Piloting Pathways, a Hope-enhancing Intervention to Address Activity and Role Function in Metastatic Lung Cancer Patients
Phase: NA
Conditions: Metastatic Lung Cancer
Sponsor: Laurie McLouth

Document Coversheet 
 
 Study Title: Piloting Pathways, a Hope-enhancing Intervention to Address Activity and Role 
Function in Metastatic Lung Cancer Patients 
Institution/Site:  
University of Kentucky 
Document (Approval/Update) Date: 
1/18/2022 
NCT Number: 
NCT04161157 
IRB Number 
52168 
Coversheet created: 
7/28/2023 
 
 

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Consent and Authorization to Participate in a Research Study 
 
KEY INFORMATION FOR PILOTING PATHWAYS  
 
We are asking you to choose whether to volunteer for a research study. This study involves completing a 
couple of brief surveys and participating in a program called Pathways. Pathways is a brief program to 
help lung cancer patients think about what areas of life matter most to them and to set and pursue goals 
and activities related to those areas. We are asking you because you are receiving treatment for lung 
cancer. This gives you key information to help you decide whether to participate. We have included 
detailed information after this page. Ask the research team questions. If you have questions later, the 
contact information for the researcher in charge of the study is below.   
WHAT IS THE STUDY ABOUT AND HOW LONG WILL IT LAST?   
We have developed a new program for lung cancer patients called Pathways. We now want to evaluate 
the program and get feedback on how to improve it prior to offering it others. By doing this study, we 
hope to learn if the Pathways program is acceptable to patients and can be carried out in clinic. Your 
participation in this research will last about 4-5 hours total over the course of roughly 6-8 weeks.  
Pathways involves:  
x 
5 “appointments” with a nurse or other healthcare professional: 2 face-to-face appointments when 
you are at the hospital for cancer treatment (can be done remotely) and 2-3 phone calls to check in  
x 
Face-to-face appointments may take 30 minutes to an hour. Phone calls may take 15-20 minutes.  
Surveys and Interview involve:  
x 
Survey: Answering questions about your quality of life, sociodemographics (e.g. income), 
personality, and experiences with lung cancer and the Pathways program (1 survey before you start 
Pathways, 1 survey after; ~ 30 minutes each; a brief (~5 minute) phone survey one week into 
Pathways to ask about your first appointment)  
x 
Interview: Talking with study team member about what you liked and did not like about Pathways 
and ways we could improve it (can be done in person or over the phone; ~ 15 minutes)  
WHAT ARE KEY REASONS YOU MIGHT CHOOSE TO VOLUNTEER FOR THIS STUDY? 
You might volunteer to contribute to knowledge that could help other people going through lung cancer 
in the future.  
WHAT ARE KEY REASONS YOU MIGHT CHOOSE NOT TO VOLUNTEER FOR THIS STUDY? 
You might choose not to volunteer for this study if you think answering survey questions or talking with a 
nurse about what areas of daily life matter most to you and/or setting goals for those areas of life would 
be upsetting. For a complete description of risks, refer to the Detailed Consent. If you choose not to 
participate, you can could access other supportive services.  For a complete description of alternate 
treatment/procedures, refer to the Detailed Consent.  
DO YOU HAVE TO TAKE PART IN THE STUDY? 
If you decide to take part in the study, it should be because you really want to volunteer. You will not 
lose any services, benefits or rights you would normally have if you choose not to volunteer.  
WHAT IF YOU HAVE QUESTIONS, SUGGESTIONS OR CONCERNS? 
If you have questions, suggestions, or concerns regarding this study or you want to withdraw from the 
study contact Laurie McLouth, PhD of the University of Kentucky, Department of Behavioral Science at 
859-562-2526 or laurie.mclouth@uky.edu. If you have any concerns or questions about your rights as a 
volunteer in this research, contact staff in the University of Kentucky (UK) Office of Research Integrity 
(ORI) between the business hours of 8am and 5pm EST, Monday-Friday at 859-257-9428 or toll free at 
1-866-400-9428. 
IRB Approval
1/18/2022
IRB # 52168
IRB2

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DETAILED CONSENT (PILOTING PATHWAYS): 
ARE THERE REASONS WHY YOU WOULD NOT QUALIFY FOR THIS STUDY? 
You will not quality for this study if you are under 18 years of age.  
WHERE WILL THE STUDY TAKE PLACE AND WHAT IS THE TOTAL AMOUNT OF TIME 
INVOLVED? 
The research procedures will be conducted at the Markey Cancer Center/UK Chandler Hospital.  You 
will need to come 2-3 times during the study and complete 2-3 phone sessions as part of the program. 
In-person visits will take about 30 minutes to an hour. Phone sessions will take about 15-20 minutes. 
The total amount of time you will be asked to volunteer for this study is 4-5 hours over the next 6-8 
weeks.  
WHAT WILL YOU BE ASKED TO DO? 
Participating in this study involves filling out 2 surveys, participating in a program we have developed 
for lung cancer patients (described below), and completing a brief interview to give feedback on the 
program. 
This study involves a pilot test of a program we have developed for lung cancer patients. The program 
is called Pathways.  
Pathways involves:  
x 
5 appointments with a nurse or other healthcare professional: 2 face-to-face appointments when 
you are at the hospital for cancer treatment (can be done remotely, if needed. For example: 
phone or video technology) and 2-3 phone calls to check in 
x 
Face-to-face appointments may take 30 minutes to an hour. Phone calls may take 15-20 minutes.  
x 
During face-to-face appointments, we will work with you to identify what matters most to you, 
goals that fit with your priorities, and ways to work on those goals.  
x 
During phone calls, we will check in with you on the progress you are making on your goals and 
problem-solve with you about any obstacles to them.  
To help us test Pathways, you will be asked to complete an initial survey before you enroll in Pathways. 
This survey will ask you about your quality of life, personality, and experiences with lung cancer. It 
should take about 30 minutes to complete. You will be paid for completing it. You will complete a brief 
(~5 minute) set of questions about a week after your first Pathways appointment to ask how that 
appointment went. You will complete a survey after you complete Pathways. It will ask many of the 
same questions as the initial survey and will also ask a few questions about your experience with 
Pathways. You will be paid for completing it. Finally, you will be asked to complete a brief interview with 
a study team member to talk more about what you liked and did not like about the Pathways program. 
This interview should take no longer than 15 minutes. You will be paid for completing it.   
 
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WHAT ARE THE POSSIBLE RISKS AND DISCOMFORTS? 
The risk of harm or discomfort that may happen as a result of taking part in this research study is not 
expected to be more than in daily life or from routine physical or psychological examinations or tests. 
There is some risk that answering some of the survey questions may be upsetting or that you may 
become bored answering questions. This happens occasionally. For example, some of the survey 
questions will ask you about your physical limitations and how others have treated you since being 
diagnosed with lung cancer. Sometimes questions are asked in different ways, which can be boring 
and/or frustrating. You can choose not to answer any question that you do not wish to. There is also 
some risk that you may become upset while talking with the study nurse about your goals, particularly if 
you are having trouble with a goal. This rarely happens, but if it does, the study nurse will talk with you 
about it and work with you to develop a plan to manage it. Finally, there is some risk for loss of privacy 
and confidentiality. Because the nurse may be meeting with you in clinic, it may be difficult to maintain a 
high level of privacy. You should let the study team know if you are ever uncomfortable discussing 
anything about the study in your current environment. We will make every effort to keep all of your 
information confidential. The situations where we are unable to maintain confidentiality are described in 
detail below. If we have any safety concerns about your or someone else, we will prioritize safety, 
which may involve sharing your information.  
In addition to risks described in this consent, you may experience a previously unknown risk or side 
effect. 
WILL YOU BENEFIT FROM TAKING PART IN THIS STUDY? 
We do not know if you will get any benefit from taking part in this study. However, some people may 
find the program helpful or feel positive about participating. Information learned from this study may 
help others with your condition.  
IF YOU DON’T WANT TO TAKE PART IN THE STUDY, ARE THERE OTHER CHOICES? 
If you do not want to take part in the study, there are other choices such as seeking existing supportive 
oncology services at the Markey Cancer Center.   
WHAT WILL IT COST YOU TO PARTICIPATE? 
You and/or your insurance company, Medicare, or Medicaid will be responsible for the costs of all care 
and treatment that you would normally receive for any conditions you may have. These are costs that 
are considered medically necessary and will be part of the care you receive even if you do not take part 
in this study. 
The University of Kentucky may not be allowed to bill your insurance company, Medicare, or Medicaid 
for the medical procedures done strictly for research.  
Therefore, these costs:    
x 
will be your responsibility;  
x 
may be paid by your insurer if you are insured by a health insurance company (you should ask 
your insurer if you have any questions regarding your insurer’s willingness to pay these costs);  
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x 
may be paid by Medicare or Medicaid if you are covered by Medicare or Medicaid. (If you have 
any questions regarding Medicare/Medicaid coverage you should contact Medicare by calling 1-
800-Medicare (1-800-633-4227) or Medicaid at 1-800-635-2570.) 
Your insurer, Medicare, or Medicaid, may agree to pay for the costs. However, a co-payment or 
deductible may be needed from you. The amount of this co-payment or deductible may be costly. 
WHO WILL SEE THE INFORMATION THAT YOU GIVE? 
When we write about or share the results from the study, we will write about the combined information. 
We will keep your name and other identifying information private.  
We will make every effort to prevent anyone who is not on the research team from knowing that you 
gave us information, or what that information is. We will not include your name or medical record 
number on surveys you complete or audio recordings from the program sessions or interviews. We will 
assign you a unique number to link your survey and audio recordings to you. Only a few study staff will 
be able to access that link. Your unique number will appear on your surveys. All hard copies of files will 
be stored in locked files in secure buildings. All electronic copies of files will be protected by the UK 
firewall. Only a few study staff will be able to access files.  
You should know that in some cases we may have to show your information to other people. For 
example, the law may require us to share your information with a court or agencies, if you have a 
reportable disease/condition; or authorities, if you report information about a child or elder being 
abused; or if you pose a danger to yourself or someone else. To ensure the study is conducted properly, 
officials of the University of Kentucky and National Cancer Institute the University of Kentucky, and may 
look at or copy pertinent portions of records that identify you. 
We will make every effort to safeguard your data, but as with anything online, we cannot guarantee the 
security of data obtained by way of the Internet. Third-party applications used in this study may have 
Terms of Service and Privacy policies outside of the control of the University of Kentucky.  
REDCap is a secure, web-based program to capture and store data at the University of Kentucky. We 
will make every effort to safeguard your data in REDCap. However, given the nature of online surveys, 
we cannot guarantee the security of data obtained by way of the Internet.   
CAN YOU CHOOSE TO WITHDRAW FROM THE STUDY EARLY? 
You can choose to leave the study at any time. You will not be treated differently if you decide to stop 
taking part in the study. 
If you choose to leave the study early, data collected until that point will remain in the study database 
and may not be removed.  
The investigators conducting the study may need to remove you from the study. You may be removed 
from the study if: 
x 
you are not able to follow the directions, 
x 
we find that your participation in the study is more risk than benefit to you, or  
x 
the agency paying for the study chooses to stop the study early for a number of scientific 
reasons.  
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The study intervention will no longer be provided to you and may not be available for purchase. This 
may occur for a number of reasons. 
ARE YOU PARTICIPATING, OR CAN YOU PARTICIPATE, IN ANOTHER RESEARCH STUDY AT 
THE SAME TIME AS PARTICIPATING IN THIS ONE? 
You may take part in this study if you are currently involved in another research study as long as it does 
not overlap with this study. For example, you can be on a cancer treatment trial and on this study at the 
same time.  It is important to let us know if you are in another research study. You should discuss this 
with us and your doctor before you agree to participate in another research study while you are in this 
study. 
WHAT HAPPENS IF YOU GET HURT OR SICK DURING THE STUDY? 
If you believe you are hurt or if you get sick because of something that is due to the study, you should 
first seek appropriate medical care and then call Laurie McLouth, PhD, at 859-562-2526 immediately.  
It is important for you to understand that the University of Kentucky does not have funds set aside to 
pay for the cost of any care or treatment that might be necessary because you get hurt or sick while 
taking part in this study. Also, the University of Kentucky will not pay for any wages you may lose if you 
are harmed by this study.   
Medical costs related to your care and treatment because of study-related harm  
x 
will be your responsibility;  
x 
may be paid by your insurer if you are insured by a health insurance company (you should ask 
your insurer if you have any questions regarding your insurer’s willingness to pay under these 
circumstances);  
x 
may be paid by Medicare or Medicaid if you are covered by Medicare or Medicaid (If you have 
any questions regarding Medicare/Medicaid coverage you should contact Medicare by calling 1-
800-Medicare (1-800-633-4227) or Medicaid 1-800-635-2570.). 
A co-payment/deductible may be needed by your insurer or Medicare/Medicaid even if your insurer or 
Medicare/Medicaid has agreed to pay the costs. The amount of this co-payment/deductible may be 
costly. 
You do not give up your legal rights by signing this form. 
WILL YOU RECEIVE ANY REWARDS FOR TAKING PART IN THIS STUDY? 
You will receive up to $60 ($20 for the initial survey, $30 for the post-survey, and $10 for the interview 
at the end of the program) for taking part in this study. You will be receiving this compensation as a gift 
card. You will be paid for each assessment after you complete it.   
With a few exceptions, study payments are considered taxable income reportable to the Internal 
Revenue Service (IRS). A form 1099 will be sent to you if your total payments for research participation 
are $600 or more in a calendar year.  
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WHAT IF NEW INFORMATION IS LEARNED DURING THE STUDY THAT MIGHT AFFECT YOUR 
DECISION TO PARTICIPATE? 
We will tell you if we learn new information that could change your mind about staying in the study. We 
may ask you to sign a new consent form if the information is provided to you after you have joined the 
study.  
WILL YOU BE GIVEN INDIVIDUAL RESULTS FROM THE RESEARCH TESTS? 
Generally, tests done for research purposes are not meant to provide clinical information. We will not 
provide you with individual research results.  
WILL WE CONTACT YOU WITH INFORMATION ABOUT PARTICIPATING IN FUTURE 
STUDIES? 
The research staff would like to contact you in the future with information about participating in 
additional studies. If so, it will be limited to 2 times per year.   
Do you give your permission to be contacted in the future by Dr. Laurie McLouth regarding your 
willingness to participate in future research studies?   
   Yes 
   No  
Initials_________ 
 
WHAT ELSE DO YOU NEED TO KNOW? 
If you volunteer to take part in this study, you will be one of about 55 people to do so.   
The National Cancer Institute and UK Markey Cancer Center is providing financial support for this 
study. 
A description of this clinical trial will be available on ClinicalTrials.gov as required by U.S. Law. This 
website will not include information that can identify you. At most, the website will include a summary of 
the results. You can search this website at any time. 
WILL YOUR INFORMATION) BE USED FOR FUTURE RESEARCH? 
All identifiable information (e.g., your name, medical record number, or date of birth) will be removed 
from the information or samples collected in this study. After we remove all identifiers, the 
information may be used for future research or shared with other researchers without your additional 
informed consent.  
STORING AND SHARING YOUR INFORMATION FOR FUTURE USE:  
We would like to store, use, and share your survey data, data obtained from the electronic health 
record as part of this study, and recordings from your exit interview and Pathways sessions for 
future research.  Having information from many people helps researchers identify trends and 
discover better ways to diagnose, prevent, and treat many conditions. Researchers can use the 
stored information to learn more about cancer or research additional scientific questions.   
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We also would like to have permission to look at your medical records from the time you were 
diagnosed with lung cancer until at most 12-months after you complete this study. We would collect 
general information related to your health such as test results, treatments, and doctor’s notes. The 
confidentiality section below provides details about how we will keep your information private. 
WHERE WILL INFORMATION BE STORED AND FOR HOW LONG? 
The information will be stored at the University of Kentucky Healthy Research Building for no 
longer than 6 years after study completion.  
ARE THERE RISKS FROM ALLOWING YOUR INFORMATION TO BE STORED FOR FUTURE 
RESEARCH? 
There is a risk that someone could get access to the stored information or samples. In spite of the 
security measures and safeguards we will use, we cannot guarantee that your identity will never 
become known. 
There may be risks that at this time are unknown. As technology advances, there may be new ways 
of linking information back to you that we cannot foresee now. 
HOW WILL YOUR PRIVACY AND CONFIDENTIALITY BE PROTECTED? 
We will take careful steps to keep your information confidential.  
We will remove your name or other direct identifiers from your information. We will label your information 
with a code and will store the key separately from the master code list. Only select staff will have access 
to the list that links the code to you. 
We will store hard copies of study materials in a locked filing cabinet in a secure building. These files 
will only be accessible by designated study staff.  We will store your identifiable information, in a 
password protected database and/or encrypted files. Your audio files from the exit interview and 
Pathways session recordings will be stored on a computer network with a firewall. These audio files 
will be labeled with your study code, not your name or other identifying information. Only designated 
study staff will have access to these files. 
The staff follow procedures to protect your identity to the extent allowed by law. In very unusual 
cases, staff may be required to release your identifiable medical and research information in 
response to an order from a court of law. Officials of the National Cancer Institute and the University of 
Kentucky may look at or copy pertinent portions of records that identify you. 
HOW WILL WE SHARE YOUR INFORMATION WITH OTHER RESEARCHERS? 
The researchers requesting access to information must complete an application process and sign 
an agreement to obtain any information. The researchers who receive your information will sign an 
agreement to use the data responsibly. 
Before sharing your information, we will remove identifiers such as (e.g., your name, medical record 
number, or date of birth). Your de-identified information may be shared with other University of 
Kentucky (UK) researchers and researchers outside of UK, without your additional informed consent. 
We will use software to track information shared without releasing your identity. 
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WHAT IF YOU CHANGE YOUR MIND AND WANT TO WITHDRAW YOUR INFORMATION? 
You may withdraw your permission to allow your information or samples to be used for future 
research. To do so, you must send a written withdraw request to:  
 
 
 
Laurie McLouth, PhD 
 
 
Center for Health Equity Transformation 
 
 
Suite 371, Health Kentucky Research Building 
 
 
University of Kentucky 
 
 
760 Press Avenue 
 
 
Lexington, KY 40508-0679  
 
We will destroy any remaining information that has been stored. In addition, it may be possible to 
destroy the code that links you with your information. However, we cannot withdraw the information 
that has already been used. 
WILL YOU RECEIVE ANY COMMERCIAL PROFIT FROM FUTURE RESEARCH DISCOVERIES?  
The information and samples that you provide will no longer belong to you. The research may lead to 
new medical knowledge, tests, treatments, or products. These products could have some financial 
value. There are no plans to provide financial payment to you or your relatives should this occur. 
WILL YOU BE GIVEN INDIVIDUAL RESULTS FROM THE FUTURE RESEARCH TESTS?  
Tests done for research purposes are not meant to provide clinical information or help care for 
you. The results are only important for research. Therefore, the results of tests done with your 
information will not be provided to you. In the rare event that a finding might affect the health of 
you or your family, we will contact you and you can choose whether to receive or refuse the 
information.  
 
OPTIONAL FUTURE USE: Do you give permission for Laurie McLouth, PhD to store your survey data, 
data obtained from the electronic health record as part of this study, and recordings from your exit 
interview and Pathways sessions for future research?  Yes      No      Initials _______ 
Remember, you can still be in the main study even if you even if you do not wish to allow your 
information and/or specimens stored for this investigator’s future research. 
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AUTHORIZATION TO USE OR DISCLOSE YOUR INDENTIFIABLE HEALTH INFORMATION  
The privacy law, HIPAA (Health Insurance Portability and Accountability Act), requires researchers to 
protect your health information. The following sections of the form describe how researchers may use 
your health information.   
Your health information that may be accessed, used and/or released includes: 
x 
Name, address, and medical record number 
x 
age 
x 
gender 
x 
racial and ethnic data 
x 
zip code 
x 
lung cancer diagnosis 
x 
date started lung cancer treatment 
x 
comorbidities (other health conditions) 
x 
type of cancer treatments received and dates received 
x 
types of other services received for cancer care and dates received 
x 
response to cancer treatment 
x 
dates of hospitalizations and reasons hospitalized 
x 
referrals to services for cancer care 
x 
documentation of advance care planning 
x 
date of death, place of death (hospital, home) 
The Researchers may use and share your health information with: 
x 
The University of Kentucky’s Institutional Review Board/Office of Research Integrity; 
x 
Law enforcement agencies when required by law; 
x 
University of Kentucky representatives; 
x 
UK Hospital  
x 
Center for Clinical and Translational Science (CCTS)  
x 
National Cancer Institute (NCI) who is sponsoring this study 
x 
Your oncologist, if in the course of the project we learn of a medical matter that needs 
immediate attention   
The researchers agree to only share your health information with the people listed in this document.   
Should your health information be released to anyone that is not regulated by the privacy law, your 
health information may be shared with others without your permission; however, the use of your health 
information would still be regulated by applicable federal and state laws.   
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You may not be allowed to participate in the research study if you do not sign this form. If you decide 
not to sign this form, it will not affect your: 
x 
Current or future healthcare at the University of Kentucky; 
x 
Current or future payments to the University of Kentucky; 
x 
Ability to enroll in any health plans (if applicable); or 
x 
Eligibility for benefits (if applicable). 
After signing the form, you can change your mind and NOT let the researcher(s) collect or 
release your health information (revoke the Authorization). If you revoke the authorization: 
x 
Send a written letter to Dr. McLouth at the address below to inform her of your decision.  
Laurie McLouth, PhD 
 
 
Center for Health Equity Transformation 
 
 
Suite 371, Health Kentucky Research Building 
 
 
University of Kentucky 
 
 
760 Press Avenue 
 
 
Lexington, KY 40508-0679 
x 
Researchers may use and release your health information already collected for this research 
study. 
x 
Your protected health information may still be used and released should you have a bad 
reaction (adverse event). 
The use and sharing of your information has no time limit.  
If you have not already received a copy of the Privacy Notice, you may request one. If you have 
any questions about your privacy rights, you should contact the University of Kentucky’s 
Privacy Officer between the business hours of 8am and 5pm EST, Monday-Friday at (859) 323-
1184. 
 
AUDIORECORDING  
 
As part of this research study, your individual sessions with the study nurse and the interview at the end 
of the study will be audio recorded. The purpose of audio recording the individual sessions with the 
study nurse is to monitor the sessions for quality. Only the PI and other supervisory team members will 
review those audio files. If you have a family member or friend present with you during the sessions, 
their voices will be on the audio file.  You will not have access to the individual session recordings.  
 
The interview at the end of the study where you give feedback on the program may be transcribed 
(typed out word for word). This is being done to make sure that the conversation you have with the 
interviewer is captured accurately. You may request the recording be stopped at any time during the 
interview. If you have a friend or family member present with you during the interview and they 
participate, their feedback will be included. Once the interviews are transcribed, the study team will 
clean them to remove any instances where your name or other identifying information is used.   You 
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should understand that you will not be able to inspect, review, or approve the audiotapes before they 
are used in this study.  
 
You can also withdraw your consent to use and disclose the audiotape before it is used. If you choose 
to withdraw your consent for the audiotapes:  
 
x 
Send a written letter to Dr. McLouth at the address below to inform her of your decision.  
Laurie McLouth, PhD 
 
 
Center for Health Equity Transformation 
 
 
Suite 371, Health Kentucky Research Building 
 
 
University of Kentucky 
 
 
760 Press Avenue 
 
 
Lexington, KY 40508-0679 
INFORMED CONSENT SIGNATURES 
 
This consent includes the following: 
x Key Information Page 
x Detailed Consent  
 
You will receive a copy of this consent form after it has been signed. 
 
 
 
___________________________________________                      _____________________ 
Signature of research subject 
 
 
  
         Date 
 
 
 
 
 
 
 
___________________________________________ 
 
 
 
Printed name of research subject  
 
 
 
___________________________________________                      _____________________ 
Signature of person obtaining informed consent 
 
   
         Date 
 
 
________________________________________________________________          ___________ 
Printed name of [authorized] person obtaining informed consent and  
HIPAA authorization  
 
 
 
 
                                       Date 
 
 
 
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Piloting Pathways, a Hope-enhancing Intervention to Address 
Activity and Role Function in Metastatic Lung Cancer Patients 
Grant Title: Piloting Pathways, a Hope-enhancing Intervention to Address Activity and Role 
Function in Metastatic Lung Cancer Patients 
Grant Number: 1R03CA235171-01A1 
Funded by: National Cancer Institute 
Protocol Number: 52168 
National Clinical Trial (NCT) Identified Number: NCT04161157   
 
Principal Investigator: 
 
Laurie McLouth, Ph.D. 
Assistant Professor 
Behavioral Science 
University of Kentucky College of Medicine 
laurie.mclouth@uky.edu 
Phone: 859-562-2526 
 
 
Version Number:  7 
20 Dec 2021 

Piloting Pathways 
 
Version 7 
Protocol 52168 
 
20 Dec 2021 
 
 
 
Table of Contents 
1 
PROTOCOL SUMMARY ............................................................................................................................... 1 
1.1 
Synopsis ................................................................................................................................................ 1 
1.2 
Schema ................................................................................................................................................. 3 
2 
INTRODUCTION ............................................................................................................................................ 5 
2.1 
Study Rationale .................................................................................................................................... 5 
2.2 
Background........................................................................................................................................... 5 
3 
OBJECTIVES .................................................................................................................................................. 7 
Primary Objectives of PHASE I ......................................................................................................................... 7 
Primary Objectives of PHASE II ........................................................................................................................ 7 
4 
STUDY DESIGN ............................................................................................................................................. 7 
4.1 
Overall Design ...................................................................................................................................... 7 
4.2 
Scientific Rationale for Study Design................................................................................................ 8 
4.3 
Justification for Intervention ............................................................................................................... 8 
4.4 
End-of-Study Definition ....................................................................................................................... 8 
5 
STUDY POPULATION .................................................................................................................................. 8 
5.1 
Inclusion Criteria .................................................................................................................................. 8 
5.2 
Exclusion Criteria ................................................................................................................................. 9 
5.3 
Screen Failures .................................................................................................................................... 9 
5.4 
Strategies for Recruitment and Retention, Participant compensation ......................................... 9 
6 
STUDY INTERVENTION ............................................................................................................................ 10 
6.1 
Study Intervention Administration.................................................................................................... 11 
6.1.1 
Study Intervention Description ..................................................................................... 11 
6.1.2 
Administration and/or Dosing ....................................................................................... 12 
6.2 
Fidelity ................................................................................................................................................. 12 
6.2.1 
Interventionist Training and Tracking .......................................................................... 12 
6.3 
Measures to Minimize Bias: Randomization and Blinding ........................................................... 13 
6.4 
Study Intervention .............................................................................................................................. 13 
6.5 
Concomitant Therapy ........................................................................................................................ 13 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL .................................................................................................................... 14 
7.1 
Discontinuation of Study Intervention ............................................................................................. 14 
7.2 
Patient Discontinuation/Withdrawal from the Study ..................................................................... 14 
7.3 
Lost to Follow-Up ............................................................................................................................... 15 
8 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 15 
8.1 
Endpoint and Other Non-Safety Assessments .............................................................................. 15 
9 
STATISTICAL CONSIDERATIONS .......................................................................................................... 17 
9.1 
Statistical Hypotheses ....................................................................................................................... 18 
9.2 
Sample Size Determination .............................................................................................................. 18 
9.3 
Populations for Analyses .................................................................................................................. 18 
9.4 
Statistical Analyses............................................................................................................................ 18 
9.4.1 
General Approach .......................................................................................................... 18 
9.4.2 
Analysis of the Primary Endpoint(s) ............................................................................ 19 
9.4.3 
Analysis of the Secondary Endpoint(s) ....................................................................... 19 
10 
RISK/Benefit Assessment ........................................................................................................................... 20 

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Known Potential Risks ................................................................................................... 20 
10.1.2 
Known Potential Benefits .............................................................................................. 20 
10.1.3 
Assessment of Potential Risks and Benefits and procedures to minimize risks .. 21 
10.2 
safety monitoring and adverse events ............................................................................................ 23 
10.2.1 
Definition of Adverse Events ........................................................................................ 23 
10.2.2 
Monitoring for AE’s and follow-up ................................................................................ 23 
10.2.3 
Adverse Event Reporting .............................................................................................. 24 
10.3 
Unanticipated Problems .................................................................................................................... 24 
10.3.1 
Definition of Unanticipated Problems .......................................................................... 24 
10.3.2 
Unanticipated Problems Reporting .............................................................................. 24 
11 
SupPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ............................... 24 
11.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 25 
11.1.1 
Informed Consent Process ........................................................................................... 25 
11.1.2 
Confidentiality and Privacy ........................................................................................... 26 
11.1.3 
Key Roles and Study Governance .............................................................................. 27 
11.1.4 
Quality Assurance and Quality Control ....................................................................... 28 
11.1.5 
Data Handling and Record Keeping ............................................................................ 29 
11.1.6 
Protocol Deviations ........................................................................................................ 30 
11.1.7 
Publication and Data Sharing Policy ........................................................................... 30 
11.2 
Abbreviations and Special Terms ................................................................................................... 30 
12 
Appendices list .............................................................................................................................................. 32 
13 
Amendment History ...................................................................................................................................... 32 
14 
REFERENCES ............................................................................................................................................. 35 
 

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1 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
 
Title: 
Piloting Pathways, a Hope-enhancing Intervention to Address Activity 
and Role Function in  Metastatic Lung Cancer Patients  
 
Grant Number: 
1R03CA235171-01A1 
 
Principal Investigator:  
 
 
Study Description and 
Objectives: 
Laurie McLouth, PhD 
Assistant Professor, Behavioral Science 
 
This is a Stage I, single-site trial to refine and then test the feasibility and 
acceptability of a novel intervention, Pathways. 
 
Primary Objectives 
1. To refine the Pathways intervention and study protocol based on 
acceptability feedback from an open pilot study (i.e., fully 
implement the intervention) with patient exit interviews (n = 6). We 
will use feedback on the acceptability of session content, length, and 
delivery, and review intervention session recordings to refine the 
intervention. If necessary, we will refine the procedures for 
enrollment and retention.  
 
2. To determine Pathways intervention feasibility in a single-arm pilot 
study (n = 55 Pathways). Feasibility will be defined by enrollment 
(≥60%; primary feasibility outcome), retention (≥70%), adherence 
(≥70% of patients completing 3 of 5 sessions), and mean 
acceptability ratings (scores of ≥7 out of 10 on intervention 
relevance, helpfulness, and convenience). 
 
Secondary Objective 
1. To assess preliminary data on intermediate and outcome variables and 
clinical utility in the single-arm pilot of Pathways. We will assess pre 
(baseline) to post (~8 weeks after baseline) changes in intermediate (e.g., 
hope) and outcome (primary: activity and role function) variables related 
to a future efficacy trial.  
 
 
Endpoint: 
Feasibility, primary endpoint defined as ≥60% eligible and approached 
patients enrolled 
Study Population: 
61  (n = 6, Phase I; n = 55, Phase II) patients receiving infusion-based 
systemic therapy for stage III, IV non-small cell lung cancer, extensive 
stage small cell lung cancer, 3-12 weeks into tx, ECOG 0-2  
Stage: 
Stage I (Pilot – Refining and Feasibility testing) 
   
Facilities Enrolling: 
UK Markey Cancer Center   

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Description of Study 
Intervention:  
 
5-session, supportive care intervention designed to coincide roughly with 
infusion schedules (2 in-person sessions, 3 phone sessions), delivered 
1:1, supporting materials (handouts) 
 
Study Duration: 
18 months 
 
Participant Duration: 
4.5 hours over ~6-8 weeks 
 
 
 

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1.2 
SCHEMA  
 
  
 
(Primary Objective 1) 
(Primary Objective 2; Secondary Objective 1) 

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Schedule of Activities  
 
Pre-
screening 
(Pre-
consent) 
Visit 1 
day 1 
(must be 
within 21 
days of 
screening) 
Visit 2  Visit 
3  
Visit 4  Visit 
5  
 
Visit 
6  
 
Visit 
7  
 
Day 
360 
EHR Review 
Eligibility 
X 
 
 
 
 
 
 
 
 
Activities involving patient contact 
Patient refusal 
form 
 
X 
 
 
 
 
 
 
 
Informed 
Consent 
 
X 
 
 
 
 
 
 
 
Baseline (T0) 
Patient-
reported 
outcome 
assessment 
 
X 
 
 
 
 
 
 
 
Post (T2) 
Patient-
reported 
outcome 
assessment 
 
 
 
 
 
 
 
X 
 
Treatment 
receipt 
assessment 
(T1) 
 
 
 
X 
 
 
 
X 
 
Treatment 
expectancy 
assessment 
(T1) 
 
 
 
X 
 
 
 
 
 
Intervention 
 
 
X 
X 
X 
X 
X 
 
 
As needed, 
patient 
withdrawal, 
discontinuation 
form  
 
X 
X 
X 
X 
X 
X 
 
 
Activities involving research staff (No patient contact)  
Fidelity rating 
 
 
X 
X 
X 
X 
X 
 
 
Intervention 
process notes 
 
 
X 
X 
X 
X 
X 
 
 
Treatment 
enactment 
assessment 
 
 
X 
X 
X 
X 
X 
 
 
EHR review 
for services 
used, events 
 
 
 
 
 
 
 
X 
X 
 
 
 

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2 
 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
 
Each year, roughly 130,000 people are diagnosed with advanced stage lung cancer. Despite its 
high incidence and considerable disease burden, patients with lung cancer are psychosocially 
underserved, with very few interventions developed to meet their needs and address their 
concerns. Chief among these concerns for 40-65% of patients is concern about difficulty 
pursuing activities and roles related to family, social, work, and leisure (i.e., activity and role 
function). These concerns are associated with significant distress, yet are not a focus of existing 
lung cancer interventions. Our preliminary work has demonstrated that patients with higher 
hope, defined as perceiving that one is working towards personal goals, is associated with 
better function. Hope may be an appropriate intervention target to support function.  
 
Based on patient feedback and preliminary data, we have developed a brief intervention, 
Pathways, to improve activity and role function in patients with metastatic non-small cell lung 
cancer. We propose to implement Pathways and conduct patient interviews to refine materials 
and procedures (Phase I, n = 6) and test intervention feasibility and acceptability in a single arm 
trial (Phase II, n = 55). It is critical to establish acceptable materials and feasible procedures 
before testing efficacy.1 
 
Premise: Based on theory and preliminary data, increasing patient hope (i.e., patient perception 
that they are pursuing their goals and have multiple routes to those goals) through an 
intervention in primary oncology may be a feasible approach to improve activity and role 
function.  
Impact: This intervention is inherently patient-centered and designed to overcome utilization 
barriers. It may be generalized to other advanced cancers and sustained beyond research to 
improve care 
2.2 
BACKGROUND  
 
Lung cancer patients represent a large and underserved population in high need of 
supportive care interventions that overcome utilization barriers. Lung cancer has the 
second highest incidence and highest cancer mortality among men and women in the U.S.2 
Each year, 90,000 people are diagnosed with metastatic non-small cell lung cancer (NSCLC).2 
Lung cancer is associated with high physical and psychosocial morbidities,3 including poorer 
physical and role function,4 higher depression,5,6 and more unmet supportive care needs 
compared to other cancers.7 Lung cancer patients face major barriers (e.g., time constraints, 
stigma about psychosocial care) to utilizing supportive services,3,8-10 including stigma related to 
the disease’s poor prognosis and association with smoking.11-14 Stigma reflects perceived 
negative appraisal from others, constrained disclosure of diagnosis and concerns, and 
internalized self-blame, shame, or guilt11,15 and is associated with depression15-17 and poorer 

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social, role, and physical function.18,19 Despite a clear need, few supportive care interventions 
have been developed for lung cancer patients.20-22  
Activity and role function concerns are prevalent, distressing, and not addressed by 
interventions. Between 40-65% of lung cancer patients report impaired activity and role 
function (i.e., activities and roles related to family, social, work, and leisure) as an unmet 
supportive care need.23-25 The consequences of these concerns are decreased survival and 
quality of life,26-28 including depression, loss of life purpose, and perceived burden on others.29-32 
Functional concerns are prominent and distressing to lung cancer patients throughout cancer 
treatment,33 yet are under addressed in primary oncology20,34 and supportive care interventions 
for lung cancer,21 which emphasize symptom or distress management.21,22,35,36 This is a critical 
time to develop interventions to address functional concerns; metastatic NSCLC patients are 
living longer with potentially more tolerable side effects due to immunotherapy.37-42 Our work 
with patients on immunotherapy suggests activity and role function concerns are still common, 
as are barriers to utilizing supportive care.43  
Increasing patient hope is a promising approach to improve activity and role function. 
Patients with metastatic cancer strive to maintain function in valued activities and roles by 
setting and pursuing personal goals.23,44-46 Patient hope, a motivational state that reflects goal-
directed determination (i.e., agency) and planning to meet goals (i.e., pathways),47 directly 
supports goal setting and pursuit. People with higher hope set more goals and ways to reach 
them and better attain goals.48,49 Our work suggests increasing hope may improve activity and 
role function in lung cancer patients, even in the presence of likely goal obstacles such as 
symptom burden and stigma.18 Our work also shows higher hope is related to better function, 
less depression, and less stigma in metastatic NSCLC (Preliminary Data). A person’s level of 
hope varies,18,50 does not depend on symptom burden,18 and can be increased through 
intervention,51-53 including brief intervention.54 Hope interventions have reduced distress in other 
cancer and non-cancer samples.51-53  
An intervention in primary oncology that incorporates stigma resources could overcome 
barriers and increase impact. Hope interventions have not been tested with lung cancer 
patients. Prior hope-enhancing interventions have used mental health providers, but providers 
are scarce in areas with high lung cancer incidence (ruralhealthinfo.gov) and not acceptable to 
many patients.8 Hope interventions help patients overcome obstacles to goals, which, in lung 
cancer may include symptom or physical concerns and lung cancer stigma. Therefore, an 
intervention with symptom and stigma resources delivered in primary oncology is a strong 
approach. Nurses and other healthcare providers know the symptom and psychosocial 
concerns patients face,55 are acceptable to patients (Preliminary Data),55 and are effective in 
leading supportive care interventions.55-63 Embedding the intervention in oncology reduces 
utilization barriers and may help the oncology team address symptom or physical obstacles to 
goals that often are not detected.34,64-66 Finally, addressing stigma as a goal obstacle fills a 
major intervention gap.11  
 
Preliminary Data 
Study 1: Daily Diary Study of Lung Cancer Patient Quality of Life during Active Treatment (PI: 
McLouth). Dr. McLouth (PI) designed and conducted a 21-day daily diary study of hope, stigma, 

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symptoms, and function in 50 lung cancer patients on chemotherapy or chemoradiotherapy.18 
Nearly all patients consented (90%) and completed daily diaries (90%; M daily diaries = 20, SD 
=1.3). Patients with higher hope had better function and within-person increases in hope related 
to function, adjusting for stigma, symptoms, and baseline depression.  
 
Study 2: Cross-Sectional Study of Metastatic NSCLC Patients on Immunotherapy (PI: McLouth; 
NC Lung Cancer Initiative Grant) supports the significance of the intervention in a contemporary 
treatment era and the intervention design. Dr. McLouth (PI) designed and conducted a cross-
sectional survey purposively sampling 60 stage IV NSCLC patients on immunotherapy in 8 
months. This study showed (a) activity and role function concerns remain a top unmet 
supportive care need (reported by 42% of patients); (b) higher patient hope relates to better role 
function (r = .43), patient goal progress (r = .43), and less depression (r = -.61) and stigma (r = -
.40) (p’s <.005); (c) low patient supportive care utilization  (<12% had used any service, <2% 
had seen a mental health provider) and multiple barriers (e.g., time concerns, perceptions about 
services) to using services.43 
 
3 
OBJECTIVES  
 
PRIMARY OBJECTIVES OF PHASE I 
 
1. To refine the Pathways intervention and study protocol based on acceptability feedback 
from an open pilot study (i.e., fully implement the intervention; Phase I) with patient exit 
interviews (n = 6). We will use feedback on the acceptability of session content, length, and 
delivery, and review intervention session recordings to refine the intervention. If necessary, 
we will refine the procedures for enrollment and retention.  
 
PRIMARY OBJECTIVES OF PHASE II 
 
1. To determine Pathways intervention feasibility (Phase II; n = 55 Pathways). Feasibility 
will be defined by enrollment (≥60%; primary feasibility outcome), retention (≥70%), 
adherence (≥70% of patients completing 3 of 5 sessions), and mean acceptability ratings 
(scores of ≥7 out of 10 on intervention relevance, helpfulness, and convenience). 
 
2. To assess preliminary data on intermediate and outcome variables and clinical utility in 
the single-arm pilot of Pathways (Phase II). We will assess pre (baseline) to post (~8 
weeks after baseline) changes in intermediate (e.g., hope) and outcome (primary: 
activity and role function) variables related to a future efficacy trial. We will also describe 
the number of referrals to supportive services made based on the Pathways intervention.  
 
4 
STUDY DESIGN 
 
4.1 
OVERALL DESIGN 

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This is a Stage I, single-site trial to refine and then test the feasibility and acceptability of a novel 
intervention, Pathways, through a single arm design. Pathways is a 5 session (2 in-person; 3 
phone) intervention designed to help patients identify and pursue personal goals and valued 
activities. To accomplish study objectives, we will 1) fully implement proposed study procedures 
with 6 patients and conducting patient exit interviews to refine intervention and study procedures 
(phase I); and 2) conduct a single arm trial of the refined Pathways protocol with 55 patients 
(phase II). The primary feasibility outcome that will be tested in phase II is enrollment (≥60%). 
Our secondary objective is to gather preliminary patient-reported outcome and clinical utility 
data (e.g., referrals to supportive services to support a patient goal) on hypothesized 
intervention mechanisms (hope) and outcomes (e.g., satisfaction with roles and activities) 
related to a future efficacy trial. Patient-reported data will be collected at baseline and post-
intervention (within 14 days of completing the intervention).  
 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 
We considered a control arm to test the feasibility of randomization, but in accordance with the 
behavioral clinical trial stage model,1 decided to maintain focus on identifying appropriate 
intervention materials, eligibility criteria, enrollment/retention strategies, and fidelity monitoring. 
 
4.3 
JUSTIFICATION FOR INTERVENTION 
 
The Pathways intervention was developed based on theory, prior hope-enhancing intervention 
protocols, consultation with content experts, and patient and provider input. Patient feedback 
informed the number of sessions, frequency, and interventionist.  
 
4.4 
END-OF-STUDY DEFINITION 
 
A patient is considered to have completed the study if he or she has completed the baseline 
assessment, at least 3 intervention sessions, and the post-assessment. The end of the study is 
defined as completion of the post-assessment.  
 
5 
STUDY POPULATION 
 
5.1 
INCLUSION CRITERIA 
 
In order to be eligible to participate in this study, an individual must meet all of the following 
criteria: 
1. New or recurrent AJCC stage III, IV NSCLC or extensive stage small cell lung cancer 
2. 18 years of age or older 
3. ECOG performance status 0-2/Karnofsky 60-100; 

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4.  3-12 weeks into active oncologic treatment (chemotherapy, immunotherapy, chemo-
immunotherapy – infusion based systemic treatments).  
 
Rationale: We chose 3-12 weeks into active treatment based on patient input to allow time to 
begin treatment. 
 
5.2 
EXCLUSION CRITERIA 
 
An individual who meets any of the following criteria will be excluded from participation in this 
study: 
 
1. Unstable brain metastases (i.e., progressive neurological deficits, inadequately 
controlled seizures, or requiring escalating steroid doses);  
2. Cognitive (i.e., dementia) or psychiatric condition (e.g., psychotic disorder) for which 
participating would be inappropriate 
3. Receiving palliative care or actively receiving psychological services at the cancer center 
(see Rationale for allowances) 
4. Unable to speak and read English. 
 
Rationale: Based on preliminary data,43 most patients will not be using palliative or 
psychological services. We will consider allowing patients to enroll who are using these 
services, depending on their focus (e.g., we will allow palliative care for symptom 
management, counseling for couples’ therapy). These cases will be reviewed by the study 
team. We are unable to include non-English speaking participants in this study because 
several of the assessment instruments have not been translated or validated in other 
languages.   
 
5.3 
SCREEN FAILURES 
 
Screen failures will be defined as patients who consent to participate in this study but are not 
subsequently assigned to the study intervention due to ineligibility or are assigned to 
intervention, but do not meet eligibility criteria and are withdrawn by investigators. Patients who 
do not meet the criteria for participation in this trial because of meeting one or more exclusion 
criteria that are likely to change over time may be rescreened. Examples include improvement 
in functional status and a progression of disease or disease recurrence for which a patient will 
begin treatment for metastatic disease. Rescreened participants will be assigned the same 
participant number as for the initial screening. 
 
5.4 
STRATEGIES FOR RECRUITMENT AND RETENTION, PARTICIPANT COMPENSATION 
 
Recruitment and Enrollment.  
Feasibility of Recruitment. The Markey Cancer Center sees 294 newly diagnosed advanced 
stage lung cancer patients a year. We estimate 80% will meet performance status and brain 

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metastases criteria, 85% will receive required active oncologic treatments, and 10% will be 
excluded for already accessing palliative care or actively receiving psychological services. We 
estimate 179 patients per year will meet eligibility criteria. With a 50% recruitment rate (based 
on current estimates during COVID-19), we project recruiting 6 patients in 2 months (Phase I) 
and 55 patients (Phase II) in 8-9 months.  
 
Recruitment Strategies. As in prior work, we will use two primary recruitment strategies: direct 
patient referral from oncologists and providers at the Markey Cancer Center and review of 
patient (per report of patients coming to clinic with diagnostic codes for metastatic lung cancer) 
and provider appointment schedules at the MCC. To facilitate pre-screening for eligibility, we will 
use the UK CCTS to have an honest broker build a report in Tableau of patients with upcoming 
Markey Cancer Center appointments and diagnostic codes for metastatic lung cancer. Tableau 
will link the CCTS Enterprise Data Warehouse data for this information and generate a report 
that the study team can access via a dashboard in Tableau. Tableau is a secure system that 
requires SSL and linkblue authentication. Additional eligibility checks may need to occur from 
within the UKHC medical record. Study personnel will identify upcoming oncology appointments 
of patients pre-screened for eligibility. Study personnel will then recruit patients in person at 
clinic appointments or by telephone. 
We are requesting a waiver of HIPAA authorization for recruitment purposes. This 
waiver will allow us to review appointment schedules at the MCC to pre-screen potential 
patients for eligibility through the electronic health record. Patients will be pre-screened for 
documentation in their EHR for inclusion and exclusion criteria.  
 
Inclusion of Women and Minorities. Men and women of all races and ethnicities who meet 
the above-described eligibility criteria are eligible to participate in this study. We expect 
approximately 42% of participants to be women. Translating this to our sample size estimate of 
61 (6 pilot; 55 single arm), we plan to enroll at least 25 women. We expect to enroll racially and 
ethnically diverse patients in proportions that reflect our catchment area: Hispanic/Latino (n = 1), 
Black or African American (n = 3), American Indian/Alaska Native (n = 1), and Asian (n = 1).  
 
Retention. Patients will have up to 12 weeks (from the point of their first session) to complete 
Pathways. We will use previous retention strategies, including reminding patients of study visits, 
and offering sessions and assessments when they are in clinic for care. If they are hospitalized 
and want to participate, the study interventionist will meet them or resume upon discharge. 
 
Participant Compensation. Patients in both Phase I and Phase II will receive a $20 gift card 
for completing the baseline assessment and a $30 gift card for completing the post-assessment. 
Patients in Phase I and II will receive an extra $10 for completing the exit interview.  Patients will 
receive gift cards upon completion of an assessment. Patients will receive the full gift card 
amount even if they elect to skip measures within an assessment, or, in the case of the exit 
interview, discontinue the interview.  
 
6 
STUDY INTERVENTION 
 

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6.1 
STUDY INTERVENTION ADMINISTRATION 
6.1.1 STUDY INTERVENTION DESCRIPTION 
 
Theoretical Basis for Pathways. Hope Theory49,67 and Hamann’s model of lung cancer 
stigma15 guide the conceptual foundation of Pathways (Figure 2). Hope theory is recommended 
as a theory-based approach to goal setting interventions 
in palliative care.68 It suggests the disruption cancer 
causes to goal pursuit67,69-71 can be addressed by setting 
values-based goals and increasing agency (will to work 
on goals) and pathways (planning ways to reach 
goals).67 In Hamann’s model of lung cancer stigma, 
stigma comprises negative perceptions from others, 
constrained disclosure, and internalized self-blame, 
guilt, or shame, with proximal effects of isolation and 
inhibited disclosure.15,72 Hope combats these effects by 
helping patients build ways and will to work toward 
values-based goals, ultimately supporting function. 
  
Pathways Development was informed by: (a) Dr. McLouth’s prior work with 60 stage IV 
NSCLC patients to establish patient interest in the intervention and modality; (b) Dr. Cheavens’ 
prior hope interventions and Dr. Peterman’s cancer goal interference study to develop content 
(c) review of resources (e.g., Lung Cancer Alliance) and approaches73,74 for lung cancer stigma 
and consultation with Dr. Studts to develop stigma content; (d) provider input on the intervention 
concept; and (e) patient feedback on intervention materials and concept. (see Figure 3).  
 
Table 1. Overview of Intervention Components 
Component 
IP  
IP 
P  P 
P 
Main Purpose 
Values Clarification Exercise 
 
- Review list of potential values and priorities (e.g., 
family, spirituality) 
X 
* 
* 
* 
* 
To Increase 
- Intrinsic motivation to work on goals 
Values-Based Goals 
 
- Generate list of potential goals aligned with top 
values and priorities 
 
- Select goals to pursue based on importance and 
desire for progress 
X 
* 
* 
* 
* 
To Increase 
- Agency, Awareness of important goals still 
available to pursue 
Identify Pathways for Goals 
 
- Generate list of all potential ways to pursue top 
goal, including action that is consistent with the goal 
and feasible even on high symptom days 
 
- Select pathways to use and plan to implement 
pathways 
X 
X 
X 
X 
X 
To Increase 
- Pathways thinking 
- Agency thinking  
- Goal setting skills (specific, realistic) 
Plan Ways around Goal Obstacles, 
Responding to Blocked Goals 
 
X 
 
 
X To Increase 
- Pathways thinking 
Figure 3. Completed Stepwise Process to Develop Pathways 
1. Identified patient interest and needs 2. Elicited provider input 
3. Patients reviewed intervention 

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Pathways Content and Procedures. See Appendix A for a draft of the intervention manual and 
Appendix B for a draft of patient materials. The ~6-8 week intervention focuses on increasing 
patient hope, including reducing obstacles to patient goals, through 5 sessions: 2 in-person and 
3 phone-based (Table 1 Overview of Intervention Components). The treatment manual is 
scripted, with scenario guides (e.g., “goal of living long enough to see…”; self-blame as obstacle 
to goal related to family). To reduce patient burden, in-person sessions align with typical 3-4 
week infusion schedules. To increase adherence, the study coordinator will remind them of 
sessions. 
6.1.2 ADMINISTRATION AND/OR DOSING 
 
As described in Table 1, the intervention will be delivered in 5 sessions over approximately 5-8 
weeks. Two sessions will be in-person when patients are in clinic; 3 sessions will be delivered 
on the phone when patients are not in clinic. In-person sessions are expected to take 30-45 
minutes; phone sessions are expected to take 15-20 minutes. In-person sessions can be 
completed via Zoom or phone, if needed. Phone sessions can be delivered in-person, if needed, 
when patients are in clinic. The interventionist will be a member of the health profession (e.g., 
training as nurse, nurse navigator, rehabilitation or occupational therapist). A full dose of the 
intervention will be defined as completing 2 in-person sessions and at least 1 phone session. 
  
6.2 
FIDELITY 
 
6.2.1 INTERVENTIONIST TRAINING AND TRACKING 
- Identify potential obstacles to goals (e.g., 
symptoms, stigma, treatment    information or 
resource needs) and plan (e.g., if [obstacle], then 
[solution]) 
 
- Identify new goals to pursue if goal is blocked 
(i.e., not feasible) 
- Agency thinking 
To Reduce- impact of goal blockages 
Review Past Success, Personal Strengths 
 -Identify time when persisted in goal when it was 
difficult 
 -Identify personal strengths from list of potential 
characteristics 
 
X 
 
 
 
To Increase 
- Agency thinking 
Stigma Resources (Workbook) 
 - Responses: what to do if someone asks you if you 
smoked; people are distancing themselves or unsure 
how to act; feelings about lung cancer creating 
isolation 
 - Lung cancer advocacy resources; Peer support 
networks 
* 
* 
* 
* 
* 
To Reduce 
- Stigma’s impact on patient-identified goals 
Symptom Resources (Workbook) 
 
- Cancer center patient guides for coping with 
fatigue, dyspnea, and pain 
 
- Strategies to communicate symptoms to the 
oncology team 
* 
* 
* 
* 
* 
To Reduce 
- Undermanaged symptom’s impact on patient-
identified goals 
Documentation of Patient Goals and 
Obstacles in EHR (as needed) 
X 
X 
X 
X 
X To Reduce patient goal obstacles 
 
 
 
 
 
  
Note. IP = in-person session; P = Phone session; X = component is main focus of session; * = as needed; EHR = 
electronic health record 

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Interventionist training and fidelity monitoring will follow guidelines of the Fidelity Workgroup of 
the Behavior Change Consortium. Multiple interventionists will be trained in case of 
interventionist attrition. Dr. McLouth (PI) and the study team will conduct an in-person training 
with review of procedures, treatment manual, and role plays. To minimize drift and evaluate 
fidelity, the interventionist will audiorecord all sessions and complete fidelity self-checklists each 
session (topics covered, session duration, and proscribed behaviors; Appendix E). Dr. McLouth 
and the study team will review recordings to rate fidelity (topics, length, interventionist 
competence; Appendix F).  
 
For Phase I, which is intended to inform refinements needed to the treatment manual or fidelity 
forms, the study interventionist will have regular (e.g., every week a patient is seen) supervision 
with Dr. McLouth, and Dr. McLouth and the study team will review all recorded intervention 
sessions. For Phase II, the single arm feasibility test of the refined intervention, the study 
interventionist will have regular (e.g., every week a patient is seen) supervision with Dr. 
McLouth. To determine if remedial training is needed (fidelity <80%), the study team will review 
all sessions for the first 10 patients. Two members of study team will randomly select 10% of 
remaining sessions and rate fidelity. 
 
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
 
This is a single arm intervention design. To help minimize bias, the study coordinator, not the 
interventionist, will collect patient-reported data and data from the electronic health record 
related to referrals that could be associated with the intervention.  
 
6.4 
STUDY INTERVENTION  
 
Treatment adherence will be defined by patient participation (“yes/no” to whether a patient was 
present and agreed to participate in the session) in at least 3 of 5 intervention visits. We will also 
track engagement through study interventionist ratings of patient engagement in each session 
(Appendix G) 
Treatment receipt will be assessed through patient ratings of components received and non-
specific factors after in-person session 1 and post-intervention with the coordinator and a pre-
posttest goal setting exercise (Appendix H).75  
Treatment enactment will be assessed from review of recordings for demonstration of skills.75  
 
6.5 
CONCOMITANT THERAPY 
 
Patients will be able to receive concomitant treatment while on study. This may include 
counseling, palliative care, complementary and alternative therapies, psychotropic medications, 
and rehabilitation. Indeed, one of the anticipated effects of the intervention is a facilitated 
referral to supportive services. We will track concomitant treatment use through review of 

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electronic health record for services used during the study intervention period as well as by 
asking patients at follow-up whether they engaged services while completing the intervention.  
 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
 
7.1 
DISCONTINUATION OF STUDY INTERVENTION 
 
If a patient discontinues the intervention, but not the study, remaining study procedures will be 
completed (e.g., post-assessment). Patients who discontinue the intervention will be asked to 
indicate the reason why they are discontinuing (e.g., intervention burden, decline in functional 
status, etc.; Appendix I). If a patient’s post-assessment is due to be completed within 2 weeks of 
discontinuing the intervention, the post will be administered at the time of discontinuation. If the 
post assessment is scheduled for more than 2 weeks from the date they discontinue the 
intervention, the post assessment will be administered at the originally scheduled assessment.  
 
Patients may be discontinued from the intervention by the investigative team if the study team or 
treating physician has concerns about the patient’s mental status or psychological wellbeing, at 
which point procedures for managing patient safety and evaluating adverse events will be 
followed. The study will document reasons for discontinuing a patient (Appendix I).  
 
7.2 
PATIENT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
Participants are free to withdraw from participation in the study at any time upon request.  
 
An investigator may discontinue a participant from the study for the following reasons: 
 
x 
Significant study intervention non-compliance  
x 
Lost-to-follow up; unable to contact subject (see Section 7.3, Lost to Follow-Up) 
x 
Any event or medical condition or situation occurs such that continued collection of 
follow-up  study data would not be in the best interest of the participant (Note: patients 
who are hospitalized during the study period will be offered the opportunity to continue 
the intervention in the hospital or resume  upon discharge. Patients who become 
hospitalized and elect to discontinue the intervention will still have option to continue the 
study to complete assessments).  
x 
The participant meets an exclusion criterion (either newly developed [e.g., change in 
mental status] or not previously recognized) that precludes further study participation.  
 
The reason for participant discontinuation or withdrawal from the study will be recorded 
(Appendix I). Patients who sign the informed consent form but do not receive the study 
intervention may be replaced.  Patients who sign the informed consent form and receive the 

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study intervention and subsequently withdraw, or are discontinued from the study, will not be 
replaced. 
 
7.3 
LOST TO FOLLOW-UP 
 
A patient will be considered lost to follow-up if he or she fails to appear for 3 intervention visits 
or return an assessment and study staff are unable to contact the participant after at least 3 
attempts.  
 
The following actions will be taken if a patient fails to return to the clinic for a required study visit: 
 
x 
Staff will attempt to contact the participant, reschedule the missed intervention within 10 
days, counsel the participant on the importance of maintaining the assigned visit 
schedule and determine if the participant wishes to and/or should continue in the study 
x 
Before a participant is deemed lost to follow-up, the investigator or staff will make every 
effort to regain contact with the participant (where possible, 3 telephone calls and check-
in at upcoming cancer care visit, and if necessary, a certified letter to the participant’s 
last known mailing address). These contact attempts will be documented in the 
participant tracking log (Appendix J).  
x 
Should the participant continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up. 
 
8 
STUDY ASSESSMENTS AND PROCEDURES 
 
8.1 
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
 
Screening. We will build a separate REDCap project for screening. This screening project will 
include an eligibility database (i.e., REDCap form) of patients who are screened for eligibility, 
and a master list database (i.e., separate REDCap form) linking patient names, MRNs, and 
screening IDs (Appendix K). Because all patients in the study will have an MRN (which includes 
contact information in it), we will not extract contact information for patients at the screening 
stage. The eligibility screening database will include patient screener ID, date screened, date 
must be enrolled by (21 day window), eligibility criteria (e.g., performance status, time on cancer 
treatment, age, etc.), whether the patient is being rescreened for eligibility, and, if rescreened, 
the last date of screening (Appendix L). If deemed potentially eligible, additional fields will 
appear in the eligibility database for tracking dates of upcoming appointments and contact with 
patients. Patients must be enrolled within 21 days of screening or else they will need to be 
rescreened.  
 
Administration of Questionnaires. Patient-reported measures related to a future efficacy trial 
and of treatment processes were chosen based on their validity and sensitivity to change in 
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patients in both Phase I and Phase II pre-intervention (TP0), during (T1), and post-intervention 
(TP2) on paper, online (REDCap), or by phone. Patients will use a participation ID on their 
questionnaires. See Table 2 for a list of measures to be administered, psychometric properties, 
assessment schedule, and role in analysis plan. All patient-reported measures will be entered in 
REDCap (Appendix M, N, O) in the REDCap project built for those patients who enroll. 
 
Exit Interviews. Patients participating in Phase I (n = 6) and Phase II (n = 55) of the study will 
complete an exit interview (Appendix P). The interview will last approximately 15-20 minutes 
and will query overall satisfaction with the intervention, reactions to the session content, length, 
and delivery, and assessment relevance. The interviews will take place over the phone or in-
person, according to patient preference. Interviews will be conducted by the study team (not the 
interventionist) and audiorecorded. After each interview, the interviewer will write up 
observations in the form of field notes (Appendix Q), which will include information about the 
setting (e.g., details about room if in-person vs. on the phone), personal environment (e.g., 
respondent’s attitude and openness), social environment (e.g., presence of caregiver or others 
in room), and summary of patient’s responses. Recordings will be transcribed verbatim, the 
transcripts checked for accuracy and deidentified.  
 
Table 2. Patient-Reported Measures Related to a Future Efficacy Trial  
Construct 
Role 
Time Measure  
Description   
Activity and 
Role Function 
Primary 
outcome in 
future trial 
T0, 
T2 
PROMIS Satisfaction 
with Social Roles 
and Activities 8a 
Short Form  
8 items; Alpha reliability of T-score of 50 = .98; 
high correlation with well-validated functioning 
measures.77 Recommended for longitudinal 
research on function in cancer.78,79 
Distress 
Secondary 
outcome  
T0, 
T2 
PROMIS Depression 
Short Form 8a 
8 items; Alpha reliability of T-score of 50 = .98. 
The PROMIS depression measure has been 
validated for use in cancer patients. 80 
Purpose 
Secondary 
outcome  
T0, 
T2 
PROMIS Meaning 
and Purpose 4a81 
4 items; Assesses one’s sense of purpose and 
that there are reasons for living. Alpha reliability of 
T-score of 50 = .98.  
Hope  
Intermediate 
outcome 
T0, 
T2 
State Hope Scale47 
6 items; e.g., “I can think of many ways to reach 
my current goals”; 2 subscales: agency, hope 
pathways. Good internal consistency in lung 
cancer patients (α = .88).18 
Goal 
Interference 
Intermediate 
outcome 
T0, 
T2 
Cancer-Related Goal 
Interference Scale82 
8 items; e.g., “To what extent did the effects of 
disease/treatment interfere with progress on this 
project?” Has shown internal (α = .90) and 
concurrent validity.82 
Stigma 
Intermediate 
outcome 
T0, 
T2 
Lung Cancer Stigma 
Inventory72 
25 items; Assesses internalized, perceived, and 
constrained disclosure. Correlates with previous 
measures of stigma used in our studies with lung 
cancer patients. 
Physical 
Function 
Covariate 
T0, 
T2 
PROMIS Physical 
Function Short Form 
6 
6 items; This measure has been validated in lung 
cancer patients, with high internal consistency (α = 
.92) and strong correlations with the FACT-G 
Physical Wellbeing.83 
Symptom 
Severity 
Covariate 
T0, 
T2 
FACT- Lung 
Symptom Index84,85 
7 items; Items are an independent subscale of the 
Functional Assessment of Cancer Therapy – 
Lung/NCCN Lung Symptom Index. 
Immunotherapy-specific items used in C1.2 or 
FACIT system (if available) will be incorporated.   

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Review of Existing Data in EHR. As part of the consent, all patients will be asked to consent to 
a HIPAA release for permission to collect the following protected health information for up to 12 
months post-enrollment:  
x 
age 
x 
gender 
x 
racial and ethnic data 
x 
zip code 
x 
lung cancer diagnosis 
x 
date started lung cancer treatment 
x 
comorbidities (other health conditions) 
x 
type of cancer treatments received and dates received 
x 
types of other services received for cancer care and dates received 
x 
response to cancer treatment 
x 
dates of hospitalizations and reasons hospitalized 
x 
referrals to services for cancer care 
x 
documentation of advance care planning 
x 
date of death, place of death (hospital, home) 
 
This information will be collected by study staff and entered in REDCap or obtained through 
clinical informatics service.  
9 
STATISTICAL CONSIDERATIONS  
 
Tobacco use 
Comorbidity 
Covariate 
T0 
Cancer Patient 
Tobacco Use 
Questionnaire86,87;  
4 items; Assesses lifetime and current tobacco 
use. 
 
Social Support Covariate 
T0 
PROMIS Emotional 
Support, 
Instrumental Support 
V2. 4a;  
4 items; Assesses perceived emotional support 
and instrumental support (e.g., help with tasks). 
Demoralization Secondary 
outcome 
T0, 
T2 
Demoralization 
Scale –II 
16 items; 2 factors: meaning and purpose; distress 
and coping ability. Patients with low and 
or/moderate levels are less likely to have major 
depressive disorder; those with high levels are 
more likely to have major depressive disorder.  
Care Quality 
Secondary 
outcome 
T0, 
T2 
Patient-centered 
communication in 
cancer care 
8 items; (e.g., To what extent do you and your 
doctor discus how cancer is affecting your 
everyday life?...what is important to you when 
planning your care?”)  
Treatment 
Expectancy 
Covariate 
T1 
HEAL Treatment 
Expectancy 
6 items; Assesses expectations for treatment (e.g., 
“I am confident in this treatment”) 
Treatment 
Receipt 
Covariate 
T1, 
T2 
 
7-9 items; (Assesses whether patients perceived 
that they set goals, discussed values, etc. with the 
interventionist)  
Survey Length 
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9.1 
STATISTICAL HYPOTHESES 
  
Primary Endpoint: We hypothesize that at least 60% of eligible patients approached will enroll in 
the Pathways intervention in the Phase II feasibility study.  
 
9.2 
SAMPLE SIZE DETERMINATION 
 
The target sample of 6 patients for Phase I is based on the aim of refining procedures and 
content.88-90  We anticipate that 6 will be sufficient given that we have already had patients 
review proposed intervention materials to provide feedback and initial refinement.  
 
The target sample size of 40 evaluable cases for Phase II is based on the goal of estimating the 
probabilities and means for 3 feasibility outcome measures (enrollment ≥ 60% [primary], 
retention ≥ 70%, adherence [defined as completing at least 3/5 sessions] >=70%). We will use 
feasibility outcomes to inform an efficacy trial. Here we present some basic power calculations 
for the above 3 outcomes. Assuming a negative binomial distribution and true probability of 
enrollment of 60%, the probability that we would have to approach 55 or more people to recruit 
40 is <0.05. If we approach ≥55 patients to enroll 40, it is unlikely the true probability of 
enrollment is 60% or greater, concluding a future efficacy study with our criteria may not be 
feasible. Out of 40 patients, if the true probability of retention is 60% we expect at least 19 
patients will be retained (i.e., probability of n≤19 retained given true retention probability of 60% 
is <0.05), so if more than 21 patients are not retained, an efficacy study may not be feasible. We 
have 80% power (using a 2-tailed alpha of 0.05) to detect an adherence proportion of 0.72 if we 
assume a null hypothesis adherence proportion of 0.50. 
 
9.3 
POPULATIONS FOR ANALYSES 
 
The sample from phase I (n = 6) will be used to refine procedures and the intervention protocol.  
The sample from phase II (n = 55) will be used to analyze feasibility and acceptability data and 
describe pre-post changes in patient-reported outcomes.  
 
9.4 
STATISTICAL ANALYSES 
 
9.4.1 GENERAL APPROACH 
 
For Phase I we will use qualitative methods to analyze patient feedback from the exit interviews 
and descriptive statistics to summarize participants’ acceptability ratings of the intervention. The 
interviews will be transcribed verbatim and managed in ATLAS.ti or other qualitative software for 
analysis. The PI and study coordinator will code interviews by domains (e.g., session relevance, 
delivery mode, ease of participation). Data will be analyzed using thematic content analysis91 to 
describe patient perceptions and identify patterns in the patient experience. Quantitative and 
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included in a report. This report will be used to determine potential refinement in the recruitment 
procedures, intervention content, intervention delivery, fidelity forms, and retention strategies. 
The study team will review this report to reach consensus on refinements needed for Phase II 
testing.  
 
For Phase II, we will use descriptive statistics (means, standard deviations, median, range) to 
examine the distribution of continuous variables. We will calculate 95% CIs for each of the 
feasibility measures to determine the range of estimates that are consistent with our data.  
 
We will use one-sample negative binomial probabilities and tests of binomial proportions to 
compare rates of feasibility to hypothesized values. We will also summarize reasons for patient 
ineligibility and refusal to participate. In exploratory analyses, we will monitor and compare the 
patients who drop out or do not complete 3 or more sessions by demographic and clinical 
characteristics, and baseline scores of the measures (e.g., distress, lung cancer stigma). We 
will also investigate any differences in patient enrollment, retention, or adherence by treatment 
type (chemotherapy vs. immunotherapy) to identify an optimal patient population for a future 
study.  
 
We will calculate inter-rater reliability for fidelity scores between raters of intervention fidelity. 
 
Statistical significance will be indicated by p < .05.  
 
9.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
 
The primary outcome of the feasibility is enrollment (≥60%). A one-sample binomial test will be 
used to compare the observed enrollment percentage to 60%.  
 
Enrollment (primary): Number of patients enrolled divided by the number of eligible 
patients approached 
Retention: The percentage of patients who complete baseline and post-treatment 
questionnaires 
Adherence: The percentage of patients who complete at least 3 of 5 sessions in 10 
weeks.  
Acceptability: Mean post-treatment patient ratings ≥ 7/10 on intervention satisfaction 
(primary), convenience, helpfulness, relevance, recommendation to others, worth doing 
(0 = not at all to 10 = extremely); and a brief semi-structured interview to explore factors 
associated with acceptability 
 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
 

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We will describe pre-post changes in intermediate (e.g., hope) and outcome (primary: activity 
and role function; secondary: distress, purpose) variables using descriptive statistics. The 
primary goal of these analyses will be to estimate the standard deviations (SD) for use in future 
studies. Exploratory analyses will include intermediate variables as covariates to model the 
relation between outcome variables and hypothesized mediators.  
 
We will calculate means, sd, and range of minutes per session (including preparation and 
documentation), interventionist post-session ratings (e.g., ease of delivering content), and mean 
caseload (i.e., number of patients) a week.  
 
10 RISK/BENEFIT ASSESSMENT  
 
10.1.1 KNOWN POTENTIAL RISKS  
 
The proposed study poses minimal risks. Potential risks that might exist fall into three 
categories: (a) risks associated with the intervention; (b) risks associated with research 
assessments, and (c) risks associated with potential loss of confidentiality.  We describe each 
below. 
 
Risks of the intervention. The intervention asks patients to think about their personal 
goals, to identify actions to take towards those goals, and to identify potential barriers. For some 
patients, thinking about goals may cause frustration or prompt thoughts related to the ways that 
cancer has disrupted their lives. However, our pilot work with 60 stage IV non-small cell lung 
cancer patients indicates that patients can complete assessments related to their personal goals 
and the interference cancer has caused, identify goals that are meaningful, and view 
assessments of their goals and goal progress as important. As patients are asked to set goals 
for themselves during the week, there is a possibility that patients will not be able to meet their 
planned goals that week and will become distressed or discouraged as a result. We have 
considered this in developing our intervention protocol and identified ways to minimize risk. An 
additional potential risk of the intervention could be that patients may identify physical goals 
(i.e., activities that are physically demanding). Our pilot work suggests 10% of patients may 
identify a physical goal (e.g., “to start walking more”).  
        Risks associated with research assessments. Research assessments include 
questions about depression, demoralization, lung cancer stigma, interference from cancer with 
personal goals, physical function, and disease-related symptoms. The instruments and 
methodologies are well tested and are not known to cause problems or distress on the part of 
the participants; however, there is the possibility that some individuals may find answering the 
questions distressing.  
 Risks associated with potential loss of confidentiality and privacy. There is a risk 
of loss of confidentiality and privacy as patients will be met in person at the Interdisciplinary 
Lung Clinic at Markey Cancer Center and will receive phone calls from the study coordinator.  
10.1.2 KNOWN POTENTIAL BENEFITS  

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Participants may experience some benefit from feeling that they have contributed to a study that 
can help inform ways to help future lung cancer patients. Participants may benefit from being 
asked about their personal goals and monitoring their own behavior to identify areas of their 
lives that they want to pay more attention to for their own benefit. Participants may experience 
an increase in goal-directed thought and decrease in lung cancer stigma as a result of 
treatment. These benefits may or may not occur for any and all participants. For society as a 
whole, the findings will inform future intervention development and testing with lung cancer 
patients. Future patients may benefit from an intervention that is low burden in terms of time and 
cost, potentially widely available due to delivery mode, and aligned with personal values and 
unmet supportive care needs. 
10.1.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS AND PROCEDURES TO MINIMIZE 
RISKS 
 
The risk of harm or discomfort that may happen as a result of taking part in this research study 
is not expected to be more than in daily life or from routine physical or psychological 
examinations or tests. This study will determine whether a hope-enhancing intervention is 
feasible for advanced stage lung cancer patients in primary oncology. Results of this study will 
inform whether an efficacy study is warranted. 
 
Procedures to Minimize Risks.  
Protection for risks associated with the intervention. The biggest risk we perceive 
with the intervention is distress resulting from the potential of patients in the intervention to not 
meet their personal goals. We aim to reduce the risk of patients not meeting their goals by 
helping them evaluate the feasibility of goals they are setting for themselves and emphasizing 
small actions to help set themselves up for success. Dr. Cheavens (consultant) has been able 
to implement a hope-enhancing protocol that this intervention is based in with patients with 
depression where self-efficacy is low and sensitivity to perceived failure may be high. Patients 
will have the option of calling the study interventionist during the week if they are encountering 
problems with their goal. During these calls, the study interventionist will query their mood, 
reinforce effort and consistency in working towards meaningful activities and goals, and help 
problem-solve. The interventionist will help the patient set more feasible goals for the next week 
if needed.  
As mentioned above, 10% of our sample may identify a physical health goal (e.g., to 
start walking more). To help minimize risk if patients identify physical goals (e.g., exercise-
related or physically demanding goals), the study interventionist will communicate patient-
identified goals with the oncology team, will discuss physical limitation and safety concerns 
related to the goal with the patient, and, if necessary, will ask the patient to wait to pursue the 
goal until the oncology team has cleared the activity.  
Protection for risks associated with assessment. Patients will give voluntary 
responses to questions; they are told that they can decline to answer any questions that they 
choose. If patients express distress or frustration with the questions, study staff will remind them 
that these questions are voluntary and that they are meant to apply to a broad range of patients 

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and may not necessarily reflect each person’s experience. If patients remain distressed, the 
study PI, Dr. McLouth or other qualified member of the study team will contact them. If concerns 
remain, participants will be directed either to the chair of the IRB to discuss their concerns about 
the assessments and will be referred for psychological services at the Markey Cancer Center. 
Protection for risks associated with potential loss of confidentiality.  Prior to any 
contact with study participants or data, the Principal Investigator will ensure study team 
members have completed required institutional training in maintaining confidentiality of study 
data. Further, all study staff will complete training in Good Clinical Practice, which is required for 
clinical trial research.  
Assessments completed on paper will have the participant’s assigned unique ID and not 
the participant’s name on it. Assessments completed online will be done through a secure 
survey site, REDCap. REDCap requires HTTPS login access. Hypertext Transfer Protocol 
Secure (HTTPS) is a combination of the Hypertext Transfer Protocol with the SSL/TLS protocol 
to provide encryption and secure identification of the server. HTTPS connections are used for 
payment transactions on the Internet and for sensitive transactions in corporate information 
systems. Assessments completed on the phone with the study coordinator will be conducted an 
agreed upon time by the participant when they believe they will not be interrupted. The study 
coordinator will complete the phone assessments from a private office. At the start of the call, 
the study coordinator will query whether it is a good time and whether the participant is 
comfortable answering questions in their current location.  
 
Data for all participants will be kept strictly confidential, except as mandated by law.  All 
research files will be kept on secure, password protected departmental and medical school 
servers. All electronic data will be stored on secure servers behind firewalls.  Any paper 
documentation will be kept in locked file cabinets or a locked file room.  Participants will be 
assigned a numerical code for identification in the files.  Names and other identifiers will be kept 
in separate password protected files.  Audio data will be stored on secure servers with 
password protected files. Study team members who are not at UK will access audio data of 
intervention session recordings through an FTP server. FTP divides files into segments and 
assigns a reference number to each segment, which are transmitted in a sequence for the 
receiving computer to reassemble. FTP performs automatic error detection and correction in file 
transfers. FTP files are considered encrypted.   
All data presentation will be of aggregate-level data; patients will not be individually named.  
Psychiatric emergencies. In the case of psychiatric emergencies, patient care will take 
precedence over treatment protocol. If the study coordinator or interventionist identifies 
concerns about a patient’s mental state, the study PI or other qualified member of the study 
team will contact the participant and determine whether a referral to psychological counseling is 
needed or whether emergency services are needed. If the patient is able to continue the study, 
the PI or other qualified member of the study team will develop a follow-up plan using clinical 
judgment based upon the data and any additional information acquired through interview. This 
may include assessing distress prior to interventionist check-in calls or periodic telephone 
check-ins by the PI or other qualified member of the study team Referrals and assistance will be 
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issues.  Reports will be filed with all necessary governing bodies, including the University of 
Kentucky IRB and the NCI program officer. 
 
10.2 SAFETY MONITORING AND ADVERSE EVENTS 
 
10.2.1 DEFINITION OF ADVERSE EVENTS 
 
This study is considered to carry a low risk to patients. All AEs will be recorded regardless of 
whether they are study related. AEs will be reported if they are study related. For example, 
patient hospitalization or death due to disease is expected in this population and unlikely to be 
an AE related to the study. However, if the AE could be related the study (i.e., there is a 
temporal relationship between the study procedures and the event or reasonable possibility 
means that there is evidence to suggest a causal relationship between the study procedures 
and the AE), it will be reported as an AE. An example of an AE for this study would be severe 
distress during the intervention session that requires additional clinical management for safety. 
Any psychiatric condition that is present at the time the patient is screened and enrolled will be 
considered as baseline and not reported as an AE. However, if the patient’s condition 
deteriorates during the study, it will be reported as an AE.  
 
The PI and/or other qualified Co-I will be responsible for reviewing the AE to grade its severity 
(mild, moderate, severe) and relatedness (definitely, probably, potentially) to the study 
intervention.  
 
10.2.2 MONITORING FOR AE’S AND FOLLOW-UP 
 
Several mechanisms for monitoring the occurrence of adverse events will be employed. The 
study coordinator will oversee day-to-day monitoring of the study activities and will have daily 
contact with the PI.  
 
There will be ongoing communication among the research team. This will be facilitated by: 1) 
regular (weekly or bi-weekly) meetings with project staff and investigators to discuss study 
progress, reactions to the intervention, and any adverse events; 2) supervision of the study 
interventionist, study coordinator, and data manager; 3) the principal investigator and other 
member of the study team will monitor the audiotaped intervention sessions; and 4) a study 
phone number patients may call in the event of a non-medical adverse event. For medical 
adverse events, patients will contact their oncology care team or emergency medical services 
as they would in routine care. 
  
The study interventionist will receive training on how to effectively communicate via telephone 
and assess for actual or potential adverse psychological reactions.  For patients who exhibit 
excessive or worrisome emotional reactions, the study interventionist or PI will follow-up with the 
patient by telephone within 24 hours and again within 1 week of the session to ensure that these 
patients receive adequate mental health care.  

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10.2.3 ADVERSE EVENT REPORTING  
 
The PI or designated personnel will be responsible for reporting the results of an AE evaluation 
to the NIH and the IRB as soon as possible, but no later than 14 working days after the study 
team first learns of the event. 
 
10.3 UNANTICIPATED PROBLEMS 
 
10.3.1 DEFINITION OF UNANTICIPATED PROBLEMS 
 
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human 
Research Protections (OHRP).  OHRP considers unanticipated problems involving risks to 
participants or others to include, in general, any incident, experience, or outcome that meets all 
of the following criteria: 
 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures 
that are described in the protocol-related documents, such as the Institutional Review 
Board (IRB)-approved research protocol and informed consent document; and (b) the 
characteristics of the participant population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means 
there is a reasonable possibility that the incident, experience, or outcome may have 
been caused by the procedures involved in the research); and 
• 
Suggests that the research places participants or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously known 
or recognized. 
 
An example of an unanticipated problem would include loss of data or sensitive information due 
to a study laptop being stolen or a complaint from a participant or participant family member. If a 
participant complaint identifies a newly recognized risk, the informed consent document will be 
updated and previously enrolled participants will be informed of the additional potential risk.  
 
10.3.2  UNANTICIPATED PROBLEMS REPORTING  
 
The PI or designated personnel will report unanticipated problems to the IRB. This information 
will include a detailed description of the event, an explanation of the basis for determining that 
the event constitutes an unanticipated problem, and a description of any changes to the protocol 
or other corrective actions that have been take or are proposed in response to the unanticipated 
problem.  
 
11 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 

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11.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
11.1.1 INFORMED CONSENT PROCESS 
 
11.1.1.1 CONSENT 
 
Written documentation of informed consent will be required prior to starting the intervention 
(Phase I, Phase II).  
 
For Phase I, the consent form will describe the intervention, study procedures, including 
audiorecording of the semi-structured interview and intervention sessions, risks, and potential 
benefits (Appendix R).  
 
For Phase II, the consent form will describe the intervention, study procedures, including 
audiorecording of intervention sessions and semi-structured interview, risks, and potential 
benefits.  
 
11.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
 
Once patients are deemed eligible and express interest in the study, they will be consented in 
person at either an upcoming clinic appointment or as a unique clinic visit. Consent will take 
place in a private space within the clinic (e.g., consultation room, infusion suite with curtain 
drawn). Consent will review information that will be collected from the electronic medical record 
and how it will be used. Consent will include information for the process and purpose of the 
study interventionist documenting their activity and role-related goals and potential sources of 
disease or treatment interference in the electronic medical record. These notes will briefly 
describe the type of activity the patient wants to engage in and potential obstacles they need 
help overcoming (e.g., “The patient wants to be able to go on a fishing trip in a month, but is 
worried about fatigue.”).. The consent will also describe information about the rationale for 
audiorecording intervention sessions and procedures to protect confidentiality of session data. 
Patients will be informed that they can request that the recording be paused if they are 
discussing sensitive information they do not want on the recording.  
 
Patients will review the consent form with study personnel and have the opportunity to ask 
questions. To check understanding, patients will be asked to describe their understanding of key 
aspects of the study (rationale, intervention topic, what is involved to participate, decision not to 
participate not affecting their medical care) and study staff will review any aspects that do not 
appear understood.  
 
As part of the consent, all patients will be asked to consent to a HIPAA release for permission to 
use the following protected health information:  
x 
age 

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x 
gender 
x 
racial and ethnic data 
x 
zip code 
x 
lung cancer diagnosis 
x 
date started lung cancer treatment 
x 
comorbidities (other health conditions) 
x 
type of cancer treatments received and dates received 
x 
types of other services received for cancer care and dates received 
x 
response to cancer treatment 
x 
dates of hospitalizations and reasons hospitalized 
x 
referrals to services for cancer care 
x 
documentation of advance care planning 
x 
date of death, place of death (hospital, home) 
 
A copy of the consent form will be sent with the patient on paper or electronically and retained 
via paper or electronically for study records.  
 
11.1.2 CONFIDENTIALITY AND PRIVACY  
 
Confidentiality will be protected by collecting only information needed to assess study 
outcomes, minimizing to the fullest extent possible the collection of any information that could 
directly identify subjects, and maintaining all study information in a secure manner. To help 
ensure subject privacy and confidentiality, only a unique study identifier will appear on the data 
collection forms. All interactions with patients will be conducted in as private atmosphere as 
possible. Any collected patient identifying information corresponding to the unique study 
identifier will be maintained on a linkage file, store separately from patient data. The linkage file 
will be kept secure, with access limited to designated study personnel. Following data collection 
subject identifying information will be destroyed 6 years after the closure of the study, producing 
an anonymous analytical dataset. Data access will be limited to study staff. Data and records 
will be kept locked and secured, with any computer data password protected. No reference to 
any individual participant will appear in reports, presentations, or publications that may arise 
from the study. Specific procedures for protecting confidentiality and privacy by study stage are 
detailed below.  
 
Screening. We will build a separate REDCap project for screening. This screening project will 
include a database (i.e., RedCap form) of patients who are screened for eligibility and a master 
list database (i.e., separate RedCap form or Excel file) linking patient names, MRNs, and 
screening IDs. Because all patients in the study will have an MRN (which includes contact 
information in it), we will not extract contact information for patients at the screening stage. Only 
the minimum necessary information will be collected prior to ascertaining desire to participate. 
The eligibility screening database will include patient screener ID, eligibility criteria (e.g., 

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performance status, time on cancer treatment, age, etc.), and, if deemed potentially eligible, 
dates of upcoming appointments. 
 
Patient Interactions. Study staff will ask patients for permission to discuss anything related to 
the research study with them and whether patients are comfortable to proceed. Consent will 
take place in a private space within the clinic (e.g., consultation room, infusion room). Based on 
our preliminary work, patients prefer to receive the intervention during infusion. Patients will be 
offered the option of completing the intervention in a private consultation room in clinic or in 
infusion clinic space, based on patient preference. Patients who choose to complete their in-
person sessions via Zoom will have their session conducted using a UK-HIPAA compliant Zoom 
account. Prior to interacting with patients in any clinic space, the study interventionist and/or 
study staff will confirm with the patient whether they are comfortable to proceed and take 
precautions to help protect privacy (e.g., closing infusion suite curtains if in shared space, 
pausing recordings and the intervention or interaction if medical staff approach the patient, 
reminding the patient they can ask to pause the recording if they wish to discuss something they 
do not want recorded, etc.). Phase I testing will help inform whether the intervention can be 
delivered to most patients during infusion or whether it will require a separate appointment to 
assure an enclosed, private room.  
 
 
11.1.3 KEY ROLES AND STUDY GOVERNANCE 
 
Principal Investigator: 
 
Laurie McLouth, Ph.D. 
Assistant Professor 
Behavioral Science 
University of Kentucky College of Medicine 
Laurie.mclouth@gmail.com 
Phone: 620-532-6425 
 
 
Co-Investigator(s):  
 
 
 
 
 
 
Susanne Arnold, MD 
Professor 
Internal Medicine 
University of Kentucky College of Medicine 
Associate Director of Clinical Translation, University of 
Kentucky Markey Cancer Center 
 
Jessica Burris, PhD 
Assistant Professor 
Psychology 
University of Kentucky College of Arts and Sciences 
Burris.jessica@gmail.com; jessica.burris@uky.edu 
 
 
 
Biostatistician: 
 
 
Brent Shelton, PhD 
Professor 
Division Chief of Cancer Biostatistics 

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University of Kentucky Markey Cancer Center 
bshelton@kcp.uky.edu 
 
Andrew Shearer 
SAS Programmer I 
Markey Cancer Center Core Support 
Ajsh225@uky.edu 
 
 
Study Interventionists:  
 
 
 
 
 
 
 
Lexandra Overby 
 
 
 
 
 
Lexandra.overby@uky.edu 
 
 
 
 
 
 
Constance Murrie, RN 
 
 
 
 
 
Constance.murrie@uky.edu 
 
Study Coordinators:  
 
Amy Christian 
 
 
 
 
 
Research Associate 
UK Markey Cancer Center Behavioral and Community 
Oncology Shared Resource Facility 
Amy.christian@uky.edu 
 
 
Vilma Bursac, MPH 
Research Program Manager 
UK Center for Health Equity Transformation 
Vbu222@uky.edu 
 
Shaylla Shelton 
Undergraduate study research assistant 
Srsh234@uky.edu 
 
Kaitlyn Weyman, BA 
Medical student research assistant 
Kaitlyn.weyman@uky.edu 
 
 
Regulatory Contact:  
 
 
Laura Ashe 
 
 
 
 
 
Regulatory Manager 
 Center for Clinical and Translational Science (CCTS)  
Llashe2@email.uky.edu 
 
 
 
 
 
 
 
 
11.1.4 QUALITY ASSURANCE AND QUALITY CONTROL 
 

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Quality control procedures will be implemented as follows: 
 
Informed consent. Study staff will review both the documentation of the consenting process as 
well as a percentage of the completed consent documents.  This review will evaluate 
compliance with Good Clinical Practice, accuracy, and completeness.  Feedback will be 
provided to the study team to ensure proper consenting procedures are followed.  
 
Source documents and the electronic data. Some data will be initially captured on source 
documents (see Section 11.1.5, Data Handling and Record Keeping), but all will ultimately be 
entered into the study database.   
 
The biostatistician and programmer will download the patient-reported outcome REDCap 
data and examine it for errors after completing Phase I to identify any refinements that need to 
be made in the Manual of Procedures regarding data entry procedures. The PI will review all 
data sources for accuracy with study staff in Phase I.  
 
In the single arm pilot (Phase II), biostatistician and programmer will download the 
REDCap data after the first 5 patients have enrolled to check for errors. We will perform logic 
and range checks. Patient-reported data and medical record data entered by the study 
coordinator in REDCap will be examined for accuracy. Specifically, the study team will compare 
the patient-reported packet with entries in REDCap for 50% of the data. The study team will 
review medical record data extracted for accuracy and consult with Dr. Arnold or other member 
of the thoracic oncology team on the protocol if there are questions about clinical data.  
 
Intervention Fidelity. Consistent delivery of the study intervention will be monitored throughout 
the intervention phase of the study. Procedures for ensuring fidelity of intervention delivery are 
described in Section 6.2.1, Interventionist Training and Tracking.  
 
Protocol Deviations. Protocol compliance will be monitored and discussed at weekly team 
meetings. The study team will review protocol deviations and will implement corrective actions 
when the quantity or nature of deviations are deemed to be at a level of concern. 
 
Should independent monitoring become necessary, the PI will provide direct access to all trial 
related sites, source data/documents, and reports for the purpose of monitoring and auditing by 
the sponsor/funding agency, and inspection by local and regulatory authorities. 
 
 
11.1.5 DATA HANDLING AND RECORD KEEPING  
 
11.1.5.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Data sources include:  

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x 
Information from the electronic medical record (e.g., eligibility screening and upon 
enrollment demographic, clinical data; electronic only) 
x 
Audiorecorded intervention sessions (electronic only) 
x 
Audiorecorded exit interviews and transcripts (Phase I and II; electronic) 
x 
Patient-reported treatment receipt, enactment (paper source then electronic) 
x 
Patient-reported measures (T0, T1, T2; Phase I and Phase II; paper and/or electronic 
source; electronic management) 
x 
Interventionist process notes (e.g., session length, ratings of patient engagement; paper 
source; electronic management) 
x 
Fidelity ratings (paper source; electronic management) 
x 
Participant tracking (e.g., upcoming appointments; withdrawal; discontinuation; 
electronic) 
All data except for audiofiles and transcripts will be stored in REDCap, a secure electronic data 
capture system, or Excel behind a UK firewall on a study-specific shared drive. REDCap 
provides a real-time record of any changes made to data. 
Patient-reported outcome data will be collected via mail, telephone, or in-person. Based on our 
prior studies, we anticipate that most patients will complete the assessments in-person with the 
study coordinator when they are at the Markey Cancer Center for other oncologic appointments.  
 
 
11.1.5.2 STUDY RECORDS RETENTION  
 
All records pertaining to the study will be retained for 6 years.  
 
11.1.6 PROTOCOL DEVIATIONS   
A protocol deviation is defined as any noncompliance with the clinical trial protocol or Manual of 
Procedures. Deviations will be reported to the IRB and corrective actions will be developed by 
the study team and implemented.  
 
11.1.7 PUBLICATION AND DATA SHARING POLICY  
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-
Funded Clinical Trial Information and the Clinical Trials Registration and Results Information 
Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results 
information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be 
made to publish results in peer-reviewed journals.   
 
11.2 ABBREVIATIONS AND SPECIAL TERMS 

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AE 
Adverse Event 
NSCLC 
Non-small cell lung cancer 
HIPAA 
Health Insurance Portability and Accountability Act  
MOP 
Manual of Procedures 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
NIH IC 
NIH Institute or Center 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SOA 
Schedule of Activities 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
 
 

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12 APPENDICES LIST 
 
 
13 AMENDMENT HISTORY 
 
Version 
Date 
Description of Change  
Brief Rationale 
2 
8/25/19 
Added project members (Dr. Shelton, 
BCBR staff, CCTS staff); updated 
questionnaires and treatment 
information 
Previous forms were rough 
drafts and missing information 
(e.g., treatment receipt items) 
 
11/25/2019 
Added project members (Mary 
Valen, study nurse; Vilma Bursac, 
Program Manager; Hannah Bowlds, 
CCTS regulatory) 
 
3 
12/09/2019 
Updated tracking forms, 
questionnaires, templates for 
participant postcard, magnet 
Identified formatting changes 
that were needed to improve 
questionnaires. Identified 
formatting and minor changes 
needed to administrative 
tracking forms for study.  
4 
02/11/2020 
Updated participant handouts, added 
S. Shelton, K. Weyman, and B. 
Estridge to protocol, added CCTS 
Tableau for recruitment pre-
screening 
Identified formatting changes 
needed to improve patient 
materials. New study personnel 
(research assistants, study 
interventionist). Tableau 
through CCTS added to help 
Appendix A 
Draft Intervention Manual 
Appendix B 
Draft Intervention Patient Materials 
Appendix C 
Electronic health record note template about patient goals  
Appendix D 
Letter template: patient goals for patient to share with oncology team  
Appendix E 
Interventionist fidelity self-checklist  
Appendix F 
Fidelity reviewer rating form 
Appendix G 
Interventionist process notes 
Appendix H 
Patient assessment of treatment receipt 
Appendix I 
Patient discontinuation/withdrawal form 
Appendix J 
Patient tracking log (enrolled) 
Appendix K 
Masterlist template 
Appendix L 
Patient screening form & recruitment tracking log 
Appendix M 
Patient baseline (T0) questionnaire 
Appendix N 
Patient post (T2) questionnaire 
Appendix O 
Patient treatment enactment, expectancy questionnaire (T1)  
Appendix P 
Patient exit interview  
Appendix Q 
Patient exit interview field note template 
Appendix R 
Phase I patient consent form 
Appendix S 
Patient refusal questionnaire 

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reduce screening to potentially 
eligible patients 
 
10/23/2020 
Removed Studts, Edwards, and 
Westgate from personnel list 
Co-Is were not actively 
involved in study and roles were 
replaced by other faculty on 
campus  
 
12/14/2020 
Added Burris to protocol 
Dr. Burris is replacing Dr. 
Studts on the protocol.  
6 
1/26/2021 
Increased aim 2 sample size to 40; 
expanded eligibility criteria to 
include advanced stage lung cancer 
patients; added income question to 
patient baseline questionnaire 
Recruitment opportunities have 
lessened during COVID 
(patients coming into clinic less 
often). Dr. Arnold, Co-I, and 
NCI program officer, Dr. Lee 
were supportive of expanding to 
advanced stage LC patients 
given similar treatment and 
disease characteristics. 
Increasing sample size to 
strengthen single arm pilot data 
and potentially allow for 
subgroup comparisons to 
identify ideal eligibility criteria 
for future trial. Discovered 
income was erroneously omitted 
from paper version of patient 
baseline questionnaire.  
7 
11/10/2021 
Increased aim 2 sample size to 55; 
added Lexandra Overby as additional 
study interventionist 
We need 40 evaluable cases 
(pre-post data) for aim 2 patient-
reported outcome analyses. 
Based on attrition and patients 
who had to be discontinued, we 
expect enrolling 55 will yield 40 
evaluable cases. Ms. Overby is 
replacing Brittany Estridge and 
Mary Valen as a study 
interventionist, as both are no 
longer working for the study.  
8 
12/15/2021 
Updated Word version of protocol 
and consent forms to reflect 
increased aim 2 sample size 
approved in 11/2021.  
The protocol and consent forms 
should have been updated 
during the last modification 
request.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Analysis Plan. Protocol 52168; Pathways R03 (PI McLouth)  
 
For Phase II, we will use descriptive statistics (means, standard deviations, median, range) to 
examine the distribution of continuous variables. We will calculate 95% CIs for each of the 
feasibility measures to determine the range of estimates that are consistent with our data. 
 
We will use one-sample negative binomial probabilities and tests of binomial proportions to 
compare rates of feasibility to hypothesized values. We will also summarize reasons for patient 
ineligibility and refusal to participate. In exploratory analyses, we will monitor and compare the 
patients who drop out or do not complete 3 or more sessions by demographic and clinical 
characteristics, and baseline scores of the measures (e.g., distress, lung cancer stigma). We 
will also investigate any differences in patient enrollment, retention, or adherence by treatment 
type (chemotherapy vs. immunotherapy) to identify an optimal patient population for a future 
study. 
 
We will calculate inter-rater reliability for fidelity scores between raters of intervention fidelity. 
Statistical significance will be indicated by p < .05. 
 
 
The primary outcome of the feasibility is enrollment (≥60%). A one-sample binomial test will be 
used to compare the observed enrollment percentage to 60%. 
 
Enrollment (primary): Number of patients enrolled divided by the number of eligible 
patients approached 
Retention: The percentage of patients who complete baseline and post-treatment 
questionnaires 
Adherence: The percentage of patients who complete at least 3 of 5 sessions in 10 
weeks. 
Acceptability: Mean post-treatment patient ratings ≥ 7/10 on intervention satisfaction 
(primary), convenience, helpfulness, relevance, recommendation to others, worth doing 
(0 = not at all to 10 = extremely); and a brief semi-structured interview to explore factors 
associated with acceptability 
 
 
9.4.2
ANALYSIS OF THE PRIMARY ENDPOINT(S) 
9.4.3
ANALYSIS OF THE SECONDARY ENDPOINT(S) 

We will describe pre-post changes in intermediate (e.g., hope) and outcome (primary: 
activity and role function; secondary: distress, purpose) variables using descriptive 
statistics. The primary goal of these analyses will be to estimate the standard deviations 
(SD) for use in future studies. Exploratory analyses will include intermediate variables as 
covariates to model the relation between outcome variables and hypothesized 
mediators. 
 
We will calculate means, sd, and range of minutes per session (including preparation 
and documentation), interventionist post-session ratings (e.g., ease of delivering 
content), and mean caseload (i.e., number of patients) a week.