Exploratory Evaluation of Family Caregiver Application (FCA) on Quality Among Persons With Lung Cancer and Their Family Caregivers
Phase: NA
Conditions: Lung Cancer
Sponsor: Geisinger Clinic

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Exploratory Evaluation of Family Caregiver Application 
(FCA) on Quality among Persons with Lung Cancer and 
their Family Caregivers 
 
 
 
 
Principal Investigator: 
 
Lisa Bailey-Davis, DEd, RD 
 
 
 
 
 
Assistant Professor, Epidemiology 
and Health Services Research 
100 N. Academy Avenue 
 
 
 
 
 
Danville, PA 17822 
 
 
 
 
 
570-214-9625 
 
 
 
 
 
ldbaileydavis@geisinger.edu 
 
Co-Investigators: 
 
 
Rebecca Stametz, DEd, MPH 
Senior Director, Clinical Innovation 
Institute for Advanced Application 
100 N. Academy Avenue 
Danville, PA 17822 
570-214-2953 
rastametz@geisinger.edu 
 
Christian Adonizio, MD, MLA, FACP 
Medical Director, Oncology Innovation and Analytics 
100 N. Academy Avenue 
Danville, PA 17822 
570-214-3523 
csadonizio@geisinger.edu 
 
 
Project Manager:  
 
 
Chelsie Hauer, MPH 
 
 
 
 
 
Research & Development Manager II  
 
 
 
 
 
Institute for Advanced Application 
100 N. Academy Avenue 
Danville, PA 17822 
570-214-2038 
clhauer@geisinger.edu  
 

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TABLE OF CONTENTS 
1 
ABBREVIATIONS USED IN THE PROTOCOL ................................................................5 
2 
BACKGROUND AND SIGNIFICANCE .............................................................................6 
3 
SPECIFIC AIMS ....................................................................................................................9 
3.1 
Specific Aim 1 ..............................................................................................................9 
3.2 
Specific Aim 2 ..............................................................................................................9 
3.3 
Specific Aim 3 ..............................................................................................................9 
4 
STUDY DESIGN .................................................................................................................10 
4.1 
Description ..................................................................................................................10 
4.2 
Study Population .........................................................................................................11 
4.2.1 
Approximate Number of Subjects ................................................................12 
4.2.2 
Inclusion Criteria ..........................................................................................13 
4.2.3 
Exclusion Criteria .........................................................................................13 
4.3 
Recruitment .................................................................................................................13 
4.4 
Study Duration ............................................................................................................15 
4.4.1 
Approximate Duration of Subject Participation ...........................................15 
4.4.2 
Approximate Duration of Study ...................................................................15 
4.5 
Procedures ...................................................................................................................16 
4.5.1 
Study Flow Diagram ....................................................................................19 
4.6 
Primary Endpoints ......................................................................................................20 
4.7 
Secondary Endpoints ..................................................................................................21 
4.8 
Statistics ......................................................................................................................21 
4.8.1 
Statistical Analysis Plan ...............................................................................21 
4.8.2 
Statistical Power and Sample Size Considerations ......................................25 
4.9 
Data Management .......................................................................................................25 
4.9.1 
Data Collection and Storage .........................................................................25 
4.9.2 
Records Retention ........................................................................................26 
5 
PROTECTION OF HUMAN SUBJECTS ...........................................................................26 
5.1 
Informed Consent .......................................................................................................26 
5.2 
Protection of Human Subjects Against Risks .............................................................26 

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5.3 
Data Monitoring Plan .................................................................................................26 
6 
PUBLICATION PLAN ........................................................................................................27 
7  
REFERENCES .....................................................................................................................28 
8    
ATTACHMENTS ................................................................................................................29 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1 
 ABBREVIATIONS USED IN THE PROTOCOL 
 
Abbreviation 
Term 
AE 
Adverse event 
EHR 
FCA 
GCMC 
GHS 
GIRB 
Electronic Health Record 
Family Caregiver Application 
Geisinger Community Medical Center 
Geisinger Health System 
Geisinger IRB 
GMC 
GWV 
ID 
IRB 
MRN 
MDC 
PA 
RA 
Geisinger Medical Center 
Geisinger Wyoming Valley 
Identification 
Institutional Review Board 
Medical Record Number 
Multi-Disciplinary Clinic 
Pennsylvania 
Research Assistant 
RedCAP 
Research Electronic Data Capture 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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2 
BACKGROUND AND SIGNIFICANCE 
Cancer Incidence 
Over 1.5 million new cases of cancer will be diagnosed in the United States in 2017 (American 
Cancer Society, 2017).   
Family Caregivers 
Family caregivers (or informal caregivers) are people who “provide a complex array of support 
tasks that extend across physical, psychological, spiritual, and emotional domains” (Honea et al., 
2008).  Family caregivers perform a multitude of tasks such as picking up prescriptions, assisting 
with adherence to medical regimens, providing custodial care and nourishment, scheduling 
medical appointments, transporting patients to and from medical appointments, managing billing 
and insurance documentation, coping, and emotional and mental stress management.  There are 
an estimated 65 million unpaid family caregivers in the United States (National Alliance for 
Caregiving & AARP, 2009) that require specific knowledge bases and skills to administer 
disease-specific care (Given et al., 2008).   
Cancer and Family Caregivers 
Despite the pivotal role of family caregivers, there are few published studies evaluating 
interventions with family caregivers and these have been characterized as being of poor quality 
(Chan et al., 2011).  Furthermore, specific to cancer, the National Cancer Institute stated that 
“family caregivers form the foundation of the health care system in the United States” and that 
this network and system of caregivers is responsible for supporting many advances in cancer care 
and likely play a role in the improvement in cancer care and survival seen in the U.S. (National 
Cancer Institute, 2017).   
Much of the focus of existing caregiver interventions in cancer has been on improving 
knowledge of conditions, symptom management, and caregiver stress management but there has 
been little attention to a leading contributor to caregiver stress: interaction with the healthcare 
system.  Upon the project team’s review of formative data gathered from patients and caregivers, 
a major source of experienced stress is the actual coordination of multiple appointments, 
therapies, scans, and personal lives of patients and their caregivers.   
Considering the real-life challenges to care coordination, the Geisinger Innovation Team 
developed a health information technology solution, called the Family Caregiver Application 
(“FCA”) to address some of these needs in a thoughtful and meaningful way.  FCA is a tool that 
is shared with patients, caregivers, and medical providers to help coordinate and involve patients 
and their caregivers as partners in care.  Care is not something that is given or done to patients, 
but rather it is a circle of care that envelops the patient and family.   
The FCA is a web-based application designed to  enhance care coordination and offer benefit 
across four domains: patient and family satisfaction, quality of care, patient safety, and 
healthcare system operations.  The tool is EHR-agnostic and designed with the ability to 
consume clinical data and integration with existing functions and patient portals.  There is also 
integration within the EHR for the provider dashboard to use as part of medical encounters and 

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therapeutic treatments.  The tool in its current state is designed for lung cancer however, is 
extensible to other cancers and other therapeutic areas.  Merck Regulatory has reviewed the FCA 
and determined that it does not meet the criteria for a medical device. 
Patient and Caregiver Satisfaction 
While some facets of patient and caregiver stress are very difficult to relieve: the unpredictable 
effects of a cancer diagnosis, the constant witness to suffering, and the physical and emotional 
strain that comes with this role, the reduction of uncertainty in the delivery and coordination of 
care is more amenable to a technological solution.  FCA harnesses the power of electronic 
medical records, scheduling systems, and medication management systems to take some of the 
uncertainty and feeling of powerlessness out of the delivery of care.  Instead of anxiously 
awaiting a return phone call for scheduling questions, this application is integrated with 
scheduling information systems (Aria® and Epic®) and electronic medical records so that patients 
and families (authorized proxies) not only have easy access to this information, but they can also 
use FCA to securely coordinate personal and medical calendars.  This application, unlike others 
commercially available, does not require the manual entry of multiple appointments and 
medications which steals precious hours from families, rather many of these events and 
information are virtually automatically available and automatically updated.  
Quality of Care 
With the ability to better coordinate and more accurately share appointment times, FCA may 
help to improve overall compliance in combined-modality therapy for lung cancer.  The well-
coordinated administration of combined-modality therapy in this population is associated with 
improved clinical outcomes (Curran et al., 2011).  With increased patient and caregiver 
involvement, it is anticipated there will be a reduction in the number of non-planned 
interruptions in care (as opposed to therapeutic pauses in care for toxicity or other medical 
issues).  This may translate to an improvement in multiple clinically relevant indicators such as 
compliance with a care plan.  
Patient Safety 
Much has been written about the problems with polypharmacy in older patients with cancer 
(Balducci, 2013).  FCA employs a modest medication management tool to assist patients and 
families in this difficult task.  Since patients with lung cancer are frequently seen in oncology 
outpatient settings, FCA allows patients and caregivers to either post a non-urgent medication 
question via the tool or make a note (a reminder to themselves) to address a specific question 
during the next provider encounter.   
FCA’s provider view allows the clinician access to the medication questions and concerns, so 
that they may be addressed in the context of the clinical encounter. The provider view of FCA 
includes a feature in which providers can indicate if they addressed a specific medication 
question.  For urgent issues, patients and their caregivers are directed to call oncology clinics 
directly to speak with a triage nurse, a medication management pharmacist, or another provider.  
FCA has an easy-to-use medication scheduling tool which may help to decrease home 
medication errors.  

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Healthcare System Operations 
With the pressures to look for efficiencies within the healthcare system, FCA could potentially 
aid in the triaging of patient and family logistics questions --as compared to questions associated 
with symptoms or direct medical care.  These questions occupy additional patient, caregiver, 
administrative, and clinician time.  In one study, up to 15% of calls to telephone triage were 
scheduling questions (Flannery, 2009).  FCA could potentially free patients, their caregivers, and 
providers to focus on other domains of concern rather than on scheduling of care.   
Caregivers: Their value and needs 
Efforts to strengthen the quality of caregiving has had a direct impact on the care of patients.  In 
many instances, the most important determinant of successful healthcare management may be 
the involvement of an engaged and effective family caregiver.  For example, cancer patients 
were less likely to have unmet needs when family caregivers demonstrated high involvement and 
effective management (McMullen et al., 2014).  Patients are also likely to have unmet needs if 
the family caregiver burden is high (Deeken et al., 2003).  The quality of caregiving may mediate 
outcomes of interest such as admissions, readmissions, and the ability of the patient to live 
independently.  Enhancing caregiving effectiveness may help to reduce health care costs.  For 
example, an intervention to support family caregivers of patients with dementia could save 
Minnesota $996 million in direct care costs over fifteen years (Long et al., 2014).    
Family caregivers are demanding technologic solutions to help them perform their roles and 
communicate with the health care team. FCA potentially responds to this demand with a 
technological solution that virtually connects the family caregiver, patient, and the healthcare 
team.  The purpose of this project is to evaluate how exposure to and use of the FCA may 
impact quality indicators associated with oncology care, as indicated for advanced lung cancer, 
among patients, caregivers, and clinicians during a brief, 8-week period. 
 
Preliminary work:  Several years of work lead to the project team to the exploratory evaluation 
of FCA.  Previous worked occurred in two phases that are described below.  
Application Development - Phase I:  The primary goal of Phase I was to design and build a 
working prototype. The project team accomplished this as planned by partnering with patients, 
caregivers and healthcare team members, internally to rapidly conduct market research regarding 
pain points in managing and performing tasks associated with lung cancer episodes.  An external 
market assessment was also developed.  Both efforts informed the design and development of 
FCA.  A Minimally Viable Product (“MVP”) resulted from these efforts.  
Usability Testing - Phase II:  The primary goal of Phase II was to maximize likelihood of 
commercialization and end-user adoption by ensuring the application was usable and useful.  The 
project team accomplished this as planned by deploying the application in one oncology clinic 
with twelve (12) patient-caregiver dyads (“Dyads”). Dyads, along with providers in the oncology 
clinic, provided feedback that was evaluated and translated into application enhancements.   
The work conducted under Phase I (#2015-051) and Phase II (#2015-188) was determined to be 
exempt upon Geisinger Human Research Protection Program review on 04/23/2015 and 
12/29/2015, respectively.  

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3 
SPECIFIC AIMS 
3.1 
Specific Aim 1 
Observe FCA in clinical oncology practice to evaluate quality and performance indicators. 
Integrate exposure to FCA as standard of care in a conveniently selected clinic for persons with 
lung cancer and their caregivers.  Clinicians in this clinic have contributed to the development 
and testing of FCA as standard of care at Geisinger Medical Center in Danville, PA (“GMC”). 
This clinic will serve as the treatment site.  Electronic health records and FCA dashboard 
analytics will be used to evaluate clinician use of the tool.  Clinicians at the treatment site will 
provide interview data describing their experience related to quality, FCA adoption and 
implementation into workflow integration at the post-period;  
3.2 
Specific Aim 2 
Observe FCA use among patients and caregivers to evaluate quality and performance 
indicators associated with oncology care.  From the treatment site, identify, recruit, consent and 
enroll persons with lung cancer (newly diagnosed or recent recurrence of disease) and their 
caregivers.  Recruitment will continue until 25 patients and 25 caregivers (Case Dyads) are 
enrolled. Electronic health records for patients (appointment, clinical, and patient-reported data 
such as the M.D. Anderson Symptom Inventory that is standard of care) and study questionnaires 
will be used to evaluate quality and performance indicators. Questionnaires will be fielded with 
Case Dyads, as hereinafter defined, at baseline and after 8 weeks of exposure to FCA.  Pre-post 
changes will be evaluated among cases.  
3.3 
Specific Aim 3 
Observe quality and performance indicators among usual oncology care in similar patient-
caregiver population to compare with cases.  From non-treatment sites, identify, recruit, 
consent, and enroll persons with lung cancer (newly diagnosed or recent recurrence of disease) 
and their caregivers into the evaluation study. Recruitment will continue until 25 patients and 25 
caregivers are enrolled (Control Dyads). Electronic health records for patients (appointment, 
clinical, and patient-reported data such as the M.D. Anderson Symptom Inventory that is 
standard of care) and study questionnaires will be used to evaluate quality and performance 
indicators however, questionnaires will be fielded at the post-period only. Non-treatment sites 
will not provide FCA as standard of care and function as control sites.  These sites will include 
Geisinger Wyoming Valley in Wilkes-Barre, PA (“GWV”), and Geisinger Community Medical 
Center in Scranton, PA (“GCMC”).  A case-matched controlled design will be used to evaluate 
differences in quality and performance indicators between groups at the post-period only.  
 

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4 
STUDY DESIGN 
4.1 
Description 
The project team will implement a case-matched controlled design where the Case Dyads, 
are exposed to the FCA as standard of care in the treatment site and Control Dyads will be 
exposed to standard of care in the control sites.  The study team will collect primary data 
including study questionnaires from Dyads and interview data from providers; collect secondary 
operational data (e.g., patient-reported data, FCA analytics, and EHR data; analyze data; 
interpret results; and disseminate findings in the literature and to study sponsor).   
This study is characterized as an exploratory evaluation as the design limits the 
generalizability of findings and these findings will be biased in several ways.  First, the treatment 
clinic and clinicians have been intimately involved in the development and implementation of 
the FCA. This factor likely influences clinician adoption of the FCA in care and could be 
limiting factor in other settings where FCA may be tested.   Additionally, sites were conveniently 
chosen and site-level factors may bias study findings. The administration of the study sites is 
centralized to infer some consistency with operational procedures however this is a limiting 
factor in this exploratory evaluation.  Quality and performance metrics are not routinely collected 
in these outpatient settings.  In the absence of system-level data to describe variation in care, the 
study will depend on study questionnaires to evaluate quality and performance, which is a 
limiting factor as the perspective is contained to the study participants rather than the aggregate 
patient-population at each site.  Secondly, a convenient sample of patients receiving care at the 
study clinics will be recruited into the study on a first-come, first serve basis and without random 
assignment to treatment or control groups.  Additionally, Case Dyads must enroll in 
MyGeisinger patient portal to use FCA and although not required for the study, we will 
encourage Control Dyads to enroll in MyGeisinger patient portal to minimize bias related to 
health literacy using technology. Another potential bias is that some caregivers may reside out of 
state and this distance may impact the quality of their relationship with the patient; every effort 
will be made to match Case and Control Dyads with similar spatial situations but this may be 
prohibitive given the project timeline. These factors limit the assumption that any observations 
associated with FCA are related to the treatment use as variation in patient factors or the quality 
of care at clinics may account for observed associations.   Potential participants (patients) are 
reasonably expected to receive an intense, brief oncology care with multiple appointments thus 
offering the opportunity to measure the impact of FCA use. Dyads will not be randomly assigned 
to treatment or control but offered standard of care per the clinic site.  The study team will 
provide hands-on technical assistance to Case Dyads and associated clinicians to facilitate 
implementation and observe key learnings.   Changes from baseline to post-study period will be 
evaluated within the Case Dyads, but given the severity of the condition and brief study period, 
the project team expects to observe greater differences in post-study period indicators between 
Case Dyads vs. Control Dyads.    
 
The first purpose of this project is to evaluate 
how exposure to FCA may impact quality indicators 
associated with oncology care, among patients, 
caregivers, and clinicians during a brief, 8-week 
period, the project team expects to observe 
differences in post-period study indicators between 

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Case Dyads vs. Control Dyads.  No differences are expected between these groups at baseline, 
only Case Dyads are exposed to FCA, and thus a post-only design is an appropriate study design 
to evaluate this question or purpose.  Case and Control Dyads will provide post-surveys and 
clinicians will be interviewed.  
 
 
 
The second propose this project is to evaluate how use of 
the FCA may impact quality indicators associated with 
oncology care. In this exploratory evaluation study, we aim 
to evaluate whether quality indicators change with exposure 
to FCA, thus pre-post difference within the Case group is 
an appropriate study design to answer this question or 
purpose.  Future studies may use these exploratory 
evaluation findings to more rigorously evaluate or test 
between group differences using appropriate study designs.  Case Dyads will provide baseline 
and post-surveys.  
 
NOTE:  Throughout the protocol and IRB application we will refer to the study as the 
Exploratory Evaluation of Family Caregiver Application.  In the consent form and other patient 
facing materials, we will abbreviate the project title and description to the Care Coordination in 
Oncology Study. 
Also, the data analyst described throughout the proposal will serve in two roles 1) as a data 
analyst for research activities such as patient eligibility lists, recruitment reports, reporting needs, 
etc. and 2) as a data broker to maintain the application.  The data analyst will be listed as 
research support staff in the IRB application given the research role. 
4.2 
Study Population 
Participants will be enrolled across three Geisinger locations, Geisinger Medication Center, 
Geisinger Wyoming Valley Medical Center and Geisinger Community Medical Center.  GMC 
will serve as the intervention site and GWV and GCMC as the control site.  Description of all 
three locations are listed below. 
 
Geisinger Medical Center (GMC) - Danville is a fully integrated, community-based, health 
system with teaching programs (medical students, residents, fellows and other healthcare 
professionals). GMC is a quaternary/tertiary care hospital, that includes the Janet Weis 
Children’s Hospital, a neonatal intensive care unit; a Level I Regional Trauma Center; and the 
GMC Outpatient Surgery—Woodbine Lane Campus.  
 
Geisinger Wyoming Valley Medical Center (GWV) is an acute/tertiary hospital and regional 
referral center serving the healthcare needs of northeastern Pennsylvania. It is an open staff 

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hospital with 981 physicians having medical staff privileges. Located in Plains Township, near 
Wilkes-Barre, PA, it is approximately 60 miles northeast of Danville.  
 
GWV, including its South Wilkes-Barre ambulatory campus and a series of regional clinics, 
form the System’s northeastern hub. GWV offers an expanding range of services through 
multiple clinical departments: medicine, surgery, anesthesia, anatomic/clinical pathology, 
emergency medicine, family practice, obstetrics and gynecology, pediatrics, neurosciences, 
oncology, trauma services, orthopaedics, transplant services and diagnostic imaging services. 
GWV operates a full-time hospitalist program. The hospitalists work in conjunction with 
admitting and referring physicians to care for patients admitted to the medical center.  
 
Geisinger Community Medical Center (GCMC), a Level II Trauma Center is located in 
Scranton, PA. G-CMC offers a complete continuum of educational, diagnostic, therapeutic and 
rehabilitative services and programs. The Emergency Medicine Department is home to the 
Northeast Pennsylvania Trauma Center. G-CMC provides complete cardiac services, including 
open heart surgery. Other services at G-CMC include; Orthopedics, Surgical services and 
Women’s Radiological services.  
 
4.2.1 Approximate Number of Subjects 
Approximately 135 Geisinger subjects (65 patients and 50 caregivers) will participate in the 
study.  Patients are able to participate independent of having a caregiver; therefore the number of 
Geisinger patients enrolled is reflective of this possibility. Our goal is to include 100 participants 
in our analysis (50 patients and 50 caregivers) organized as 25 Cases Dyads and 25 Control 
Dyads.    We will enroll 20 Geisinger providers in the treatment site who will participate in this 
study. If a caregiver receives care at Geisinger, his/her patient-related records are not of interest 
to or related to this study. 
 
Background Logic Regarding Sample Size: The number of eligible lung cancer patients was 
estimated from a twelve-month report (May 2016-April 2017) ("Estimate Time Period") from 
each respective hospital which informed the Exploratory Evaluation Study design. Patients were 
included if, during the Estimate Time Period, they had an active lung cancer diagnosis on the 
EHR problem list and had an encounter at one of the following oncology departments 
(Hematology Oncology Danville, Radiation Oncology Danville, Hematology OncologyGWV, 
Radiation Oncology GWV) ("Inclusion Criteria"). There were 153 eligible patients from GMC 
("GMC Lung Cancer Patients"), 137 eligible patients from GWV ("GWV Lung Cancer 
Patients"), and 21 eligible patients from GCMC ("GCMC Lung Cancer Patients") for potential 
inclusion in the Exploratory Evaluation Study and Phase Ill FCA expansion rollout. Given that 
the Exploratory Evaluation Study period is 6 months, the estimated count of eligible patients is 
reduced by 50% to 77 Case patients at GMC, 69 Control patients at GWV and 11 Control 
patients at GCMC.  
Based upon Phase II enrollment at GMC, it is anticipated that 37% of eligible GMC Lung 
Cancer Patients (i.e., 28) will consent to participate in the evaluation and enroll as a Dyad. Based 
on Phase II enrollment at GMC, 100% of these patients will identify a caregiver who consents to 

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participate as part of a dyad.  Based on Phase II observations, 90% of these Dyads (i.e., 25) will 
complete an intensive 8-week treatment cycle. Recognizing variability in the incidence of 
disease, we chose the more conservative sample size of 25 patients enrolling in the study as part 
of a dyad for each arm thus resulting in 25 Case Dyads and 25 Control Dyads or 100 patient-
caregiver participants.  Based on Phase II observations, 90% are estimated to complete the 8-
week treatment cycle and study.  
 
4.2.2 Inclusion Criteria 
Patients  
• Patients who are 18 years of age or older and diagnosed with lung cancer who 1) are 
scheduled to start Oncology Care (chemo and/or radiation-therapies) OR 2) on active 
Oncology Care and recently started within 3 weeks (<27 days)  
• Receive care at GMC, GWV, or GCMC 
• English-speaking 
• Established/intends to establish a MyGeisinger Account (cases only) 
Caregiver 
• Recognized/intends to be recognized as proxy for patient’s MyGeisinger Account (cases 
only) 
• English-speaking 
Providers: 
• Any health care provider within Medical Oncology or Radiation Oncology at GMC, 
where FCA is standard of care, who has a patient enrolled. 
4.2.3 Exclusion Criteria 
Patients  
• Patients who are not diagnosed with lung cancer. 
• Patients who are diagnosed with lung cancer and are on active Oncology Care exceeding 
3 weeks (>27 days). 
Providers: 
• Any healthcare provider not within the Medical Oncology or Radiation Oncology 
departments. 
• Any healthcare provider within Medical Oncology or Radiation Oncology who does not 
have a patient enrolled (Case Dyad). 
4.3 
Recruitment 
Cases (GMC): 
Eligible patients will be identified through a database that runs an algorithm designed to 
consume aggregate electronic health record data to find potential participants that meet inclusion 
(and do not meet exclusion) criteria at the treatment site.  A weekly occurrence of the eligibility 
list will occur however, depending on the rate of recruitment the study team will determine 
whether this needs to occur more frequently 
 

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The research assistants will verbally review the list of potential participants with clinical staff to 
validate that patients on the list meet inclusion criteria and can be approached for recruitment.  
The research assistant will be available to speak with patients before or after their scheduled 
medical appointments. 
 
For the purpose of study awareness, informational flyers will also be available to patients in the 
exam rooms, waiting rooms, and Oncology Care’s MDC. (Attachment W: Recruitment Flyer - 
Cases).  
 
MDC lung cancer clinic is held weekly as a multidisciplinary treatment with a goal of 
prospective treatment planning to increase alignment with nationally recognized guidelines for 
cancer care.  Patients and their families meet with the MDC team to review their diagnosis and 
determine the appropriate treatment plan.  MDC team members include surgical, medical and 
radiation oncology, pathologsy, radiology, dieticians, case management, oncology nursing 
(including nurse navigators) and pharmacy.   
 
Controls (GCMC and GWV): 
For every Case patient enrolled at GMC, a data analyst will run the algorithm to consume 
aggregate electronic health record data to find and create a database of potential participants that 
meet inclusion (and do not meet exclusion) criteria at control sites.  A weekly occurrence of the 
eligibility list will occur however, depending on the rate of recruitment the study team will 
determine whether this needs to occur more frequently.    Study team members will apply a 1:1 
case-matched control strategy to identify potential control patients that match case patients in 
terms of sex, age category, lung cancer histology, and lung cancer clinical and/or pathological 
staging information.   This will be done after the Case patient-participant has a Case caregiver-
participant consented to ensure that Case Dyads are enrolled and available for matching.  If a 
Case patient-participant has enrolled but the Case caregiver-participant fails to enroll, the Case 
patient-participant will still be eligible for the study however the study team will recruit a 
replacement Case Dyad with the goal of enrolling 25 Case Dyads. Case patient-participants 
without caregiver-participants will be removed from analyses.  Similarly, if a Control patient-
participant consents but a Control caregiver-participant fails to enroll, the study team will 
identify a replacement Control Dyad with the goal of enrolling 25 Control Dyads. Research 
assistants will use the database to run weekly reports to identify potential control patients at 
GCMC or GWV to approach for recruitment. The research assistants will verbally review the list 
of potential participants as well as the weekly MDC list at GCMC and GWV with clinical staff 
to validate that patients on the list meeting inclusion criteria and can be approached for 
recruitment.  The research assistant will be available to speak with patients before or after their 
scheduled medical appointments. 
 
For the purpose of study awareness, informational flyers will also be available to patients in the 
exam rooms, waiting rooms, and through Oncology Care’s MDC (Attachment X: Recruitment 
Flyer - Controls). 
 
Demographic information will be collected on all eligible participants who are asked to 
participate. This information will be collected as part of the Pre-Treatment Survey for Case 

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Dyads and Post-Treatment Survey for Control Dyads.  Patients and caregivers that are 
approached, but decline participation will be asked to complete an anonymous brief demographic 
survey (Attachment Z:  Non-Participant Survey).  
 
Providers (GMC only): 
Providers will be invited to take part in the study by receiving an invitation e-mail (Attachment 
AA: Provider Interview Email Invitation) from the study team.  We will use an opt-out 
approach when inviting providers to participate.  Providers who are not interested in participating 
are asked to respond to the e-mail invitation within 14 days of receipt.  Those who do not 
respond within the 14-day window will be scheduled for an interview. 
4.4 
Study Duration 
4.4.1 Approximate Duration of Subject Participation 
Case Dyads (patient and caregiver) will participate in the study for approximately a 10-week 
duration (study period week 1 (baseline) followed by 7 weeks of intervention and a post-study 
questionnaire completed by week 10), however Control Dyads may have a shorter study period 
as they will be identified and recruited after Case Dyads and our intent is to authentically 
represent an early, 8-week Oncology Care period. The end of the study is the completion of the 
post-period survey.  We anticipate most patients’ Oncology Care cycles occurring over an 8-
week period, however the post-period survey may be completed 1-2 weeks post-Oncology Care.  
Providers will be asked to participate in a one-time interview at the post-period when all Case 
Dyads have completed the study.  
 
4.4.2 Approximate Duration of Study 
 
We anticipate recruitment, consent, and enrollment of 115 Geisinger participants (65 patients and 
50 caregivers) to occur over the course of seven (7) months.  Patients are able to participate 
independent of having a caregiver; therefore, the number of Geisinger patients enrolled is 
reflective of this possibility. Our goal is to include 100 participants in our analysis (50 patients 
and 50 caregivers) organized as 25 Cases Dyads and 25 Control Dyads Case and Control Dyads 
will be in the study for approximately an 8-10-week duration.  Their study participation ends 
once they have completed the post-period survey. The post-period survey may be completed 1-2 
weeks post-Oncology Care. We estimate that study participation for all Dyads will end within 
ten (10) months after recruitment begins. 
 
Providers participation in the study will end once their interview has been completed.  Provider 
interviews will take approximately two (2) months to schedule and complete.  We anticipate 
enrolling up to 20 providers. 
 
As we near the end of data collection, data analysis and reporting of the study findings will 
begin.  We estimate that this work will take approximately six (6) months. 

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We estimate that the study duration is eighteen (18) months. 
 
 
4.5 
Procedures 
 
Case Dyads:    
The research assistant will approach all eligible patients in the clinic (Attachment U:  RA 
talking points) to inform them of the FCA study opportunity.  Patients will learn about the need 
to identify a caregiver who can participate in using FCA with them to enroll in the study, 
however patients can participate in the study regardless of caregiver participation.  Also, as part 
of agreeing to participate the patient will need to have or establish a MyGeisinger account and 
the caregiver will need to have or establish proxy access to the patients’ medical record (some 
caregivers may already have this access). Interested dyads (patient and caregiver) that agree to 
participate will provide consent (Attachment F:  Informed Consent - Controls) and this will 
be electronically stored in REDCap by the Research Assistant, who will also facilitate access or 
registration to MyGeisinger for the patient and caregiver.  Participants who do not receive a copy 
of their consent form at the time of consent will be mailed a copy of their consent form for their 
records (Attachment BB:  Consent Form Letter). 
 
Prior to enrollment in the Family Caregiver Application, the dyad will be asked to complete a 
Pre-Treatment Survey (Attachment A:  Pre-Treatment Survey Patient and Attachment B: 
Pre-Treatment Survey Caregiver).  The terms “Study Questionnaires” and “Surveys” are used 
interchangeably throughout this protocol and represent the same items.  Patients and caregivers 
will receive unique Surveys. Electronic versions of the consent and survey will be available via 
REDCap (paper versions available upon request).  Patients and caregivers can complete the 
consent and survey in the clinic at the baseline time point using a secure study device (i.e., study 
iPad with a secure link populated through REDCap) or in hard copy.  When a survey is 
completed and returned to the study team, the patient and caregiver will each receive a $25 gift 
card.  The gift card will be mailed to each participant (Attachment T:  Compensation Letter). 
 
Once appropriate MyGeisinger access has been received, the research assistant will activate the 
dyad in FCA intervention and provide an overview of FCA’s features and functions and answer 
questions that arise (Attachment U:  RA talking points).  The dyad will be asked to use FCA 
throughout the course of Oncology Care and provided with technical assistance as needed.  The 
research assistant will assist the dyad with troubleshooting and ask the dyad to confirm that they 
have at least a basic level of comfort in using FCA. 
 
At the end of the 8-week study period, the dyad will be asked to complete a post-period survey 
(Attachment C:  Post-Treatment Survey Patient and Attachment D:  Post-Treatment 
Survey Caregiver) based on their stated format preference determined during consent – in 
clinic, electronically, or mailed survey. If the Post-Treatment Survey is completed in the clinic, 
the RA will help to facilitate completion of the survey on an iPad or laptop.  If the post-period 
survey is completed by e-mail or mail, the patient and/or caregiver will receive a letter/email 
(Attachment I:  Initial Post-Treatment Patient Communication – Case and Attachment J:  

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Initial Post-Treatment Caregiver Communication).   Patients and caregivers will receive 
unique Surveys. Follow-up will be made in one week to non-responders of the survey 
(Attachment K: Reminder- Post Treatment Patient Communication – Case and 
Attachment L:  Reminder – Post Treatment Caregiver Communication – Case).   Three 
total follow-up attempts will be made to non-responders approximately one week apart; attempts 
will be made if no data or incomplete data are received with the goal of obtaining completed 
surveys Once the study team receives the completed survey, the patient and caregiver will each 
receive a $25 gift card.  The gift card will be mailed to each individual (Attachment T:  
Compensation Letter). 
 
The caregiver identified by the patient may not be present for appointments (e.g., caregiver 
resides out of state).  In such cases, enrollment in the study will need to be coordinated over the 
phone and by email. When this occurs and as possible, the study team will match Case Dyads to 
Control Dyads who have remote caregivers, but given the logistics of enrolling Case patients, 
then Case caregivers, matching and recruiting Control patients, and then recruiting Control 
caregivers in the brief study period, this may be difficult to operationalize and therefore be a 
source of bias as the Dyads’ situations differ by distance.  The study staff will ask the patient to 
speak with the identified caregiver about their interest in participation.  Once the study team 
receives confirmation from the patient, the RA will ask the patient to provide the caregivers 
name and contact information.  The study team will then reach out to the caregiver to explain the 
study in more detail and determine their interest in participation (Attachment V:  RA Scripts).  
The RA will facilitate the applicable MyGeisinger and Proxy Access (Attachment S: Remote 
Caregiver Letter) and send an e-mail to the caregiver to consent and complete the baseline 
survey (Attachment G:  Initial Recruitment Email Caregiver – Case).  Follow-up will be 
made in one week if the caregiver has not consented or completed the baseline survey 
(Attachment H:  Reminder – Pre-Treatment Caregiver Communication – Case). Three total 
follow-up attempts will be made to non-responders approximately one week apart; attempts will 
be made if no data or incomplete data are received with the goal of obtaining completed surveys.  
Once the study team receives the completed survey, the caregiver will receive a $25 gift card.  
The gift card will be mailed to each individual (Attachment T:  Compensation Letter). 
 
Once consent is obtained, the baseline survey is complete and all applicable MyGeisinger and 
proxy access has been set up, the RA will call the caregiver to activate them in FCA intervention, 
offer and provide technical assistance, and confirm that the participating caregiver has at least a 
basic level of comfort with the FCA (Attachment V:  RA Scripts) 
 
Control Dyads:   
 
The research assistant will approach all eligible patients in the clinic to inform them of patient-
caregiver study (Attachment U:  RA Talking Points). Interested patients will be asked to 
identify a caregiver to participate, however patients can participate in the study regardless of 
caregiver participation.  The dyad will provide consent (Attachment F:  Informed Consent – 
Control) (eConsent).  At the completion of the control participant’s 8-week study period, the 
dyad will complete the post-period survey (Attachment C – Post Treatment Survey Patient 
and Attachment D:  Post Treatment Survey Caregiver) based on their stated format 

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preference determined during consent - in clinic, electronically or mailed (Attachment O:  
Initial Post- Treatment Survey Patient Communication – Control and Attachment P:  
Initial Post Treatment Survey Caregiver Communication – Control).  Patients and/or 
caregivers that do not complete the survey in one week will receive a reminder to complete the 
survey (Attachment Q: Reminder- Post Treatment Patient Communication – Control and 
Attachment R:  Reminder – Post Treatment Caregiver Communication – Control).  Three 
total follow-up attempts will be made to non-responders approximately one week apart; attempts 
will be made if no data or incomplete data are received with the goal of obtaining completed 
surveys.   Once the study team receives the completed survey, the patient and caregiver will each 
receive a $25 gift card.  The gift card will be mailed to each individual (Attachment T:  
Compensation Letter).  Participants who do not receive a copy of their consent form at the time 
of consent will be mailed a copy of their consent form for their records (Attachment BB:  
Consent Form Letter). 
 
The caregiver identified by the patient may not be present for appointments (e.g., caregiver 
resides out of state).  In such cases, enrollment in the study will need to be coordinated over the 
phone and by email.  The study staff will ask the patient to speak with the identified caregiver 
about their interest in participation.  If interested, the study team will ask the patient to provide 
the caregivers name and contact information.  The study team will then reach out to the caregiver 
to explain the study in more detail and determine their interest in participation (Attachment V:  
RA Script).    If the caregiver is interested in participating, the RA will explain to the caregiver 
that they will receive an e-mail to provide their consent to participate (Attachment M:  Initial 
Recruitment Email Caregiver – Control).  If after one week the caregiver does complete their 
consent, a reminder will be sent to the participant (Attachment N:  Reminder –Recruitment E-
mail Caregiver – Control).  Once the patient reaches the end of their study period, the caregiver 
will receive request (Attachment P:  Initial Post-Treatment Survey Caregiver 
Communication – Control) to complete the survey. In one week, a follow-up will be sent to 
non-responders (Attachment R:  Reminder – Post Treatment Survey Caregiver 
Communication – Control).  Three total follow-up attempts will be made to non-responders 
approximately one week apart; attempts will be made if no data or incomplete data are received 
with the goal of obtaining completed surveys.  Once the study team receives the completed 
survey, the caregiver will receive a $25 gift card.  The gift card will be mailed to each individual 
(Attachment T:  Compensation Letter)  
 
Providers:  Providers in the treatment site will be asked to participate in a 30-minute interview 
(Attachment Y:  Physician Interview Guide with the study team at the post-period. The 
interview will occur in a private setting either in an office or conference room. Providers will 
identify the best time to meet with the study team to participate in the interview.  Participation 
will not interfere with the delivery of patient care, perhaps brief one-on-one interviews will be 
held in parallel or adjacent to regularly scheduled administrative meetings or meal times, 
strategies that reduce provider burden. In addition to the interview, application metrics and 
demographic data will be collected on all providers.  See section 4.8.1 for more details. 
 
 
 
 

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4.5.1 Study Flow Diagram 
Dyad activated in FCA 
Information Meeting and Informed Consent – MDC or Clinic Visit 
Patient Identified as Eligible to Participate 
Case Dyads (Danville) & Control Dyads (GCMC/GWV) Enrolled 
Control Dyads at GCMC/GWV (N= 50) 
25 patients and 25 caregivers 
 
Post-Treatment Survey 
Post-Treatment Survey 
FCA Exposure (8 weeks) 
Pre-Treatment Survey 
Case Dyads at GMC (N= 50) 
25 patients and 25 caregivers 
 
Provider Interviews (N = 20) 
MyGeisinger and Proxy Established 

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4.6 
Primary Question 
The primary endpoint will be difference in quality and performance metrics at the post-period 
associated with FCA exposure, evaluated between the Case Dyads and Control Dyads. 
Aggregate means will be calculated for dyads and compared between groups. Sensitivity 
analyses may stratify these results by low-moderate-high FCA use. FCA exposure is designed to 
impact care coordination, patient satisfaction, patient and caregiver quality of life, perceived 
involvement in care, and symptom management, all quality indicators, over standard of care in 
control clinic sites where care coordination is less efficient, labor-intense, and often frustrating to 
patients and caregivers. Additionally, the Consumer Assessment of Healthcare Provider Survey, 
performance metrics, for Cancer Care and Health Information Technology scores for FCA users 
vs. controls is expected to be greater as controls would have standard of care with no additional 
enhancements and could utilize MyGeisinger portals.   
 
Theoretical 
Domain  
Parameter of interest operationalized 
Perspective 
Data sources or location 
Quality of Care 
 
 
Patient Satisfaction with Service Quality 
Hospital operations and services; physicians and staff; endorsements 
for others 
 
Family Satisfaction with Advanced Cancer Care 
Information giving, availability of care, physical care, psychosocial care 
 
 
Patient 
 
 
Caregiver 
 
 
Patient Survey13-15 
Attachment A and C:  Pre and 
Post Survey 
 
Caregiver Survey13-15 
Attachment B and D:  Pre and 
Post Survey 
Patient-Caregiver 
Outcomes 
Quality of Life 
Patient’s functional scales, symptoms, financial impact and global 
health and quality of life ratings 
 
Caregiver’s own state, relationships, outlook, patient condition, 
finances, environment 
 
Caregiver Burden 
Personal impact, other family members, medical issues, concerned 
about loved one 
 
Clinical Outcomes 
Survival, remission, exacerbation, MD Anderson Symptom Inventory 
 
 
 
Patient 
 
 
 
Caregiver 
 
 
 
 
 
Caregiver 
 
 
 
 
Patient 
 
 
 
Patient Survey16 
Attachment A and C:  Pre and 
Post Survey 
 
 
 
Caregiver Survey17 
Attachment B and D:  Pre and 
Post Survey 
  
 
 
Caregiver Survey18 
Attachment B and D:  Pre and 
Post Survey 
  
 
 
Epic EHR 
See section 4.8.1 
Coordination of Care 
Coordination of Care Establish accountability and negotiate 
responsibility; communication; information transfer; proactive plan of 
care; monitoring; support of patient and family self-management 
goals; teamwork focused on coordination 
 
Patient- 
Caregiver 
Patient and caregiver 
surveys19 
Attachments A-D: Patient 
and Caregiver Pre and Post 
Survey 
 
Coordination of Care Adoption of FCA 
Communicate, monitoring, patient- and caregiver- centered care, 
efficient, timely 
 
Health Care 
Provider  
Provider Interview 
Attachment Y: Physician 
Interview Guide 
 
Coordination of Care Health care utilization (scheduled vs. missed 
 
Epic EHR and Aria 

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appointments, hospital admissions, ED visits), costs 
Health System 
Representative 
See section 4.8.1 
 
Adoption  
Proportion of patients and families adopting and using app 
Health System 
Representative 
Epic patient lists, recruitment 
records, and FCA usage data 
 
Patient Survey20 
Attachment A and C:  Pre and 
Post Survey 
 
Caregiver Survey20 
Attachment B and D:  Pre and 
Post Survey 
 
Demographics 
Collection of standard demographics variables 
Patient-
Caregiver 
 
Health Care 
Provider 
Patient Survey 
Attachment A and C:  Pre and 
Post Survey 
 
Caregiver Survey 
Attachment B and D:  Pre and 
Post Survey 
 
Epic HER 
See section 4.8.1 
FCA Metrics 
See section 4.8.1 
Human Resources 
See section 4.8.1 
 
4.7 
Secondary Question 
The secondary question, how does FCA use impact quality indicators will be evaluated as a 
change in these endpoints across two points in time, baseline and post-survey. Change in these 
quality and performance metrics among the Case Dyads from baseline to post period will be 
evaluated. . These observations may be enriched with qualitative feedback from the healthcare 
providers that participate in interviews after all Case Dyads have completed their 8-week study 
period.  This question relates to use of FCA only and therefore only data from the users of FCA 
will be used to address this question, e.g., Case Dyads and healthcare providers of the Case 
patient-participants. This exploratory evaluation aims to describe how the use of FCA may 
impact quality indicators.  Future studies may use these findings to design more rigorous studies 
that evaluate or test the use of FCA on quality indicators.  
4.8 
Statistics 
Biostatistics Core will perform the statistical analyses. 
4.8.1 Statistical Analysis Plan 
The study team will describe quality and performance indicators observed among study 
participants and evaluate associations between 1) difference in quality of care (satisfaction, 
quality of life, burden, coordinated care) associated with FCA exposure (Case Dyads vs. Control 
Dyads, Post-Treatment Surveys only):  and 2) change in quality of care (satisfaction, quality of 
life, burden, coordinated care)  associated with FCA use (Case Dyads Pre-Treatment Surveys vs. 
Post-Treatment Surveys). 
 

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Case Dyads and Control Dyads demographic and clinical information and survey responses will 
be fully described using frequencies and percentages for categorical variables and mean and 
standard deviation or median and interquartile range for continuous variables distribution 
dependent. To evaluate the difference in quality of care associated with FCA exposure (Case v. 
Control) will be evaluated using chi-square test, t-tests and non-parametric univariate tests 
distribution dependent.  Mean patient and caregiver scores will be calculated for each dyad and 
compared between groups. Sensitivity analyses may stratify by level of FCA use (low-moderate-
high) per dyad and opportunity time for FCA exposure. Case to Control patient analyses and 
Case to Control caregiver analyses will also be performed to detect role-level differences in 
perceptions of quality and performance associated with FCA exposure. To evaluate the 
association of the change in quality of care associated with FCA use difference in response 
between pre- and post- surveys paired t-test or ANCOVA depending on data type and 
distribution. Within Case Dyads, patient means will be compared with caregiver means to detect 
difference in quality and performance perceptions based on role. 
 
All statistical analyses will be performed using SAS v9.4 (SAS Institute, Inc., Cary, NC, USA). 
All statistical tests are meant to be descriptive since this is purely an exploratory analysis. 
 
Data Sources 
Four core data sources will be utilized as part of the study including the Pre-Treatment Survey 
and Post-Treatment Survey of patients and caregivers; provider post-interviews; EHR and Aria 
(Geisinger’s radiation oncology software) data; FCA administrative metrics/analytics; and health 
system operational data.  For example, GHS’ Oncology Service Line collects symptom burden 
(patient-reported outcomes data using the MD Anderson Symptom Inventory) as standard 
clinical practice during active chemotherapy in the outpatient setting; these data are available in 
the EHR to evaluate as clinical indicators. Prior to baseline survey data collection, patient and 
caregiver questionnaires will be field tested for content validity (e.g., do the questions make 
sense, is anything duplicative or unclear, etc.).  Feedback regarding completion time will be 
evaluated to reduce burden, a sensitive topic considering the clinical status of participants.  
Collectively, this feedback will be used to finalize the study tools included in surveys (e.g., study 
questionnaires).  Any revisions made to the surveys as part of the field test will be submitted as 
an IRB amendment. 
 
The data elements collected and used as part of the analysis purposes are as follows: 
I. Patient: 
• Study ID 
• Patient Survey Responses 
• Date of birth 
• Date of death (where applicable) 
• Gender 

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• Treatment Location (GMC, GWV, GCMC) 
• Problem list diagnoses 
• Outpatient Encounters 
o Date 
o Flag for interpreter used  
 # distinct specialties seen 
o Visit type 
o Provider ID 
o Provider type 
o Clinic/department/location/specialty 
o Diagnosis codes associated with visit (flag primary)  
o Disposition (completed/no-show/cancel) 
• Inpatient Encounters 
o Admission date 
o Diagnosis codes associated with discharge (flag primary) 
o Location (e.g. ICU)   
o Discharge date 
• ED encounter data  
o Date 
o Diagnoses associated with visit (flag primary) 
o Flag if resulted in an admission 
o MD Anderson Symptom Inventory 
• FCA (Harmonized Care) Usage 
o Dates of log-on 
o All features accessed in the application including dates accessed and 
number of views 
o Interest and Information 
 Number of topics added 
 Number of events added 
 Number of photos added 
o Appointments 
 Number of calendars added 
 Number of appointments added 
o Care Partners 
 Number of care partners added 
o Medication Management 
 Number of medications scheduled 
 Number of questions added 
o Notes 
 Number of private notes 
 Number of shared notes 
o Profile 

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 Number of profile pictures added 
II. Caregiver: 
• Study ID 
• Caregiver Survey Responses 
• Age 
• Gender 
• FCA (Harmonized Care) Usage 
o Dates of log-on 
o All features accessed in the application including dates accessed and 
number of views 
o Interest and Information 
 Number of topics added 
 Number of events added 
 Number of photos added 
o Appointments 
 Number of calendars added 
 Number of appointments added 
o Care Partners 
 Number of care partners added 
o Medication Management 
 Number of medications scheduled 
 Number of questions added 
o Notes 
 Number of private notes 
 Number of shared notes 
o Profile 
 Number of profile pictures added 
III. Non-Participants: 
• Non-Participant Survey Responses 
IV. Providers: 
• Study ID 
• Provider Type (MD, PA, NP, etc) 
• Practice Site (e.g Rad/Onc, Hem/Onc, etc.) 
• Age 
• Race/Ethnicity 

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• Gender 
• Interview Responses 
• FCA (Harmonized Care) Usage: 
o Opened Dashboard 
o Encounter Type 
o Medication Questions 
 Number of Responses 
o Calendars 
 Number of filters on calendars 
 
4.8.2 Statistical Power and Sample Size Considerations 
Power nor sample size was estimated for this exploratory evaluation study. Therefore, a sample 
size of 50 Case Dyads and 50 Control Dyads was selected to describe any differences in quality 
and performance metrics associated with FCA use. Any statistical tests are meant to be 
descriptive only. 
4.9 
Data Management 
4.9.1 Data Collection and Storage 
Each patient, caregiver, and provider will be assigned a unique study ID number by the data 
broker that will enable linkage of data from different data sources.  The study ID number will be 
used to track their participation in the surveys and to link the patient, caregiver, and provider 
FCA usage, demographics, and EHR data.  
 
Electronic informed consent and study surveys will be administered using a user-friendly, 
HIPAA compliant package that supports secure online data collection, REDCap.  Hard copy 
surveys and informed consents will be entered and tracking in REDCap.  All data will be stored 
within secure Geisinger databases and that password protected on secure network servers.  Any 
hard copy study data will be stored in a locked filing cabinet in a locked office.   
 
Aggregate reports will be shared with Merck to provide updates on recruitment and outcomes 
related to the evaluation (Milestones 5-7: Progress Report for Enrollment of Exploratory 
Evaluation Study Dyads) as well as study finding as part of the Exploratory Evaluation 
(Milestones 8-10:  Exploratory Evaluation Study Reports).  All reports will be sent via e-secure.  
All analysis will occur at Geisinger and no data sets will be shared with Merck. 
 
While this project is sponsored by Merck, there are no Merck medications or devices used in the 
project and we do not anticipate hearing about a Merck product from any participant. However, 

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consistent with the sponsor’s request, we’ve agreed to anonymously report adverse events related 
to Merck products that might be “collected” via the project. For instance, a participant (patient) 
may offer an unsolicited comment to a research assistant about a Merck product or there may be 
a free text comment in FCA that specifically names a Merck product. No PHI would be shared 
with Merck. Merck will provide adverse event training to the study staff.  See Appendix A for 
more details on the sponsors reporting requirements and administrative and regulatory details. 
4.9.2 Records Retention 
At the completion of the study, data generated as part of the study will be retained for 6 years in 
accordance with Geisinger policy.  At the end of that 6-year period the data set will be available 
for use for future studies as approved by GHS IRB.   
5 
PROTECTION OF HUMAN SUBJECTS 
5.1 
Informed Consent 
We are asking for a waiver of consent/authorization for recruitment purposes.  This study 
involves no more than minimal risk and will not affect the rights and welfare of the patients or 
providers. The recruitment and research could not be conducted without a waiver of consent 
because passive recruitment strategies typically yield low rates of recruitment, and this study is 
being conducted in a targeted population of patients and providers. 
 
Dyads (patients and caregivers) who meet inclusion criteria will be approached and will provide 
informed consent (eConsent OR paper) to participate in the study.   
 
We request a waiver of documentation of consent with an alteration of the consent to not include 
all elements of the consent for provider interviews.  Providers will provide implied consent by 
agreeing to participate in the interview.   
5.2 
Protection of Human Subjects Against Risks 
For participating patients, caregivers, and providers, there are minimal risks involved. 
 
A participant’s decision regarding participation in this study will not affect their care, access to 
care or employment.  While there is always a risk of loss of privacy and confidentiality, the study 
team will do the following to make sure risks remain minimal: 
• All data will be stored on password-protected computers 
• All paper copies will be kept in a locked office or locked filing cabinet 
• Unique study ID’s will be used to link patient, caregiver, and provider information. 
• Geisinger will retain the document linking the study ID back to the patient MRN. 
5.3 
Data Monitoring Plan  
Data will not be shared outside of Geisinger. 
 
Any problematic clinical issues that arise as part of the study will be reported immediately to the 
study investigators and oncology leadership.  The issues will be reviewed as a group and 
addressed as soon as possible.  All clinical issues and resolutions will be documented. 

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6 
PUBLICATION PLAN   
Results of this project will be used to create manuscripts for publication, abstracts for submission 
to appropriate national conferences, and reports to the study sponsor.  All information shared will 
be aggregate with no possibility of identifying participants from information provided.  
Geisinger will submit to Office of Scientific and Technical Clearance (OSTIC) for review prior 
to submission of any abstracts or publications. 
 

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7  REFERENCES 
 
1. American Cancer Society: Cancer Facts and Figures 2017. Atlanta, GA: American Cancer 
Society, 2017.  
 
2. Balducci L, Goetz-Parten, Steinman MA. Polypharmacy and the management of the older 
cancer patient. Ann Oncol. 2013, 24(suppl 7): vii36-vii40. 
 
3. Chan RJ, Webster J, Marquart L: Information interventions for orienting patients and their 
carers to cancer care facilities. Cochrane Database Syst Rev (12): CD008273, 2011. 
 
4. Curran WJ, Paulus R, Langer CJ, et al. Sequential vs Concurrent Chemoradiation for Stage 
III Non-Small Cell Lung Cancer: Randomized Phase III Trial RTOG 9410. J Natl Cancer 
Inst. 2011; 103(19):1452-1460. 
 
5. Deeken JF, Taylor KL, Mangan P, et al. Care for the Caregivers: A Review 
of Self-Report Instruments Developed to Measure the Burden, Needs, and Quality of Life of 
Informal Caregivers. J Pain & Symptom Mgmt. 2003; 26 (4): 922-953. 
 
6. Flannery M, Phillips SM, Lyons CA. Examining Telephone Calls in Ambulatory Oncology. J 
Oncol Pract. 2009; 5(2):57-60. 
 
7. Given B, Sherwood PR, Given CW. What Knowledge and Skills Do Caregivers Need? 
American J Nursing. 2008; 108 (9): 28-34. 
 
8. Honea NJ, Brintnall R, Given B et al. Putting Evidence into Practice: nursing assessment and 
interventions to reduce family caregiver strain and burden. Clin J Oncol Nurs. 2008; 
12(3):507-16. 
 
9. Long KH, Moriarty JP, Mittelman MS, et al. Estimating The Potential Cost Savings From 
The New York University Caregiver Intervention In Minnesota. Health Affairs. 2014; 33 (4): 
596-604. 
 
10. McMullen CK, Schneider J, Altschuler A, et al. Caregivers as healthcaremanagers: 
healthmanagement activities, needs, and caregiving relationships for colorectal cancer 
survivors with ostomies. Support Care Cancer. 2014; 22: 2401–2408. 
 
11. National Alliance for Caregiving, AARP. Caregiving in the U.S. 2009. November 2009. 
Available at: http://www.caregiving.org/data/Caregiving_in_the_US_2009_full_report.pdf.  
 
12. National Cancer Institute: Family Caregivers in Cancer: Roles and Challenges (PDQ-Health 
Professional Version). Bethesda, MD. 2017. 
 
 

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8   ATTACHMENTS 
 
Attachment A:  Pre-Treatment Survey: Patient 
Attachment B:  Pre-Treatment Survey:  Caregiver 
Attachment C:  Post-Treatment Survey:  Patient 
Attachment D:  Post-Treatment Survey:  Caregiver 
Attachment E:  Informed Consent – Case 
Attachment F:  Informed Consent – Control 
Attachment G:  Initial Recruitment Email Caregiver – Case 
Attachment H:  Reminder -  Pre-Treatment Caregiver Communication – Case 
Attachment I:   Initial Post- Treatment Patient Communication- Case 
Attachment J:   Initial Post- Treatment Caregiver Communication- Case 
Attachment K:  Reminder - Post-Treatment Patient Communication – Case 
Attachment L:   Reminder - Post-Treatment Caregiver Communication – Case 
Attachment M:  Initial Recruitment Email Caregiver- Control  
Attachment N:   Reminder - Recruitment Email Caregiver- Control 
Attachment O:   Initial Post-Treatment Survey Patient Communication- Control 
Attachment P:  Initial Post-Treatment Survey Caregiver Communication- Control 
Attachment Q:  Reminder - Post-Treatment Survey Patient Communication – Control 
Attachment R:  Reminder - Post-Treatment Survey Caregiver Communication – Control 
Attachment S:  Remote Caregiver Letter 
Attachment T:  Compensation Letter 
Attachment U:  RA Talking Points  
Attachment V:  RA Scripts 
Attachment W:  Recruitment Flyer – Cases 
Attachment X:  Recruitment Flyer – Controls 
Attachment Y:  Physician Interview Guide 
Attachment Z:  Non-Participant Survey 
Attachment AA:  Provider Interview Email Invitation 
Attachment BB:  Consent Form Copy Letter