Promoting Cancer Symptom Management in Older Adults
Phase: NA
Conditions: Neoplasms, Chemotherapy-induced Nausea and Vomiting
Sponsor: University of Central Florida

Project Title: Promoting Cancer Symptom Management in Older Adults 
Grant Number: 1R15NR015851-01 
NT #: NA 
Date of original submission: 12/11/2019 
Date of update with cover sheet: 08/09/2021 

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A. SPECIFIC AIMS 
This research addresses the critical need to improve symptom self-management of chemotherapy-induced 
nausea and vomiting (CINV) among older (≥ 65) adults by developing and testing an avatar-based Serious 
Game (SG) designed to build CINV self-management skills. Older adults undergoing cancer treatment are at 
high risk for progressive severe effects resulting from nausea and vomiting1-4 such as fluid and electrolyte 
imbalances, dehydration, muscle weakness, generalized fatigue, weight loss, dizziness, altered mental status, 
low blood pressure, changes in cardiac function, falls, and non-adherence with treatment plans. CINV is among 
the top five reasons why patients call their doctor while under treatment for cancer5, 6 and has shown to lead to 
increased use of resources (e.g., unplanned emergency department (ED) and/or hospital admissions).7  Severe 
CINV-related symptoms occur in up to 80% of older adults undergoing chemotherapy treatment,2  resulting in 
high direct and indirect costs.8, 9 Additionally, quality of life (QOL) and daily functioning are greatly reduced 
with CINV.10 Guidelines exist for treating CINV; 11, 12 however, anti-emetics are often under-prescribed in the 
elderly3 and, to our knowledge, there is no evidence regarding older adults’ use of anti-emetics or non-
pharmacologic self-management strategies at home or within structured CINV intervention programs. Because 
of the increased risk for treatment-related toxicity, there is a significant need for effective educational strategies 
that assist older adults in making self-management decisions and taking action against CINV.   
   The Common Sense Model of illness provides a framework explaining how older adults with cancer make 
decisions regarding symptom self-management. Actions taken are related to a person’s beliefs (cognitive 
representation) about the identity, cause, timeline, consequences, and ability of the symptom to be controlled 
or cured.13, 14 Older people are able to identify a symptom and attribute it to cancer;15, 16 however, barriers to 
taking action to self-manage symptoms include beliefs about symptom consequences17 and the symptom’s 
ability to be controlled or cured. Our intervention addresses these barriers to self-managing symptoms by 
actively engaging older adults in a simulated gaming experience, where an avatar experiences positive or 
negative outcomes, based on the player’s symptom self-management decisions.  Our preliminary data suggests 
that such an intervention is needed, feasible, and acceptable to older adults in order to mitigate the challenges 
of self-managing symptoms of cancer treatment.  This project is planned in two phases: Phase I will consist of 
the design and development of an interactive avatar-based Serious Game that will engage and prepare older 
adults to make CINV self-care decisions.  Phase II will be a two-arm, randomized clinical trial comparing the 
newly developed simulation system, electronic Symptom Self-Management Training- CINV (eSSET-CINV) 
with attention control.  Once shown to be effective, this novel educational strategy can be widely disseminated 
for use at the bedside and be adapted to educate older adults on self-management strategies for other cancer-
related symptoms with negative outcomes.  
Research AIMS are: 
Phase I: Game prototype and production 
1. Identify real-life scenarios involving CINV incidence, self-management, and consequences using a 
peer Community Advisory Board of older adults who have undergone cancer treatment, their family 
members, and oncology nurses to design and develop a serious game for CINV self-care decision 
making. 
2. Identify design aspects and elements of eSSET-CINV game play, audio, and visual avatar 
development that have the greatest appeal for older adults with cancer. 
Phase II: Game prototype testing 
1. Estimate effect size of the eSSET-CINV in changing patient outcomes: cognitive representation, self-
management behaviors, CINV severity, QOL, and resource use. 
2. Examine differences in cognitive representation, self-management behaviors, CINV severity, QOL, 
and resource use between, and within, the intervention and attention control groups. 
3. Obtain preliminary data regarding the feasibility and acceptability of the game in older adults 
experiencing CINV. 
This study builds on the investigators’ prior work in older adults’ cancer symptom experience and gaming.15, 16, 
18-21 The eSSET-CINV intervention is expected to have a positive impact on the self-management choices 
related to CINV. Participants will use knowledge gained during game play to manage their own care resulting 
observable changes in outcomes: cognitive representation, self-management behaviors, CINV severity, QOL, 
and resource use. 
 

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RESEARCH STRATEGY 
B. SIGNIFICANCE 
Adults ages 65 and older represent 13.3% (41.4 million people) of our population.22 By 2040, older adults will 
represent 21% of the population.22  However, older adults account for the majority of cancer diagnoses.23  With 
an increasing older population, the number of older adults with cancer will also increase, taxing limited 
healthcare resources. These factors make managing cancer in older adults a healthcare priority.24, 25 
Complications from cancer treatment are more common in older adults with cancer compared to younger 
adults.26  Aging and associated limitations in organ systems that prolong plasma levels of chemotherapy (e.g., 
renal, gastrointestinal, and liver dysfunction1, 27, 28) and increase risk of treatment-related toxicity and poor 
outcomes in older adults include co-morbidity, poly-pharmacy, functional and physical limitations, nutrition, 
emotional status, and social support (caregiver).1, 24  Because of this increased risk for treatment-related 
toxicity due to severe CINV, there is a significant need for effective educational strategies that assist older 
adults in making self-management decisions and taking action against CINV that are rooted in their beliefs 
about that symptom.   
   The significance of the proposed intervention lies in its ability to allow older adults to visualize the 
consequences of self-management decisions and reframe cognitive representation. It can result in improved 
control of CINV.  This intervention educates older adults to more effectively self-manage symptoms at home, 
optimizing quality of life. eSSET-CINV is poised to reduce healthcare costs by decreasing use of resources 
(unplanned ED or hospital admissions) for CINV due to poor symptom management. 
  Conceptual Framework for Intervention Development and Testing 
Phase I: Game prototype and production.  Phase I will consist of the design, development, and 
production of the serious game: eSSET-CINV.  Game design will be guided by the principles of serious gaming 
and a user-centered approach that involves the older cancer patient at all stages of development to ensure ease 
of use and value to the player (patient).29, 30 Serious Gaming is a well-established method designed to support 
learning and change health-related behavior by engaging individuals in an entertaining experience.31-33  It is 
also consistent with the representational approach to behavior change used in Phase II of this project. Serious 
gaming capitalizes on fun while promoting change.32 Social cognitive theory34 is the most widely used theory 
for game design31 and can provide behavior change as a result from enhancing skills and confidence in using 
the new behavior while receiving feedback about these new skills. By introducing training to reinforcing 
positive self-management strategies related to CINV early in the treatment trajectory, the risk for negative 
sequela and unnecessary costs associated with unplanned hospital admission due to severe CINV will be 
reduced.   
   Our proposed eSSET-CINV intervention will use an electronic format (study-provided tablet or laptop 
computer) to deliver a game that promotes cognitive reframing of CINV and effective self-management.  Five 
older adults who have undergone cancer treatment with emetogenic chemotherapy, three family caregivers, 
and two oncology nurses who have experience managing CINV will be involved as co-designers (Community 
Advisory Board [CAB]) as the game is developed and refined.  The CAB will be convened at the start of the 
study and will assist the principal investigator (PI) in developing real-life CINV scenarios to be used in 
eSSET:CINV. Focus groups will allow the CAB to discuss their experiences with CINV.  These experiences will 
provide the foundation for CINV scenarios for the game.  Subsequent focus groups will validate scenarios, 
provide feedback to game designers, and allow for game testing 
Phase II: Game prototype testing. Phase II is guided by a representational approach to educational 
interventions and grounded in the Common Sense Model of Illness (CSM) which asserts that illness-related 
beliefs frame how older adults make decisions about self-management of illness and treatment-related 
symptoms.35  Action is related to a person’s beliefs (cognitive representation) about the identity, cause, 
timeline, consequences, and ability of the symptom to be controlled or cured.13, 14 Representations developed 
from past experiences guide self-management of illness or symptoms, and incorrect representations can lead to 
consequences such as delays in seeking care and/or non-adherence to prescribed or recommended 
treatments.13, 35, 36 Beliefs about consequences are important predictors of self-management.36 Older adults’ 
beliefs regarding their ability to cure or control a symptom also determine the likelihood of self- management.37  
People who do not believe a symptom has consequences or that their actions will lead to positive outcome likely 
do nothing to self-manage.36  
   Studies have demonstrated that older adults are less responsive than younger people to symptoms, including 
those that might indicate a serious condition.35   The tendency to minimize symptoms and their impact has 

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been seen in breast cancer survivors38 and the elderly with symptoms related to myocardial infarction.39  Many 
older people interpret symptoms as part of aging, leading them to delay seeking treatment.35  Adults of all ages 
may normalize symptoms and subsequently minimize the significance of their symptoms on their health, 
leading to delays in treatment.40  Further, cancer patients worry more over symptoms that indicate worsening 
disease, compared to symptoms that they interpret as a sign that chemotherapy is working to kill the cancer.41  
Other reasons for delayed treatment in the elderly include being uncertain about the symptom’s severity or 
seriousness and believing that treatment or management is not possible.39 Interventions that specifically 
address people’s illness or symptom representations may be able to alter their response to illness.36 
   A representational approach: 1) assesses a person’s illness or symptom representation (beliefs), 2) seeks to 
restructure existing representations, and 3) elicits a conceptual change in which learning can occur.42, 43 During 
a representational intervention, symptom beliefs are assessed, misperceptions and gaps are explored and 
corrected, new information is introduced and processed to replace old misperceptions, and new goals and 
strategies are set.43   The representational approach has been successful in improving outcomes related to 
cancer pain,43 end-of-life communication,44 end stage renal disease, and symptom distress.45  It is also being 
tested online to help women with recurrent ovarian cancer manage symptoms.43    
   As shown in the overall study model (Figure 1), older adults begin treatment for cancer with a preconceived 
cognitive representation about chemotherapy treatment-related symptoms.  The eSSET-CINV intervention is 
designed to restructure the older adult’s known erroneous representations and introduce new information 
regarding the efficacy of using self-management strategies for CINV.  We propose that “a picture paints a 
thousand words” and images are more powerful than the written word.  In the proposed approach, visualizing 
CINV consequences (positive and negative) experienced by the character in the game as a result of symptom 
management decisions, coupled with discussion with a nurse, will help the older adult reframe his or her 
cognitive representation, set new goals, prompt use of self-management strategies for CINV, and improve 
outcomes.  We hypothesize that through the eSSET-CINV intervention, older adults undergoing treatment with 
emetogenic chemotherapy who reframe their CINV cognitive representation will engage in more effective 
symptom self-management behaviors, resulting in decreased CINV severity, increased QOL, and decreased 
resource use. 
Figure 1: Overall Study Model: Representational Framework 
 
Background  
Approximately 63% of all cancers are diagnosed in people age 65 and older.46  In addition, most older adults 
report at least one co-morbid condition (e.g. arthritis, heart disease, diabetes).47 Older people with a history of 
cancer report more comorbid conditions compared to people without cancer (7 versus 5, respectively); however 
symptoms related to comorbid conditions are not unique to people with cancer.48  While cancer treatment 
often results in a myriad of treatment-related symptoms, symptoms may be more related to comorbid illnesses 
instead of cancer and its treatment.48 In addition, symptoms from comorbid conditions may be present at 
diagnosis, making the onset of some cancer treatment-related symptoms difficult to discern (e.g., fatigue, 
bowel disturbances, sleep disturbances, pain).   
  Nausea is a frequent, readily identifiable side effect of cancer treatment.   Up to 64% of adults being treated 
for cancer report delayed nausea, and 33% report acute nausea.10 In addition, patients who developed nausea 
at cycle 1 are more likely to report it in subsequent cycles.10  While pharmacologic and non-pharmacologic 
practice guidelines for prevention and treatment of CINV in adults exist (see Figure 2),11, 12, 49 none are specific 
to treating older adults.    To our knowledge, few studies have examined the effectiveness of any CINV self-
management strategy in older adults. Only one intervention study for CINV was found that included the elderly 
as a specific group(n=23); this study demonstrated that palonosetron-a 5-HT3 receptor antagonist, plus 
dexamethasone is safe and effective at reducing moderate acute and delayed CINV in this population.2  This 
study will address these gaps by examining the effects of an interactive intervention for CINV (eSSET-CINV) 

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in older cancer patients to reinforce the use of self-management strategies based on clinical guidelines and 
recommendations.  
Self-management of CINV in older adults is unknown  
Printed patient education material for CINV based on the treatment and 
prevention guidelines are routinely provided to new patients and their family 
members so they can self-manage CINV at home. No studies were found that 
examined older adults’ use of CINV self-management strategies based on these 
guidelines. Studies have reported that adults (age 18 and older) in China 
experienced an average of 14 treatment-related symptoms and used 16 to 21 
self-management strategies per week.50  Another study from China reported 
that cancer patients used an average of 8.56 strategies for managing CINV and 
reported low to moderate relief. Strategies used by this sample included dietary 
(e.g., small frequent meals) and environmental (e.g., avoid smells) 
modification, psychological strategies (e.g., relaxation), acupuncture/pressure, 
and taking anti-emetics.   
   Patients who experienced more severe or prolonged CINV engaged in more types self-management behaviors.  
However, timing (preventive versus active management) of the self-management behaviors was unknown. 
Patients treated in an outpatient setting reported using fewer self-management behaviors than those treated in 
inpatient settings.  Regarding CINV relief, those with delayed CINV or greater symptom distress reported less 
relief51 indicating the more severe the CINV, the less likely it is to be relieved. Because there are no studies that 
specifically focus on the older cancer patient with either acute or prolonged CINV, one goal of the proposed 
intervention is to help older adults identify and manage CINV in the early stages to reduce negative 
consequences. 
   In related symptom and self-management literature, studies show that other cancer treatment-related 
symptoms (fatigue, chemotherapy-induced peripheral neuropathy) are generally accepted or perceived as 
inevitable. Most adults modify their activities to reduce the impact of symptoms rather than actively engage in 
self-management behaviors.52-55 Perceived control influences self-management.  A qualitative study of 
perceived control and self-care in colorectal cancer patients found that some people believed symptoms were 
expected and had to be endured.  Others believed nurses were responsible for managing treatment-related 
symptoms and doubted their personal ability to make an impact on a symptom.  Some patients believed they 
should be active in their own care, but those who engaged in self-care believed they could make a difference 
and symptoms were temporary.37 While these beliefs have not been well studied, it is reasonable to apply these 
attitudes and behaviors to other symptoms such as CINV. Older adults may be using strategies to minimize the 
impact of CINV on daily life rather than treat the symptom itself. How they make decisions to use symptom 
self-management recommendations is unknown.  Through the examination of differences in self-management 
strategies used between the intervention and attention control groups, this study will identify pharmacologic 
and non-pharmacologic self-management strategies used by older adults receiving cancer treatment with 
emetogenic chemotherapy  and describe the magnitude of effect (i.e., effect size) of those strategies in 
managing or reducing CINV. 
Symptoms and QOL in older adults with cancer are related 
The literature related to CINV and QOL in older adults is extremely limited and unclear.  One study reported 
significant declines in QOL and functioning in adults (mean age 56 years) with both acute and delayed CINV 
over 3 treatment cycles.10  Other studies have shown that older adults receiving cancer treatment report 
functional loss,56 and adults with more treatment-related symptoms report poorer functioning and QOL.57, 58  
However, other studies have not appreciated a decline in QOL in older adults with CINV under treatment for 
lung cancer.59 This study will further the knowledge related to quality of life and the symptom experience in 
older adults undergoing treatment for cancer with emetogenic chemotherapy. 
Older adults are unique learners and need non-generic intervention 
Teaching older adults about self-care is critical to improving chemotherapy-related outcomes from CINV.60  
While some healthcare providers believe that intellectual capacity declines in older age, research shows that 
intellectual functioning is maintained by older adults61. Most older adults do not experience dementia.62 Adult 
teaching theories emphasize the independence of the learner and the importance of being ready and motivated 
to learn.63  While most teaching strategies for educating older adults apply to written material (e.g., using large 
print, lower reading levels)62, 64, 65 these strategies can be applied to novel methods of education, such as 
Common Recommended 
CINV Interventions
Pharmacologic: Antiemetic therapy as 
prescribed by MD
Non-Pharmacologic: 
Nutrition: Eat- dry food, small meals, bland 
and easy to digest foods. Sit up after eating. 
Avoid cooking odors, spicy and greasy 
foods.  
Hydration: 8 to 12 cups of liquid per day.  
Drink even if not thirsty.  Include liquids like 
soup, ice pops, flavored ices, gelatin.  Limit 
caffeine products
Complementary: Relaxation, yoga, 
behavioral therapy (distraction, 
meditation), guided imagery, controlled 
breathing, environmental changes, 
acupuncture/acupressure

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technology-based programs.  Effective educational strategies for older adults focus on “must know” concepts62 
such as self-care activities.  In addition, practicing new skills is essential62, 66 to produce patterns of behavior66 
and may be an effective way to introduce and reinforce new information and learning.  The use of storytelling 
by either using the patient’s own experiences as a learning tool, or introducing new stories is also an effective 
means of promoting learning in elders.67 By eliciting stories from older adults, healthcare providers can better 
understand how older cancer patients cope with illness and suggest more effective strategies.  The proposed 
intervention will improve learning by introducing a “story” about a character experiencing CINV that older 
adults can relate to and then transfer knowledge gained from the intervention into their own lives.  Images of 
positive and negative consequences (termed “after-imaging”60) related to CINV symptom management may 
be retained by the older adult after playing the game and going home to manage their own symptoms.  
Serious Game education in older adults has potential to improve learning 
Serious gaming has been used mostly in children and adolescents with diabetes68-70 and depression,71 adults 
with chronic pain,72 and for various topics in medical education to teach decision making in women’s health,73 
surgical skills,74 disaster preparedness75 and surrogate decision making.20 New applications in older adults 
include interventions involving “exergaming” for balance in residents of assisted living facilities. Exergaming 
has shown to be safe and potentially effective at encouraging physical activity using the Wii Fit game system.72, 
76-78  Other interactive technologies being used with older adults include use of avatars and interactive 
touchscreen technology for diabetes education,79 and mobile devices to promote activity in sedentary elders.80 
Studies that have used technology including avatars report that they are well liked by older adults.79, 81  
   The success of these technology-based interventions in older populations, combined with our preliminary 
work82, suggests eSSET-CINV has the potential to be feasible and acceptable to the older cancer patient.  This 
study will address the limitations of previous studies by intervening during active chemotherapy treatment 
when side effects are likely to be at their worst.  In addition, eSSET-CINV can be used in the outpatient 
chemotherapy setting before treatment, requiring no additional use of healthcare resources or patient travel. 
Innovation 
This application proposes the development of a novel serious game that will educate and engage older cancer 
patients, through their interactions with avatars, to reframe their cognitive representation of CINV, increase 
CINV self-management behaviors, reduce CINV severity, improve overall QOL, and reduce healthcare resource 
use. This proposed project addresses NIH research priorities by investigating the use of serious gaming to 
facilitate changes in cancer symptom self-management through health behaviors and improved health 
outcomes in an understudied population. This approach departs from traditional methods of education 
(passive receipt of information) because our game uses simulation and gaming technology to engage older 
adults in active learning (game playing) instead of passive learning (traditional printed patient education 
material) to improve CINV self-management at home.  Our methodology eschews a “one size fits all” approach 
common to standard adult patient education and is expected to dynamically challenge older adults’ core 
representations about controlling symptoms.  The intervention targets known barriers to symptom self-
management (cognitive representation related to symptom consequence, and cure/control) in older adults 
and seeks to change these representations and promote self-management behaviors.  This game allows older 
adults to learn by actively reframing misperceptions and using new knowledge to practice making self-
management decisions in a safe environment before they attempt to manage CINV at home.  In contrast to 
interventions that are developed by healthcare professionals from their own perception of patient need, our 
method of game development involves a Community Advisory Board (CAB) that included older adults with 
cancer who have undergone treatment with emetogenic chemotherapy, family members and oncology nurses 
who have had experience with treatment-related side effects such as CINV. The CAB is crucial to developing 
an intervention based on real life experiences that is mature, relatable, practical and salient for their peers.  
Finally, this study seeks to address the numerous gaps in the literature regarding older adults, CINV, 
cognitive representation, and self-management behaviors. If the eSSET-CINV intervention is shown to be 
effective in this population, the intervention can be easily adapted to educate older adults about self-managing 
other treatment-related symptoms (e.g., fatigue, sleep disturbances).   
C. APPROACH: 
Team:  
Dr. Vicki Loerzel (VL, PI) is an Oncology Certified Nurse with over 20 years of oncology experience.  Since 
2004, Dr. Loerzel has been the project director and research nurse on an NINR funded RCT (R01) and the PI 
on several small funded studies investigating the symptom experience of older adults with cancer. Dr. Loerzel 

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has a long-standing history with the UF Health Cancer Center- Orlando at Orlando Health and has excellent 
experience in recruiting and retaining older adults in research. Her qualitative and descriptive quantitative 
research focusing on older cancer survivors and adults with cancer, symptom experience, and cognitive 
representation provide foundation for this study.  She is a new investigator to NIH; however, she has extensive 
research administration experience to lead this team.  In addition, Co-I Clochesy and consultant Given will also 
provide support to the PI. 
Dr. John M. Clochesy (JC, Co-I) is an expert in developing and adapting serious games for health in different 
patient populations with over 20 years of experience as a PI. These interventions have improved outcomes by 
reducing health disparities using simulation-based avatars to promote self-efficacy in self-management of 
healthcare providers from medically and socially disenfranchised groups (eSMART-HD) and reducing 
depressive symptoms in young adults (eSMART-MH). A current study focuses on avatar-based decision 
support for surrogate decision makers (eSMARTT). Clochesy has also served as a mentor to several researchers 
developing serious games for different populations. Loerzel and Clochesy are well known to each other through 
alumni events with Case Western Reserve University and through conference meetings and reside in the same 
region, permitting them to work closely in the execution of this project. 
Dr. Barbara Given (BG, Consultant) is an expert in older people with cancer, cancer symptom management, 
and cancer intervention research with over 30 years of intervention research for symptom management and 
funding from the National Institutes of Health.  Her current intervention research is using technology 
(eCancer- A technological approach to symptom management from home to practice; Text messaging to 
improve adherence to oral chemotherapy agents) to help patients receiving chemotherapy self-manage the 
severity of their symptoms at home so they can continue to adhere to medications.  Given has served as a 
mentor to numerous researchers in oncology for a variety of topics.  Given and Loerzel are known to each other 
through common research interests and the development of this project. 
Dr. Xin Yan (XY) will work as Biostatistician for statistical design, analysis and interpretations of results.  Dr. 
Yan has 20 years of experience in design and analysis of more than 70 clinical trials (Phase I through Phase IV) 
in various therapeutic areas.  He has been PI for several funded research projects in design and analysis of 
clinical trials and Co-PI for NIH funded research projects.  Loerzel and Yan have worked closely together 
during the development of this proposal. 
Ms. Patricia Geddie (PG) is an Advanced Oncology Clinical Nurse Specialist at the UF Health Cancer Center- 
Orlando, has over 28 years of clinical oncology experience and is a doctoral student at the UCF College of 
Nursing.  Geddie has expertise in the symptom experience of older adults undergoing treatment for cancer.  
She has extensive experience recruiting and retaining older adults for research. She will be the study’s research 
nurse and have primary responsibility for recruitment, enrollment, data collection and intervention delivery. 
Loerzel and Geddie are well known to each other through the Central Florida ONS Chapter, previous working 
relationship, and partnership on several pilot studies in preparation for this proposal. 
Our team will be supported by Eileen Smith (ES, Co-I) of E2i Creative Studios (E2i), a media lab within 
the University of Central Florida’s Institute for Simulation and Training (IST).  E2i has created several avatar-
based training systems in partnership with nursing (DRAMA-RAMA83) and has collaborated with Loerzel in 
pilot focus groups in preparation for this study. 
Nursing students will be an integral part of the team and will be active research assistants (RAs) throughout 
this study. All students will receive training in research and will be required to undergo CITI training as 
required by the UCF Institutional Review Board.  All students will be educated on cancer chemotherapy side 
effects and self-management behaviors prior to working with research subjects.  In phase I, students will be 
trained to participate in focus groups (e.g., note taking), analyze focus group data (e.g., review transcripts, 
code, and develop themes), and pre-test the eSETT:CINV game.  In phase II, students will be trained in the 
following: 1) data base setup, data entry, and cleaning; 2) conduct follow-up phone calls and data collection; 
and 3) develop a questionnaire to elicit feedback about the games appeal and usability.  Pre-nursing students, 
undergraduate Honors in the Major students, and graduate students have a strong record of research within 
our college with many students conducting their own research or working on faculty projects.  Students 
engaged in this project will be exposed to cutting-edge technology and patient education and have 
opportunities to publish and present their work related to this project at university, local, and regional research 
conferences.  This project will provide a research foundation that they can use for their own research careers. 
 
 

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Preliminary Studies: 
Symptom experience and cognitive misperceptions:  Dr. Loerzel (PI) initially investigated QOL and the 
symptom experience of older breast cancer survivors and found that older breast cancer survivors experienced 
high QOL while experiencing treatment-related symptoms.18, 38, 84 These women accepted symptoms as “part of 
life,” a belief that prompted their decision to not manage current symptoms.16 Grounded theory research, 
funded by the American Nurses Foundation, found that older breast cancer survivors “pushed” cancer into the 
background using a process involving: expecting illness with aging, keeping cancer in perspective, and sensing 
a partnership in the fight against breast cancer. Again, women minimized their experience with breast cancer, 
choosing to focus on the positive aspects of their recovery, not lingering treatment-related symptoms.  While 
symptoms were present, older women rarely volunteered their experience with symptoms.15  Following these 
studies, Dr. Loerzel used a mixed method approach in a series of small funded studies to examine the symptom 
experience and cognitive representation of older people with cancer. In one pilot study, Loerzel found that 
older breast cancer survivors (N=9) within a year of completing treatment reported an average of 6 (range 3-9) 
cancer treatment-related symptoms. The most common long-term symptoms were sleep disturbances, pain 
and fatigue.  Contrary to prior studies17, this study identified cognitive misperceptions in symptom cause, 
consequence, and ability to control/cure the symptom.85   In another pilot study, older adults (n=43) under 
treatment for cancer reported an average of 7 (range 2-13) symptoms. Twenty-five percent reported CINV as 
one of the most bothersome symptoms with a mean symptom severity rating of 6.8 on a 0 to 10 scale. This 
study again identified cognitive misperceptions in symptom consequence and ability to control/cure 
symptoms.86  In addition, there was poor self- management of CINV with only 33.3% of older adults actively 
managing it with medication.  Medication was rated moderately effective at managing CINV.87  In summary, 
these studies indicate that older adults with cancer experience multiple treatment-related symptoms 
throughout the cancer treatment trajectory. Older adults do little to manage symptoms (including CINV) due 
to cognitive misperceptions related to symptom consequences and ability to be controlled/cured. 
Current standard education is overwhelming, technology accepted by older adults: Currently, Dr. 
Loerzel, Ms. Geddie, and Ms. Smith collaborate on a study using qualitative focus groups to evaluate current 
education strategies for older adults and explore new approaches for educating older adults with cancer.  
Preliminary data suggest that older adults consider standard symptom patient education: 1) overwhelming; 2) 
difficult to prioritize; and 3) challenging t0 apply to their own care.  Older adults value engaging others in 
conversation (peers and MD) and learning from other patients experiences. This current study and prior 
studies indicate that most older adults use technology, including playing electronic games (e.g., Words with 
Friends, Solitaire, Candy Crush) on a daily basis and are receptive to new technology based educational 
interventions above and beyond typical written handouts.82  
Experience with Novel Technology 
The proposed application builds on the collective experience of our team to develop a serious game for 
managing CINV using the Unity 3d gaming platform.  Based on prior experience in game design and 
development, Dr. Clochesy (eSMART-HD20; eSMART-MH19) and  Ms. Smith (DRAMA-RAMA83) will lead the 
team in developing an interactive decision making game for CINV using avatars and CINV scenarios.  The 
CINV game scenarios will be developed in partnership with the CAB. Educational and CINV self-management 
content for the scenarios will be created by Dr. Loerzel and Ms. Geddie using common recommended CINV 
interventions (Figure 2).11, 12  
   In summary, these multiple preliminary studies and experiences informed our decision to focus on 
developing a technology-based intervention to help older adults restructure existing cognitive 
representations and promote a conceptual change in which learning can occur. This intervention will 
introduce new information about CINVs ability to be managed (cured/controlled) at home by providing 
visual cues to the consequences (positive and negative) of using CINV self-care strategies.    
Research Design and Methods 
Design: This project incorporates qualitative and quantitative research designs.  Phase I consists of three 
focus groups with the CAB who have personal and professional experience with CINV and can identify realistic 
scenarios and educational content to build the game.  Phase II is a two-arm randomized trial to establish effect 
size of the intervention.  Nursing students, as research assistants (RAs), will be involved in both phases of this 
study. 

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Phase I: Game design and production: The goal of phase I in this proposed research is to design and 
develop a serious game that offers older adults practical skills to reframe cognitive representation of CINV, 
reduce CINV severity, enhance CINV self-management behaviors, reduce healthcare resource use, and improve 
overall QOL. This game will put the user in the center of the action and focus on a specific outcome.33 It will 
also affect motivation to self-manage CINV.33  Phase I will be guided by a formative evaluation (FE) process88 
using a Community Advisory Board (CAB) and principles of serious game design (Figure 3).31, 32, 68, 89 The FE 
process will allow the team to present the project’s status, talk about changes, observe and capture feedback 
during play testing of the emerging learning scenario, and receive 
objective feedback from the CAB as to the project’s progress. Members of 
the CAB will participate in 3 focus groups. Focus Group 1: Participants 
will be asked to describe their personal and professional experiences 
(incidence, self-management, perceived and actual consequences) with 
CINV in order to begin building realistic game scenarios. In addition, 
standard CINV interventions11 such as taking antiemetic’s, eating small 
frequent meals, and staying hydrated (Figure 2) will be used to guide the 
emerging scenarios and self-management choices made by the player that 
may lead to positive or negative outcomes. Focus Group 2: Participants 
will validate themes from the first focus group and provide feedback on 
game scenario context related to CINV, character development, reality of the setting, scripts, self-management 
choices and subsequent outcomes.  Focus Group 3: Participants will pre-test the game and provide feedback on 
game consistency, usefulness, likelihood of changing symptom representation related to CINVs ability to be 
cured/controlled, engagement, entertainment factor, and potential “dose” of the intervention.   
   All focus groups will be digitally audiotaped, transcribed verbatim, and uploaded into HyperRESEARCH™ 
software for content analysis. Under the guidance of the PI, student RAs will take notes during the focus groups 
and be involved in data analysis and game pre-testing.  The focus groups will be held at the E2i lab in the UCF 
Institute for Simulation and Training. 
Phase I outcomes: The primary outcome of this phase is the development of an interactive dialogue system 
that allows older adults to progress through a serious game through interacting with characters inside the 
game. The main form of participant interaction is making dialogue decisions at specific times in a serious 
game. When a virtual character is asked a question, the participants can pick which response they feel is most 
appropriate. This function behaves much like the popular “choose your own adventure” books where readers 
pick the direction in which a story progresses. Interactive dialogue systems allow for the participant to follow 
an intended story, while still making decisions of how the story unfolds. Another benefit of this approach is that 
the participant can engage in the serious game multiple times and explore varying story arcs. The main design 
priority is planning for all possible paths in the experience (scenarios). For this project, we propose to have an 
“either/or” approach to the types of decisions participants can make in the game, thus witnessing the effect of 
their choice.  For example, the avatar will show early signs of CINV (e.g., mild queasiness, not wanting to eat or 
drink).  The decisions a player could make include: 1) no management (wait it out), 2) self-manage with 
prescribed medication, or 3) self-manage with distraction techniques.  Once the player makes a choice, the 
avatar will show the consequences of their decision (e.g., progressive nausea leading to vomiting, controlled 
nausea and being able to do normal activities, or persistent mild nausea). The player will be led through 
progressive scenarios based on their decisions and asked to make self-management choices at different time 
points until the avatars CINV is either controlled or a serious effect such as dehydration and/or fall at home 
leads to an unplanned ED or hospital admission. 
Recruitment of CAB:  Sampling will be purposive. The CAB will consist of 5 older adults who have finished 
cancer treatment with chemotherapy within the past 3 years, 3 family caregivers, and 2 oncology staff nurses 
who deliver chemotherapy treatments. Older adults and caregivers are the critical voice of the target audience, 
and oncology trained nurses are important to verify accuracy of recommended CINV self-management 
strategies within the game and current treatment center discharge instructions.  To the greatest extent possible, 
all CAB members will be present at each focus group.  CAB members will provide input for scenarios 
(incidence, self-management, perceived and actual consequences) based on their experiences with CINV. Older 
adults will be recruited from a pool of approximately 109 participants from the PIs prior research studies who 
agreed to be contacted for further research.   
   Names will be randomly drawn from this pool; an invitation to participate will be mailed in batches of 10 
• 
Knowledge sets stage for behavioral 
change
• 
Practicing skills leads to self-mastery
• 
Modeling is an effective way to learn 
new skills
• 
Tailored games facilitate character 
identification
• 
Game must be entertaining

9 
 
until target numbers are reached.  Nurses will be recruited from the UF Health Cancer Center-Orlando 
chemotherapy treatment center. Retention will be enhanced by offering a $50 stipend/gift card to the CAB 
members for each focus group they participate in.  Informed consent and participant characteristics (e.g., age, 
gender, race, educational level, CINV experience) information will be collected from all CAB members. 
Phase II - Game prototype testing  
Phase II will use a prospective 2-group randomized, longitudinal design to evaluate effect size of the 
intervention, examine group differences and evaluate game appeal.  Patients who meet the inclusion criteria 
will be randomly assigned into the intervention group or control group at a 1:1 ratio. All participants will be 
followed for four chemotherapy cycles (approximately 4 months).   
Setting: The outpatient treatment center at the UF Health Cancer Center-Orlando will be the primary site for 
enrollment due to its long-standing relationship with these researchers. In 2013, UF Health Cancer Center-
Orlando saw approximately 4,694 patients. Of these 2,573 patients were age 65 or older, and 565 of these 
patients received outpatient chemotherapy. These numbers indicate an ample sampling pool of older adults.    
Sample size: The target sample is older adults receiving emetogenic chemotherapy for the first time. Sixty-six 
participants will be enrolled if they meet the following inclusion criteria: age 65 and older, newly diagnosed 
with any cancer, treatment with any chemotherapeutic agent with a moderate to severe emetic potential (on a 
3- or 4- week cycle), proficient in English, and have a telephone.  Exclusion criteria include: previous 
diagnosis and treatment for cancer, advanced or end stage disease with a palliative intent, visually or hearing 
impaired.  Dementia or cognitive impairment is not a concern with the population since they have already been 
cognitively screened in order to consent to treatment at this cancer center. There will be no exclusion based on 
gender or racial/ethnic status. Retention of all participants will be enhanced by the following strategies 1) 
weekly telephone follow-up phone calls by the RA; 2) a $50 incentive/gift card at the end of the study period; 
and 3) attention control group offered eSSET-CINV at the end of the study.  We will oversample by 20% in 
order to account for attrition. 
Phase II Procedures: 
Recruitment and randomization: Successful recruitment and retention strategies previously established 
by the team will be used during this phase.7, 15, 16, 18, 90 Convenience sampling, followed by randomization will be 
used. All new patients will be screened for eligibility by the Research Nurse (RN-PG) using the Sunrise XA -
electronic medical record 
system used by Orlando 
Health. Eligible patients 
will be approached by the 
RN at their first 
chemotherapy 
appointment and asked to 
participate. This timing is 
not expected to add to or 
create patient anxiety.  
Patients usually wait 30 to 
60 minutes for lab results 
and chemotherapy to be 
delivered. Participating 
may act as a distraction, thus reducing anxiety. In addition, patients have already received standard written 
education regarding treatment effects and will expect CINV as a possible effect of treatment.  Written informed 
consent will be obtained in a private area of the clinic open to the RN.  A signed copy of the consent will be 
given to the patient. Once informed consent is obtained, baseline measures will be completed, and participants 
will be randomized (Intervention Group [IG] and Attention Control Group [ACG]) to either group by choosing 
an envelope with a group assignment.  
   Participants in each group will receive standard care: 1) on admission to the cancer center (receipt of 
standard written educational materials that patients are instructed to bring to each appointment), 2) at a 
treatment planning visit (receipt of specific handouts regarding treatment and potential side effects, and 3) at 
time of treatment (verbal review of chemotherapy and symptom handouts by treatment center nurses). See 
Table 1 for an outline of standard education and eSSET-CINV intervention. 
 
Table 1: Intervention schema 
 
Pre-treatment 
First Treatment Visit 
Post -
treatment 
Standard 
written 
patient 
education at 
admission 
to cancer 
center 
Standard 
written 
patient 
education at 
treatment 
planning 
visit 
ENROLL/ 
RANDOMIZE 
 
eSSET-CINV 
Intervention: 
1) 
Game 
2) 
Decision 
discussion 
with 
research 
nurse  
Standard 
review of 
written 
patient 
education 
on side 
effects  
Follow-up 
phone call 
All 
subjects 
x 
x 
IG 
x 
x 
x 
ACG 
 
x 
x 
Note: IG= Intervention Group, ACG=Attention Control Group 

10 
 
Study Variables 
Independent variable: Intervention versus Attention Control group 
1) Intervention Group 
 The intervention will consist of two parts: 1) the eSSET-CINV game and 2) decision discussion with research 
nurse (RN). The game will be administered by the RN. Participants will play the game at the outpatient 
treatment center prior to their first chemotherapy treatment using either a study-provided laptop or smart 
tablet using headphones to ensure privacy and limit distraction.  Please see Table 2 for the eSSET-CINV 
intervention process. At the end of game play, the RN will engage the participant in a discussion about the self-
management choices the player made and suggest changes or discuss possible outcomes based on different 
choices. For example, if the player chose not to treat the avatar’s mild nausea and vomiting occurred, the RN 
would discuss more effective self-management choices as outlined in Figure 3. 
   The players will be allowed to play the game as many times as 
they choose during that chemotherapy visit in order to practice 
making decisions and visualizing consequences and outcomes. 
Once the participant is discharged home, a student RA, blinded 
to the treatment group, will call participants weekly to see how 
they are doing and remind them to record self-management 
data. To reduce bias, a scripted interview form will be used. 
Student RAs will instruct the participant to follow cancer center 
procedures and call their oncologist if they are having problems 
or have questions. 
Intervention fidelity.  eSSET-CINV will be presented and 
delivered by the same RN each time. The RN will base the 
discussion on common self-management options (Figure 3). 
Minor interruptions (< 10 minutes) to game play will be 
recorded and participants will resume game play where they 
left off.  Technology malfunctions (e.g,. system crash or frozen screen) will be recorded and participants will be 
asked to start eSSET-CINV over.  For players with caregivers, caregiver involvement (e.g., helping, prompting) 
in the game will be recorded for subgroup analysis.  
2) Attention Control Group 
Participants in the control group will receive: 1) standard care; 2) follow-up phone calls from the student RAs 
to remind them to record self-management data; and 3) the opportunity to play eSSET:CINV at the end of the 
study period. During the follow-up phone calls, the student RAs will instruct the participant to follow cancer 
center procedures and call their oncologist if they are having problems or have questions. Contamination 
between groups is not expected since participants are likely scheduled for chemotherapy at different times and 
receiving treatment in different areas of the treatment center.  
Co-variates 
Participant characteristics: Demographic and experiential characteristics that may influence CINV and 
ability to self-manage this symptom will be measured at T1 (baseline). Demographics include: age, gender, 
comorbidity information, education level, and income level. Experiential characteristics include: cancer 
diagnosis and stage, chemotherapy regimen with antiemetics, discharge antiemetic prescriptions, use of the 
Internet to research symptom management information, and caregiver presence (yes/no) and involvement at 
home. All cancer information will be collected from the patient’s electronic medical record by the RN. Delays in 
chemotherapy treatment and rationale for delay will also be recorded at each time point by the RN. 
Dependent Variables 
An overview of study variables, measures and data collection timeline are presented in Table 3. Data will be 
collected for 4 treatment cycles (3 or 4 months depending on cycle length).  Questionnaires will use a 
paper/pencil format with enlarged font and be entered into Excel™ software. 
1) Symptom severity:  The Symptom Representation Questionnaire (SRQ)91 , a 24-item self-report 
measure will be used to identify presence and severity of common treatment-related symptoms (0-10 Likert 
scale), including nausea and vomiting (N/V). This measure asks respondents to think about their 
symptoms over the past week. 
Table 2: eSSET-CINV Intervention process  
1 
Game introduction and orientation 
2 
Choose avatar 
3 
Avatar discharged home after treatment 
4 
Avatar begins to experience nausea 
5 
Player makes self-management decisions 
6 
Avatar responds based on player decisions 
7 
Avatar experience continues with periodic 
nausea as player continues to make self-
management decisions 
8 
Game ends when avatar achieves goal of mild 
or no nausea or has an unplanned ED or 
hospital admission 
9 
Discussion of decision choices with Research 
Nurse 

11 
 
2) Cognitive representation: The Symptom Representation Questionnaire (SRQ)91 has an additional 15 
questions to assess cognitive representation (identity, cause, timeline, consequences, and cure/control) or 
beliefs about specific symptoms (0-4 agreement scale). This measure includes subscales for symptom cause 
(2 questions), timeline (3 questions), cure/control (3 questions), and consequence (6 questions).  Only the 
cognitive representation of nausea will be evaluated. This tool is reliable with alpha co-efficients  from 0.63 
to 0.88 for the subscales.91 The cognitive representation questions will be modified at baseline to assess 
participants’ beliefs about potential CINV consequences and their ability to be controlled/cured. 
Subsequent data collection time points will focus on current cognitive representations. 
3) Self-management 
behaviors:  An 
investigator-developed 
Symptom Management 
Checklist [SMC] will 
measure CINV: 1) self-
management behaviors 
and 2) prevention 
behaviors.  Participants 
will complete this daily at 
home between 
chemotherapy cycles. 
When experiencing CINV, 
the participant will use 
the SMC to record: 1) 
CINV severity (0-10 
Likert scale) prior to self-
management, 2)  the type 
of self-management strategies used and, 3) the strategies perceived helpfulness in reducing nausea (0-10 
Likert scale).  Preventative self-management activities for CINV will also be recorded. All self-management 
strategies are coded (e.g,. “MED”= taking antiemetic, “DIS”- using distraction), and the participants will fill 
in the strategy code they are using on the form. To lessen the risk of the SMC becoming an intervention for 
the Control Group, all participants will be asked to record self-management behaviors of other common 
treatment-related symptoms (i.e. fatigue, mouth/throat sores). The SMC will be collected by the research 
nurse at chemotherapy cycles 2, 3 and 4.   
4) Health-related Quality of Life- The EORTC-3092 will measure QOL at each treatment cycle.  This 
frequency is consistent with others studies that have measured QOL in older adults over time.59, 93. This 
well-known scale includes 5 functional scales, 3 symptom scales, and 6 single items using a 4-point Likert 
scale (“not at all” to “very much”), and 2 global health/QOL items using a 7-point Likert scale (“very poor” 
to “excellent”).   Higher scores on the functional and health/QOL scale indicate better functioning, while 
higher scores on the symptom-related scales and items indicate higher symptoms.  Reliabilities (Cronbach’s 
alphas) range from 0.52 (role functioning scale) to 0.89 (QOL).92 
5) Resource Use: Any unplanned Emergency Department or hospital admission will be recorded via 
participant report using a dichotomous (Y/N) variable at each follow-up phone contact and treatment visit.  
Follow-up questions about the reason for the admission, length of time for admission and treatment will 
also be asked. The report will be verified by medical record review whenever possible.  
Additional Outcomes:  
Game appeal: Under the guidance of the PI, student RAs will develop and pre-test a short survey to evaluate 
game appeal at the first follow-up phone call.  Using a 4-point agreement scale, participants will be asked the 
extent to which the agree or disagree with statements regarding ease of game play, game likability, clarity of 
self-management choices, usefulness in educating about CINV consequences and ability to be controlled/cured, 
and realism (setting and scenario).  Additional comments about the game will be recorded. 
Willingness to recommend the game will be assessed using one item: Would you recommend this game to 
other older adults about to start chemotherapy treatment (yes/no)?  This will be collected at Cycle 4 (T4). 
 
 
Table 3: Summary of dependent variables, measures and data collection time 
points 
 
Data Collection Time points 
Dependent 
Variable/Outcome
s 
Measure 
T1 
Baseline 
T2 
Cycle 2 
T3 
Cycle 3 
T4 
Cycle 4 
Symptom severity  
SRQ- patient 
report 
x 
x 
x 
x 
Cognitive 
representation 
SRQ-patient 
report 
x 
x 
x 
x 
Self-management 
behaviors* 
SMC- patient 
report 
 
x 
x 
x 
Resource Use 
Patient report 
 
x 
x 
x 
QOL 
EORTC-patient 
report 
x 
x 
x 
x 
*Note: self-management behaviors will be recorded daily by participants, but collected by the 
research nurse at each treatment visit 

12 
 
DATA ANALYSIS 
Phase I: Game prototype and production 
AIM 1: Identify real-life scenarios involving CINV incidence, self-management, and consequences using a peer 
Community Advisory Board of older adults who have undergone cancer treatment, their family members, and 
oncology nurses to design and develop a serious game for CINV self-care decision making. 
AIM 2: Identify design aspects and elements of eSSET-CINV game play, audio, and visual avatar development 
that have the greatest appeal for older adults with cancer. 
     Data from focus groups will be digitally audio-recorded and transcribed.  Methods consistent with classic 
content analysis will be used to analyze data from the focus groups and will begin immediately after each focus 
group.94  The focus group recordings will be reviewed by the PI and student RAs and content analysis will be 
conducted to thematically categorize responses. Data will be de-identified in analysis-no names will be used.  
In order to eliminate bias, the analysis will remain grounded in the data.  Themes will be created and coded 
using language similar to what the participants use. These codes will then be grouped by similarity and used to 
summarize feedback about the game and suggestions for improvement.94 The notes taken by the RAs during 
and after the focus groups will serve as a “trail of evidence” to increase the trustworthiness of the data and 
confirm final findings.  Data are not intended to be generalized but will answer specific study AIMS.  
Phase II: Game prototype testing   
Preliminary data analysis:  Descriptive statistics will be provided to characterize the study participants for 
all demographic and experiential variables at baseline and at each treatment cycle time point.  Summary tables 
will be provided to present participant characteristics (e.g., gender, age group, race), major study variables, 
game appeal, and willingness to recommend game to others.  Internal consistency of study measures will be 
checked and evaluated to ensure data quality. Effort will be taken as much as possible to avoid missing data. If 
there are significant missing data that may impact analysis results, the multiple imputation method may be 
used for the analysis of primary endpoint. All statistical analyses will be performed using Statistical Application 
Packages (SAS®), version 9.4.  
Principle data analysis: The primary endpoints for the study are N/V severity score and the number of self-
management behaviors. The secondary endpoints are ED/hospital admission and QOL. Summary statistics for 
the primary and secondary endpoints will be provided. The t-test will be used if the normality of the endpoint 
can be confirmed. Otherwise, the Wilcoxon Rank-Sum test will be used to assess the difference between the two 
groups at each treatment cycle time point.  
AIM 1: Estimate effect size of the eSSET-CINV in changing patient outcomes: cognitive 
representation, self-management behaviors, CINV severity, QOL, and resource use. The effect 
size of N/V severity score will be estimated using the Cohen’s d, which is defined as the difference between two 
means divided by a standard deviation for the data.  
AIM 2: Examine differences in cognitive representation, self-management behaviors, CINV 
severity, QOL, and resource use, between, and within, the intervention and attention control 
groups.  For the primary endpoints, the data will be collected over 4 treatment cycles, and the method of 
analysis of longitudinal data will be used to compare the difference between intervention and control groups 
over time. The generalized estimating equation (GEE) approach may be used to enhance the robustness of the 
estimation of model parameters when the ideal working correlation structure is difficult to pre-specify. In the 
longitudinal model treatment cycle time, interaction of time and treatment, or both, whenever feasible, may be 
added into the model to assess the time effect on treatment difference.   
    The one-way repeated measures ANOVA will be used to assess the difference between the two groups. The 
mixed effect model may be used as exploratory analysis to account for unobservable variations from each 
individual patient. In addition, comparisons between two groups at each treatment cycle time point will be 
performed for all primary and secondary endpoints. For this particular comparison, the univariate normality of 
each endpoint will be assessed graphically at each treatment cycle time point. An appropriate time window will 
be determined to define the treatment cycles for the study. 
AIM 3: Obtain preliminary data regarding the feasibility and acceptability of the game in older 
adults experiencing CINV. Feasibility- Computer science and digital media undergraduate students will 
work under the direction of Ms. Smith and Dr. Loerzel to identify patterns in game play data (e.g., self-
management decisions, scenario patterns of progression), time to game completion, and number of times the 
game was played (intervention dose). The RN will track any instance of game play interruptions or 

13 
 
malfunction. This data will be summarized with descriptive statistics. Game Appeal: Responses to the game 
appeal and willingness to recommend questions will be scored and summed using descriptive statistics.  
Additional comments about the game will be recorded and analyzed for themes.    
Sample size and statistical power: 
Based on the assumption of a nausea severity mean score of 6.20, range from 2 to 9, a standard deviation of 
2.44, and a clinically meaningful difference in mean nausea severity score of one between the intervention and 
control groups, with 90% power, the required sample size is 33 participants for each group, yielding a total 
sample size of 66 for the study. To reduce the patient selection bias, single-blinded randomization may be used 
whenever feasible. Due to lack of available data from prior research the sample size for secondary endpoints is 
not possible for the study at first stage. However, the power statistical analysis will be assessed when data 
become available from the planned study. 
Potential challenges and strategies for addressing:  
Although prior research participants have agreed to be contacted for future research projects, it is possible, that 
we will not be able to recruit enough CAB members for phase I. In that unlikely event, we would recruit 
additional CAB members from the UF Health Cancer Center who recently completed treatment. Challenges 
related to creating a credible educational game (e.g., does not appeal to older people, unrelatable 
characters/avatars) will be minimized through the partnership of the CAB who will lend credibility to the 
scenarios for CINV.  Prototypes will be created first so credibility issues can be addressed and corrected in 
phase I focus groups.  In addition, Dr. Clochesy (Co-I) and our partners at E2i have a successful history of game 
development for many different populations and settings. Challenges inherent to having team members at a 
distance will be addressed through face-to-face meetings at critical time-points related to each phase of the 
project.  Team meetings will be scheduled for every 2 to 3 weeks and distance team members will have the 
option to Skype into those meetings. 
Student engagement in clinical research: The PI, Dr. Loerzel has involved undergraduate and graduate 
students in prior clinical research and has the necessary experience and expertise to guide them through this 
innovative project. Students will be involved in all phases of this project. Their participation in this project will 
expose them to cutting-edge technology and opportunities to build multidisciplinary connections. 
Study Start-up and Training:  During the first 3 months of the study, ES will hire the technical team for 
game development, and VL will hire UCF CON nursing students as RAs.  At the start of each study phase, VL 
will provide appropriate staff training and education for the RAs on the following topics: Collaborative IRB 
Training Initiative (CITI), human subject protection, CINV, CINV self-management behaviors, conducting 
focus groups, coding and analyzing qualitative data, collecting data during follow-up phone calls.  Regular team 
meetings will be held with investigators, consultants, and study staff to ensure study protocols are maintained 
(Table 4).   
 
 
 
 
 
Table 4: Project Timeline 
Activity 
Year 
1 
2 
3 
Quarter 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
Project startup 
x 
 
 
 
 
 
 
 
 
 
 
 
Team meeting prior to game development 
x 
 
 
 
 
 
 
 
 
 
 
 
RA training (both phases) 
 
x 
 
 
x 
 
 
 
 
 
 
 
Phase I - CAB recruitment  
 
x 
 
 
 
 
 
 
 
 
 
 
Phase I - Focus groups, game development, and initial testing 
 
 
x 
x 
 
 
 
 
 
 
 
 
Phase II - Participant recruitment and enrolment, data collection, intervention delivery  
 
 
 
x 
x 
x 
x 
x 
x 
 
 
 
Phase II - Database set up 
 
 
 
x 
 
 
 
 
 
 
 
 
Phase II - Data entry and cleaning 
 
 
 
x 
x 
x 
x 
x 
x 
 
 
 
Phase II - Data analysis 
 
 
 
 
 
 
x 
x 
x 
x 
 
 
Dissemination and final grant reports 
 
 
 
 
 
 
 
 
x 
x 
x 
x 

14 
 
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