investigator, which must be completed before a CTEP-IAM account can be requested.) 
An active CTEP-IAM user account will be needed to access all CTEP and CTSU (Cancer Trials 
Support Unit) websites and applications, including the CTSU members’ website. 
Additional 
information 
can 
be 
found 
on 
the 
CTEP 
website 
at 
<http://ctep.cancer.gov/branches/pmb/associate_registration.htm>.  For questions, please 
contact 
the 
CTEP 
Associate 
Registration 
Help 
Desk 
by 
email 
at 
. 
4.3 
CTSU Site Registration Procedures 
This study is supported by the NCI Cancer Trials Support Unit (CTSU). 
IRB Approval:   
Each investigator or group of investigators at a clinical site must obtain IRB approval for this 
protocol and submit IRB approval and supporting documentation to the CTSU Regulatory 
Office before they can be approved to enroll patients.  Study centers can check the status of their 
registration packets by querying the Regulatory Support System (RSS) site registration status 
page of the CTSU members’ website by entering credentials at https://www.ctsu.org.  For sites 
under the CIRB initiative, IRB data will automatically load to RSS. 

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4.3.1 Submitting Regulatory Requirements 
Submit required forms and documents to the CTSU Regulatory Office, where they will be 
entered and tracked in the CTSU RSS.  
CTSU Regulatory Office 
 
 
 
4.3.2 Checking Your Site’s Registration Status 
Check the status of your site’s registration packets by querying the RSS site registration 
status page of the members’ section of the CTSU website.  (Note: Sites will not receive 
formal notification of regulatory approval from the CTSU Regulatory Office.) 
• 
Go to https://www.ctsu.org and log in to the members’ area using your CTEP-IAM 
username and password 
• 
Click on the Regulatory tab at the top of your screen 
• 
Click on the Site Registration tab 
• 
Enter your 5-character CTEP Institution Code and click on Go 
4.4 
Registration Requirements 
4.4.1 Informed consent:  
The patient must be aware of the neoplastic nature of his/her disease and willingly consent 
after being informed of the intervention, the experimental nature of the intervention, 
alternatives, potential benefits, and discomforts. Current human protection committee 
approval of this protocol and a consent form is required prior to patient consent and 
registration. Patients may be enrolled in other clinical trials while participating in this study. 
4.4.2 Limited Access and Site Credentialing 
This is a limited access study. Each participating Alliance member site must be individually 
approved by the study chair or designate and be listed as a participating site on the cover 
page of the protocol. All participating sites will be approved by the study chair prior to being 
listed on the protocol cover page. See also Sections 5.3 and 12.0. 
The confirmation of site participation eligibility by the study chair is required before any 
patients may be enrolled on this study.  
4.4.3 Patient/Family Caregiver Completed Booklets 
Patient and family caregiver assessment questionnaire booklets for A221303 are to be 
ordered prior to the registration of any patients.  
Questionnaire booklets are to be ordered prior to the registration of any patients and family 
caregivers. Booklets can be ordered by downloading and completing the QOL booklet order 
form (located under the ‘Supplemental Documents’ section of the A221303 study web page 
on the Alliance member website) and faxing the form to the Mayo Operational Support 
Clerk at 
. Samples of the booklets are found in Appendices II and III, which 
are to be used for reference and IRB submission only. They are not to be used for patient or 
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4.5 
Patient Registration/Randomization  
Patient enrollment will be facilitated using the Oncology Patient Enrollment Network (OPEN).  
OPEN is a web-based registration system available on a 24/7 basis.  To access OPEN, the site 
user 
must 
have 
an 
active 
CTEP-IAM 
account 
(check 
at 
< 
https://eapps-
ctep.nci.nih.gov/iam/index.jsp >) and a 'Registrar' role on either the LPO or participating 
organization roster. 
All site staff will use OPEN to enroll patients to this study.  It is integrated with the CTSU 
Enterprise System for regulatory and roster data and, upon enrollment, initializes the patient in 
the Rave database. OPEN can be accessed at https://open.ctsu.org or from the OPEN tab on the 
CTSU members’ side of the website at https://www.ctsu.org. A user manual is available for 
OPEN users on the CTSU site. 
Prior to accessing OPEN, site staff should verify the following: 
• 
All eligibility criteria have been met within the protocol stated timeframes.  
• 
All patients have signed an appropriate consent form and HIPAA authorization form (if 
applicable). 
Note: The OPEN system will provide the site with a printable confirmation of registration and 
treatment information. Please print this confirmation for your records. 
Further instructional information is provided on the OPEN tab of the CTSU members’ side of 
the CTSU website at https://www.ctsu.org or at https://open.ctsu.org.  For any additional 
questions contact the CTSU Help Desk at 
. 
4.5.1 Family Caregiver Participation  
Family caregiver consent and eligibility is captured on the OPEN enrollment form. 
Participating family caregivers must have signed and dated all applicable consents and 
authorization forms and source documents should be kept with the patient record.   
See section 4.5 regarding OPEN site staff verification and OPEN access requirements.  
Note: An eligible patient may be enrolled in this this study with or without the enrollment 
of an eligible family caregiver. 
4.6 
Stratification Factors 
4.6.1 Tumor type:  lung vs. esophageal/gastric vs. hepatic/biliary/pancreatic/unknown primary 
4.6.2 Family caregiver participation: yes vs. no. 
4.7 
Study Arm Assignments  
4.7.1 The factors defined in Section 4.4 will be used as stratification factors. 
4.7.2 After the patient has been registered into the study, the values of the stratification factors 
will be recorded, and the patient will be assigned to one of the following study groups using 
the Pocock and Simon dynamic allocation procedure55 which balances the marginal 
distributions of the stratification factors between the two groups.  
• 
Early palliative care 
• 
Standard oncology care 

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5.0 
STUDY IMPLEMENTATION 
5.1 
Palliative Care Clinic Requirements 
Institutions must have an outpatient palliative care clinic that meets the study site requirements 
listed in Section 12.1 for participation in this trial. Participating institutions need to be approved 
for participation by the study chair, or the study chair’s designate.   
5.2 
Palliative Care Physician and Advanced Practice Nurse Requirements 
The outpatient clinic leadership must include a physician and/or advanced practice nurses board 
certified in palliative care. See Section 12.2.  
5.3 
Palliative Care Manual and Training Requirements 
5.3.1 General Requirements 
Palliative care clinicians participating in this study are required to follow the guidance and 
instructions for the palliative care intervention as detailed in the ‘Early Integration of 
Palliative and Oncology Care: An Intervention Manual’ as Appendix I of this protocol. 
Please refer to this manual for guidance regarding the implementation of the palliative care 
intervention, as well as, the training requirements for administering palliative care for the 
PC team at each study site. These guidelines should be reviewed prior to initiating this trial. 
Palliative care clinicians will be required to: 
1. Review the ‘Early Integration of Palliative and Oncology Care: An Intervention 
Manual’ in its entirety; and 
2. At least one leader of the outpatient palliative care clinic must complete registration 
with CTEP (see Sections 4.1 and 4.2) , if not currently registered;  
3. At least one leader of the outpatient palliative care clinic must complete the two 
web-based training courses, each approximately 1-hour in length: 
• 
Site Staff: Palliative Care Training Video One 
• 
Site Staff: Palliative Care Training Video Two  
4. At least one leader of the outpatient palliative care clinic must be willing to 
participate in phone conference calls with the protocol leadership every 1-2 month 
to discuss any issues that arise during this protocol. 
5.3.2 PC Web-based Training 
The goal of the training courses will be to educate the clinicians on ways in which the 
provision of outpatient palliative care differs from inpatient delivery models. These courses 
will be informed by the educational needs assessment and focus on two areas: (1) 
Psychosocial aspects of outpatient palliative care, specifically the cultivation of prognostic 
awareness and the promotion of adaptive patient coping strategies over the course of the 
illness; and (2) developing a collaborative practice with oncology clinicians through role 
definition and joint patient visits.  
The 
Web-based 
training 
module 
can 
be 
found 
at 
https://www.phscpd.org/ 
palliativecarewebinars. Full instructions for completing the web-based training are located 
in  Appendix VI) 
If you have any issues or questions please contact the Partners Office of Continuing 
Professional Development at 
. 

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5.4 
Patient Recruitment 
Oncology clinicians will offer study participation to eligible patients. Some suggested language 
to help the oncology clinician discuss the protocol with eligible patients is included in Appendix 
V. Willing participants will provide written informed consent and receive a signed copy of the 
consent form. Also, family caregivers (e.g., relative or friend) upon whom the patient relies for 
help and who will likely accompany them to clinic visit will be asked to enroll. We will invite 
this person to participate in the family caregiver portion of the study.  
o Family caregivers will be eligible to enroll and provide written informed consent on the 
same day as the patient.  Patients and family caregivers who provide consent will 
complete the baseline participant reported measures. 
o Patients without a willing family caregiver will not be excluded from study 
participation. Patients and family caregivers who provide written informed consent will 
complete study measures, including a demographic questionnaire. 
o Patients who decline study entry, but desire early palliative care referral based on their 
preference, may be referred to palliative care based on the individual Cancer Center’s 
standard protocol or approach. 
6.0 
DATA SUBMISSION  
6.1 
Data collection and submission 
Data collection for this study will be done exclusively through the Medidata Rave clinical data 
management system.  Access to the trial in Rave is granted through the iMedidata application to 
all persons with the appropriate roles assigned in Regulatory Support System (RSS).  To access 
Rave via iMedidata, the site user must have an active CTEP-IAM account (check at < 
https://eapps-ctep.nci.nih.gov/iam/index.jsp >) and the appropriate Rave role (Rave CRA, Read-
Only, Site Investigator) on either the LPO or participating organization roster at the enrolling 
site. 
Upon initial site registration approval for the study in RSS, all persons with Rave roles assigned 
on the appropriate roster will be sent a study invitation e-mail from iMedidata.  To accept the 
invitation, site users must log into the Select Login (https://login.imedidata.com/selectlogin) 
using their CTEP-IAM user name and password, and click on the “accept” link in the upper 
right-corner of the iMedidata page.  Please note, site users will not be able to access the study in 
Rave until all required Medidata and study specific trainings are completed.  Trainings will be 
in the form of electronic learnings (eLearnings), and can be accessed by clicking on the link in 
the upper right pane of the iMedidata screen. 
Users that have not previously activated their iMedidata/Rave account at the time of initial site 
registration approval for the study in RSS will also receive a separate invitation from iMedidata 
to activate their account.  Account activation instructions are located on the CTSU website, Rave 
tab under the Rave resource materials (Medidata Account Activation and Study Invitation 
Acceptance).  Additional information on iMedidata/Rave is available on the CTSU members’ 
website under the Rave tab at www.ctsu.org/RAVE/ or by contacting the CTSU Help Desk at 
.  The accompanying tables in the 
following subsections detail the schedule of administration of assessment tools for patients 
(Section 6.2) and family caregivers (Section 6.3). Questionnaires will be completed as described 
below for each group.  
At each scheduled assessment time, the site staff will document participant compliance (patient 
and family caregiver) with study questionnaires, noting whether the participants completed 
questionnaires on time as well as the method of administration (e.g., via in-person or phone 

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interview). For those participants who fail to complete questionnaires, the site staff will note the 
reason for noncompliance. 
Patient and family caregiver assessment questionnaire booklets for A221303 are to be ordered 
prior to the registration of any patients. Samples of questionnaire/booklets are available in 
Appendices II and III, respectively, for reference and IRB submission only. They are not to be 
used for patient or family caregiver completion.  Booklets must be given to patients and family 
caregiver to complete, and they should be instructed to return the booklets to site staff either in 
person or by mail. Site staff will enter patient and family caregiver responses into the Medidata 
Rave database. 
6.2 
Patient Reported Measures 
Site staff will administer the questionnaires for patient reported measures during the time 
scheduled as detailed in the table below and are included as Appendix III.  They will review 
each questionnaire with the patient and instruct the patient to complete as much of the 
questionnaire as possible. It is anticipated that the patient reported measures will take 
approximately 15-20 minutes to complete based on previous experience administering similar 
questionnaires in this patient population. Patient and family caregiver assessment questionnaires 
are not required once patients are in hospice care. 
Data submission schedule for questionnaires to be completed by the patient: 
 
Form 
Baseline 
6*  
Weeks 
12*  
Weeks 
24*  
Weeks 
Demographics  
X 
 
 
 
As applicable 
For lung – FACT-L; OR 
For esophageal and gastric – FACT-E; OR 
For hepatic, biliary and pancreatic – FACT-Hep  
X 
X 
X 
X 
HADS  
X 
X 
X 
X 
PTPQ 
 
X 
X 
X 
*+/- 2 weeks before or after each time point for completion of the self-report measures will be 
allowed.  
 
 

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6.3 
Family Caregiver Reported Measures 
Site staff will administer the questionnaires for family caregiver reported measures during the 
time scheduled as detailed in the table below which are included as Appendix IV.  They will 
review each questionnaire with the family caregiver and instruct the family caregiver to 
complete as much of the questionnaire as possible. It is anticipated that the family caregiver 
measures will take approximately 10 minutes 
to complete based on previous experience 
administering similar questionnaires to the family caregiver population. 
Data submission schedule for questionnaires to be completed by the family caregiver: 
Form 
Baseline 
6*  
Weeks 
12*  
Weeks 
24*  
Weeks 
Demographics 
X 
 
 
 
SF-36 
X 
X 
X 
X 
HADS 
X 
X 
X 
X 
PTPQ 
 
X 
X 
X 
*+/- 2 weeks before or after each time point for completion of the self-report measures will be 
allowed.  
6.4 
Chart Abstraction 
The following data regarding measures of health service utilization and EOL care will be 
submitted using Medidata Rave® through chart abstraction by site staff at 1, 2, and 3 years (from 
enrollment) and at death. 
6.4.1 Administration of anticancer therapy 
• 
Chemotherapy: For each line of therapy, note name of agent, route of administration 
(intravenous or oral) and dates of administration. 
• 
Radiation therapy: For each course of radiation therapy course, note site treated and 
dates of administration. 
6.4.2 Enrollment to hospice: (yes [date of enrollment]/no) 
6.4.3 Hospital Care 
• 
Emergency room visits: For each emergency room visit, note reason for visit and date 
and if patient was hospitalized (yes/no) 
• 
Hospital admissions: For each hospital admission, note reason for admission, dates of 
admission, and documented code status. 
• 
ICU admissions: For each ICU admission, note reason for ICU admission and dates of 
admission 
6.4.4 Date and location of death 
6.4.5 The number of PC visits (in both the outpatient and inpatient setting) for participants in each 
study group and the reason for PC referral for patients assigned to standard care 
6.4.6 Referrals to other supportive care services, including social work, chaplain and 
psychiatry/psychology and referring provider 
 
 

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7.0 
INTERVENTION 
During registration, patients will be randomized to receive either early palliative care (Arm 1) or 
standard oncology care (Arm 2).  
Over the course of the study patients and their family caregivers in both arms will be asked to 
complete questionnaires about quality-of-life, mood, and their perception of prognosis and treatment 
goals during regularly scheduled oncology clinical visits at baseline and week 6, 12, and 24 visits.  
7.1 
Early Palliative Care Arm 
The intervention will be comprised of one baseline visit and palliative care visits or phone calls 
(if a clinic visit is not feasible) at least every four weeks throughout the patient’s life. 
7.1.1 Day of Registration   
• 
Patient and family caregiver will be asked to complete baseline self-report 
questionnaires. See Appendices II and III, respectively, for questionnaires. 
7.1.2 Subsequent Medical Oncology/Infusion Visits 
• 
A PC clinician will meet with patients randomized to early PC within one month of 
registration. This should be done at the patient’s next medical oncology or infusion visit 
following registration.  
• 
The PC clinician will meet with patients and family caregivers (if present at the 
appointments) at a minimum of every four weeks in the outpatient care setting 
(oncology clinic or infusion suite). PC visits will be coordinated with regularly 
scheduled cancer center appointments to reduce burden of multiple hospital visits.  
• 
If patients are unable to come to the clinic for a scheduled PC visit, at least one attempt 
will be made to reschedule the visit within seven days of the scheduled PC visit.  If a 
rescheduled in-person visit is not feasible, the PC clinician will conduct the visit over 
the telephone and document the content and nature of the visit in the medical record. 
Clinic visits are strongly preferred to telephone visits and should be attempted as much 
as possible. 
• 
Patients, family caregivers, or the PC team may initiate consultations as needed.  
• 
PC clinicians should follow the guidelines as detailed in Appendix I.  
• 
Depending on clinic space, workflow, and patient preference, PC clinicians may see 
patients in the clinic or in the chemotherapy infusion room. 
• 
If a patient is admitted to the hospital during the study period, they should be seen at 
least once by either their outpatient palliative care clinician or the inpatient palliative 
care hospital based team. Additional follow up during the hospital admission is not 
dictated by the study requirements and patients should be followed as per their 
institution practice. 
7.1.3 Completion of Study Measures 
Patients and family caregivers will be asked to complete quality-of-life questionnaires at 
weeks 6, 12, and 24. See Appendices II and III, respectively. A 2-week window, before and 
after each time point, for completion of the self-report questionnaires will be allowed. For 
example, the 12-week time point can be completed by patients and family caregivers 
between weeks 10 through 14. 

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7.2 
Standard Oncology Arm 
The standard oncology treatment will consist of questionnaire assessment only as outlined 
below. 
7.2.1 Day of Registration  
Patient and family caregiver will be asked to complete baseline self-report questionnaires. 
See Appendices II and III, respectively for questionnaires.  
7.2.2 Subsequent Medical Oncology/Infusion Visits 
 
After patients and family caregivers have been enrolled, the patient will meet with the 
treating oncologist(s) for the patient’s standard treatment visit activities without the 
scheduled study intervention of palliative care. 
Patients and family caregivers may consult with PC clinicians at their request or at the 
discretion of their treating oncologist. In such instances, individual PC clinicians will follow 
standard oncology participants per their clinical judgment, rather than according to the 
required time intervals for study patients receiving the early palliative care intervention.  
7.2.3 Completion of Study Measures 
Patient and family caregiver will be asked to complete self-report questionnaires at weeks 
6, 12, and 24. See Appendices II and III, respectively, for questionnaires. A 2-week window, 
before and after each time point, for completion of the self-report questionnaires will be 
allowed. 
7.3 
Duration of Intervention 
The intervention will end when the patient is deceased. Submission of patient and caregiver-
provided assessments will end with the completion of week 24 assessments. 
7.4 
Duration of Follow-Up 
Survival follow-up will be every 4 months from week 24 until death or up to 3 years (with chart 
abstraction at death, per section 6.4).  Chart abstraction will be performed at year 1, 2, and 3 
from enrollment, per section 6.4.   
8.0 
ADVERSE EVENTS 
We do not anticipate any adverse events related to participation in this study. Based on prior 
experience, the study chair has enrolled over 450 patients and their family caregivers to early 
palliative care studies and there have been no adverse events reported for the intervention.  
If patients or family caregivers experience any emotional discomfort when completing the 
questionnaires, they may choose not to complete them and/or speak with the site staff. Patients 
experiencing any physical or psychological complications as related to their standard care treatment 
should discuss this with their treating physician.  
9.0 
MEASURES 
Demographics: All study participants will complete a demographic questionnaire (see Appendix III 
for patient, Appendix IV for family caregiver) at the time of baseline data collection detailing their 
age, sex, race, ethnicity, religion, relationship status, education level, annual household income, and 
living situation (specify number of dependent children living at home). Family caregivers will also 
specify their relationship with the patient, living situation (specify number of dependent children 
living at home) and employment status. 

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QOL-Patient: To assess quality of life over time in study patients, we will use the Functional 
Assessment of Cancer Therapy (FACT) Questionnaires, which have been validated for use in 
multiple care settings and with diverse tumor types. The FACT consists of four subscales assessing 
well-being across four domains (physical, functional, emotional and social) during the prior seven 
days. Additional questions specific to cancer symptoms will be added to the measure for each tumor 
type, including lung (FACT-L), esophageal and gastric (FACT-E), and hepatic, biliary, and 
pancreatic (FACT-Hep) – See Appendix III.58-61 Patients will complete this questionnaire at baseline, 
6, 12 and 24 weeks. 
QOL-Family caregiver: We will use short-form health survey (SF-36) to assess change in health-
related QOL over time in family caregivers (see Appendix IV).62 The SF-36 measures eight domains 
of health-related quality-of-life: physical functioning, role limitations due to physical health, bodily 
pain, general health perceptions, vitality, social functioning, role limitations due to emotional health, 
and mental health. Family caregivers will complete this questionnaire at baseline, 6, 12 and 24 weeks. 
Mood: We will use the Hospital Anxiety and Depression Scale (HADS) to assess symptoms of 
depression and anxiety in all study participants (see Appendix III for patient, Appendix IV for family 
caregiver).63 The HADS is a 14- item questionnaire that contains two 7-item subscales assessing 
depression and anxiety symptoms during the past week. Scores on each subscale range from 0 to 21, 
with a cutoff of 8 or greater denoting clinically significant depression or anxiety symptoms. Patients 
and family caregivers will complete questionnaire at baseline, 6, 12 and 24 weeks. 
Prognosis and Treatment Perceptions Questionnaire: Dr. Temel has evaluated the content validity 
and readability of a thirteen-item Prognosis and Treatment Perception Questionnaire (PTPQ) to 
assess perceptions of prognosis, goals of treatment, and quality of communication with oncologists 
among patients with incurable cancer (see Appendix III for patient, Appendix IV for family 
caregiver). The PTPQ was recently used to assess illness and prognostic understanding in patients 
with advanced gastrointestinal cancers.64  We will administer the PTPQ to patients and their family 
caregivers in order to assess (1) illness knowledge and understanding; (2) communication and 
perceptions regarding prognosis and goals of care; and (3) discussions and preferences regarding 
EOL care. Patients and family caregivers will complete this questionnaire at 6, 12, and 24 weeks. 
10.0 END OF INTERVENTION 
10.1 
Duration of Intervention 
The patient case evaluations will continue until the patient is deceased.  
10.2 
Early Withdrawal 
Patients and/or family caregivers may request early withdrawal from the study.  Research staff 
will inquire regarding the reason for withdrawal and document the date and reason in the case 
report form.  If patients assigned to the intervention arm request withdrawal due to a preference 
to discontinue palliative care visits, the research staff will inquire if they are still willing to 
complete questionnaires and allow us to access their medical records.  If patients assigned to the 
intervention arm request withdrawal due to the questionnaires, they will still be permitted to see 
the palliative care clinician as per their preference.  The research staff will ask for continued 
permission to access their medical records.  Similarly, if patients assigned to the standard care 
arm request withdrawal due to the questionnaires, the research staff will ask for continued 
permission to access their medical records.  
 
 

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11.0 STATISTICAL CONSIDERATIONS 
11.1 
Study Overview 
This is a randomized phase III clinical trial to determine the efficacy of early palliative care vs. 
standard oncology care on patient and family caregiver reported outcomes, quality of EOL care 
and resource utilization in newly diagnosed incurable lung or non-colorectal gastrointestinal 
cancer. This trial implements a group sequential design without interim analysis. 
11.2 
Sample Size, Accrual Time, and Study Duration 
11.2.1 Sample Size 
A 4-5 point change in the FACT is considered a clinically meaningful change (CMC) and 
was the difference detected between arms in our previous study.65 Enrolling 140 patients per 
study arm will provide 80% power to detect at least a 4-point change from baseline to week 
12 (standard deviation was 11.87 from the pilot study) between arms using a two-sided two-
sample t-test with at 5% significance level.  
Based on our previous palliative care study, the rate of missing data for primary endpoint 
patient-reported measures was approximately 20-30%. We will therefore increase our 
sample size to 200 patients per arm to ensure a sufficiently large margin to have adequate 
power to detect the CMC. Based upon our current study enrollment rates, we estimate that 
with 400 patients, approximately 300 family caregivers will also enroll. 
11.2.2 Accrual Rate and Accrual Duration 
We anticipate being able to accrue approximately 20 patients per month based on our best 
estimate for this new area of research. Using this estimate, we would complete accrual 
within 20 months and data maturation within 26 months from study initiation. 
11.2.3 Primary Endpoint Completion Date for ClinicalTrials.gov Reporting 
For purposes of ClinicalTrials.gov reporting, the Primary Endpoint Completion Date 
(PECD) for this study is the time the last patient registered has been followed for at least 12 
weeks. 
11.3 
Statistical Design and Analysis for the Primary Endpoint 
11.3.1 Primary Endpoint 
The total scores of FACT-G will be calculated using the accompanying scoring algorithms. 
They will be further converted into a 0-100 quality of life scale for standardization. Change 
in FACT-G scores from baseline to 12 weeks between study arms will be the primary 
endpoint for this study. The disease-specific questions (additional concern) of FACT-L, 
FACT-E or FACT-Hep will be summarized in a descriptive manner between study arms. 
11.3.2 Analysis Plan 
A modified intent-to-treat principle38 will be applied for statistical analysis of efficacy in 
evaluable patients. Evaluable patients are defined as all patients meeting the eligibility 
criteria who did not cancel prior to receiving intervention. 
The primary analysis is to compare the change in FACT score from baseline to 12 weeks 
between study arms. We will perform preliminary analyses to examine how much QOL data 
are likely missing at random (MAR) or missing not at random (MNAR). However, missing 
data are expected to be MNAR as patients with poor QOL tend to have lower chances of 
completing a questionnaire, especially immediately prior to death.66 We will examine the 

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pattern of missing data by comparing average scores among patient subsets defined by their 
available data and survival status. We will then use the pattern mixture models67,68 to adjust 
for MNAR bias by stratification based on survival data. We will compare study arms overall 
by weighting the within-stratum estimates with the estimated probability of being in each 
distinct combination of intervention arm and survival duration. 
Sensitivity analysis will be conducted by exploring imputation method such as the last-
observation carried forward, and the worst rank score analysis69, favoring the more 
conservative method. 
In the pattern mixture model, repeated measures of FACT will all be included in the 
repeated measures model to estimate the change from baseline to 12 weeks for primary 
analysis. Selected demographic and clinical factors (including stratification factors) may be 
incorporated when examining change in QOL scores across the four time points (baseline, 
6, 12, and 24 weeks). 
11.4 
Supplementary Analysis Plans 
11.4.1 Secondary Endpoints 
11.4.1.1 The efficacy of early integrated palliative care (PC) on patient reported outcomes in 
patients with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer 
will be assessed by analyzing: 
1. Change in QOL on the FACT over time 
2. Rate of depressive symptoms as per HADS at 12 weeks and over time 
3. Rate of anxiety symptoms  as per HADS at 12 weeks and over time 
4. Change in illness understanding over time 
11.4.1.2 The efficacy of early integrated palliative care (PC) on family caregiver reported 
outcomes in those with newly diagnosed incurable lung or non-colorectal 
gastrointestinal cancer will be assessed by analyzing: 
1. Change in QOL on the SF-36 over time 
2. Rate of depressive symptoms as per HADS at 12 weeks and over time 
3. Rate of anxiety symptoms  as per HADS at 12 weeks and over time 
4. Change in illness understanding over time 
11.4.1.3 The impact of early, integrated PC on quality of EOL care and resource utilization in 
patients with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer 
will be assessed by analyzing: 
1. Rate of referral, enrollment and length of stay on hospice 
2. Location of death 
3. Number of hospital and ICU admissions and days 
4. Chemotherapy and radiation administration 
5. Overall survival 
11.4.1.4 Concordance between patient and family caregiver report of prognosis/curability. 

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11.4.2 Secondary Analysis 
We will adopt the gatekeeping procedure for the primary analysis of efficacy of early PC on 
patient reported outcomes, the secondary analysis of efficacy of early PC on family 
caregiver reported outcomes, and the secondary analysis of impact of early PC on quality of 
EOL care and resource utilization. Therefore, they will be tested at the 5% significance level 
in sequence, and the subsequent analysis (hypothesis testing) will only be carried out if the 
previous analysis is statistically significant. Otherwise, subsequent analysis will be 
descriptive in nature. Multiplicity will not be adjusted for other secondary analyses, hence, 
statistically significant findings from secondary analyses are exploratory in nature and 
therefore shall be interpreted as such. Descriptive statistics and graphical approaches will 
form the basis for most secondary analyses. 
11.4.2.1 To assess the changes in QOL over time among patients, generalized linear model 
with repeated measures will be used for comparison between treatment arms. To 
compare rates of psychological distress between treatment arms, we will transform 
the HADS score into a dichotomous outcome with categories reflecting the presence 
or absence of clinically significant depression and anxiety. We will then use 
generalized linear models with repeated measures to assess the association between 
the presence of depression/anxiety and study arm, using risk difference and relative 
risk to compare proportions between the study arms. To compare the illness 
understanding, we will analyze each item of the PTPQ separately using the 
appropriate test to determine the significance of the between-group differences. To 
assess additional measures of family caregiver perceptions of quality of death, we 
will employ the Jonckheere-Terpstra test, which is appropriate for contingency tables 
with ordinal data. 
11.4.2.2 To assess the changes in QOL among family caregivers, we will use the similar 
approach as for QOL among patients. Change in the total score and subscales will be 
compared with generalized linear models with repeated measures. Analysis of 
psychological distress and illness understanding will be the same as above. 
11.4.2.3 To assess differences in quality of EOL care, we will use Fisher’s exact test to 
determine the association between the composite EOL care measure categories and 
study arm and a comparison of rates between the groups based on the risk difference 
and relative risk. To assess the difference in resource utilization, we will also 
compare days on hospice and in the hospital and ICU using the Mann-Whitney U 
test. To compare patient survival, we will use Kaplan-Meier estimates, testing the 
difference between the curves with the log-rank test. 
11.4.2.4 To assess the concordance between patient and family caregiver report of 
prognosis/curability, we will analyze each of the primary and secondary endpoints 
using the matched-pair subset. Simple tests such as paired t-test, Wilcoxon signed-
rank test, and generalized linear models for matched pair data will be utilized. 
 
 

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11.5 
Study Monitoring 
11.5.1 Adverse Event Stopping Rule 
Not applicable.  
11.5.2 Accrual Monitoring Stopping Rule 
Slow Accrual: Patient accrual will be closely monitored by the investigators and secondary 
statistician on a monthly basis. If the accrual rate falls below 50% of expected accrual rate, 
investigators will carefully review feedback from sites and consider taking measures to 
encourage patient enrollment. 
11.5.3 Community vs Academic Accrual  
The NCI has requested that at least half the patients enrolled on this study be accrued from 
community centers. Therefore, patient accrual will be monitored by community vs academic 
accrual.  If the accrual target for academic is met, we may limit future patient accrual to 
community sites only. 
11.6 
Study Reporting 
11.6.1  This study will be monitored by the Alliance Data Safety Monitoring Board (DSMB), an 
NCI-approved functioning body. Reports containing efficacy, adverse event, and 
administrative information will be provided to the DSMB every month as per NCI 
guidelines. 
11.6.2  Results Reporting on ClinicalTrials.gov: At study activation, this study will have been 
registered within the “ClincialTrials.gov” web site. The Primary and Secondary Endpoints 
(i.e., “Outcome Measures”) along with other required information for this study will be 
reported on ClinicalTrials.gov.  
11.7 
Descriptive Factors  
None. 
11.8 
Inclusion of Women and Minorities 
This study will be available to all eligible patients, regardless of race, gender, or ethnic origin. 
There is no information currently available regarding differential effects of this intervention in 
subsets defined by race, gender, or ethnicity, and there is no reason to expect such differences 
to exist. Therefore, although the planned analysis will, as always, look for differences in 
treatment effect based on racial and gender groupings, the sample size is not increased in order 
to provide additional power for subset analyses. 
The geographical region served by the Alliance includes approximately 13.5% minorities. Based 
on prior Alliance studies involving similar disease sites, we expect about 11.6% of patients will 
be classified as minorities by race and about 60% of patients will be women. Expected sizes of 
race by gender subsets for patients randomized to this study are shown in the following table. 
 
 

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Racial Categories 
Ethnic Categories 
Not Hispanic or Latino Hispanic or Latino 
Total 
Female 
Male 
Female 
Male 
American Indian/ Alaska Native 
2 
1 
0 
0 
3 
Asian 
4 
3 
0 
0 
7 
Native Hawaiian or Other Pacific Islander 
0 
0 
0 
0 
0 
Black or African American 
20 
16 
0 
0 
36 
White 
209 
137 
5 
3 
354 
More Than One Race 
0 
0 
0 
0 
0 
Total 
235 
157 
5 
3 
400 
12.0 GENERAL REGULATORY CONSIDERATIONS AND CREDENTIALING 
12.1 
Institutional Palliative Care Requirements  
The requirements for the PC teams at participating Alliance sites are as follows: 
• 
Sites must have the capacity to perform visits at the cancer practice. 
• 
PC service must have the ability to see patients on the same days as their oncology 
visits (clinic, radiation, or chemotherapy).  
• 
The PC clinic must have a minimum of six months of experience of providing care 
in the outpatient setting. 
• 
The outpatient PC service must be led by a board certified palliative care physician or 
advanced practice nurse.   
• 
If patients randomized to the PC study arm are admitted to hospitals with an inpatient 
PC team, they must be followed by that inpatient PC team.  
• 
 At least one lead member of the PC outpatient team must be willing to complete two 
1-hour web-based training courses and review the protocol intervention manual and use 
this information to train the rest of the palliative care team that is participating in this 
trial. 
• 
At least one lead member of the PC outpatient team must be willing to participate in 
periodic PC teleconferences (no more frequently than monthly) with 
. 
12.2 
Individual Palliative Care Credentialing 
The requirements for the PC teams at participating Alliance sites are as follows: 
• 
The physician or advanced practice nurse PC leader for this study must be board 
certified. 
• 
Leader must provide verification of completion of both A221303 web-based training 
courses. 
• 
Palliative care provider must have read ‘Early Integration of Palliative and Oncology 
Care: An Intervention Manual’ in Appendix I.  

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10. Hui D, Elsayem A, De la Cruz M, et al. Availability and integration of palliative care at US 
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cancer: effects of early palliative care. J Clin Oncol 2012;30:1310-5. 
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16. Davis MP, Dreicer R, Walsh D, Lagman R, LeGrand SB. Appetite and cancer-associated 
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17. Miovic M, Block S. Psychiatric disorders in advanced cancer. Cancer 2007;110:1665-76. 
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adults receiving treatment for lung cancer. Psychooncology 2003;12:694-708. 
19. Covinsky KE, Goldman L, Cook EF, et al. The impact of serious illness on patients' families. 
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20.  Rhee YS, Yun YH, Park S, et al. Depression in family caregivers of cancer patients: the feeling 
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21. Sandler A, Gray R, Perry MC, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-
small-cell lung cancer. N Engl J Med 2006;355:2542-50. 

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22. Cunningham D, Starling N, Rao S, et al. Capecitabine and oxaliplatin for advanced 
esophagogastric cancer. N Engl J Med 2008;358:36-46. 
23. Burris HA, 3rd, Moore MJ, Andersen J, et al. Improvements in survival and clinical benefit with 
gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. 
J Clin Oncol 1997;15:2403-13. 
24. Vauthey JN, Lauwers GY, Esnaola NF, et al. Simplified staging for hepatocellular carcinoma. J 
Clin Oncol 2002;20:1527-36. 
25. anonymous. Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data 
on individual patients from 52 randomised clinical trials. Non-small Cell Lung Cancer 
Collaborative Group.[see comment]. BMJ 1995;311:899-909. 
26. Eton DT, Fairclough DL, Cella D, Yount SE, Bonomi P, Johnson DH. Early change in patient-
reported health during lung cancer chemotherapy predicts clinical outcomes beyond those 
predicted by baseline report: results from Eastern Cooperative Oncology Group Study 5592. J 
Clin Oncol 2003;21:1536-43. 
27. Maione P, Perrone F, Gallo C, et al. Pretreatment quality of life and functional status assessment 
significantly predict survival of elderly patients with advanced non-small-cell lung cancer 
receiving chemotherapy: a prognostic analysis of the multicenter Italian lung cancer in the 
elderly study. J Clin Oncol 2005;23:6865-72. 
28. Pirl WF, Temel JS, Billings A, et al. Depression after diagnosis of advanced non-small cell lung 
cancer and survival: a pilot study. Psychosomatics 2008;49:218-24. 
29. Lutz S. Symptom frequency and severity in patients with metastatic or locally recurrent lung 
cancer: a prospective study using the Lung Cancer Symptom Scale in a community hospital. 
Journal of Palliative Medicine 2001;4:157-65. 
30. Temel JS, McCannon J, Greer JA, et al. Aggressiveness of care in a prospective cohort of 
patients with advanced NSCLC. Cancer 2008;113:826-33. 
31. Earle CC, Neville BA, Landrum MB, Ayanian JZ, Block SD, Weeks JC. Trends in the 
aggressiveness of cancer care near the end-of-life. J Clin Oncol 2004;22:315-21. 
32. Earle CC, Park ER, Lai B, Weeks JC, Ayanian JZ, Block S. Identifying potential indicators of 
the quality of end-of-life cancer care from administrative data. J Clin Oncol 2003;21:1133-8. 
33. Weeks JC, Cook EF, O'Day SJ, et al. Relationship between cancer patients' predictions of 
prognosis and their treatment preferences. Jama 1998;279:1709-14. 
34. Rose JH, O'Toole EE, Dawson NV, et al. Perspectives, preferences, care practices, and outcomes 
among older and middle-aged patients with late-stage cancer. J Clin Oncol 2004;22:4907-17. 
35. Casarett DJ, Fishman JM, Lu HL, et al. The terrible choice: re-evaluating hospice eligibility 
criteria for cancer. J Clin Oncol 2009;27:953-9. 
36. Christakis NA, Escarce JJ. Survival of Medicare patients after enrollment in hospice programs. 
N Engl J Med 1996;335:172-8. 
37. Teno JM, Clarridge BR, Casey V, et al. Family perspectives on end-of-life care at the last place 
of care. Jama 2004;291:88-93. 
38. Christakis NA, Iwashyna TJ. The health impact of health care on families: a matched cohort 
study of hospice use by decedents and mortality outcomes in surviving, widowed spouses. Soc 
Sci Med 2003;57:465-75. 
39. The Quality Oncology Practice Initative. 2009. (Accessed December 21, 2009, at 
40. Jenkins V, Fallowfield L, Saul J. Information needs of patients with cancer: results from a large 
study in UK cancer centres. Br J Cancer 2001;84:48-51. 
41. Parker SM, Clayton JM, Hancock K, et al. A systematic review of prognostic/end-of-life 
communication with adults in the advanced stages of a life-limiting illness: patient/caregiver 
preferences for the content, style, and timing of information. J Pain Symptom Manage 
2007;34:81-93. 

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42. Hagerty RG, Butow PN, Ellis PM, et al. Communicating with realism and hope: incurable 
cancer patients' views on the disclosure of prognosis. J Clin Oncol 2005;23:1278-88. 
43. Hagerty RG, Butow PN, Ellis PA, et al. Cancer patient preferences for communication of 
prognosis in the metastatic setting. J Clin Oncol 2004;22:1721-30. 
44. Steinhauser KE, Christakis NA, Clipp EC, McNeilly M, McIntyre L, Tulsky JA. Factors 
considered important at the end-of-life by patients, family, physicians, and other care providers. 
Jama 2000;284:2476-82. 
45. Steinhauser KE, Clipp EC, McNeilly M, Christakis NA, McIntyre LM, Tulsky JA. In search of 
a good death: observations of patients, families, and providers. Ann Intern Med 2000;132:825-
32. 
46. Gabrijel S, Grize L, Helfenstein E, et al. Receiving the diagnosis of lung cancer: patient recall 
of information and satisfaction with physician communication. J Clin Oncol 2008;26:297- 302. 
47. Temel JS, Greer JA, Admane S, et al. Longitudinal Perceptions of Prognosis and Goals of 
Therapy in Patients with Metastatic Non-Small-Cell Lung Cancer: Results of a Randomized 
Study of Early Palliative Care. J Clin Oncol 2011;29(17):2319-26 
48. Fried TR, Bradley EH, Towle VR, Allore H. Understanding the treatment preferences of 
seriously ill patients. N Engl J Med 2002;346:1061-6. 
49. Haidet P, Hamel MB, Davis RB, et al. Outcomes, preferences for resuscitation, and physician-
patient communication among patients with metastatic colorectal cancer. SUPPORT 
Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of 
Treatments. Am J Med 1998;105:222-9. 
50. Cosgriff JA, Pisani M, Bradley EH, O'Leary JR, Fried TR. The association between treatment 
preferences and trajectories of care at the end-of-life. J Gen Intern Med 2007;22:1566- 71. 
51. Mack JW, Weeks JC, Wright AA, Block SD, Prigerson HG. End-of-life discussions, goal 
attainment, and distress at the end-of-life: predictors and outcomes of receipt of care consistent 
with preferences. J Clin Oncol;28:1203-8. 
52. Zimmermann C, Riechelmann R, Krzyzanowska M, Rodin G, Tannock I. Effectiveness of 
specialized palliative care: a systematic review. Jama 2008;299:1698-709. 
53. Temel JS, Jackson VA, Billings JA, et al. Phase II study: integrated palliative care in newly 
diagnosed advanced non-small-cell lung cancer patients. J Clin Oncol 2007;25:2377-82. 
54. Bakitas M, Lyons KD, Hegel MT, et al. Effects of a palliative care intervention on clinical 
outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. 
Jama 2009;302:741-9. 
55. Rabow MW, Dibble SL, Pantilat SZ, McPhee SJ. The comprehensive care team: a controlled 
trial of outpatient palliative medicine consultation. Arch Intern Med 2004;164:83-91.  
56. Pocock, S. J. and R. Simon (1975). "Sequential treatment assignment with balancing for 
prognostic factors in the controlled clinical trial." Biometrics 31(1): 103-115. 
57. Yoong J, Park ER, Greer JA, et al. Early palliative care in advanced lung cancer: a qualitative 
study. JAMA internal medicine 2013;173:283-90. 
58. Cella D. The Functional Assessment of Cancer Therapy-Lung and Lung Cancer Subscale assess 
quality of life and meaningful symptom improvement in lung cancer. Semin Oncol 2004;31:11-
5. 
59. Darling G, Eton DT, Sulman J, Casson AG, Celia D. Validation of the functional assessment of 
cancer therapy esophageal cancer subscale. Cancer 2006;107:854-63. 
60. Debb SM, Arnold B, Perez B, Cella D. Validation of the FACT-Gastric cancer quality of life 
questionnaire for use in Spanish-speaking countries. Psychooncology. 
61. Yount S, Cella D, Webster K, et al. Assessment of patient-reported clinical outcome in 
pancreatic and other hepatobiliary cancers: the FACT Hepatobiliary Symptom Index. J Pain 
Symptom Manage 2002;24:32-44. 

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62. Ware JE, Kosinski M, Dewey JE. How to Score Version 2 of the SF-36 Health Survey. Lincoln, 
RI: QualityMetric Incorporated, 2000.  
63. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatrica 
Scandinavica 1983;67:361-70. 
64. El-Jawahri A, Traeger L, Greer JA, et al. Associations among prognostic understanding, quality 
of life, and mood in patients with advanced cancer. Cancer 2014;120(2):278-85 
65. Cella D, Hahn EA, Dineen K. Meaningful change in cancer-specific quality of life scores: 
differences between improvement and worsening. Qual Life Res 2002;11:207-21. 
66. Donaldson GW, Moinpour CM. Learning to live with missing quality-of-life data in advanced-
stage disease trials. J Clin Oncol 2005;23:7380-4. 
67. Little RJA and Rubin DB (2002). Statistical Analysis with Missing Data.  New Jersey: John 
Wiley & Sons, Inc. 
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69. Lachin JM. Worst-rank score analysis with informatively missing observations in clinical trials. 
Control Clin Trials 1999;20:408-22. 
 
 

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14.0 MODEL CONSENT FORMS 
Patient Model Consent 
 
Testing the addition of early palliative care to usual cancer care in patients with 
incurable lung or non-colorectal gastrointestinal cancers 
 
Official Study Title for Internet Search on http://www.ClinicalTrials.gov: 
(Randomized Study of Early Palliative Care Integrated with Standard 
Oncology Care versus Standard Oncology Care Alone in Patients with 
Incurable Lung or Non-Colorectal Gastrointestinal Malignancies) 
 
What is the usual approach to my incurable lung or non-colorectal gastrointestinal cancer? 
You are being asked to take part in this study because you have incurable lung or non-colorectal 
gastrointestinal cancer.  When patients are diagnosed with advanced cancer, their oncology doctors 
and nurses usually provide most of their care.  At a later time, when their disease worsens and they 
develop more symptoms, they may also be referred to doctors and nurse who specialize in 
palliative care.  
 
If you are not familiar with the term “palliative care”, this refers to doctors and nurses who 
specialize in the lessening (“palliation’) of symptoms associated with cancer. Palliative care 
focuses on improving the quality of life for patients with advanced diseases and their family 
members by providing support for relief of physical symptoms, emotional and psychological 
support, and counseling. 
 
What are my other choices if I do not take part in this study? 
If you decide not to take part in this study, you have other choices. For example: 
• you may choose to have the usual approach to your cancer care 
• you may choose to take part in a different study, if one is available 
• you may choose to discuss palliative care at any time with your doctor in addition to 
having your usual cancer care without participating in this study.  
 
Why is this study being done? 
Patients with advanced cancer often feel stress and worry and have symptoms such as fatigue or 
pain.  The purpose of this study is to see whether patients who receive care from palliative care 
doctors and nurses at an earlier time in their disease, along with their regular cancer care, will 
experience less emotional and physical issues from their cancer.   
 
The effects of the early involvement of the palliative care team will be compared to the usual 
approach of receiving care mostly from the cancer treatment team (as described in the beginning 
of this consent form).  
 
There will be about 400 patients enrolled in this intervention study and there will be about 300 
family caregivers enrolled as well. 
 
 

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What are the study groups? 
This study has two study groups. Group 1 will receive early palliative care in addition to their 
usual cancer care and Group 2 will receive their usual cancer care. 
 
A computer will by chance assign you to one of the two groups in the study. This is called 
randomization. This is done by chance because no one knows if one study group is better or worse 
than the other. 
 
Another way to find out what will happen to you during this study is to read the chart below. Start 
reading at the left side and read across to the right, following the lines and arrows. 
 
 
How long will I be in this study? 
You will be on this study for as long as you receive care for your disease. 
 
What extra tests and procedures will I have if I take part in this study? 
There are no extra exams, tests, or procedures that you will need to have if you take part in this 
study, with the exception of completing questionnaires.  If you are seeing the palliative care team 
in addition to your usual cancer care, the palliative care team will try to have their visits with you 
when you are at the cancer center for your regular cancer care or treatment.  If the palliative care 
team cannot see you when you attend regular doctor visits for cancer care or treatment, they may 
schedule their visit with you on another day. 
 
You will be asked to complete a packet of questions when you start the study and in 6, 12 and 24 
weeks when you come for your regular cancer care visits.  These questions will ask about some 
personal information (such as your ethnicity), about how you are feeling (including symptoms like 
fatigue or sadness), and about what you understand about your diagnosis and planned treatment. 
The questionnaire should take about 15-20 minutes to complete each time. 
 
We will also ask your family caregiver to complete a packet of questionnaire when you start the 
study and in 6, 12, and 24 weeks. 
 
What possible risks can I expect from taking part in this study? 
If you choose to take part in this study, there is a risk that: 
• You may be asked sensitive or private questions in the study question packet.  If you feel 
uncomfortable about answering any questions, you do not have to answer them.  
 
Let your study doctor know of any questions or concerns you may have about the study question 
packet. You can ask the study doctor about these questions at any time. 
 
What possible benefits can I expect from taking part in this study? 
It is not possible to know at this time if the early palliative care in addition to usual cancer care 
approach is better than the usual cancer care approach so this study may or may not help you. This 
study will help researchers learn things that will help people in the future. 
 

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Can I stop taking part in this study? 
Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let 
the study doctor know as soon as possible. If you stop, you can decide whether or not to let the 
study doctor continue to provide your medical information to the organization running the study. 
 
The study doctor will tell you about new information or changes in the study that may affect your 
health or your willingness to continue in the study. 
 
The study doctor may take you out of the study: 
• If your health changes and the study is no longer in your best interest 
• If new information becomes available 
• If you do not follow the study rules 
• If the study is stopped by the sponsor, Institutional Review Board or Food and Drug 
Administration. 
 
What are my rights in this study? 
Taking part in this study is your choice. No matter what decision you make, and even if your 
decision changes, there will be no penalty to you. You will not lose medical care or any legal 
rights. 
 
For questions about your rights while in this study, call the ________________________ (insert 
name of center) Institutional Review Board at __________________ (insert telephone number). 
(Note to Local Investigator: Contact information for patient representatives or other individuals 
at a local institution who are not on the IRB or research team but take calls regarding clinical 
trial questions can also be listed here.) 
 
What are the costs of taking part in this study? 
The palliative care team visits will be billed to your health plan/insurance company. Before you 
decide to be in the study, you should check with your health plan or insurance company to find out 
exactly what they will pay for.  
 
You will not be paid for taking part in this study. 
 
What happens if I am injured or hurt because I took part in this study? 
You are not expected to have a physical injury related to this study. 
 
If you are injured or hurt as a result of taking part in this study and need medical treatment, please 
tell your study doctor. The study sponsors will not offer to pay for medical treatment for injury. 
Your insurance company may not be willing to pay for study-related injury. If you have no 
insurance, you would be responsible for any costs. 
 
If you feel this injury was a result of medical error, you keep all your legal rights to receive 
payment for this even though you are in a study. 

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Who will see my medical information? 
 
 
Your privacy is very important to us and the researchers will make every effort to protect it. Your 
information may be given out if required by law. For example, certain states require doctors to 
report to health boards if they find a disease like tuberculosis. However, the researchers will do 
their best to make sure that any information that is released will not identify you. Some of your 
health information, and/or information about your specimen, from this study will be kept in a 
central database for research. Your name or contact information will not be put in the database. 
 
There are organizations that may inspect your records. These organizations are required to make 
sure your information is kept private, unless required by law to provide information. Some of these 
organizations are: 
• The Alliance for Clinical Trials in Oncology 
• The Institutional Review Board, IRB, is a group of people who review the research with the goal of 
protecting the people who take part in the study. 
• The Food and Drug Administration and the National Cancer Institute in the U.S., and similar ones if 
other countries are involved in the study. 
 
Where can I get more information? 
You may visit the NCI Web site at http://cancer.gov/ for more information about studies or general 
information about cancer. You may also call the NCI Cancer Information Service to get the same 
information at: 1-800-4-CANCER (1-800-422-6237). 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the Web 
site will include a summary of the results. You can search this Web site at any time. 
 
Who can answer my questions about this study? 
You can talk to the study doctor about any questions or concerns you have about this study or to 
report side effects or injuries. Contact the study doctor __________________ (insert name of study 
doctor[s]) at __________________ (insert telephone number). 
 
WHAT IF I HAVE MORE QUESTIONS? 
If you have questions about the use of your samples for research, contact the study doctor, 
________________, (insert name of study doctor for main trial), at _____________________ 
(insert telephone number of study doctor for main trial). 
 
 
 

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My Signature Agreeing to Take Part in the Study 
I have read this consent form or had it read to me. I have discussed it with the study doctor and my 
questions have been answered. I will be given a signed copy of this form. I agree to take part in 
the main study.  
 
Participant’s signature________________________________ 
 
Date of signature_____________________________________ 
 
Signature of person(s) conducting the informed consent 
discussion___________________________________ 
 
Date of signature_____________________________________ 
 
 
 

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Family Caregiver Model Consent  
Testing the addition of early palliative care to usual cancer care in patients with incurable 
lung or non-colorectal gastrointestinal cancers 
 
You are being asked to take part in a research study about how the treatment of a friend or family 
member who has incurable lung or non-colorectal gastrointestinal cancer has affected your 
everyday life. You are being asked to participate in this study because your friend or family 
member has agreed to participate in this study to determine whether having patients get palliative 
care at an earlier time in their disease treatment along with their regular cancer care will improve 
the emotional and physical issues related to having cancer.  
 
If you are not familiar with the term “palliative care”, this specialty refers to health care clinicians 
who specialize in the lessening (“palliation’) of disease symptoms. Palliative care focuses on 
improving the quality of life for patients with advanced diseases and their family members by 
providing support for relief of physical symptoms, emotional and psychological support, and 
counseling. 
 
Participation in this study is purely voluntary. Your decision to participate will not affect your 
friend or family member's ability to receive medical care in any way. 
 
There will be about 400 patients enrolled in this intervention study and about 300 friend or family 
caregivers enrolled. If you should accept our invitation to participate in this study, we would like 
to ask you questions about how your significant other's having cancer has affected you emotionally 
and physically, as well as your everyday activities, family and social life, and finances. You will 
be asked to complete questionnaires at four time points – shortly after you sign this consent form, 
and at 6, 12, and 24 weeks. These questions will ask about some personal information, such as, 
about how you are feeling and about your understanding of your friend or family member’s disease 
and planned treatment. Completing the questionnaires will take approximately 15-20 minutes each, 
and will be done at a time during your friend or family member’s regular cancer care visits, at no 
cost to you. The answers that you give to the interviewer will be confidential, meaning that your 
answers will not be shared with your significant other or members of his/her medical team. If your 
friend or family member decides not to take part in this study at any time, it will also end your 
participation in this study. Your participation in this study will help us better understand how early 
palliative care intervention affects how cancer patients are feeling and whether it improves their 
quality of life. Please sign below if you agree to complete the questionnaires described in this 
document at the indicated time points. We thank you for your cooperation. 
I have read this consent form or had it read to me. I have discussed it with the study doctor and my 
questions have been answered. I will be given a signed copy of this form. I agree to take part in 
this study. 
_____________________________________ 
 
_____________________________ 
 
(Participant's Signature) 
     (Date) 
_____________________________________ 
 
 
_____________________________ 
 
(Name of Responsible Investigator) 
     (Phone #) 

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APPENDIX I:  EARLY INTEGRATION OF PALLIATIVE & ONCOLOGY CARE:  A TREATMENT MANUAL 
 
 
 
 
 
 
 
 
 
Early Integration of Palliative and Oncology 
Care: An Intervention Manual 
Joseph A. Greer, Ph.D., Vicki A. Jackson, M.D., Elyse R. Park, PhD., Anthony L. Back, 
M.D., & Jennifer S. Temel, M.D. 

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Early Palliative Care Intervention Manual 
 
Background 
Palliative care represents a specialty-trained medical discipline that focuses on enhancing quality-of-
life, symptom management, coping, treatment decision-making as well as psychosocial and spiritual 
support for patients with serious illnesses and their family caregivers. Often consisting of physicians, 
nurses, social workers, and chaplains, the multidisciplinary palliative care team primarily aims to help 
patients with medical illness live as well as possible for as long as possible. However, historically, 
patients and families have received such services late in the course of disease in the inpatient setting as 
consultations for uncontrolled symptoms or for planning end-of-life care. 
New evidence from several trials suggest that patients with advanced cancer who receive palliative 
care services from the time of diagnosis experience a number of beneficial clinical outcomes, such as 
better quality-of-life, lower rates of depression, more accurate prognostic awareness, and higher quality 
end-of-life care. In a comprehensive review of the literature, Greer and colleagues (2013) have 
documented the rationale and evidence base for early palliative care for patients with advanced cancer. 
Given these positive results, national professional organizations such as the American Society of 
Clinical Oncology, have recommended consideration of referral to palliative care early in the course of 
disease for patients diagnosed with metastatic cancer. 
The integration of palliative care and standard oncology care in the outpatient setting includes unique 
features of practice that are distinct from the traditional model of inpatient palliative care. To ascertain 
the components of early palliative care, we have gathered data from multiple sources including: 1) 
chart review, 2) focus group interviews with palliative care clinicians, and 3) qualitative analyses of 
audio-recordings of early palliative care consultations for patients diagnosed with metastatic lung or 
advanced non-colorectal gastrointestinal cancers. Based on these data sources, we have outlined the 
following six domains of early palliative care: 
• 
Developing and maintaining the therapeutic relationship with patients and family caregivers 
• 
Assessing and treating patient symptoms 
• 
Providing support and reinforcement of coping with advanced cancer in patients and family 
caregivers 
• 
Assessing and enhancing prognostic awareness and illness understanding in patients and 
family caregivers 
• 
Assisting with treatment decision‐making 
• 
Planning for end‐of‐life care 
In the following treatment manual, we detail the essential content and processes of the aforementioned 
early palliative care domains, in order to facilitate clinician education and dissemination of such 
services. Although the content domains of early palliative care often occur across multiple sessions or 
several may occur within a single consultation, we will present the information according to the types 
of palliative care interventions that occur most prominently during the following time frames: at 
initiation of treatment; throughout the entire course of disease; at clinical turning points (e.g., changing 
to a new regimen of chemotherapy or after being discharged from the hospital); and upon the 
conclusion of outpatient treatment and/or transition to hospice services. 
Initial Outpatient Palliative Care Visits in the Oncology Setting 
Key Domain: Therapeutic Relationship 
Although developing and maintaining the therapeutic relationship is essential across all palliative 
care visits throughout the course of disease, the prominent focus of initial consultations soon after 
diagnosis in the outpatient setting is rapport building and establishing trust. 
• 
Introducing Palliative Care: The primary focus of the early palliative care consultation soon after 

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diagnosis involves the development of a strong therapeutic relationship and rapport building with 
patients and family caregivers. In the context of a new cancer diagnosis for patients with 
incurable disease, the referral to palliative care works best if the oncologist either personally 
introduces the palliative care clinician during a joint visit or discusses the value of the palliative 
care team and collaborative nature of treatment to support the patient and family. 
o The PC clinician will often begin the first consultation by eliciting the patient’s and family 
caregiver’s understanding of palliative care, ideally to identify their baseline knowledge 
and familiarity with the service as well as to debunk any myths about the treatment. 
o To help reduce potential resistance, the PC clinician will then emphasize the role of 
palliative care to help the patient and family caregivers achieve the best possible quality-
of-life through expert symptom management, support, and assistance with treatment 
decision‐making. 
o The PC clinician explains the nature of the service as a multidisciplinary team that is 
available to the patient and family caregiver throughout the disease process. This 
conversation may also need to differentiate early outpatient palliative care from hospice 
care. 
• 
Understanding the Patient and Family Caregiver Experience: A key feature of building rapport 
is learning about the values, life goals, and experiences of patients and their family caregivers 
both prior to and after the cancer diagnosis. The PC clinician can accomplish this by asking about 
the following areas: 
o The patient’s life experiences outside the context of disease (including work, family, 
hobbies/interests, spiritual or religious involvement, etc.) 
o Lifestyle changes that have resulted from the diagnosis and treatment of cancer 
o Patients’ and family caregivers’ current wishes, priorities, and emotions, while providing 
validation 
• 
Building Trust with the Patient and Family Caregiver: PC clinicians develop trust and credibility 
with patients and family caregivers by outlining the parameters of communication and providing 
reassurance. For example, the following strategies help facilitate trust: 
o Acknowledging the role of the PC clinician in helping the patient to “live as well as possible 
for as long as possible.” 
o Clarifying and validating what the patient wishes and does not wish to discuss 
o Encouraging the patient to disclose symptoms and other concerns to the PC clinician 
o Reinforcing the partnership between the patient and family caregiver and PC clinician 
o Reassuring the patient and family caregiver that discussions about end‐of‐life care or other 
medical decisions will be raised when necessary. 
 
Outpatient Palliative Care Visits throughout the Entire Course of Disease 
Key Domain: Patient Symptoms 
Based on our review of early PC consultations, symptom management is a prominent focus of all 
palliative care visits from initial consultation and throughout the course of disease. Assessing and 
treating symptoms to enhance quality-of-life is one of the primary ways that PC clinicians establish 
trust and credibility with patients and family caregivers. In this way, PC clinicians demonstrate the 
collaborative nature of integrated palliative and oncology care. 
• 
Preparing for Symptoms: Patients and families often experience concern about the trajectory of 
illness and treatment side effects. PC clinicians in the outpatient setting provide an invaluable 
service by clarifying the likely symptoms patients will experience, while offering reassurance 
about the methods for reporting and treating such symptoms as they occur. PC clinicians will 

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want to explain their role and availability for symptom management both during and between 
clinic visits. 
• 
Assessing and Treating Symptoms: At every consultation, the PC clinician will conduct a review 
of systems to elicit existing and new symptom concerns, especially as related to disease and 
treatment side effects. 
o The common symptoms patients with incurable cancer will report in the outpatient setting 
include: pain, dyspnea/cough, fatigue, gastrointestinal symptoms, neurologic symptoms, 
edema, mood/emotional symptoms, sleep‐related symptoms, issues of sexuality, and other 
symptoms including pre‐existing or co‐morbid conditions. 
o Our review of PC consultations for patients with incurable lung or non‐colorectal GI 
cancers revealed that while symptoms can be quite variable per individual patient, pain and 
fatigue are frequently reported across all palliative care visits. Also, PC clinicians note that 
they treat nausea/vomiting more often with transitions in chemotherapy, whereas dyspnea 
and anxiety symptoms occur more frequently later, such as after hospitalization and referral 
to hospice care. 
o PC clinicians draw on their expert training and skill in medical management of complex 
symptom clusters with use of opioids, non‐opioid analgesics, anti‐emetic agents, and 
psychotropic agents, etc. 
• 
Coordinating Symptom Management with Oncology: When working closely with the oncologist, 
the PC clinician will need to maintain ongoing, effective communication with the treatment team 
to define this mutual collaboration and work within the preferred practice patterns of individual 
oncologists. Specifically, some oncology clinicians may want to take a more or less active role 
in managing symptoms. Thus, PC clinicians provide an extra layer of support for both the 
oncology team and patient. 
• 
Providing Referral for Symptom Management: Although PC clinicians possess expertise to 
assess and treat severe and poorly controlled symptoms, they also emphasize the team approach 
to comprehensive cancer care by referring to specialty care, mental health (e.g., psychiatry,   
psychology, social work), alternative medicine (e.g., acupuncture, massage, art therapy), and  
spiritual support as needed. 
 
Key Domain: Coping with Advanced Cancer 
As in the case of symptom management, early PC clinicians address how patients and family 
caregivers are coping with advanced cancer across clinic visits throughout the course of disease. The 
provision of early palliative care affords the opportunity and time for counseling patients and family 
caregivers to enhance adjustment and coping with the many existential and lifestyle changes that 
occur as a result of cancer and its treatment. In particular, the aim is to help patients maintain hope 
and engagement with life activities to the extent that is possible and consistent with their functioning. 
• 
Reviewing and Validating Prior Coping Efforts: PC clinicians value and recognize that patients 
and family caregivers bring their own expertise in coping to the current circumstance based on 
how they have managed difficulties and crises in the past. 
o The PC clinician often begins the discussion of coping by asking patients and family 
caregivers what strategies (e.g., use of social support, seeking counseling, increasing self‐
care activities, etc.) they have used to adjust to other life transitions or losses. During this 
conversation, the PC clinician strives to highlight and reinforce all adaptive forms of 
coping, while also assessing for potentially harmful behaviors (e.g., substance use, social 
withdrawal, etc.). 
o While it is natural in times of crisis to doubt one’s capacity to cope, the PC clinician 

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communicates to patients and family caregivers that they have the strength and abilities to 
meet their imminent challenges by highlighting successful prior coping efforts. Moreover, 
by emphasizing the partnership with the treatment team, the PC clinician reinforces that 
patients and family caregivers are not alone as they navigate the many treatments, scans, 
symptoms, and uncertainties of related to advanced cancer. 
• 
Discussing and Advocating for Different Methods of Coping: After assessing and validating 
prior coping, PC clinicians also introduce various strategies and approaches to help improve 
adjustment and meaning in life. For example, the following topics may be explored: 
o Behavioral approaches: Specifically, PC clinicians may employ evidence‐based techniques 
for stress reduction (e.g., breathing and relaxation exercises); behavioral activation 
(remaining engaged with important activities and sustaining normal life as much as possible 
even with the disease); sleep hygiene; exercise; and activity pacing as needed due to pain, 
fatigue or other symptoms. 
o Spiritual approaches: PC clinicians assess the role that spirituality plays in a patient’s life 
in a respectful and non‐judgmental manner and with a broad perspective to incorporate 
multiple meanings of spirituality (such as religious affiliation and participation in 
community of faith, personal spiritual beliefs and practices, cultural traditions, etc.). 
o Accepting Illness while Maintaining Hope: PC clinicians help patients and family 
caregivers understand that acceptance of illness has cognitive, behavioral, and emotional 
elements. For example, although patients may more or less intellectually understand their 
prognosis and course of disease, they often experience difficulty in emotionally processing 
this information. By offering a safe venue for patients and family caregivers to ask questions 
about the disease, clarify uncertainties, and experience the related affect, PC clinicians 
facilitate cognitive and emotional acceptance of illness. Also, PC clinicians help patients 
and family caregivers achieve behavioral acceptance by defining the parameters of what is 
their control, acknowledging the limitations due to disease, and maintaining hope for 
achieving valued quality-of-life goals. 
• 
Social Support: PC clinicians help patients and family caregivers define the different forms of 
social support they need, such as pragmatic versus emotional support. In other words, they clarify 
which individuals help with making meals, transportation to appointments, going shopping etc., 
as well as those who are available to listen and offer emotional support for discussing the 
experience of life‐limiting cancer. Also, the PC clinician works with patients and families to 
identify any gaps and problem‐solve strategies for soliciting needed support. Conducting Life 
Review: Although not all patients will have the interest or capacity to reflect on their life 
experiences in a meaningful way, some will appreciate the process of life review as a form of 
existential coping. Specifically, as patients approach the end‐of‐life, some seek to take time to   
reflect on their life story and experiences, consider their legacy, and explore how they want to   
spend their remaining time. Such life review work might also include specific activities such as  
writing letters to loved ones, completing unfinished tasks, reconciling relationships with family 
and friends, completing a creative or artistic project (e.g., scrapbook, personal history, quilt, 
woodworking, etc.), as a representation of who the patient is and expression of love for others. 
• 
Supporting Family Caregiver Coping: Research shows that patient distress is highly related to 
family caregiver distress and vice versa. In the early palliative care setting, PC clinicians have 
the rare opportunity to bolster family caregiver coping by conducting ongoing assessments of 
burden, enhancing communication between patients and loved ones, and providing 
recommendations for additional support or referral. 
• 
Referring for Additional Support: Again, the PC clinician calls upon other members of the 

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supportive care team as needed for patients and family caregivers who may be experiencing 
complicated or severe distress. Referrals to social work, psychology, psychiatry, and pastoral 
care may be useful depending on the specific presenting circumstances and concerns. 
 
Outpatient Palliative Care Visits during Clinical Turning Points 
Key Domain: Prognostic Awareness and Illness Understanding 
Based on our review of early PC consultations during clinical turning points, such as starting a new 
chemotherapy regimen or after hospitalization, symptom management and coping with illness remain 
prominent foci of treatment. However, PC clinicians also report with increased frequency discussions 
about illness understanding and treatment decision-making. Of note, the assessment and discussion of 
prognosis and illness understanding is not a single event but rather occurs over multiple visits, a 
benefit of the longer relationship that early PC clinicians develop in the outpatient setting. 
• 
Communication with Oncologist: The PC clinician must first consult with the primary oncologist 
to ensure the care team is consistent with their understanding of patient prognosis before 
engaging in detailed communication with the patient about the likely course of disease. When 
possible, joint clinic visits between oncology and palliative care will reinforce the team approach 
to care and ensure clear and effective communication with patients and family caregivers. 
• 
Assessing and Informing Patient Expectations of Prognosis and Illness Process: We require 
reading the article by Jackson et al. (2013), which provides a detailed account of how to cultivate 
prognostic awareness and deliver information about the disease process of advanced cancer in 
the early palliative care setting. By way of summary, PC clinicians recognize that patient and 
family caregiver illness understanding often vacillates between more and less realistic 
expectations over time, or even within the same clinic visit, which can be confusing for 
clinicians. The following strategies help improve prognostic awareness in a manner that is 
consistent with the degree of cognitive‐emotional coping and acceptance observed in patients 
and family caregivers. 
o Assessment of prognostic awareness begins with asking patients and family caregivers in 
an open‐ ended manner about their understanding of the disease and their future. The 
responses from patients provide some clarity about the level of awareness and also their 
ability to tolerate discussions regarding prognosis. For patients who struggle to have these 
conversations, framing questions with the hypothetical of “imagining a poorer health state” 
may be useful. 
o Communication strategies for delivering prognostic information include the “Ask‐Tell‐
Ask” and “Pairing Hope with Worry” techniques (for further details, see Jackson et al., 
2013). PC clinicians understand that they must clarify the type of information patients and 
family caregivers want to know, such as questions about expected length of life versus 
concerns about how the disease changes over time and what the dying process is like. 
o As patients and family caregivers begin to understand and integrate information about 
prognosis, they will often experience heightened affect such as disbelief, sadness, anger, 
etc. Rather than blocking or providing false reassurance, the PC clinician’s role is to witness 
and validate these emotions with silence, an empathic touch, re‐statement of realistic hopes, 
and “I wish” statements (e.g., “It sounds like that was hard to hear. I wish I had better 
news.”) 
o The PC clinician can then pivot to discuss again those aspects of care and the disease that can 
be controlled, emphasizing realistic hopes and quality-of-life goals (e.g., helping patient to 
feel well enough to spend valuable time with grandchildren). 
• 
Conducting Separate Conversations with Family Caregivers about Illness Understanding: The 

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vacillation in patients’ prognostic awareness over time is not only challenging for clinicians but 
can also be   difficult for family caregivers. Ideally, conversations about prognosis and illness 
understanding occur with both patients and family caregivers present, though this may not 
always be possible or clinically appropriate. In such circumstances, the PC clinician obtains 
consent from the patient to discuss illness concerns separately with identified family caregivers. 
Such conversations can help family caregivers understand the process of illness understanding, 
including the normal pattern of vacillation between more and less accurate prognostic awareness, 
offering strategies for communication and support. 
 
Key Domain: Treatment Decision-making 
As noted earlier, although discussion of treatment decision-making can occur at any point along the 
illness trajectory for patients with advanced cancer, early PC clinicians report more frequent 
discussions of this topic during times of clinical transitions, such as when starting or stopping 
chemotherapy or initiating hospice services. 
• 
Assessing Patient Values in Treatment Decision‐making: In the shared decision‐making process 
about cancer care, the early PC clinician elicits information from patients and family caregivers 
regarding their decision‐making style, quality versus quantity of life concerns, and life goals. 
The aim of this assessment is to determine the extent to which patient’s preferences and values 
align with current or potential treatments. 
• 
Discussing Treatment Considerations: Given their medical expertise, early PC clinicians provide 
an extra layer of support for patients and family caregivers to understand the efficacy, risks and 
benefits, side effects, and potential burdens associated with different forms of cancer treatment. 
Furthermore, these conversations provide an opportunity to reinforce the role of palliative care 
for mitigating symptoms and toxicities. 
• 
Supporting Treatment Decisions: PC clinicians value and reinforce patient autonomy in making 
informed treatment decisions. At multiple points during the course of cancer care, patients must 
discern whether to start, continue, or stop treatments in collaboration with their cancer care team, 
as well as decide the extent to which family caregivers are consulted about these decisions. In 
this context, early PC clinicians help clarify any misunderstanding about treatment, support 
patient decision‐making and freedom to change course, as well as facilitate communication with 
family caregivers and members of the oncology team. 
 
Final Outpatient Palliative Care Visits and Transition to Hospice Services 
Key Domain: End-of-Life Care 
Based on our review of early PC consultations, PC clinicians generally raise the discussion of end-of-
life (EOL) care incrementally over time and most prominently later in the course of illness, after having 
established a strong, trusting therapeutic relationship with patients and family caregivers. Typically, 
the final palliative care visits in the outpatient setting focus not only on symptom management, illness 
understanding, and decisions about stopping cancer therapy but also on advance care planning. 
• 
Discussing End‐of‐Life Care Options: Given the longer length of the clinical relationship with 
early palliative care, PC clinicians have the advantage to reduce patient anxiety in discussing 
EOL care concerns by having such conversations in a piecemeal fashion over time. The primary 
topics for EOL care planning include discussions regarding: selection of healthcare proxy, 
determination of resuscitation preferences, will/estate planning, hospice care, location of death, 
and funeral planning. 
• 
Supporting Family caregivers in EOL Care Coordination and Bereavement: Most patients with 
advanced cancer will experience progressive decline in their functional status over time. Thus, 

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they often require additional assistance from family and loved ones for personal care and 
communication of their values and wishes as they approach the end-of-life. This caregiving role 
can be both personally meaningful and stressful for family members and loved ones. 
o The PC clinician works closely with patients and family caregivers to determine the 
available resources for EOL care and whether it is appropriate for patients to receive their 
terminal care in the home or other hospice or inpatient settings. PC clinicians can also serve 
as advocates for family caregivers in making plans for the will/estate and funeral. 
o Early PC clinicians recognize that their specialized care considers the family unit as the 
focus of treatment. As such, they continue to provide resources, support, counseling, and 
referral for bereavement in family caregivers after the patient has died. 
 
Conclusion 
Our intent in developing this treatment manual is to support palliative care clinicians in the outpatient 
setting who provide care for patients with advanced cancer and their families. While the manual offers 
an organizational framework and highlights the essential components and processes of early palliative 
care, we recognize the value of the PC clinicians’ clinical judgment in discerning the appropriate timing 
and exact tailoring of these interventions for delivery in a patient-centered manner. 
 
Highly Recommended Readings: 
1. Jackson VA, Jacobsen J, Greer JA, et al: The cultivation of prognostic awareness through the 
provision of early palliative care in the ambulatory setting: a communication guide. J Palliat 
Med 16:894‐900, 2013 
2. Jacobsen J, Thomas J, Jackson VA. Misunderstandings about prognosis: an approach for 
palliative care consultants when the patient does not seem to understand what was said. J Palliat 
Med. 2013 Jan;16(1):91-95. 
3. Jacobsen J, Kvale E, Rabow M, Rinaldi S, Cohen S, Weissman D, Jackson V. Helping Patients 
with Serious Illness Live Well through the Promotion of Adaptive Coping: A Report from the 
Improving Outpatient Palliative Care (IPAL-OP) Initiative. J Palliat Med. 2014 Feb; 17 (4):1-
6. 
 
Additional Recommended Readings: 
1. Greer JA, Jackson VA, Meier DE, et al: Early integration of palliative care services with 
standard oncology care for patients with advanced cancer. CA Cancer J Clin 63:349‐63, 2013 
2. Greer JA, Pirl WF, Jackson VA, et al: Effect of early palliative care on chemotherapy use and 
end‐ of‐life care in patients with metastatic non‐small‐cell lung cancer. J Clin Oncol 30:394‐
400, 2012 
3. Jacobsen J, Jackson V, Dahlin C, et al: Components of early outpatient palliative care 
consultation in patients with metastatic nonsmall cell lung cancer. J Palliat Med 14:459‐64, 
2011 
4. Temel JS, Greer JA, Muzikansky A, et al: Early palliative care for patients with metastatic 
non‐ small‐cell lung cancer. N Engl J Med 363:733‐42, 2010 
5. Temel JS, Greer JA, Admane S, et al: Longitudinal perceptions of prognosis and goals of 
therapy in patients with metastatic non‐small‐cell lung cancer: results of a randomized study 
of early palliative care. J Clin Oncol 29:2319‐26, 2011 
6. Yoong J, Park ER, Greer JA, et al: Early palliative care in advanced lung cancer: a qualitative 
study. JAMA Intern Med 173:283‐90, 2013 
 
 

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APPENDIX II: PATIENT AND CAREGIVER INFORMATION SHEETS 

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PATIENT INFORMATION SHEET 
Patient Completed Booklet 
(Baseline) 
________________________________________________________________________ 
 
You have been given a booklet to complete for this study visit.  The booklet contains some questions 
about your ‘quality-of-life’ as a patient receiving treatment for cancer.  Your answers will help us to 
better understand how the treatment you are receiving is affecting the way you feel. 
 
1. You are being asked to complete a questionnaire booklet for this study. This booklet must be 
completed on the day you enroll in the study.  
 
a. This booklet contains of the following questionnaires: 
o Demographics 
o FACT-L Questionnaire (as applicable to your disease) 
o Hospital Anxiety and Depression Scale 
 
2.  Directions on how to complete each set of questions are written on the top of each set. 
 
3.  It is very important that you return the booklets to us, whether you finish the study or not. 
 
4. You will be given the nurse’s or study coordinator’s name and telephone number. You can call 
anytime with any concerns or questions. 
 
5. After completing this booklet, please return it to your nurse or physician at your next visit or mail 
it back in the provided envelope. 
 
Thank you for taking the time to help us. 
 
 

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PATIENT INFORMATION SHEET 
Patient Completed Booklet 
(Baseline) 
________________________________________________________________________ 
 
You have been given a booklet to complete for this study visit.  The booklet contains some questions 
about your ‘quality-of-life’ as a patient receiving treatment for cancer.  Your answers will help us to 
better understand how the treatment you are receiving is affecting the way you feel. 
 
1. You are being asked to complete a questionnaire booklet for this study. This booklet must be 
completed on the day you enroll in the study.  
 
a. This booklet contained 3 sets of questions: 
o Demographics 
o FACT-E Questionnaire (as applicable to your disease) 
o Hospital Anxiety and Depression Scale  
 
2.  Directions on how to complete each set of questions are written on the top of each set. 
 
3.  It is very important that you return the booklets to us, whether you finish the study or not. 
 
4. You will be given the nurse’s or study coordinator’s name and telephone number. You can call 
anytime with any concerns or questions. 
 
5. After completing this booklet, please return it to your nurse or physician at your next visit or mail 
it back in the provided envelope. 
 
Thank you for taking the time to help us. 
 
 

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PATIENT INFORMATION SHEET 
Patient Completed Booklet 
(Baseline) 
________________________________________________________________________ 
 
You have been given a booklet to complete for this study visit.  The booklet contains some questions 
about your ‘quality-of-life’ as a patient receiving treatment for cancer.  Your answers will help us to 
better understand how the treatment you are receiving is affecting the way you feel. 
 
1. You are being asked to complete a questionnaire booklet for this study. This booklet must be 
completed on the day you enroll in the study.  
 
a. This booklet contained 3 sets of questions: 
o Demographics 
o FACT-Hep Questionnaire (as applicable to your disease) 
o Hospital Anxiety and Depression Scale  
 
2.  Directions on how to complete each set of questions are written on the top of each set. 
 
3.  It is very important that you return the booklets to us, whether you finish the study or not. 
 
4. You will be given the nurse’s or study coordinator’s name and telephone number. You can call 
anytime with any concerns or questions. 
 
5. After completing this booklet, please return it to your nurse or physician at your next visit or mail 
it back in the provided envelope. 
 
Thank you for taking the time to help us. 
 
 

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PATIENT INFORMATION SHEET 
Patient Completed Booklet 
(6, 12, and 24 Weeks) 
________________________________________________________________________ 
You have been given a booklet to complete for this study visit.  The booklet contains some questions 
about your ‘quality-of-life’ as a patient receiving treatment for cancer.  Your answers will help us to 
better understand how the treatment you are receiving is affecting the way you feel. 
 
1. You are being asked to complete a questionnaire booklet for this study for the following time points: 
• 
6 weeks after your first study visit 
• 
12 weeks after your first study visit 
• 
24 weeks after your first study visit 
 
a. Each booklet contains the following questionnaires: 
o FACT-L Questionnaire (as applicable to your disease) 
o Hospital Anxiety and Depression Scale 
o Prognosis and Treatment Perceptions Questionnaire 
 
2.  Directions on how to complete each set of questions are written on the top of each set. 
 
3.  It is very important that you return the booklets to us, whether you finish the study or not. 
 
4. You will be given the nurse’s or study coordinator’s name and telephone number. You can call 
anytime with any concerns or questions. 
 
5. After completing this booklet, please return it to your nurse or physician at your next visit or mail 
it back in the provided envelope. 
 
Thank you for taking the time to help us. 
 
 
 
 

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PATIENT INFORMATION SHEET 
Patient Completed Booklet 
(6, 12, and 24 Weeks) 
________________________________________________________________________ 
 
You have been given a booklet to complete for this study visit.  The booklet contains some questions 
about your ‘quality-of-life’ as a patient receiving treatment for cancer.  Your answers will help us to 
better understand how the treatment you are receiving is affecting the way you feel. 
 
1. You are being asked to complete a questionnaire booklet for this study for the following time 
points: 
• 
6 weeks after your first study visit 
• 
12 weeks after your first study visit 
• 
24 weeks after your first study visit 
 
a. Each booklet contains the following questionnaires: 
o FACT-E Questionnaire (as applicable to your disease) 
o Hospital Anxiety and Depression Scale  
o Prognosis and Treatment Perceptions Questionnaire  
 
2.  Directions on how to complete each set of questions are written on the top of each set. 
 
3.  It is very important that you return the booklets to us, whether you finish the study or not. 
 
4. You will be given the nurse’s or study coordinator’s name and telephone number. You can call 
anytime with any concerns or questions. 
 
5. After completing this booklet, please return it to your nurse or physician at your next visit or mail 
it back in the provided envelope. 
 
Thank you for taking the time to help us. 
 
 

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PATIENT INFORMATION SHEET 
Patient Completed Booklet 
(6, 12, and 24 Weeks) 
________________________________________________________________________ 
 
You have been given a booklet to complete for this study visit.  The booklet contains some questions 
about your ‘quality-of-life’ as a patient receiving treatment for cancer.  Your answers will help us to 
better understand how the treatment you are receiving is affecting the way you feel. 
 
1. You are being asked to complete a questionnaire booklet for this study for the following time points: 
• 
6 weeks after your first study visit 
• 
12 weeks after your first study visit 
• 
24 weeks after your first study visit 
 
a. Each booklet contains the following questionnaires: 
o FACT-Hep Questionnaire (as applicable to your disease) 
o Hospital Anxiety and Depression Scale  
o Prognosis and Treatment Perceptions Questionnaire  
 
2.  Directions on how to complete each set of questions are written on the top of each set. 
 
3.  It is very important that you return the booklets to us, whether you finish the study or not. 
 
4. You will be given the nurse’s or study coordinator’s name and telephone number. You can call 
anytime with any concerns or questions. 
 
5. After completing this booklet, please return it to your nurse or physician at your next visit or mail 
it back in the provided envelope. 
 
Thank you for taking the time to help us. 
 
 

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FAMILY CAREGIVER INFORMATION SHEET 
Family Caregiver Completed Booklet 
(Baseline) 
________________________________________________________________________ 
 
You have been given a booklet to complete for this study visit.  The booklet contains some questions 
about your ‘quality-of-life’ as a family caregiver of a patient with cancer.  Your answers will help 
us to better understand how caring for a patient with cancer is affecting the way you feel. 
 
 
1. You are being asked to complete a questionnaire booklet for this study. This booklet must be 
completed on the day you enroll in the study.  
 
a. This booklet contains the following questionnaires: 
o Demographics 
o Short Form-36  
o Hospital Anxiety and Depression Scale 
 
2.  Directions on how to complete each set of questions are written on the top of each set. 
 
3.  It is very important that you return the booklets to us, whether you finish the study or not. 
 
4. You will be given the nurse’s or study coordinator’s name and telephone number. You can call 
anytime with any concerns or questions. 
 
 
5. After completing this booklet, please return it to your nurse or physician at your next visit or mail 
it back in the provided envelope.  
 
Thank you for taking the time to help us. 
 
 

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FAMILY CAREGIVER INFORMATION SHEET 
Family Caregiver Completed Booklet 
(6, 12, and 24 Weeks) 
________________________________________________________________________ 
 
You have been given a booklet to complete for this study visit.  The booklet contains some questions 
about your ‘quality-of-life’ as a family caregiver of a patient with cancer.  Your answers will help 
us to better understand how caring for a patient with cancer is affecting the way you feel. 
 
 
1. You are being asked to complete a questionnaire booklet for this study for the following time points: 
• 
6 weeks after your first study visit 
• 
12 weeks after your first study visit 
• 
24 weeks after your first study visit 
 
a. Each booklet contains the following questionnaires: 
o Short Form-36  
o Hospital Anxiety and Depression Scale  
o Prognosis and Treatment Perceptions Questionnaire  
 
2.  Directions on how to complete each set of questions are written on the top of each set. 
 
3.  It is very important that you return the booklets to us, whether you finish the study or not. 
 
4. You will be given the nurse’s or study coordinator’s name and telephone number. You can call 
anytime with any concerns or questions 
 
5. After completing this booklet, please return it to your nurse or physician at your next visit or mail 
it back in the provided envelope 
 
Thank you for taking the time to help us. 
 
 

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Update #06 
APPENDIX III: PATIENT REPORTED MEASURES  
 
 

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Patient Demographics Form 
Please check the appropriate box or boxes. 
 
 
Age __ __ __ 
 
1. Race (Mark one with an X.) 
(Choose the race which most accurately describes you.) 
 American Indian or Alaskan Native 
 Asian 
 Black or African American  
 Native Hawaiian or other Pacific Islander 
 White  
 Not reported 
 Unknown 
 
2.  Ethnicity (Mark one with an X.) 
 Hispanic or Latino 
 Not Hispanic or Latino 
 Not reported 
 Unknown 
 
3. Religion (Mark one with an X.) 
 Catholic 
 Protestant 
 Jewish 
 Muslim 
 None 
 Unknown 
 Not reported 
 Other (specify)_______________ 
 
4. What is your marital status? (Mark one with an X.) 
 Married 
 Domestic partnership 
 Widowed 
 Divorced 
 Separated 
 Never married 
 I prefer not to answer 
 Unknown/Not reported 
 
 

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5. What is the highest grade you finished in school? (Mark one with an X.) 
 8th grade or less 
 9th-11th grade 
 High school graduate/GED 
 Associate degree/some college 
 Vocational/technical school 
 Bachelor’s degree 
 Advanced degree 
 I prefer not to answer 
 
6. What was the total combined income of your household in the past year, including income from all 
sources such as wages, salaries, Social Security or retirement benefits, help from relatives and so 
forth?  Please tell us the total income before taxes. (Mark one with an X.) 
 Less than $20,000 
 $20,000 – $49,999 
 $50,000 – $89,999 
 $90,000 – $119,999 
 $120,000 or above 
 Unknown 
 I prefer not to answer 
 
7. With whom do you live? (Mark all that apply with an X.) 
 Spouse/partner 
 Girlfriend/boyfriend 
 Children aged 18 years or younger 
 Children aged 19 years or older 
 Parent(s)/parent(s)-in-law 
 Live alone 
 Other (specify) _____________ 
 Other relative (specify) _____________ 
 
 
 
 

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Hospital Anxiety and Depression Scale 
 
Name: 
 
 
 
 
 
 
 
 
 
 
Date: 
 
Doctors are aware that emotions play an important part in most illnesses. If your doctor knows about these feelings he will be 
able to help you more. 
This questionnaire is designed to help your doctor to know how you feel. Read each item and place a firm tick in the box 
opposite the reply which comes closest to how you have been feeling in the past week. 
Don’t take too long over your replies: your immediate reaction to each item will probably be more accurate than a long thought-
out response. 
Tick only one box in each section 
I feel tense or 'wound up': 
 
 
 
I feel as if I am slowed down: 
 
 
Most of the time................................. 
 
 
Nearly all the time............................... 
 
 
A lot of the time................................. 
 
Very often........................................... 
 
Time to time, Occasionally................ 
 
Sometimes........................................... 
 
Not at all............................................. 
 
Not at all.............................................. 
 
 
 
 
 
 
 
I still enjoy the things I used to enjoy:  
 
 
I get a sort of frightened feeling like 
'butterflies' in the stomach: 
 
 
Definitely as much.............................. 
 
 
Not at all.............................................. 
 
 
Not quite so much............................... 
 
Occasionally........................................ 
 
Only a little.......................................... 
 
Quite often........................................... 
 
Hardly at all......................................... 
 
Very often…………………............... 
 
 
 
 
 
 
 
I get a sort of frightened feeling as if 
something awful is about to happen: 
 
 
I have lost interest in my appearance:  
 
 
Very definitely and quite badly……... 
 
 
Definitely............................................ 
 
 
Yes, but not too badly......................... 
 
I don't take so much care as I should.. 
 
A little, but it doesn’t worry me.......... 
 
I may not take quite as much care...... 
 
Not at all.............................................. 
 
I take just as much care as ever.......... 
 
 
 
 
 
 
 
I can laugh and see the funny side of things: 
 
 
I feel restless as if I have to be on the move: 
 
 
As much as I always could.................. 
 
 
Very much indeed.............................. 
 
 
Not quite so much now....................... 
 
Quite a lot........................................... 
 
Definitely not so much now................ 
 
Not very much.................................... 
 
Not at all.............................................. 
 
Not at all............................................. 
 
 
 
 
 
 
 
Worrying thoughts go through my mind: 
 
 
I look forward with enjoyment to things:  
 
 
A great deal of the time....................... 
 
 
 
As much as ever I did......................... 
 
 
A lot of the time.................................. 
 
 
Rather less than I used to................... 
 
From time to time but not too often ...  
 
 
Definitely less than I used to.............. 
 
Only occasionally................................ 
 
 
Hardly at all........................................ 
 
 
 
 
 
 
 
 
I feel cheerful: 
 
 
 
I get sudden feelings of panic: 
 
 
Not at all.............................................. 
 
 
 
Very often indeed................................ 
 
 
Not often............................................. 
 
 
Quite often........................................... 
 
Sometimes........................................... 
 
 
Not very often..................................... 
 
Most of the time.................................. 
 
 
Not at all.............................................. 
 
 
 
 
 
 
 
 
I can sit at ease and feel relaxed:  
 
 
 
I can enjoy a good book or radio or TV 
programme: 
 
 
Definitely............................................. 
 
 
 
Often.................................................. 
 
 
Usually................................................ 
 
 
Sometimes......................................... 
 
Not often............................................. 
 
 
Not often............................................ 
 
Not at all............................................. 
 
 
Very seldom....................................... 
 
 
 
 
 
 
 
 
Do not write below this line 
232 
 
ONCOLOGY    VOLUME 4   NUMBER 5 
 

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PROGNOSIS AND TREATMENT PERCEPTIONS QUESTIONNAIRE (PTPQ) 
 
PATIENT VERSION 
 
1. 
Patients differ in the amount of information that they want to know about their diagnosis and 
treatment—some want to know everything, others want to know very little. What is your preference 
for details of information about your diagnosis and treatment? Please check one. 
 I prefer not to hear a lot of details 
 I want to hear details only in certain situations, such as when tests are abnormal or when 
treatment decisions need to be made 
 I want to hear as many details as possible in all situations relating to my cancer and its 
treatment 
 
2. 
How would you rate the quality of the information you have been given by your oncologist about 
treatment and the treatment choices available for you? Please check one. 
 Excellent 
 Good 
 Satisfactory 
 Fair 
 Poor 
 
3. 
If you had to choose one, what would you say is your primary goal of your current cancer 
treatment? Many of these goals may be important to you, but please check the one goal that you 
feel is most important to you right now. 
 To lessen my suffering as much as possible 
 For me and/or my family to be able to keep hoping 
 To make sure I have done everything 
 To extend my life as long as possible 
 To cure my cancer 
 To help cancer research 
 Other: please specify   
 
 
4. 
If you had to choose one, what would you say is your oncologist’s primary goal of your current 
cancer treatment? Please check one. 
 To lessen my suffering as much as possible 
 For me and/or my family to be able to keep hoping 
 To make sure I have done everything 
 To extend my life as long as possible 
 To cure my cancer 
 To help cancer research 
 Other: please specify 
 
5. 
How important is it for you to know about the likely outcome of your cancer over time (i.e. your 
prognosis)? Please check one. 
 Extremely important 
 Very important 
 Somewhat important 
 A little important 
 Not at all important 
 
 

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6. 
How often have you had a conversation with your oncologist about the likely outcome of your 
cancer over time (i.e. your prognosis)? Please check one. 
 Never 
 Rarely 
 Sometimes 
 Often 
 Very Often 
 
7. 
All things considered, how do you feel about the amount of information you know about the likely 
outcome of your cancer over time (i.e. your prognosis)? Please check one. 
 
I wish I had more information about my prognosis 
 
I now have about the right amount of information 
 
I wish I had less information about my prognosis 
 
8. How would you rate the quality of the information you have been given by your oncologist about 
the likely outcome of your cancer over time (i.e. your prognosis)? Please check one. 
 Excellent 
 Good 
 Satisfactory 
 Fair 
 Poor 
 
9. Patients often report that knowing about the likely outcome of their cancer over time (i.e. their 
prognosis) impacts other decisions they have to make. Please check one box for each statement. If 
you do not know at all about your prognosis, please skip this question. 
 
How helpful has knowing about your prognosis been for you in the following areas? 
 
 
Extremely 
Helpful 
Very 
Helpful 
A Little  
Helpful 
Not at all 
Helpful 
Making decisions about treatment 
 
 
 
 
Preparing for the future 
 
 
 
 
Maintaining hope 
 
 
 
 
Coping with the disease 
 
 
 
 
Overall, how helpful has knowing about 
prognosis been for you? 
 
 
 
 
 
10. How would you describe your current medical status? Please check one. 
 Relatively healthy 
 Relatively healthy and terminally ill 
 Seriously ill and not terminally ill 
 Seriously ill and terminally ill 
 
 

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11. How likely do you think it is that you will be cured of cancer? Please check one. 
 Extremely likely (more than a 90% chance of cure) 
 Very likely (75-90% chance of cure) 
 Moderately likely (50-74% chance of cure) 
 Somewhat likely (25-49% chance of cure) 
 Unlikely (10-24% chance of cure) 
 Very unlikely (less than 10% chance of cure) 
 No chance (0% chance of cure) 
 
12. Have you and your oncologist discussed any particular wishes you have about the care you would 
want to receive if you were dying? Please check one. 
 Yes 
 No 
 
13. If you had to choose, would you prefer 1) a course of treatment that focused on extending life as 
much as possible, even if it meant more pain and discomfort, or 2) a plan of care that focused on 
relieving pain and discomfort as much as possible, even if that meant not living as long? Please 
check one. 
 Extend life as much as possible 
 Relieve pain as much as possible 
 Don’t know 
 
 

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APPENDIX IV: FAMILY CAREGIVER REPORTED MEASURES 
 
 

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Family Caregiver Demographics Form 
Please check the appropriate box or boxes. 
 
1.  Age __ __ __ 
 
2. Gender (Mark one with an X.) 
 Male 
 Female 
 
3. Relationship to patient (Mark one with an X.) 
 Married or living as if married 
 Living together as roommates 
 Divorced/Separated 
 Child (daughter or son) 
 Parent (mother or father) 
 Sibling (brother or sister) 
 Friend 
 Other (specify)___________ 
 
4. Race (Mark one with an X.) 
(Choose the race which most accurately describes you.) 
 American Indian or Alaskan Native 
 Asian 
 Black or African American  
 Native Hawaiian or other Pacific Islander 
 White 
 Not reported 
 Unknown 
 
5.  Ethnicity (Mark one with an X.) 
 Hispanic or Latino 
 Not Hispanic or Latino 
 No reported 
 Unknown 
 
6. Religion (Mark one with an X.) 
 Catholic 
 Protestant 
 Jewish 
 Muslim 
 None 
 Unknown 
 Not reported 
 Other (specify)_______________ 
 
 

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7. What is the highest grade you finished in school? (Mark one with an X.) 
 8th grade or less 
 9th – 11th grade 
 High school graduate/GED 
 Associate degree/some college 
 Vocational/technical school 
 Bachelor’s degree 
 Advanced degree 
 I prefer not to answer 
 
8. What is your marital status? (Mark one with an X.) 
 Married 
 Domestic partnership 
 Widowed 
 Divorced 
 Separated 
 Never married 
 I prefer not to answer 
 Unknown/Not reported  
 
9. With whom do you live? (Mark all that apply with an X.) 
 Spouse/partner 
 Girlfriend/boyfriend 
 Children aged 18 years or younger 
 Children aged 19 years or older 
 Parent(s)/parent(s)-in-law 
 Live alone 
 Other (specify) _____________ 
 Other relative (specify) _____________ 
 
10. What is your current employment status? (Mark one with an X.) 
(Choose the most appropriate answer.) 
 Employed 32 hours or more per week 
 Employed less than 32 hours per week 
 Retired 
 Disabled 
 Full-time student 
 Part-time student 
 Homemaker 
 On medical leave 
 Only temporarily laid off, sick leave, or maternity leave 
 Unemployed 
 Unknown 
 Other (specify) __________________ 
 
11. Please indicate how long you have known the patient _________ years 
 
12. Do you live in the same residence as the patient? (Mark one with an X.) 
 Yes 
 No 

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The SF-36v2™ Health Survey 
 
 
Instructions for Completing the Questionnaire 
 
Please answer every question.  Some questions may look like others, but each one is different.  Please 
take the time to read and answer each question carefully by filling in the bubble that best represents your 
response. 
 
EXAMPLE 
 
This is for your review.  Do not answer this question.  The questionnaire begins with the section Your 
Health in General below. 
 
For each question you will be asked to fill in a bubble in each line: 
 
1. How strongly do you agree or disagree with each of the following statements? 
 
 
Strongly 
Agree 
Agree 
Uncertain 
Disagree 
Strongly 
disagree 
a) I enjoy listening to music. 
 
 
 
 
 
b) I enjoy reading magazines. 
 
 
 
 
 
 
 
 
Please begin answering the questions now. 
 
Your Health in General 
 
1. In general, would you say your health is: 
Excellent 
Very Good 
Good 
Fair 
Poor 
 
1 
2 
3 
4 
5 
GH01 
 
2. Compared to one year ago, how would you rate your health in general now? 
Much better  
now than one 
year ago 
Somewhat 
better now than 
one year ago 
About the 
same as one 
year ago 
Somewhat 
worse now than 
one year ago 
Much worse 
now than one 
year ago 
 
1 
2 
3 
4 
5 
HT 
 
 
 
Please turn the page and continue 
 
 
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3. The following questions are about activities you might do during a typical day. Does your health 
now limit you in these activities? If so, how much? 
 
Yes,  
limited 
a lot 
Yes, 
limited 
a little 
No, Not 
limited 
at all 
 
a) Vigorous activities, such as running, lifting heavy objects, 
participating in strenuous sports 
1 
2 
3 
PF01 
b) Moderate activities, such as moving a table, pushing a 
vacuum cleaner, bowling, or playing golf 
1 
2 
3 
PF02 
c) Lifting or carrying groceries 
1 
2 
3 
PF03 
d) Climbing several flights of stairs 
1 
2 
3 
PF04 
e) Climbing one flight of stairs 
1 
2 
3 
PF05 
f) Bending, kneeling, or stooping 
1 
2 
3 
PF06 
g) Walking more than a mile 
1 
2 
3 
PF07 
h) Walking several hundred yards 
1 
2 
3 
PF08 
i) Walking one hundred yards 
1 
2 
3 
PF09 
j) Bathing or dressing yourself 
1 
2 
3 
PF010 
 
4. During the past 4 weeks, how much of the time have you had any of the following problems 
with your work or other regular daily activities as a result of your physical health? 
 
All of 
the time 
Most of 
the time 
Some of 
the time 
A little of 
the time 
None of 
the time 
 
a) Cut down on the amount of time 
you spent on work or other activities 
1 
2 
3 
4 
5 
RP01 
b) Accomplished less than you would 
like 
1 
2 
3 
4 
5 
RP02
c) Were limited in the kind of work or 
other activities 
1 
2 
3 
4 
5 
RP03
d) Had difficulty performing the work 
or other activities (for example, it 
took extra effort) 
1 
2 
3 
4 
5 
RP04
 
 
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5. During the past 4 weeks, how much of the time have you had any of the following problems 
with your work or other regular daily activities as a result of any emotional problems (such as 
feeling depressed or anxious)? 
 
All of 
the time 
Most of 
the time 
Some of 
the time 
A little of 
the time 
None of 
the time 
 
a) Cut down on the amount of time 
you spent on work or other activities 
1 
2 
3 
4 
5 
RE01 
b) Accomplished less than you would 
like 
1 
2 
3 
4 
5 
RE02
c) Did work or other activities less 
carefully than usual 
1 
2 
3 
4 
5 
RE03
 
6. During the past 4 weeks, to what extent has your physical health or emotional problems 
interfered with your normal social activities with family, friends, neighbors, or groups? 
Not at all 
Slightly 
Moderately 
Quite a bit 
Extremely 
 
1 
2 
3 
4 
5 
SF01 
 
7. How much bodily pain have you had during the past 4 weeks? 
None 
Very mild 
Mild 
Moderate 
Severe 
Very severe 
 
1 
2 
3 
4 
5 
6 
BP01 
 
8. During the past 4 weeks, how much did pain interfere with your normal work (including both 
work outside the home and housework)? 
Not at all 
A little bit 
Moderately 
Quite a bit 
Extremely 
 
1 
2 
3 
4 
5 
BP02 
 
9. These questions are about how you feel and how things have been with you during the past 4 
weeks. For each question, please give the one answer that comes closest to the way you have 
been feeling. How much of the time during the past 4 weeks... 
 
All of 
the time 
Most of 
the time 
Some of 
the time 
A little of 
the time 
None of 
the time 
 
a) did you feel full of life? 
1 
2 
3 
4 
5 
VT01 
b) have you been very nervous? 
1 
2 
3 
4 
5 
MH01
c) have you felt so down in the dumps 
that nothing could cheer you up? 
1 
2 
3 
4 
5 
MH02
d) have you felt calm and peaceful? 
1 
2 
3 
4 
5 
MH03
e) did you have a lot of energy 
1 
2 
3 
4 
5 
VT02
f) have you felt downhearted and 
depressed? 
1 
2 
3 
4 
5 
MH04
g) did you feel worn out? 
1 
2 
3 
4 
5 
VT03
h) have you been happy? 
1 
2 
3 
4 
5 
MH05
i) did you feel tired? 
1 
2 
3 
4 
5 
VT04
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10. During the past 4 weeks, how much of the time has your physical health or emotional problems 
interfered with your social activities (like visiting friends, relatives, etc.)? 
All of the  
time 
Most of the 
time 
Some of the 
time 
A little of the 
time 
None of the 
time 
 
1 
2 
3 
4 
5 
SF02 
 
 
11. How TRUE or FALSE is each of the following statements for you? 
 
Definitely 
true 
Mostly 
true 
Don’t 
know 
Mostly 
false 
Definitely 
false 
 
a) I seem to get sick a little 
easier than other people 
1 
2 
3 
4 
5 
GH02 
b) I am as healthy as anybody I 
know 
1 
2 
3 
4 
5 
GH03
c) I expect my health to get 
worse 
1 
2 
3 
4 
5 
GH04
d) My health is excellent 
1 
2 
3 
4 
5 
GH05
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Hospital Anxiety and Depression Scale 
 
Name: 
 
 
 
 
 
 
 
 
 
 
Date: 
 
Doctors are aware that emotions play an important part in most illnesses. If your doctor knows about these feelings he will be 
able to help you more. 
This questionnaire is designed to help your doctor to know how you feel. Read each item and place a firm tick in the box 
opposite the reply which comes closest to how you have been feeling in the past week. 
Don’t take too long over your replies: your immediate reaction to each item will probably be more accurate than a long thought-
out response. 
Tick only one box in each section 
I feel tense or 'wound up': 
 
 
 
I feel as if I am slowed down: 
 
 
Most of the time................................. 
 
 
Nearly all the time............................... 
 
 
A lot of the time................................. 
 
Very often........................................... 
 
Time to time, Occasionally.......... 
 
Sometimes........................................... 
 
Not at all............................................. 
 
Not at all.............................................. 
 
 
 
 
 
 
 
I still enjoy the things I used to enjoy:  
 
 
I get a sort of frightened feeling like 
'butterflies' in the stomach: 
 
 
Definitely as much.............................. 
 
 
Not at all.............................................. 
 
 
Not quite so much............................... 
 
Occasionally........................................ 
 
Only a little.......................................... 
 
Quite often........................................... 
 
Hardly at all......................................... 
 
Very often…………………............... 
 
 
 
 
 
 
 
I get a sort of frightened feeling as if 
something awful is about to happen: 
 
 
I have lost interest in my appearance:  
 
 
Very definitely and quite badly……... 
 
 
Definitely............................................ 
 
 
Yes, but not too badly......................... 
 
I don't take so much care as I should.. 
 
A little, but it doesn’t worry me.......... 
 
I may not take quite as much care...... 
 
Not at all.............................................. 
 
I take just as much care as ever.......... 
 
 
 
 
 
 
 
I can laugh and see the funny side of things: 
 
 
I feel restless as if I have to be on the move: 
 
 
As much as I always could.................. 
 
 
Very much indeed.............................. 
 
 
Not quite so much now....................... 
 
Quite a lot........................................... 
 
Definitely not so much now................ 
 
Not very much.................................... 
 
Not at all.............................................. 
 
Not at all............................................. 
 
 
 
 
 
 
 
Worrying thoughts go through my mind: 
 
 
I look forward with enjoyment to things:  
 
 
A great deal of the time....................... 
 
 
 
As much as ever I did......................... 
 
 
A lot of the time.................................. 
 
 
Rather less than I used to................... 
 
From time to time but not too often ...  
 
 
Definitely less than I used to.............. 
 
Only occasionally................................ 
 
 
Hardly at all........................................ 
 
 
 
 
 
 
 
 
I feel cheerful: 
 
 
 
I get sudden feelings of panic: 
 
 
Not at all.............................................. 
 
 
 
Very often indeed................................ 
 
 
Not often............................................. 
 
 
Quite often........................................... 
 
Sometimes........................................... 
 
 
Not very often..................................... 
 
Most of the time.................................. 
 
 
Not at all.............................................. 
 
 
 
 
 
 
 
 
I can sit at ease and feel relaxed:  
 
 
 
I can enjoy a good book or radio or TV 
programme: 
 
 
Definitely............................................. 
 
 
 
Often.................................................. 
 
 
Usually................................................ 
 
 
Sometimes......................................... 
 
Not often............................................. 
 
 
Not often............................................ 
 
Not at all............................................. 
 
 
Very seldom....................................... 
 
 
 
 
 
 
 
 
Do not write below this line 
232 
 
ONCOLOGY    VOLUME 4   NUMBER 5 
 

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PROGNOSIS AND TREATMENT PERCEPTIONS QUESTIONNAIRE (PTPQ) 
 
FAMILY CAREGIVER VERSION 
 
1. 
Patients differ in the amount of information that they want to know about their diagnosis and 
treatment—some want to know everything, others want to know very little. What is your loved 
one’s preference for details of information about their diagnosis and treatment? Please check one. 
 They prefer not to hear a lot of details. 
 They want to hear details only in certain situations, such as when tests are abnormal or when 
treatment decisions need to be made. 
 They want to hear as many details as possible in all situations relating to their cancer and its 
treatment. 
 
2. 
How would you rate the quality of the information your loved one has been given by their 
oncologist about treatment and the treatment choices available? Please check one. 
 Excellent 
 Good 
 Satisfactory 
 Fair 
 Poor 
 
3. 
If you had to choose one, what would you say is your loved one’s primary goal of their current 
cancer treatment? Many of these goals may be important to them, but please check the one goal 
that you feel is most important to them right now. 
 To lessen their suffering as much as possible 
 For them and/or their family to be able to keep hoping 
 To make sure they have done everything 
 To extend their life as long as possible 
 To cure their cancer 
 To help cancer research 
 Other: please specify ____________________ 
 
4. 
If you had to choose one, what would you say is your loved one’s oncologist’s primary goal of 
their current cancer treatment? Please check one. 
 To lessen their suffering as much as possible  
 For them and/or their family to be able to keep hoping 
 To make sure they have done everything 
 To extend their life as long as possible 
 To cure their cancer 
 To help cancer research 
Other: please specify ____________________ 
 
5. 
How important is it for your loved one to know about the likely outcome of their cancer over 
time (i.e. their prognosis)? Please check one. 
 Extremely important 
 Very important 
 Somewhat important 
 A little important 
 Not at all important 
 

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6. 
How often has your loved one had a conversation with their oncologist about the likely outcome 
of their cancer over time (i.e. their prognosis)? Please check one. 
 Never 
 Rarely 
 Sometimes 
 Often 
 Very Often 
 
7. 
All things considered, how do you feel about the amount of information your loved one knows 
about the likely outcome of their cancer over time (i.e. their prognosis)? Please check one. 
 They wish they had more information about their prognosis.  
 They now have about the right amount of information. 
 They wish they had less information about their prognosis. 
 
8. 
How would you rate the quality of the information your loved one has been given by their 
oncologist about the likely outcome of their cancer over time (i.e. their prognosis)? Please 
check one. 
 Excellent 
 Good 
 Satisfactory 
 Fair 
 Poor 
 
9. 
Patients often report that knowing about the likely outcome of their cancer over time (i.e. their 
prognosis) impacts other decisions they have to make. Please check one box for each statement. If 
your loved one does not know at all about their prognosis, please skip this question. 
 
How helpful has knowing about their prognosis been for your loved one in the following areas? 
 
Extremely 
Helpful 
 Very  
Helpful 
A little  
Helpful 
Not at all 
Helpful 
Making decisions about treatment 
 
 
 
 
Preparing for the future 
 
 
 
 
Maintaining hope 
 
 
 
 
Coping with the disease 
 
 
 
 
Overall, how helpful has knowing 
about prognosis been for your loved 
one? 
 
 
 
 
 
10. 
How would you describe your loved one’s current medical status? 
 Relatively healthy 
 Relatively healthy and terminally ill 
 Seriously ill and not terminally ill 
 Seriously ill and terminally ill 
 
 

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11. 
How likely do you think it is that your loved one will be cured of cancer? Please check one. 
 Extremely likely (more than a 90% chance of cure) 
 Very likely (75-90% chance of cure) 
 Moderately likely (50-74% chance of cure) 
 Somewhat likely (25-49% chance of cure) 
 Unlikely (10-24% chance of cure) 
 Very unlikely (less than 10% chance of cure) 
 No chance (0% chance of cure) 
 
12. 
Has your loved one and their oncologist discussed any particular wishes about the care they 
would want to receive if they were dying? Please check one. 
 Yes  
 No 
 
13. 
If your loved one had to choose, would they prefer 1) a course of treatment that focused on 
extending life as much as possible, even if it meant more pain and discomfort, or 2) a plan of care 
that focused on relieving pain and discomfort as much as possible, even if that meant not living as 
long? Please check one. 
 Extend life as much as possible 
 Relieve pain as much as possible 
 Don’t know 
 
 
 
 

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APPENDIX V: PATIENT RECRUITMENT 
 
Suggested Language for Clinicians Offering the Study to Eligible Patients/Families 
 
I’d like to talk to you about a different kind of study.  Most studies or clinical trials focus on treatments for 
your x cancer.  However, the goal of this study is to figure out the best way to support you and your family 
as you face your cancer diagnosis.  Patients with x cancer often have symptoms which are difficult to 
manage, such as pain and fatigue, and both the patient and their family members often feel distressed or 
worried about their diagnosis.  The goal of this study is to figure out the best way to help patients and 
families with these important aspects of their care. 
 
The study is looking at adding an additional team – called the palliative care team – on top of your regular 
cancer care team to see if having them involved earlier is helpful for you and your family.  Participating in 
this study will not interfere with or impact your cancer treatment in any way. 
 
Palliative care clinicians assist patients with their symptoms and help patients and families cope with their 
cancer and make decisions about their care.  Traditionally, these doctors and nurses only meet people when 
they are very ill or in the hospital.  The goal of this study is to see if having the palliative care team care 
for you earlier in your illness will be helpful for you and your family.   
 
This is a randomized study – so ½ of the people will be “coin flipped” to regular or usual care where we 
would only ask this team to see you if we felt like we needed their help and ½ will have this team follow 
you along with me and pitch in all throughout your cancer treatment. 
 
This study is very little work for you.  If you are “coin flipped” to see the palliative care team early, we will 
ask them to see you on the same day as me or during your chemotherapy treatments so you won’t need to 
make extra visits.   
 
Whether you see the team early or not – we will ask you to complete about 30 minutes of questionnaires 
four times over the course of your illness; today and in 6, 12, and 24 weeks – so again, not a lot of work for 
you.  Remember the goal of this study is to see which care model is most helpful for patients and their 
families so these questions measure things like your symptoms, mood, and how you are coping so we can 
figure out which strategy is best. 
 
Important Reminders When Discussing the Study: 
1. Palliative care is NOT hospice or end-of-life care. The goal of palliative care is to help patients live as 
well as they can for as long as they can.   
2. The palliative care team will not “force” people to talk about death and dying or other topics they are 
not ready to discuss.   
3. Patients’ cancer treatment or treatment clinical trials will NOT be impacted by their participation in 
this study. 
4. Patients without willing family members are still able to participate. 
 
 

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APPENDIX VI: PC WEB-BASED TRAINING INSTRUCTIONS  
Cultivating prognostic awareness: A longitudinal framework 
This four-part online webinar series prepares palliative care clinicians to care for oncology 
outpatients. 
The goal of the training courses will be to educate the clinicians on ways in which the provision of 
outpatient palliative care differs from inpatient delivery models. These courses will be informed by 
the educational needs assessment and focus on two areas: (1) Psychosocial aspects of outpatient 
palliative care, specifically the cultivation of prognostic awareness and the promotion of adaptive 
patient coping strategies over the course of the illness; and (2) developing a collaborative practice 
with oncology clinicians through role definition and joint patient visits.  
Instructions for completing the web-based training are as follows: 
1. At least one leader of the outpatient PC clinic register with the Partners Healthcare website: 
 
After following the link to the Partners Healthcare website, select ‘Register’. 
2. For Partners Employees, click ‘Login using your Partners username’.  All other first time 
users, click ‘Create Account’.   
3. Enter the required information (indicated by red asterisk) and click ‘Complete 
Membership’ at the bottom of the page. 
4. Click Next at the bottom of the Activity Overview page. 
5. Enter Group ID 
 and click ‘Submit’ (do not click on the Purchase button). 
6. Select ‘Physician Certificate’ from the drop down box and click submit. 
7. Click Next on the CME/CE Information page. 
8. Click on each link and watch each training video (there are 4 parts).  There will be a pretest, 
resource library, webinar, and posttest.  
9. A certificate will be generated upon completion and you will be given the option to print 
it. Please print the certificate and submit to 
 
  
If you have any issues or questions please contact the Partners Office of Continuing Professional 
Development at 
. 
ACCREDITATION  
Partners HealthCare System is accredited by the Accreditation Council for Continuing Medical 
Education to provide continuing medical education for physicians. 
 
Partners HealthCare System designates this live activity for a maximum of 2.5 AMA PRA Category 
1 CreditsTM. Physicians should claim only the credit commensurate with the extent of their 
participation in the activity.