Piloting 'mPal,' a Multilevel Implementation Strategy to Integrate Non-hospice Palliative Care Into Advanced Stage Lung Cancer Treatment
Phase: NA
Conditions: Lung Cancer
Sponsor: Laurie McLouth

Document Coversheet
Study Title: Piloting 'mPal,' a Multilevel Implementation Strategy to Integrate Non-hospice 
Palliative Care Into Advanced Stage Lung Cancer Treatment
Institution/Site: 
University of Kentucky
Document (Approval/Update) Date:
8/23/2023 
NCT Number:
NCT05270395
IRB Number 
74152
Coversheet created:
3/19/2025 

 
Palliative Care into Advanced Stage Lung Cancer Treatment 
Grant Title: Piloting 
-hospice 
Palliative Care into Advanced Stage Lung Cancer Treatment  
Grant Number: KL2TR001996 
Funded by: National Institutes of Health, National Center for Advancing Translational Sciences  
Protocol Number: 74152 
National Clinical Trial (NCT) Identified Number: NCT05270395 
 
Principal Investigator: 
 
Laurie McLouth, Ph.D. 
Assistant Professor 
Behavioral Science 
University of Kentucky College of Medicine 
laurie.mclouth@uky.edu 
Phone: 859-562-2526 
 
 
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 
Susanne.arnold@uky.edu 
 
Ming-Yuan Chih, PhD 
Health Sciences 
University of Kentucky 
m.chih@uky.edu 
 
Jessica McFarlin, MD 
Associate Professor of Neurology 
University of Kentucky College of Medicine 
Jessica.mcfarlin@uky.edu 
 
Jerod Stapleton, PhD 
Associate Professor of Health, Behavior & Society 
University of Kentucky College of Public Health 
Jerod.stapleton@uky.edu 

 
 
 
 
 
Biostatistician: 
 
 
Brent Shelton, PhD 
Professor 
Division Chief of Cancer Biostatistics 
University of Kentucky Markey Cancer Center 
bshelton@kcp.uky.edu 
 
Andrew Shearer 
SAS Programmer I 
Markey Cancer Center Core Support 
Ajsh225@uky.edu 
 
 
Study Coordinators:  
 
Vilma Bursac 
Senior Research Associate 
UK Center for Health Equity Transformation 
Vbu222@uky.edu 
 
Lexandra Overby 
Study Coordinator 
UK Center for Health Equity Transformation 
Lexandra.overby@uky.edu 
 
Kimberly Haney  
Research Program Manager 
UK Center for Health Equity Transformation 
kimberlyhaney@uky.edu  
 
Project Support/Informatics: 
Isaac Hands, MPH 
 
 
 
 
 
University of Kentucky College of Medicine 
 
 
 
 
 
isaac@kcr.uky.edu 
 
 
 
 
 
 
Chaney Kieckbusch  
 
 
 
 
 
University of Kentucky College of Medicine 
 
 
 
 
 
Chaney.blu@uky.edu 
 
 
 
 
 
 
 
 
 
 
 
Justin Levens 
 
 
 
 
 
University of Kentucky College of Medicine 
 
 
 
 
 
Justin.levens@uky.edu 
 
 
Regulatory Contact:  
 
Kimberly Haney  
 
 
 
 
 
Research Program Manager 
 
 
 
 
 
UK Center for Health Equity Transformation 

 
 
 
 
 
 
kimberlyhaney@uky.edu  
 
Version Number:  9 
8/23/2023 

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PROTOCOL SUMMARY ............................................................................................................................... 1 
1.1 
Synopsis ................................................................................................................................................ 1 
1.2 
Schema ................................................................................................................................................. 3 
2 
INTRODUCTION ............................................................................................................................................ 4 
2.1 
Study Rationale .................................................................................................................................... 4 
2.2 
Background........................................................................................................................................... 4 
3 
OBJECTIVES .................................................................................................................................................. 6 
Primary Objectives ............................................................................................................................................... 6 
4 
STUDY DESIGN ............................................................................................................................................. 6 
4.1 
Overall Design ...................................................................................................................................... 6 
4.2 
Scientific Rationale for Study Design................................................................................................ 6 
4.3 
Justification for Intervention ............................................................................................................... 7 
4.4 
End-of-Study Definition ....................................................................................................................... 7 
5 
STUDY POPULATION .................................................................................................................................. 7 
5.1 
Patient Inclusion Criteria ..................................................................................................................... 7 
5.2 
Patient Exclusion Criteria ................................................................................................................... 7 
5.3 
Provider Inclusion Criteria .................................................................................................................. 8 
5.4 
Provider exclusion Criteria ................................................................................................................. 8 
5.5 
Screen Failures .................................................................................................................................... 8 
5.6 
Strategies for Recruitment and Retention, Participant compensation ......................................... 8 
6 
STUDY INTERVENTION .............................................................................................................................. 9 
6.1 
Study Intervention Administration...................................................................................................... 9 
6.1.1 
Study Intervention Description ....................................................................................... 9 
6.1.2 
Administration and/or dosing ........................................................................................ 11 
6.2 
Fidelity ................................................................................................................................................. 11 
6.2.1 
Interventionist Training and Tracking .......................................................................... 11 
6.3 
Measures to Minimize Bias: Randomization and Blinding ........................................................... 11 
6.4 
Concomitant Therapy ........................................................................................................................ 12 
7 
STUDY control condition ............................................................................................................................. 12 
7.1 
control condition description............................................................................................................. 12 
8 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL .................................................................................................................... 12 
8.1 
Discontinuation of Study Intervention ............................................................................................. 12 
8.2 
Participant Discontinuation/Withdrawal from the Study ............................................................... 13 
8.3 
Lost to Follow-Up ............................................................................................................................... 13 
9 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 13 
9.1 
Endpoint and Other Non-Safety Assessments .............................................................................. 14 
10 
STATISTICAL CONSIDERATIONS .......................................................................................................... 16 
10.1 
Statistical Hypotheses ....................................................................................................................... 16 
10.2 
Sample Size Determination .............................................................................................................. 16 
10.3 
Populations for Analyses .................................................................................................................. 16 
10.4 
Statistical Analyses............................................................................................................................ 16 
10.4.1 
General Approach .......................................................................................................... 16 
10.4.2 
Analysis of the Primary Endpoint(s) ............................................................................ 17 

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10.4.3 
Analysis of the Secondary Endpoint(s) ....................................................................... 17 
11 
RISK/Benefit Assessment ........................................................................................................................... 18 
11.1.1 
Known Potential Risks ................................................................................................... 18 
11.1.2 
Known Potential Benefits .............................................................................................. 18 
11.1.3 
Assessment of Potential Risks and Benefits and procedures to minimize risks .. 18 
11.2 
safety monitoring and adverse events ............................................................................................ 20 
11.2.1 
Definition of Adverse Events ........................................................................................ 20 
11.2.2 
-up ................................................................................ 20 
11.2.3 
Adverse Event Reporting .............................................................................................. 21 
11.3 
Unanticipated Problems .................................................................................................................... 21 
11.3.1 
Definition of Unanticipated Problems .......................................................................... 21 
11.3.2 
Unanticipated Problems Reporting .............................................................................. 21 
12 
SupPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ............................... 21 
12.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 22 
12.1.1 
Informed Consent Process ........................................................................................... 22 
12.1.2 
Confidentiality and Privacy ........................................................................................... 23 
12.1.3 
Quality Assurance and Quality Control ....................................................................... 23 
12.1.4 
Data Handling and Record Keeping ............................................................................ 24 
12.1.5 
Protocol Deviations ........................................................................................................ 25 
12.1.6 
Publication and Data Sharing Policy ........................................................................... 25 
12.2 
Abbreviations and Special Terms ................................................................................................... 25 
13 
REFERENCES ............................................................................................................................................. 26 
 

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PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
 
Title: 
Piloting 
-
hospice Palliative Care into Advanced Stage Lung Cancer Treatment   
 
Grant Number: 
Principal Investigator:  
 
 
Study Description and 
Objectives: 
Laurie McLouth, PhD 
Assistant Professor, Behavioral Science 
 
This is a pilot RCT (40 patients mPal; 40 patients usual care; 6 providers 
not randomized) to test the feasibility and acceptability of a multilevel 
implementation strategy for outpatient palliative care (PC).   
 
Primary Objectives 
1. 
will be able to enroll  
(primary 
feasibility outcome),1 
-month follow-up, and 
acceptability, we hypothesize we will be able to achieve mean 
patient and provide
qualitative data (n = 40 mPal patient interviews; n = 6 provider 
interviews) will further support the ease of use and clinical value of 
mPal. 
 
2. Obtain preliminary data on effectiveness and equity outcomes for a 
planned trial. In line with best practices for pilot studies,2-4 we are 
not testing formal hypotheses for effectiveness outcomes; however, 
we will measure patient and provider PC knowledge5,6 and 
motivation7 and PC referrals, which we expect will improve with 
mPal. For equity outcomes, we will explore whether mPal appears 
similarly effective for patients with different characteristics (e.g., 
rural vs. urban, health literacy, income, race) by analyzing survey 
and semi-structured intervention data from mPal patients (n =40). 
 
 
Endpoint: 
patients enrolled
Study Population: 
86 (n = 40, mPal; n = 40 usual care) patients with stage IIIb-IV non-
small cell lung cancer or extensive stage small cell lung cancer, at least 3 
weeks into treatment, ECOG 0-3, English speaking.  
(n = 6) oncology providers who provide care at least a half day/week to 
advanced stage lung cancer patients. 
Stage: 
Stage I (Pilot Feasibility testing) 

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Facilities Enrolling: 
UK Markey Cancer Center   
 
Description of Study 
Intervention:  
 
Multilevel implementation strategy to educate patients and providers 
about palliative care, identify patient palliative care needs, and facilitate 
referrals during treatment. mPal patient content includes 1) educational 
video, 2) assessment of PC knowledge, 3) assessment of PC needs, and 
4) assessment of whether patients would like to meet with PC/discuss PC 
n educational 
presentation.  
Study Duration: 
3 months (patient participation)  
 
Participant Duration: 
Patients: ~2.5 hours over 6-10 weeks 
Providers: ~35-40 minutes over 12 weeks  
 
 

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1.2
SCHEMA
Note. T0 = baseline; T1 = assessment ( ~3-4 weeks after baseline); T2 = 8±3 week follow-up (after T0); T3 
= ~3-month post-mpal implementation

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2 
 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
 
Over 130,000 people are diagnosed with advanced stage lung cancer (asLC) in the U.S. each 
year. asLC patients experience significant psychological and physical sequellae from the 
disease and its treatment.  Of the few supportive interventions tested in asLC patients, palliative 
care (PC) unequivocally has the strongest evidence base for addressing asLC patients' physical 
and psychological concerns. PC is an interdisciplin
mental, and spiritual concerns. Multiple randomized controlled trials have shown delivering PC 
alongside cancer treatment improves asLC patient outcomes (e.g., symptom burden, quality of 
life) and reduces care costs. The evidence for PC is so strong that national clinical oncology 
guidelines now state PC should be delivered to all asLC patients within 12 weeks of starting 
cancer treatment. Despite these guidelines, less than 15% of asLC patients receive PC. 
Underutilization of PC is an implementation problem.  
 
Barriers to implementing PC at multiple levels are well documented. Most asLC patients 1) do 
not know what PC is or what concerns it can address, 2) mistakenly equate PC with end of life, 
and 3) are relucta
Cancer care providers 1) do not understand how PC can help manage patient concerns during 
cancer treatment, 2) do not have time to adequately assess and discuss concerns that PC could 
manage, and 3) fear patient reactions when mentioning PC. Finally, healthcare systems rely on 
providers to refer patients to PC, but do not provide the tools or training needed to support PC 
communication and referrals. 
 
Our preliminary work has identified a multilevel implementation strategy as a promising 
approach to improve utilization of PC. We have developed our multilevel implementation 
strategy, called mPal, with patient, provider, and system administrator feedback. We now 
propose to conduct a pilot study of the mPal intervention with 60 patients (30 intervention, 30 
-level implementation strategies or usual 
care; provider and system intervention components will not be randomized.  
2.2 
BACKGROUND  
 
A.1. Advanced stage lung cancer (asLC) is common, highly burdensome to patients, and 
disproportionately affects rural residents. Lung cancer has the second highest cancer 
incidence and highest cancer mortality in the U.S.8 Each year, roughly 130,000 people are 
diagnosed with asLC. asLC is associated with high physical and psychosocial morbidities,9 
including poorer physical and role function,10 higher depression,11,12 and more unmet supportive 
care needs compared to other cancers.13 asLC disproportionately affects rural, impoverished, 
medically underserved residents.14 Kentucky leads the nation in asLC incidence and mortality.15  
 

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A.2. Palliative care (PC) is an evidence-based approach that mitigates patient burden, but 
it is underutilized. PC is an interdisciplinary approach to address the psychological, physical, 
and spiritual concerns of patients facing serious illness.16 In asLC, delivering palliative care 
alongside cancer treatment has improved patient symptom burden, quality of life, mental health, 
as well as key care quality outcomes such as shared decision-making and appropriate end-of-
life care.17-23 The evidence behind PC is so strong that national guidelines and accrediting 
agencies now stipulate palliative care should be delivered to all asLC patients within 12 weeks 
of starting treatment.17,24
A.3. Overcoming barriers to PC implementation is a multilevel problem. Unfortunately, 
factors at the patient, provider, and healthcare system level lead to underutilization of PC (Fig. 
1). Less than 15% of patients who could benefit from PC utilize it. Most patients have poor PC 
knowledge (i.e., do not know what palliative care is or 
what concerns it can address, equate PC with end of 
life, and/or fear using it means stopping cancer 
treatment),25,26 will not seek PC without a provider 
recommending it,27 and under-report PC concerns to 
their oncology team (see Preliminary Data).27
Providers often also have poor PC knowledge (i.e., do 
not understand how PC can help manage patient 
concerns during treatment, equate it with end of life), 
are uncertain how to talk about PC with patients, and 
face time constraints during clinic visits to assess and 
address PC needs.28-34 Most healthcare systems rely 
on providers to refer patients to PC, yet do not have 
systems in place to help identify appropriate patients 
and facilitate referrals.31,35-47 Collectively, barriers to 
PC utilization fall into determinants of knowledge, motivation, and opportunity (Fig. 1).48
A.4. Existing interventions do not address multilevel determinants of PC. A multilevel 
strategy to address the problem of underutilization of PC has not been tested. Multilevel 
interventions target two or more levels of patients, providers, or healthcare systems. In cancer 
care, these have been successfully developed and applied to improve cancer screening. They 
have not been developed and applied to PC implementation. Instead, interventions targeting 
individual barriers to PC utilization have been developed and tested. 49-54 While showing some 
benefit, every intervention to date has significant shortcomings. Either they lack educational 
components to address knowledge barriers at the patient and provider levels, do not address 
provider motivation to use PC in clinical practice, or do not address system-level barriers to 
integrating PC. Critically, none have been designed for implementation in both community and 
academic cancer care settings
a major shortcoming given that most cancer care occurs in the 
community and that asLC disproportionately affects rural residents. A multilevel implementation 
strategy to address all key determinants of PC utilization is clearly needed.  
Figure 1. Conceptual Model of PC Implementation Problem

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3 
OBJECTIVES  
 
PRIMARY OBJECTIVES  
 
1. 
 We hypothesize we will be able to enroll  
mary feasibility outcome), 
-
month follow-
acceptability, we hypothesize we will be able to achieve mean patient and provider 
ta (n = 30-40 mPal patient 
interviews; n = 6 provider interviews) will further support the ease of use and clinical 
value of mPal. 
 
2. Obtain preliminary data on effectiveness and equity outcomes for a planned trial. 
In line with best practices for pilot studies, we are not testing formal hypotheses for 
effectiveness outcomes; however, we will measure patient and provider PC knowledge 
and motivation and PC referrals, which we expect will improve with mPal. For equity 
outcomes, we will explore whether mPal appears similarly effective for patients with 
different characteristics (e.g., rural vs. urban, health literacy, income, race) by analyzing 
survey and semi-structured intervention data from mPal patients (n =30-40). 
 
4 
STUDY DESIGN 
 
4.1 
OVERALL DESIGN 
 
This is a Stage I, single-site trial to test the feasibility and acceptability of a novel intervention, 
mPal, through a pilot randomized controlled trial. Patient components are randomized. Provider 
components are not randomized. mPal is a multilevel implementation strategy designed to 
educate patients and providers about palliative care, identify patient palliative care needs, and 
facilitate referrals to palliative care during advanced stage lung cancer treatment. 
 
To accomplish study objectives, we will conduct a pilot randomized controlled trial of the mPal 
protocol with 60 advanced stage lung cancer patients (40 mPal; 40 usual care); 6 oncology 
providers will be recruited and receive the provider components of mPal. The primary feasibility 
outcome that will be tested is patient enrollment 
-
and provider-reported data on effectiveness outcomes (e.g., PC knowledge), PC referrals (from 
the EHR), and will explore ways to improve effectiveness and equity outcomes (i.e., equitable 
reach of intervention) through semi-structured interviews with a purposive sample of mPal 
patients (n = 30-40) and providers (n = 6). See Study Schema for assessment timepoints.  
 
 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 

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In line with best practices for pilot studies, we are testing feasibility, not formal hypotheses 
surrounding effectiveness outcomes. We are not randomizing provider and system-level 
strategies because 1) we do not plan to randomize providers in our next trial (rather, clinics will 
be randomized to start mPal at different times through a stepped-wedge design); and 2) 
intervention contamination would occur within the clinic. 
 
4.3 
JUSTIFICATION FOR INTERVENTION 
 
mPal was developed based on theory, preliminary studies that identified key determinants of PC 
implementation in outpatient asLC care, and preliminary data to develop specific mPal content 
with patient and provider feedback.  
 
4.4 
END-OF-STUDY DEFINITION 
 
A patient is considered to have completed the study if he or she has completed the baseline 
assessment and the follow-up (T2) assessment. A provider is considered to have completed the 
study if they complete the baseline assessment and the follow-up (T3) assessment. The end of 
the study is defined as completion of the follow-up (T2 for patients; T3 for providers) and 
completion of EHR extraction for follow-up outcomes..  
 
5 
STUDY POPULATION 
 
5.1 
PATIENT 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 IIIb-IV non-small cell lung cancer or extensive stage small 
cell lung cancer  
2. 18 years of age or older 
3. ECOG performance status 0-3/Karnofsky 40-100; 
4. At least 3 weeks into active oncologic treatment 
5. Receiving treatment at Markey Cancer Center 
 
Rationale: We chose to recruit at least one month after starting treatment to allow patients time 
to begin treatment and experience treatment-related side effects. 
 
5.2 
PATIENT EXCLUSION CRITERIA 
 
An individual who meets any of the following criteria will be excluded from participation in this 
study: 
 

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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  
4. Unable to speak and read English. 
 
 
5.3 
PROVIDER INCLUSION CRITERIA 
 
In order to be eligible to participate in this study, an individual must meet all of the following 
criteria: 
1. Oncologist  
2. Advanced practice providers and nurses who work with enrolled oncologists 
3. Provides care at least a half day a week to advanced stage lung cancer patients at 
Markey Cancer Center  
Note: Fellows will be allowed to participate in this study.  
 
5.4 
PROVIDER EXCLUSION CRITERIA 
 
An individual who meets any of the following criteria will be excluded from participation in this 
study: 
1. Unable to speak and read English. 
 
5.5 
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 advanced stage disease. Rescreened participants will be assigned the same 
participant number as for the initial screening. 
 
5.6 
STRATEGIES FOR RECRUITMENT AND RETENTION, PARTICIPANT COMPENSATION 
 
Recruitment and Enrollment.  
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 advanced stage lung cancer) and provider 

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appointment schedules at the MCC. 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, by telephone, Zoom, or through MyChart® after confirming with the oncology 
team that it is okay to approach the patient. 
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 
80, we plan to enroll at least 33 women. We expect to enroll racially and ethnically diverse 
patients in proportions that reflect our catchment area (87% White, 9% Black or African 
American, <2% Hispanic, <1% Asian, <1% Native American).  
 
Retention. We will use previous retention strategies, including reminding patients of study 
visits, and offering sessions and assessments when they are in clinic for care. 
 
Participant Compensation. Patients will receive a $20 gift card for completing the baseline 
assessment (T0), $10 for T1 survey, $10 for the T1 interview (mPal only), $30 for the 8-week 
follow-up (T2), and $10 for the T2 interview (mPal only). Providers will have the option to accept 
$20 gift cards for completing T0 (baseline), $10 for T1 (post mPal viewing), $20 for completing 
T3 (~3 months post-mPal implementation) surveys; and $30 for the interview. 
 
6 
STUDY INTERVENTION 
 
6.1 
STUDY INTERVENTION ADMINISTRATION 
6.1.1 STUDY INTERVENTION DESCRIPTION 
 
Theoretical Model and Implementation Strategies Underlying mPal. mPal is based in the 
application of the Capability, Opportunity, Motivation Model of Behavior (COM-B) and the 
Behavior Change Wheel.55,56 The COM-B distills 14 theory-based constructs that explain 
behavior (e.g., knowledge, beliefs about capabilities, environmental resources) into three 
(e.g., knowledge); motivation to the processes energizing and directing behavior; and 
opportunity to factors beyond a person that enable a behavior. The Behavior Change Wheel 
specifies intervention functions (e.g., education) that target the COM-B constructs. The COMB-
B/BCW model has been used to develop interventions and study their implementation in 
healthcare.57,58 
Recommendations for Implementing Change list of strategies59 and Preliminary Studies. 

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mPal Content and Procedures. See attachments for intervention content. Operational details 
of the mPal intervention appear in Table 1. mPal's patient content can be delivered either 
through MyChart via a "MyChart questionnaire" or a web-based tool (developed with Markey 
Cancer Center in UK IRB# 63922). The mPal patient content is comprised of two components: 
(1) a one-time educational video and knowledge check questions that seek to educate patients 
about palliative care; and (2) a palliative care needs screener (e.g., symptom concerns, 
psychological, spiritual) with questions about whether patients would like to meet with palliative 
care or discuss palliative care and their palliative care needs with their oncology provider. 
Procedures for viewing the mPal patient educational tool will vary based on whether a patient 
has MyChart. Patients with MyChart will be sent a research message requesting they complete 
mPal roughly two days before their next clinic appointment. They can complete this either in 
clinic on a tablet with study staff or from home. Patients who do not have a MyChart account will 
view Markey's web-based tool on a tablet with study staff in clinic or through a personal link 
provided via REDCap. Patients responses to the mPal palliative care needs screener and desire 
for palliative care will be entered in their electronic health record for their oncology provider to 
view. As part of the intervention, study staff will distribute the Markey Cancer Center palliative 
care FAQ document to participants that indicate yes to wanting more palliative care information 
on the mPal tool. The delivery methods for this document include email, mail, in-person 
distribution, or distribution through MyChart or EPIC as part of an after-visit summary.  
After patients complete the initial palliative care screener, it will be re-administered to patients at 
future oncology treatment visits up to 3 times over the 3-months following receipt of the mPal 
educational component, though patients will have the option to request to continue to take the 
screener as part of their cancer care. The screener can be readministered via MyChart, in-
person via tablet, or in-
 at visit check-ins. If 
patients request to re-review the mPal education, it will be provided to them.  
-based tool that provides education on: 1) Evidence for 
PC, clinical guidelines, and practice standards; 2) Education about common misconceptions of 
provider-facing procedures/content; and 5) case examples showing the use of mPal in PC 
discussions during LC care. 
Table 1. Detailed Description of mPal  
Function 
Forms tested 
ERIC 
Implementation 
Strategies59  
Operational Details  
Education  to 
target PC 
knowledge; 
motivation to 
use PC 
Patient:  
 Web-based 
tool 
Provider:  
 Web-based 
tool/recorded 
presentation 
 
Patient:  
 Distribute 
educational 
materials 
 Prepare 
patients to be 
active 
participants in 
their care 
Provider:  
Patient: This tool will include: 1) a brief video describing PC; 2) an 
assessment of potential concerns to be addressed through PC (e.g., 
pain, worry about illness); 3) options to request a referral to PC and 
to talk with their oncology team about their concerns and about PC.  
Timing: Delivered 3 weeks after starting LC treatment to allow 
symptoms/concerns to emerge; PC screener readministered at 
cancer treatment/oncologist appointments up to 3 times in the 3-
months after receiving the education component.  
Provider: Oncology providers will view a 15-20-minute mPal tutorial 
(recorded presentation) online at the time of their choosing. 
Presentation will review: 1) Evidence for PC, clinical guidelines, and 

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 Distribute 
educational 
materials 
 
practice standards; 2) Education about common misconceptions of 
PC/provider reported barriers; 3) PC resources available in their 
-facing procedures/content; and 
5) case examples showing the use of mPal in PC discussions during 
LC care. Timing: Delivered one month before the patient-level 
intervention starts. 
Incentivization 
 to increase 
provider 
motivation to 
use PC 
Provider:  
 Patient PC 
needs from 
web-based 
tool populate 
in EHR along 
with clinical 
guideline alert
 Performance 
reports 
Provider:  
 Facilitate 
relay of clinical 
data to 
providers 
 Remind 
providers 
 Audit and 
feedback 
 
Providers- Once a patient completes mPal, 
will populate in the EHR. This information can be pulled directly into 
the clinical encounter note. Timing: PC alerts will occur whenever a 
patient uses the mPal web-based tool.  
Environmental 
Restructuring
 to increase 
opportunities to 
use PC  
System:  
 Referral 
template 
 EHR tool to 
identify high 
need patients 
System:  
 Facilitate 
relay of clinical 
data to 
providers  
 Make billing 
easier 
System:  To increase patient and provider opportunities to use PC, 
we will program: 1) an EHR/provider-facing alert for patients whose 
mPal web-based tool assessment indicates high need for PC (e.g., 
multiple PC concerns, poor performance status); 2) a structured PC 
referral template providers can use.  
PC = palliative care; ERIC = Expert Recommendations for Implementing Change; EHR = electronic health record 
 
6.1.2 ADMINISTRATION AND/OR DOSING 
 
As described in Table 1, the patient intervention will be delivered during a routine oncology visit 
or at home through MyChart. It is expected to take ~15-20 minutes. Provider intervention 
content will be delivered at an existing lung cancer meeting or online through REDCap. It is 
expected to take ~15-20 minutes. Patients will be considered to have received a full dose of the 
intervention if they watch the video and complete the PC needs assessment in the web-based 
mPal tool. Providers will be considered to have received a full dose of the intervention if they 
watch the recorded presentation or attend it live.  
  
6.2 
FIDELITY 
 
6.2.1 INTERVENTIONIST TRAINING AND TRACKING 
 
Because the primary component of this intervention is a web-based multicomponent tool, 
interventionist training and fidelity monitoring procedures are minimal. Dr. McLouth (PI) and the 
study team will conduct an in-person training with review of procedures and role plays. Dr. 
McLouth or another study team member will observe the first 2-3 patient intervention sessions in 
clinic and additional sessions as needed. The study coordinator who meets patients in clinic to 
show them the mPal tool will attend weekly team meetings to receive supervision.  
 
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 

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This is a randomized controlled trial design (patient-level randomization). Study staff and 
patients will not be blinded to allocation; however, study staff and patients will not know 
allocation until after a patient has completed the baseline questionnaire. The statistician will 
generate the randomization table, which will be implemented through REDCap.  
 
6.4 
CONCOMITANT THERAPY 
 
Patients will be able to receive concomitant treatment while on study. This may include 
counseling, complementary and alternative therapies, psychotropic medications, and 
rehabilitation. Indeed, one of the anticipated effects of the intervention is a facilitated referral to 
supportive services, including palliative care. We will track concomitant treatment use through 
review of 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 CONTROL CONDITION 
 
7.1 
CONTROL CONDITION DESCRIPTION 
 
Only the patient level component of mPal is randomized. Patients not randomized to the mPal 
patient implementation strategies will receive usual care. 
 
8 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
 
8.1 
DISCONTINUATION OF STUDY INTERVENTION 
 
If a patient or provider discontinues the intervention, but not the study, remaining study 
procedures will be completed (e.g., post-assessment). Patients and providers who discontinue 
the intervention will be asked to indicate the reason why they are discontinuing (e.g., 
intervention burden,; see withdrawal form). 
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 
which point procedures for managing patient safety and evaluating adverse events will be 
followed. The study will document reasons for discontinuing a patient. 

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8.2 
PARTICIPANT 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: 
 
 
Significant study intervention non-compliance  
 
Lost-to-follow up; unable to contact subject (see Section 8.3, Lost to Follow-Up) 
 
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 become hospitalized will still have option to continue the study to complete 
assessments).  
 
The patient 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. 
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 study intervention and 
subsequently withdraw, or are discontinued from the study, will not be replaced. 
 
8.3 
LOST TO FOLLOW-UP 
 
A patient will be considered lost to follow-up if he or she fails to 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: 
 
 
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 
 
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 participan
last known mailing address). These contact attempts will be documented in the 
participant tracking log. 
 
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. 
 
9 
STUDY ASSESSMENTS AND PROCEDURES 

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9.1 
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
 
Screening. We will build a master list form in REDCap linking patient names, MRNs, and study 
IDs. We will build a separate REDCap form for screening. The eligibility screening form 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. 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 
cancer patients60 and recommendation for clinical trials. These measures will be completed by 
patients pre-intervention (TP0), ~4 weeks after baseline (T1), and post-intervention (~8-weeks 
after T0; TP2) on paper, online (REDCap), or by phone. For patients who use MyChart®, a link 
to the REDCap survey will be provided through a study research message delivered in 
MyChart®. Patients will use a participation ID on their questionnaires. If more than 30 days pass 
between baseline and participant viewing the mPal tool, key sections (e.g., palliative care 
knowledge, palliative care use) of the baseline questionnaire will be re-administered prior to 
viewing mPal. 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 in the REDCap project built for those patients who enroll. 
 
Interviews. Patients assigned to mPal (n = 20-40) will complete two interviews. The interviews 
will last approximately 10-15 minutes and will query overall satisfaction with the intervention, 
perceived impact of mPal on clinical care, and reasons patients chose or chose not to talk with 
their doctor about their palliative care needs. The interviews will take place over the phone, 
Zoom, or in-person, according to patient preference. Interviews will be conducted by the study 
team and audiorecorded. After each interview, the interviewer will write up observations in the 
form of field notes, which will include information about the setting (e.g., details about room if in-
person vs. on the phone), personal environment (e.g.
responses. Recordings will be transcribed verbatim, the transcripts checked for accuracy and 
deidentified.  
 
 
 
 
 

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Table 2. Aim 1 and 2 Measures  
Construct 
Description 
Data Sources
Level 
Schedule 
Pt Pv Sy
Aim 1. Implementation Outcomes 
Feasibility 
FIM61
= .89); Individual interviews (pts, pvs) 
Survey; 
interviews 
X 
X  
mPal Patients: T1 
 Providers: T3 
Acceptability 
AIM61: 4 item implementation measure of intervention acceptability 
 
Survey; 
interviews 
X 
X
 
mPal Patients: T1 
 Providers: T3 
Aim 2. Effectiveness and Equity Outcomes related to Planned Future Trial  
PC referral 
Proportion of patients in each arm who receive a referral to PC 
within 1-month (survey) and 3-months (EHR) post-mPal 
intervention 
EHR, Survey 
X 
 
X Patients: T2 (survey); 
System: 3-months 
post intervention 
(EHR) 
PC knowledge  HINTS PC6: 10 items; assesses self-reported PC knowledge and 
PC perceptions. PACKS 
Survey 
X 
X
 
Patients: T0, T1 
(mPal only), T2  
Providers: T0, T1, T3
Motivation to 
use PC 
PCAS-97; 9 items; assesses emotional, cognitive, and behavioral 
-.90) 
Survey 
X 
X
 
Patients: T0, T1 
(mPal only), T2  
Providers: T0, T1, T3
Opportunities 
to use PC 
5 items; perceived ability to access PC.  Based on preliminary 
study and literature.40,42,43  
Survey,  
X 
X
 
Patients: T0, T2  
Providers: T0, T3 
PC discussion 2 survey items; Interview questions to supplement (experiences 
discussing PC during clinical encounters, quality of discussion, 
how mPal was used)  
Survey, depth 
interviews 
X 
X
 
Patients: T0, T2  
Providers: T0, T3 
Demographics 15 items; sociodemographics, health literacy62 (pts), PC training 
(providers)  
Survey 
X 
X
 
Patients: T0 
Providers: T0 
Equity  
Characteristics of mPal patients who do/do not seek PC referral 
and do/do not show knowledge increase; Interview with those who 
do/do not use PC; barriers 
Survey, 
interviews 
X 
X  
mPal Patients: T2, 
3m post intervention 
Note. Pt = Patient; PV = provider; Sy = System; T = timepoint; T0 = baseline; T1 = post mPal app viewing or knowledge check (pt 
assessment); post webinar viewing (providers); T2 = 8-week follow-up (pt assessment); T3 = post-patient-level intervention period 
(for providers) 
 
 
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:  
 
age 
 
gender 
 
racial/ethnic data 
 
zip code 
 
mailing address, email, phone number (for participant payments) 
 
lung cancer diagnosis (includes histology and stage) 
 
date started lung cancer treatment 
 
type of treatments received 
 
medical record number 

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ECOG/Karnofsky performance status 
 
referrals for palliative care, palliative care consultations completed, referrals to other supportive 
care services (e.g., Social Work), dates of referrals and consultations 
 
Documentation of advance care planning/advance directive 
 
mPal palliative care screener results (for repeated screenings) 
 
This information will be collected by study staff and entered in REDCap or obtained through 
clinical informatics service.  
10 STATISTICAL CONSIDERATIONS  
 
10.1 STATISTICAL HYPOTHESES 
  
Primary Endpoint: We hypothesize that at least 60% of eligible patients approached will enroll in 
the mPal intervention.  
 
10.2 SAMPLE SIZE DETERMINATION 
 
The sample size of 80 patients is based on the goal of estimating the probabilities and means 
1,63 
feasibility outcomes to inform a future trial. For structured interviews, we anticipate we will be 
able to identify key themes with 20 interviews.64  
 
10.3 POPULATIONS FOR ANALYSES 
 
The patient sample (n = 40 mPal; n = 40 usual care) will be used to analyze feasibility and 
acceptability data and describe pre-post changes in patient-reported outcomes. The provider 
sample (n = 6) will be used to demonstrate feasibility of measurement collection.  
 
10.4 STATISTICAL ANALYSES 
 
10.4.1 GENERAL APPROACH 
 
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 to hypothesized values. We will summarize reasons for ineligibility and refusal and 
compare patients who drop out or do not adhere by demographic and clinical characteristics. 
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before and after baseline (as well as change from baseline) using the Wilcoxon Rank Sum 
statistic.  Within group comparison of the pre versus post baseline measures will be evaluated 
using the Wilcoxon Signed Rank statistic.  
 
We will use qualitative methods to analyze patient and provider feedback from the exit 
appropriateness 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., perceived impact of mPal on clinical care, barriers, facilitators 
to using mPal, suggested changes to improve equity of mPal). Data will be analyzed using 
thematic content analysis65 to describe perceptions.  
 
Statistical significance will be indicated by p < .05.  
 
10.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
 
 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 and providers who complete baseline and follow-
up questionnaires. 
Acceptability: Mean post-treatment patient and provider 
3.5/5 on intervention 
acceptability, feasibility, and appropriateness (psychometrically validated measure; 
Table 2), and a brief semi-structured interview to explore factors associated with 
acceptability.  
 
10.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
 
We will describe pre-post changes in the patient-reported outcome variables related to a future 
trial using univariate and bivariate statistics. Our chief goals will be to estimate the standard 
deviations of our key variables for use in planning future studies. We will examine, through the 
use of t-tests, whether pre-post changes in the mPal differ significantly from pre-post changes in 
the control group. If our intervention is successful, we would expect to see significantly greater 
improvement over time in our effectiveness outcomes (PC knowledge, motivation) in treatment 
vs. control. We will also examine correlations between changes in these measures and PC 
referrals; we expect changes in PC knowledge and motivation variables will be positively 
correlated with changes in PC referrals within both treatment and control groups.   
 

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11 RISK/BENEFIT ASSESSMENT  
 
11.1.1 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 has no known risks. However, it is possible 
that for people who have misperceptions about palliative care (e.g., that it is only for people for 
whom cancer treatment is not working), there may be an initial negative reaction to being 
presented information about palliative care.  It is also possible that some people may 
experience some mild distress when completing the palliative care needs assessment, which 
asks about common lung cancer symptoms and concerns (e.g., worry about family members). 
Both risks are expected to be rare occurrences and mild in severity.   
        Risks associated with research assessments. 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 (e.g., asking about their palliative care knowledge) or boring. This risk is expected to 
be a rare occurrence and mild in severity.  
 Risks associated with potential loss of confidentiality and privacy. There is a risk 
of loss of confidentiality and privacy as patients may be met in person at Markey Cancer Center 
or receive phone/Zoom calls, emails, or MyChart® messages from the study coordinator. In 
addition, patients will complete research assessments using an online form in REDCap, which 
could possibly result in a loss of confidentiality. However, the research team will take every 
precaution to safeguard participant data. 
11.1.2 KNOWN POTENTIAL BENEFITS  
 
This study will determine whether it may be feasible to conduct a fully powered randomized 
controlled trial of mPal. It is also possible that patients who receive the mPal intervention may 
benefit from receiving education about an evidence-based intervention in cancer care (palliative 
care) which may impact their care and improve health outcomes. These benefits may or may 
not occur for any and all participants. 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.  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.  
11.1.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS AND PROCEDURES TO MINIMIZE 
RISKS 

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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 the mPal tool 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 education about palliative care for patients in 
the intervention. This risk is reduced by the assessment that is built into the mPal tool, which 
asks patients to select what they learned about palliative care (e.g., that it is not the same as 
hospice, that it can be delivered at any time or stage of disease).  
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 
and 
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.  
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 
electronic data will be kept on UK OneDrive or REDCap. 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 
 
All data presentation will be of aggregate-level data; patients will not be individually named.  

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Psychiatric emergencies. In the case of psychiatric emergencies, patient care will take 
precedence over treatment protocol. If the study coordinator or interventionist identifies 
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. 
Referrals and assistance will be given in obtaining appropriate treatment for any participant 
terminated from the study for safety issues.  Reports will be filed with all necessary governing 
bodies, including the University of Kentucky IRB. 
 
11.2 SAFETY MONITORING AND ADVERSE EVENTS 
 
11.2.1 DEFINITION OF ADVERSE EVENTS 
 
This study is considered to carry a low risk to patients. 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 
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.  
 
11.2.2 
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 
coordinator, and data manager. For medical adverse events, patients will contact their oncology 
care team or emergency medical services as they would in routine care. 
  

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11.2.3 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. 
 
11.3 UNANTICIPATED PROBLEMS 
 
11.3.1 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; 
 
Re
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.  
 
11.3.2  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.  
 
12 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 

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12.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
12.1.1 INFORMED CONSENT PROCESS 
 
12.1.1.1 CONSENT 
 
For patients, written documentation of informed consent will be required prior to completing the 
baseline assessment and randomization. The consent form will describe the intervention, 
randomization, study procedures, including audiorecording of the semi-structured interviews, 
risks, and potential benefits.  
 
For providers, a study cover letter will be required prior to baseline assessment. The cover letter 
will describe the intervention, study procedures, including audiorecording of the semi-structured 
interview, risks, and potential benefits.  
 
12.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
 
Patients will provide written informed consent through a combined consent/HIPAA release form. 
The consent will describe the study purpose, procedures, risks, benefits, and provide PI contact 
information. The consent form will describe randomization and the two potential conditions 
(mPal intervention or usual care). It will also describe the possibility of being asked to complete 
an interview and the procedures for recording the interviews. Patients will be consented in 
person or remotely via REDCap or paper copies through mail. When consenting patients in 
person, we will ensure we are meeting in a private space with the patient (e.g., physician exam 
room, consult room, infusion room). When consenting patients remotely, we will first ensure the 
patient is in a place where they have privacy and feel comfortable having a conversation. We 
will then review the consent form over the phone or Zoom. The consent form will be reviewed 
with study personnel and patients will have opportunity to ask questions. To check 
understanding, patients will be asked to describe their understanding of key aspects of the study 
(rationale, what is involved, decision not to participate not affecting their medical care) and study 
staff will review any aspects that do not appear to be 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, as well as the information collected for eligibility screening: 
age 
gender 
racial/ethnic data 
zip code 
lung cancer diagnosis (includes histology and stage) 
date started lung cancer treatment 
type of treatments received 
medical record number 
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Palliative care screener results 
referrals for palliative care, palliative care consultations completed, referrals to other supportive 
care services (e.g., Social Work), dates of referrals and consultations 
advance care planning/advance directive 
 
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.  
 
For oncology providers, we will provide a study information sheet (cover letter). The study 
information sheet will be provided online (REDCap), paper, over the phone, or emailed (see 
protocol 55171 for precedent). If reviewed over the phone, the study team will email the 
participant a copy of the study information sheet and review key information verbally. Providers 
will have opportunity to ask questions about the study. Completion of the survey and interview  
will indicate implied consent. Surveys and interviews pose no more than minimal risk to the 
provider and involve no procedures for which consent would normally be required outside a 
research setting. Study information (purpose, study requirements, risks/benefits, who to contact 
for questions, contact information for investigators) will be provided and potential participants 
will be invited to contact investigators with any questions regarding the study. Potential 
participants can refuse to participate in this study. 
 
12.1.2 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.  
 
12.1.3 QUALITY ASSURANCE AND QUALITY CONTROL 
 
 
Quality control procedures will be implemented as follows: 
 

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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 12.1.4, Data Handling and Record Keeping), but all will ultimately be 
entered into the study database.   
 
The study team 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. 
 
 
12.1.4 DATA HANDLING AND RECORD KEEPING  
 
12.1.4.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Data sources include: 
eligibility screening and upon 
enrollment demographic, clinical, referral data; electronic only) 
 
 
cking (e.g., upcoming appointments; withdrawal; discontinuation; electronic) 
 

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n/tracking logs (electronic; study staff completes; e.g., payment logs, final 
study statues) 
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.  
 
12.1.4.2 STUDY RECORDS RETENTION  
 
All records pertaining to the study will be retained for 6 years.  
 
12.1.5 PROTOCOL DEVIATIONS   
A protocol deviation is defined as any noncompliance with the clinical trial protocol. Deviations 
will be reported to the IRB and corrective actions will be developed by the study team and 
implemented.  
 
12.1.6 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.   
 
12.2 ABBREVIATIONS AND SPECIAL TERMS 
 
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 

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QC 
Quality Control 
SOA 
Schedule of Activities 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
 
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