Self-monitoring Activity: a Randomized Trial of Game-oriented Applications (SMARTGOAL)
Phase: NA
Conditions: Breast Cancer, Obesity
Sponsor: The University of Texas Medical Branch, Galveston

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Self- Monitoring Activity: a Randomized Trial of Game-oriented Applications 
(SMARTGOAL) 
 
 
 
 
 
 
Principal Investigator:  
Elizabeth J. Lyons, PhD, MPH 
301 University Blvd., Galveston, Texas 7555-1124 
Phone: (409) 772-2575, Fax: (409) 772-2577 
Email: ellyons@utmb.edu  
 

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RESEARCH PLAN   
A. HYPOTHESIS AND SPECIFIC AIMS 
Physical activity produces health benefits in breast cancer (BC) survivors, including improved quality of life and 
decreased risk of recurrence and mortality.1-3 However, many breast cancer survivors do not meet activity 
recommendations,4 and racial/ethnic disparities in activity rates5 may exacerbate disparities in health 
outcomes.6 Activity interventions among BC survivors improve activity levels in the short term,7 but increases 
are rarely sustained after 6 months.8,9 Since habitual activity produces greater quality of life benefits than do 
briefer increases,10 creating sustainable interventions should be a cancer control priority.11  
Breast cancer survivors consistently include lack of motivation as one of their primary barriers to physical 
activity. Autonomous (volitional) motivation is associated with long-term increases in physical activity.12-14 
Active video games are a promising medium for intervention with demonstrated ability to increase autonomous 
motivation,15 fitness,16,17 and quality of life.18 These games are also acceptable to older19 and chronically ill 
adults and women.20 Because of their easy individualization and user-centeredness, games hold the potential 
for reaching a broad, diverse audience. 
Games that include involved narratives may be particularly effective. Narrative transportation, or 
engagement, is highly effective in persuasion to change health behaviors.21 Narrative transportation increases 
enjoyment directly22,23 and also likely impacts autonomous motivation by increasing perceptions of autonomy, 
competence, and relatedness. We hypothesize that narrative-based active games in which users role-play as 
fit characters will lead to greater autonomous motivation, in turn leading to greater physical activity. 
The goal of this research is to develop a sustainable intervention that is broadly acceptable and efficacious 
across a diverse population of breast cancer survivors. This study will test a 6-month game-based physical 
activity intervention among a sample of sedentary, overweight postmenopausal breast cancer survivors. The 
enhanced intervention will provide a mobile device (iPod touch) and two narrative-based walking game 
applications (apps). These apps include audio narratives that can change based upon player input and include 
rich feedback on physical activities. The standard exercise intervention will provide a mobile device with a 
simple activity monitor and feedback application. Both interventions will include self-monitoring and feedback 
through the mobile apps and additional feedback through weekly brief counseling phone calls. Thus, 
comparing the two interventions will allow the investigators to draw conclusions about the unique motivating 
aspects of the narrative games. A follow-up assessment at 12 months will further allow investigation of 
intervention effects on activity maintenance over time. The study will address the following specific aims: 
Aim 1. Compare a motivationally enhanced intervention to a standard intervention in a 6-month 
randomized controlled trial. Sedentary, overweight postmenopausal breast cancer survivors (N = 120) will 
be randomized to the enhanced intervention or to a standard intervention. We will test objective measures of 
physical activity, physical function, and fitness at the conclusion of intervention contact (6 months) and after a 
6-month maintenance phase (12 months). 
Aim 2. Compare quality of life and psychological outcomes across the two interventions at 6 and 12 
months. We will investigate quality of life (physical, social, emotional, functional, and breast-related), 
depression, anxiety, and fatigue at 6 and 12 months.  
Aim 3. Compare autonomous motivation across the two interventions at 6 and 12 months. Hypothesized 
psychosocial predictors (Self-Determination Theory constructs and narrative transportation) will also be 
investigated. 
Aim 4. Investigate the cultural appropriateness of the two interventions. At the 6 month assessment or 12 
months assessment (if not collected at 6 months), we will conduct brief interviews with participants (N = 120) 
and stakeholders (N = 10) to investigate acceptability of intervention components. Qualitative analyses will 
examine racial and ethnic differences. 
We hypothesize that the narrative-based enhanced intervention will produce greater increases in activity, 
physiological outcomes, and quality of life outcomes as compared to a standard intervention. This study will 
provide crucial information to inform future research and practice related to cancer control and survivorship 
care. Its results will provide the foundation for future efficacy and dissemination studies with the potential to 
quickly and significantly improve public health at a population level. 

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B. BACKGROUND AND SIGNIFICANCE 
Breast cancer is the most prevalent cancer in women worldwide.24 Physical activity improves mood,25,26 
reduces inflammation,27,28 improves physical functioning,29 and reduces pain,29 leading to improvements in 
quality of life and fatigue.1,30 Both duration and intensity appear to have a dose-response relationship with 
improved health,10 but large improvements can result from as little as 15 minutes per day of moderate-intensity 
activity.10,31-33 In BC survivors, > 150 minutes of physical activity per week has been associated with decreased 
BC recurrence and mortality, as well as improved quality of life.2,27,34,35  
However, activity levels decrease after cancer diagnosis and remain low in survivors.36,37 Objective measures 
of activity have shown that BC survivors accumulate approximately four minutes per day of moderate to 
vigorous intensity activity, compared to eleven minutes in non-BC controls.38 Only 37% of BC survivors meet 
recommendations for 150 minutes per week of moderate-intensity activity.4 The downward trend appears to 
begin one to two years after diagnosis, and levels remain low afterward.37,39  
African-American and Hispanic women are at greater risk than non-Hispanic White (hereafter referred to as 
“White”) women for outcomes exacerbated by low activity rates. Cancer mortality is higher in African-American 
than in White women,40 and disease-free survival, quality of life, and physical function are lower in African-
American and Hispanic women.5,41 Comorbidities and differences in health behaviors appear to be partially 
responsible for poorer survival.42 Though physical activity could produce beneficial effects for survival, 
comorbidities, and quality of life, minority BC survivors are less active than White survivors.5,43 
Breast cancer survivors are in serious need of effective physical activity intervention. Skills-based interventions 
(e.g., those based on SCT that target self-regulation, self-efficacy, etc.) are effective, but adherence decreases 
markedly and quickly over time.8 For example, by week 9 of a 12-week intervention, only 53% of participants 
reached their activity goals.9 What little is known about sustained activity comes mostly from longer-term 
intervention trials; measurement of behavior maintenance after investigator contact ceases is rare in physical 
activity studies, particularly in BC survivors.44 Several secondary investigations of intervention trials and review 
papers have suggested that targeting autonomous motivation may be one of the most promising methods for 
increasing long-term activity maintenance among survivors.45,46  
Thus, there is a need for improved physical activity interventions that specifically target autonomous 
motivation. We propose that a patient-centered, individualized intervention would best adapt to the needs of 
breast cancer survivors of all races and reduce ethnic/racial disparities in outcomes. Active video games that 
include motivating game mechanics and persuasive narratives hold promise as a medium for delivering such 
an intervention. Below, we discuss the theoretical background and rationale for a game-based study, 
B.1. Theoretical framework: Self-determination theory  
Figure 6.1. Conceptual model 
                           
 
 The theoretical framework for this 
intervention (see Fig. 6.1) includes 
constructs from Self-Determination Theory 
(SDT) and theories of narrative 
transportation.  
SDT proposes a continuum between 
autonomous and controlled motivation,47,48 
with autonomous motivation being more 
strongly associated with physical activity 
over time.13,14 Autonomous motivation for 
activity includes both completely intrinsic motivation (that is, motivation in the absence of external 
rewards/demands) as well as integrated and identified regulation (relatively autonomous forms of motivation 
that involve valuing the outcomes of activity). According to SDT, autonomous motivation is predicted by the 
fulfillment of psychological needs for competence, autonomy, and relatedness.47 Several large-scale 
autonomy-promoting interventions have produced excellent results, including long-term maintenance of 
physical activity49 and weight loss.50,51 
B2. Narrative transportation 
Narrative transportation (also called narrative engagement) occurs when an individual is mentally immersed in 
a narrative storyline. Transportation is typically described as consisting of empathy and mental imagery related 
to a story.52 Narratives can increase enjoyment and motivation generally22,23 and specifically towards physical 

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activity.53 We hypothesize that in addition to a direct effect on autonomous motivation due to enjoyment, 
narrative transportation also exerts an effect on autonomy, competence, and relatedness. 
When implemented as part of a video game, narratives can be particularly autonomy-supportive. Interactive 
storytelling involves the player by providing a series of choices that affect the rest of the narrative. Interactive 
narratives can be even more enjoyable than standard narratives, as they combine the suspense and 
enjoyment of a story with the autonomy of creating a personalized experience.54 Further, active video games 
may be a powerful medium for such storytelling, as embodied role-play (physically acting out the story) could 
amplify feelings of autonomy and mastery.55,56 
The use of narrative to deliver health-related information can increase persuasion and result in greater 
behavior change as compared to standard information provision.57 This persuasion is implicit and emotional 
rather than overt and analytical, which may produce more enduring effects.52 It is possible that active video 
games with a compelling narrative could persuade players that they are competent, via identification with 
competent characters.58,59 Role-play as a fit character could also increase perceived competence via social 
cognitive means, by providing opportunities for practice, modeling, and mastery experiences.60  
Narrative also has the power to change behavior by influencing individuals’ attitudes and beliefs. Identification 
with characters can lead to “trying on” their personality traits and values.59,61-64 Video game studies have found 
that playing as a soldier increased feelings of bravery, for example.59 The more individuals relate a story 
character to themselves, the greater the impact on related health behavior.65 Thus, narrative transportation 
may influence autonomous motivation by increasing perceptions of relatedness to story characters.  
B3. Using active video games to increase autonomous motivation 
Active video games are video games that require      Table 6.1. How games impact autonomous motivation 
or encourage body movement during play. 
Increasing evidence suggests that some of these 
games are an appropriate delivery method for 
behavioral physical activity interventions. Active 
games are interactive and highly individualizable. 
They contain many of the behavior change techniques that are found in clinical interventions.66 Active games 
improve mood,18 fitness,17 and physical function67-69 in older adults. Though these health outcomes should be 
mediated by increased physical activity, measurement of physical activity in game studies among older adults 
is extremely rare. Studies in other age groups suggest that these health improvements are indeed likely 
mediated by increased motivation leading to increased physical activity.15,16,70 
Games likely produce these behavior and health benefits by increasing perceptions of autonomy, competence, 
and relatedness and, in turn, autonomous motivation. Several empirical studies of video games have found 
that part of their appeal is their potential to fulfill these psychological needs,71,72 and that games that increase 
these perceptions more are more likely to be played again in the future.73 For example, games can encourage 
autonomy by allowing meaningful choices.74,75 They can encourage perceptions of competence (similar to self-
efficacy) via modeling, practice, role-play, verbal persuasion, and mastery experiences.76 Perceptions of 
relatedness can be increased using multiplayer game options or by encouraging parasocial interaction with 
engaging, compelling characters.64,77,78 Table 6.1 displays common methods by which games may influence 
these perceptions.75,79  
Games that include an engaging narrative with compelling characters may further increase these perceptions. 
For example, a recent study that manipulated feelings of identification with a character in an active video game 
found greater exercise motivation in the high identification group.80 Because video games involve enactive role 
playing rather than just passive observation of a narrative, they may exert a greater influence on motivation 
and health behavior than typical narratives.60 
B4. Using active video games to decrease disparities in motivation and activity 
There is a need for interventions that are easily adaptable to be effective across a range of races and 
ethnicities, as many current programs appear to be less effective for minority women. In a recent example, 
poor adherence to lifestyle change recommendations among minority breast cancer survivors was 
hypothesized to have influenced disappointing results of a large-scale dietary intervention.81 Thus, racial/ethnic 
minority BC survivors are in unique need of lifestyle interventions that can be individualized to suit their 
personal values and barriers, but current intervention techniques do not appear to be adequate to produce 
behavioral change. 
Construct 
Mechanisms 
Autonomy 
Choices, motion controls, embodied role-play 
Competence 
Practice, feedback, mastery experiences 
Relatedness 
Multiplayer modes, character identification 

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Video games are an ideal medium for broad tailoring and specific individualization. In fact, video games are by 
definition individualized, as user inputs guide the experience of the game and make it unique to each player. 
Active games can be adapted to suit player fitness levels, use music the player prefers, and to be played 
according to the player’s schedule. A qualitative investigation of African-American older adult women with 
lupus found that individualization was one of the reasons they enjoyed using an active video game.82 Video 
games played on mobile devices may also be more likely to reach ethnic and minority women than 
interventions delivered via personal computer. More African-American and Hispanic individuals use 
smartphones than non-Hispanic Whites.83 
Narrative persuasion has been suggested as well-suited for ethnic and racial minority groups when narratives 
involve characters who reflect their experiences and who resemble them.84,85 Effects of narratives on health 
behavior appear to be greatly influenced by personalization. The more characters resemble the 
reader/viewer/player, the more effective the narrative.65 Narrative is also a culturally appropriate intervention 
method that may contribute to greater adherence.86 Thus, interactive video games that promote physical 
activity and that include an engaging narrative show great promise for meeting the needs of a broad range of 
breast cancer survivors, regardless of their ethnicity or race. 
B.5. The role of evidentiary trials in moving forward research and practice 
Evidentiary trials represent a step between pilot testing and fully-powered efficacy testing.87 These trials are 
powered to detect effects in intermediate outcomes – typically behaviors such as physical activity. Using 
physical activity as an outcome at an early stage in intervention development is very important, as large-scale 
trials often fail to show health outcome changes due to failures to produce sustained behavior changes in 
activity.88 Evidentiary studies allow for true tests of intervention effects on outcomes of importance while also 
providing effect sizes, formative data, and a convincing rationale for investment in a large efficacy trial. It has 
been suggested that such trials will ultimately result in improved outcomes and cost savings.87 
B.6. Summary of rationale 
Breast cancer survivors are a large population with an unmet need for sustainable physical activity 
intervention. Autonomous motivation is associated with better physical activity maintenance, and both active 
video games and narrative storylines are predictive of autonomous motivation. A theory-based intervention that 
uses narrative-based active video games could produce a large impact at the public health level, reducing 
morbidity and mortality in this high-risk population. Further, because these strategies are easily individualized, 
such an intervention may be more effective across races and ethnicities than a standard intervention. This 
project will advance the survivorship research literature and potentially impact clinical practice. 
C. STATEMENT OF CANCER RELEVENCE  
There is a grave need for programs that encourage increased and sustained exercise among breast cancer 
survivors. Habitual physical activity improves physical and emotional health in BC survivors, with proven 
effects on recurrence, side effects, late effects, and quality of life. Preliminary evidence suggests that new 
technology, such as video games, may be an effective method for increasing motivation to be active. In 
comparison to traditional interventions, this technology may increase motivation by increasing feelings of 
autonomy, competence, and relatedness.  
The purpose of this study is to test whether an intervention that uses active video games improves upon a 
standard physical activity intervention. We will test the intervention in a diverse sample of inactive 
postmenopausal breast cancer survivors. In the short term, the study will provide valuable information about 
the potential of mobile technology for improving health behaviors, intermediate health outcomes 
(cardiovascular fitness, physical function etc.), and mood. In the longer term, the results of the study have the 
potential to improve cancer control on a large scale, and ultimately decrease the morbidity and mortality of BC. 
If the intervention is ultimately successful, it could be included in survivorship care plans as a standard tool for 
improving physical activity, benefiting millions of survivors and lowering overall cancer burden. Because the 
intervention was designed to be easy to individualize, similar programs could easily be targeted to other 
cancers or chronic conditions. 
D. INNOVATION 
This project is an innovative step forward for the discipline in several ways: 1) The primary focus of the 
intervention is activity maintenance, with a strong theoretical rationale for each intervention component’s effect 
on long-term change. To our knowledge, this will be the first large-scale investigation of the use of video game 
mechanics in an intervention among older adult cancer survivors. This strategy holds potential for a large 

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public health impact but has received little research attention. 2) The individualized and user-centered nature 
of the intervention may be able to address barriers that contribute to racial/ethnic disparities in physical activity 
rates and health outcomes. 3) The intervention incorporates tailoring and patient-centered outcomes in a way 
that does not decrease the potential ease of dissemination. The applications will allow for simple customization 
and autonomous choices.  
E. 
PRELIMINARY STUDIES 
Dr. Lyons has extensive experience in the areas of technology and physical activity. The research mentors 
have been carefully chosen to complement these strengths and to fill gaps in knowledge and experience. The 
major areas of preliminary evidence for this research study are outlined below. 
E.1. Video games and physical activity  
In her previous studies, Dr. Lyons has found that significant differences exist across active video game types in 
both energy expenditure and enjoyment89 and that enjoyment of an active video game predicted energy 
expenditure.90,91 Comparison of a “game” themed around exercise simulation (jogging) and a game themed 
around a true game (hula hooping) found that framing an activity as a playful game produced greater 
enjoyment than did simulating an exercise activity.90 Taken as a whole, the results of this line of research 
indicate that more enjoyable programs that integrate video game mechanics will likely produce greater 
improvements than do standard programs. 
E.2. Cancer survivors and older adults using technology to increase activity  
Dr. Lyons began her research career performing mixed methods analyses of social support provided in online 
mailing lists for cancer survivors and caregivers.92,93 Together with Dr. Basen-Engquist, she has recently 
analyzed the results of a large (N = 1053) survey of BC survivors regarding technology and health promotion. 
Breast cancer survivors reported using computers and the Internet (86%), and were more interested than other 
cancer survivors in computer (36%) and mobile interventions (though interest in smartphone interventions was 
low, 12%). In fact, interest in computer interventions was greater than interest in clinic or telephone based 
interventions.  
A series of focus groups and interviews with postmenopausal breast cancer survivors (N = 20, 4 ethnic/racial 
minority) found that these apparent low levels of interest in smartphone interventions were informed by 
survivors’ expectations. For example, one participant stated that she did not like video games or smartphones. 
Later in the discussion, she mentioned playing Angry Birds on her tablet. She saw no contradiction in these 
two statements, echoing attitudes of many of the other participants. They did not count the kinds of casual 
video games that they played as “video games,” nor did they believe that other mobile devices (tablets, iPods) 
and smartphones were similar. Thus, some video games and mobile devices are actually highly acceptable to 
older adult breast cancer survivors, despite self-reports (such as in the above study) that suggest the contrary.  
A pre-experimental pilot study (N = 10, 4 ethnic/racial minority) using mobile devices in older adults included 
two women who were long-term BC survivors. The study protocol, which involved provision of a tablet and 
activity monitor, was found to be feasible and acceptable over the brief intervention period (6 weeks). 
Participants wore the monitors as instructed and synced their data daily or multiple times per day. Adherence 
was very good, with monitors worn and synced 402 out of a possible 420 days. Participants significantly 
improved their fitness and function compared to baseline. Measures of acceptability showed that participants 
found the tablet, monitor, and application to be useful and enjoyable. 
An additional pre-experimental pilot (N = 10, 3 ethnic/racial minority) is investigating one of the games to be 
used in the proposed study (Zombies, Run!). We provided smartphones with the game app to adult women (18 
– 69), six of whom were over 55. The study is not yet complete, so we cannot estimate adherence. However, 
qualitative acceptability measures taken at the midpoint indicate two major reported reasons for non-
adherence: preference for using the participant’s own phone and preference for measuring lifestyle activity 
rather than (or in addition to) planned activity. All participants had no problems using the smartphones provided 
and reported finding the game and story very motivating. Despite these positive feelings, the requirements 
surrounding use of the game were felt to be onerous. Unlike in the above trial, participants were required to 
remember to turn on the app prior to planned walking bouts. Several women mentioned forgetting to carry a 
second phone (since they already had their own cell phone), or felt that the requirements to remember a 
second phone and to remember to turn on the app were burdensome. We hypothesize that using a non-
smartphone mobile device (like an iPod or iPad), allowing use of participants’ own phones, and providing a 
choice of apps that include lifestyle monitoring (i.e., that doesn’t require pre-planned activity bouts) would 
improve adherence.  

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E.3. Behavior change techniques and game mechanics 
Table 6.2. Differences between game and monitor apps     Dr. Lyons and colleagues recently compared  
the content of active video games and activity 
monitors to standard taxonomies of behavior 
change techniques.66 These analyses were used 
to choose games and activity monitors suitable 
for this study. Table 6.2 compares two narrative-
based active game apps to an electronic activity 
monitor app. Both the game apps and the 
monitor app include techniques that, when 
implemented, are associated with increased 
physical activity.94,95 Thus, standard intervention 
components are equivalent across the two app 
types. The major differences lie in game 
mechanics, which are common in the two games 
and entirely absent from the monitor app. Thus, 
a comparison of the games to the monitor would 
isolate the effects of game mechanics while 
providing both groups with the standard social-
cognitive intervention components necessary in 
a behavioral physical activity intervention. 
E.4. Mentor areas of expertise and previous studies 
The three co-mentors were chosen to address specific areas in which Dr. Lyons requires more training and 
education. Dr. Goodwin is an expert in aging, health disparities, and comparative effectiveness research in 
cancer. His perspective as a practicing geriatrician and health services researcher will be extremely useful for 
refining intervention components to be feasible for dissemination. He has authored or co-authored many 
papers on topics related to this research program, including on aspects of race related to obesity,96,97 breast 
cancer treatment,98,99 physical activity as an indicator of health in older adults,100-102 patient-oriented outcomes 
in older adults,103,104 interventions to improve outcomes in BC patients,105-107 and psychosocial aspects of 
cancer treatment and survivorship.106,108-111   
Dr. Basen-Engquist, at nearby M.D. Anderson Cancer Center, will provide expertise and mentoring specific to 
behavioral physical activity intervention in women cancer survivors. She is a leading expert in this field with 
significant expertise in intervention testing112 and adaptation.113 Her primary area of expertise lies in the 
application of health behavior theory to understanding physical activity in this population.29,114-117 She has 
implemented multiple large-scale interventions among survivors, including breast cancer survivors.112,118,119 
Dr. Volpi is an expert in muscle metabolism,120,121 sedentary behavior,122 aerobic exercise,123 and aging.124,125 
She has conducted numerous clinical trials involving exercise program implementation among older adults. 
She will assist with conducting objective outcome measures of physical activity, function, and fitness. 
Additionally, consultant Dr. Berenson is an expert in women’s health research with extensive experience in 
recruiting diverse samples of women in the Galveston area for energy balance research.126-128 Several of her 
research studies have specifically investigated the use of new media for health information among minority 
women.129-131 
F. 
RESEARCH DESIGN AND METHODS 
F.1. Overview and study flow 
The primary purpose of the SMART GOAL (Self-Monitoring Activity: a Randomized Trial of Game-Oriented 
AppLications) study is to investigate the impact of an enhanced motivational physical activity intervention 
among sedentary postmenopausal breast cancer survivors. We will conduct a randomized controlled trial 
(RCT; N = 120) comparing the enhanced intervention to a standard self-monitoring intervention. The enhanced 
intervention will consist of provision of two active video games and a mobile device on which to play them. 
Participants will also receive weekly brief counseling/check-in calls.  The standard intervention will consist of 
provision of an electronic activity monitor and a mobile device, with the same phone call content and schedule. 
The trial will be conducted over the course of three years, in three yearly cohorts. Participants in the trial will 
each attend four visits: a baseline assessment/orientation one week later, an initial counseling/goal-setting 
 
Games 
Monitor 
Zombies
Run! 
The 
Walk 
App 
Behavior change techniques 
 
 
 
  Goal-setting 
 
x 
x 
  Self-monitoring 
x 
x 
x 
  Feedback 
x 
x 
x 
Game mechanics 
 
 
 
  Competition/conflict 
x 
 
 
  Freedom of choice 
x 
x 
 
  Dynamic/ephemeral goals 
 
x 
 
  Narrative 
x 
x 
 
  Novelty/surprises 
x 
x 
 
  Pick-ups 
x 
 
 
  Resource management 
x 
 
 
  Rewards 
x 
x 
 
  Social status/reputation/support 
x 
 
 
  Time limits/pressure 
x 
x 
 

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meeting; an assessment at 6 months, and a final assessment at 12 months. Participants may attend an 
additional visit for randomization if we do not have a valid physical activity measurement.  A battery of 
physiological and anthropometric measures will be performed at all assessments, and psychosocial outcomes 
will be measured by questionnaire. Questionnaires will also be completed by mail at 3 and 9 months. The 
study is designed such that regular intervention contacts will occur for the first 6 months. The period between 6 
and 12 months will be monitored as a maintenance period, to determine whether behaviors are maintained in 
the absence of further counseling. Participants will receive $25 gift cards at the 6 month and 12 month 
assessments for a total of $50 incentive. They will also keep the mobile device as an additional incentive. The 
flow of the trial is displayed in Table 6.3. This pattern will be repeated for each cohort. 
Personnel conducting the study will include a clinical research coordinator and two graduate research 
assistants. The research coordinator and one of the graduate research assistants will perform counseling calls, 
oversee monitor data, and provide technical assistance, while the other research assistant (blinded to 
participant group assignments) will conduct assessments. During the maintenance phase of this intervention (6 
– 12 months), the research coordinator will continue to make monthly phone and mail contact to encourage 
continued participation (e.g., thank you and reminder postcards, calls to check for changes in contact 
information). No counseling content will be offered during these contacts. 
Table 6.3. Timeline of trial assessments and phone contact by month 
Month 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
Assess- 
ments 
Base- 
line 
 
 
By 
mail 
 
 
6 
month 
 
 
By 
mail 
 
 
Final 
Calls 
 
Weekly calls 
Monthly calls 
No counseling calls; maintenance period 
Study 
materials 
 
Participants use mobile apps daily 
F.3. Participants and procedure (Aims 2 – 4) 
For the trial, we will recruit participants in three cohorts of 40 participants each, 20 per group, with 
oversampling of African American and Hispanic women (at least 30% of the sample). Participants will be 
randomly assigned to receive an enhanced or a standard intervention. Major eligibility criteria will include 
female gender, postmenopausal status (cessation of menses for at least 12 months), aged 45-75, current 
inactivity (< 90 minutes moderate-vigorous activity per week), BMI > 25 and < 40, no psychological issues that 
would interfere with study completion, ability to walk for physical activity, safety of physical activity, and not 
currently using the monitor/application to be provided. The PAR-Q+ will be used to screen for potential 
contraindications to exercise 132. Endorsement of any of its items will require physician clearance to participate 
in the study. 
Based on incidence data from the Texas Cancer Registry, we estimate that approximately 1950 female breast 
cancer survivors aged 55 – 75 and diagnosed in the last 10 years currently live in Galveston county, 500 of 
whom are African-American or Hispanic. We will also sample from nearby counties (including Harris county, 
which includes Houston). Dr. Basen-Engquist successfully recruited a sample of 60 breast cancer survivors in 
two years for a physical activity intervention study112 (37% African American and Hispanic) as well as larger 
samples for cross-sectional research (36% African American and Hispanic).29 Recently, 6 of 10 older adults 
recruited for a similar study were African American or Hispanic. Thus, we believe our recruitment targets of 40 
per year for three years and 30 - 40% minority recruitment (12 or more per year) to be feasible. We will use a 
combination of advertisement, community engagement, pre-screen via medical record for eligibility and clinic-
based solicitation to recruit potential participants. We will sample from Galveston as well as other nearby 
counties (including at UTMB and MD Anderson clinics in Harris county, which includes Houston, and up to 
Victoria County). The clinical research coordinator also coordinates a UTMB program that encourages 
recruitment of ethnic/racial minorities into clinical trials, and has ample experience in recruiting from local 
communities.  
F.4. Enhanced intervention  
The intervention consists of several complementary components: 
1) Provision of a mobile device (iPod Touch) with armband and headphones 
2) Provision of one mobile game application  
3) Provision of online currency (e.g., iTunes gift cards) to purchase music to be used in the game ($50) 
4) Brief counseling phone calls that occur weekly for 3 months, then monthly until 6 months 

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Participants will be able to use their own smartphone devices should they wish to; however, we will provide an 
iPod Touch mobile device to ensure that they have access to a device compatible with the chosen apps. (It will 
also serve as an incentive, as iPod Touches can hold much more music and data than most smartphones and 
take high-quality pictures.) The iPod Touch is similar to an iPhone, but does not require cellular service for use 
and is primarily an app and music use device. Thus, we believe that it should be perceived as a more 
acceptable mobile device than a smartphone, despite its very similar functionality. In our preliminary studies 
(see pages 6.5 - 6.6) we found that smartphone-based interventions are acceptable among older women, but 
that allowing use of their own phone and/or providing a non-phone mobile device is preferred. 
The game to be used is Zombies, Run!, created by developers Six to Start. This game was chosen due to its 
unique blending of an involved narrative storyline with game mechanics and extensive interactive behavioral 
tools. Zombies, Run! is a game that encourages bouts of 30 – 60 minutes of walking, jogging, or running. The 
accelerometer of the mobile device measures steps taken and provides extensive feedback. Table 6.2 on 
page 6 shows several of the game mechanics most commonly used in the game, and Figure 6.2 shows 
screenshots of the game. Players use the mobile device to set up the game, but during exercise the device is 
held or worn on the arm (armbands and headphones are included with the mobile device). The game plays 
user-chosen music and places clips of an audio narrative in between those songs, to provide an illusion of 
other characters “radioing in” while the player travels by foot in a post-apocalyptic world. While songs are 
played, the game provides audio cues when players “pick up” virtual supplies or are chased by zombies. 
Zombie chases (which can be turned off) require players to increase their speed by 20% for one minute in 
order to out-run their pursuers. If the zombies catch the player, they “drop” some of their virtual supplies to 
distract the zombies and escape.  
The game consists of over 120 missions in the main storyline, with complementary side missions that provide 
additional insight into some of the characters. Additional missions will be released in April, 2015, so the 
storyline is long enough to sustain activity over the year-long period. The narrative is written by a professional 
writer and includes main characters of multiple genders and races. The player character is never referred to by 
name and is always addressed in second-person as “you” or “Runner 5.” Players can assume that their 
character is any gender, race, ethnicity, etc. Participants in the preliminary study reported high levels of 
parasocial interaction with the two main non-player characters (one of whom is an African-American woman). 
Thus, we believe that this narrative will be appropriate for testing hypotheses related to 
transportation/engagement.   
*Please note: A similar game called The Walk will be pre-loaded onto the iPod device. During orientation, 
interventionists will briefly reference it as a potential back-up should participants find the content of Zombies, 
Run! aversive. The Walk is made by the same developers and includes very similar content, but the story is 
different and less violent. Our intent is for participants to use Zombies, Run!, but we will provide the option of 
The Walk as a backup for cases in which participants feel strongly that they cannot use the zombie game. 
Counseling content for the narrative game group was adapted from the narrative counseling used in the PACT 
study133 and extended to include appropriate constructs of interest in this study. Discussions will draw from the 
Zombies, Run! game and make suggestions related to future play. For example, some sessions will call 
participants’ attention to the exercise imagery they engage in during walking sessions, and others will 
encourage participants to imagine their ideal selves when playing as their character. Participants in this group 
will also receive the basic counseling provided to the self-monitoring group that covers self-monitoring, 
feedback, action-planning, and problem-solving. 
 
During the COVID-19 pandemic, the following consenting/interview methods will be implemented: 
 
In response to the COVID-19 pandemic and related Institutional guidelines, the following modifications are 
being implemented effective immediately: 
 
 
All visits will be conducted entirely by teleconference call. We are done with enrollment for the protocol. 
Ongoing participants will receive a phone call by study staff to inform the subject of the implemented 
modifications. We will read the modification letter to the subject over the phone. If the subject agrees with the 
modifications, we will document the subject verbal response in a note to file. If we are not able to reach the 
subject, we will mail the subject a letter.   
 

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Session 1: Orientation (this meeting, approximately 1 hour) 
 
We will not have any Session 1: Orientation. We are no longer recruiting for this study. We are done with 
enrollment.  
 
Session 2: Baseline assessment and goal-setting (about 1 week later, approximately 2 hours) 
 
We will not have any Session 2: Baseline assessments and goal setting since we are no longer recruiting for 
this study.  
 
 
Session 3: Six-month assessment (approximately 2 hours) 
 
The visit will be conducted using teleconference communication (examples: via phone, skype, zoom)  
 
Ongoing participants will complete Session 3: Six-month assessment using teleconference. Some of the 
assessment will need some modification due to our current situation and to ensure the safety of our subjects, 
staff and community. The following assessment will be conducted via teleconference: 
1. 
Height and weight- we will obtain self-reported height and weight. If possible, we will obtain 
measurements at a future face to face visit if available.  
2. 
Physical fitness- we will not collect this information during our scheduled visit. If possible, we will 
conduct this at a future face to face visit if available.  
3. 
Physical function- we will not collect this information during our scheduled visit. If possible, we will 
conduct this at a future face to face visit if available.  
4. 
We will ask the participants questions about their physical activity, their motivation for exercise, and 
their physical and emotional quality of life using teleconference call. Study staff will document the answers. 
5. 
We will mail an activity monitor. For the participant to wear for 7 days, for at least 10 hours per day. We 
will also mail a time log for participants to document the time they wear the activity monitor. We will provide 
mailing supplies to use to mail back the activity monitor.   
6. 
We will ask the participants several questions about their feelings about the study during a brief 
interview. The questions will be similar to those in the questionnaires, but the interview will allow the participant 
to provide more detailed answers. Topics will include how they felt about the mobile device, aspects of the 
game or monitor that were motivating to the participant. The interview will be audio recorded.  
 
We will give the option to participants to complete an assessment visit when the recommended guidelines are 
lifted, and we are able to have a face to face visit. The visit may be completed only if participant is within a two-
month period from their scheduled appointment.  
 
 
Session 4. 12-month assessment (approximately 1 hour) 
 
The visit will be conducted using teleconference communication (examples: via phone, skype, zoom)  
 
Ongoing participants will complete Session 4: 12-month assessment using teleconference. Some of the 
assessment will need some modification due to our current situation and to ensure the safety or our subjects, 
staff and community. The following assessment will be conducted via teleconference: 
1. 
Height and weight- we will obtain self-reported height and weight. If possible, we will obtain 
measurements at a future face to face visit if available.  
2. 
Physical fitness- we will not collect this information during our scheduled visit. If possible, we will 
conduct this at a future face to face visit if available.  
3. 
Physical function- we will not collect this information during our scheduled visit. If possible, we will 
conduct this at a future face to face visit if available.  
4. 
We will ask the participants questions about their physical activity, their motivation for exercise, and 
their physical and emotional quality of life using teleconference call. Study staff will document the answers. 

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5. 
We will mail you an activity monitor. For the participant to wear for 7 days, for at least 10 hours per day. 
We will also mail a time log for participants to document the time they wear the activity monitor. We will provide 
mailing supplies to use to mail back the activity monitor.  
6. 
 If we did not perform the brief interview during the six-month visit. We will ask the participants several 
questions about their feelings about the study during a brief interview. The questions will be similar to those in 
the questionnaires, but the interview will allow the participant to provide more detailed answers. Topics will 
include how they felt about the mobile device, aspects of the game or monitor that were motivating to the 
participant. The interview will be audio recorded.  
 
We will give the option to participants to complete an assessment visit when recommended guidelines are 
lifted, and we are able to have a face to face visit. The visit may be completed only if participant is within a two-
month period from their scheduled appointment. 
 
 
Mailed questionnaire assessments 
 
We will contact participants to ask to complete a set of questionnaires via teleconference. 
 
Additional study-related procedures 
 
Participants will continue to participate in brief (<15 minute) phone calls during the initial six month period of 
the study. 
 
During the intervention period, we will continue tracking participants activities at a distance by “friending” 
participants on the mobile applications. Though we will carefully watch participants pattern of activity, we will 
not be personally supervising the exercises. Each week, participants will be able to ask questions and receive 
tips and feedback on their progress during the phone calls. However, we will not be providing participants with 
specific oversight or guidance during their exercise sessions themselves. Study staff will not encourage 
exercise outside the participants home but rather other alternatives at the participants home will be encourage.  
 
Unscheduled Visits/Phone calls: If we encounter any technical difficulties with the study material, we will 
troubleshoot the equipment by phone. We will be available by email and phone for technical consultation.  
 
We will reply to texts/emails/phone calls during business hours for technical problems or to schedule 
calls/assessments. After hours texts or calls will only occur if pre-arranged. We may contact participants via 
phone, text, or email to schedule appointments, the day before an appointment as a reminder, and if we have a 
question or concern regarding their participation such as following up on questionnaire responses or adverse 
events. Additional calls/texts/emails may occur to arrange mailing of accelerometers prior to 6 month and 12 
month assessments.  
 
Figure 6.2. Screenshots from Zombies, Run! game 

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The first screenshot above shows the timeline of a walk. An audio clip from the story (which involves reuniting 
a father and child the player rescues) is followed by a song of the user’s choosing. In this case, immediately 
upon beginning the song, a zombie chase occurred and was successfully completed. The player then picked 
up several virtual supplies during the rest of the song. Once the song was complete, another audio clip began. 
The third screenshot shows the base building portion of the game. Players use their virtual supplies to build 
their home base. Using supplies poorly or failing to protect the base adequately can have negative 
consequences in-game.  
Table 6.4 displays how several theoretical behavioral change strategies are matched to Self-Determination 
Theory constructs and narrative transportation in the games chosen for this intervention.  
Table 6.4. Examples of theoretical constructs matched to behavior change methods and strategies  
Construct 
Behavior change method 
Specific strategies 
Autonomy support 
Meaningful choices 
Base building, choosing paths, choice of music, choice of character actions 
Haptic/motion controls 
Inputs are task-specific and realistic, e.g. players walk as they “walk” in-game 
Competence support 
Verbal persuasion 
Other characters reinforce competence, e.g. “You did it!” 
 
Modeling 
Role-play as fit character, other fit characters serve as models 
 
Feedback 
Run logs, charts, zombie moans get louder as they get “closer” 
Relatedness support 
Identification 
Wishful identification, perceived similarity 
 
Parasocial interaction 
Become invested in compelling characters; feel like part of a social group 
Narrative 
transportation 
Second-person narrative 
“You” are addressed by other characters 
Engaging story 
Suspenseful storyline with twists, action, character development 
 
Well-liked characters 
Two main non-player characters and a large supporting cast 
 F.5. Self-monitoring Intervention 
Participants randomized into the self-monitoring intervention will receive a walking app preloaded onto an iPod 
touch device, headphones and an armband for using the device, and $55 in credit towards purchasing music 
and/or additional in-app features. The app Runkeeper (FitnessKeeper, Inc., Boston, MA) was chosen because 
it includes the self-regulatory tools typical of walking/running apps without additional game- or narrative-related 
components. Users set up music playlists to listen during walks and indicate when they wish to begin and end 
their walk. On the iPod, the app measures length of time as well as steps using the device’s accelerometer. 
Participants may also enter additional self-reported information, such as their mood upon completing the walk.  
Counseling will include standard self-regulatory skill building content from interventions based on Social 
Cognitive Theory, addressing behavior change techniques related to goal-setting, self-monitoring, feedback, 
problem solving, and action planning. In order to ensure that equal attention is offered to both intervention 
groups, counselors will spend additional time with the self-monitoring group participants by discussing 
monitoring and feedback topics in greater depth and with specifics related to the app (e.g., longer discussion of 
comparisons to past performance along with a guided tour through the app’s walking logs). The purpose of the 
extra time spent with these participants is to match the time spent in the narrative and game group discussing 
narrative-specific topics. 
F.6. Measurement 
Table 6.5 displays information on the physiological and anthropometric outcomes to be assessed. Physical 
activity will be measured objectively using Actigraph wGT3X BT monitors. Wear time will be seven days at 

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each assessment point. Because continuous measurement is not feasible, a week-long sample will be taken at 
the three assessment periods. Estimates will be valid if the monitor is worn ≥ 10 hours per day on ≥ 4 days. 
Non-wear time will be determined by 60 or more of consecutive minutes of zero activity counts. Based on 
criteria used for the NHANES surveys, epoch length will be one minute, and activity counts over 2020 per 
minute will be considered moderate-vigorous intensity.134 Physical activity will be measured as minutes per 
week of moderate-vigorous intensity activity. Measurements from the mobile devices will also be abstracted 
and used as an exploratory secondary measure of physical activity. A validated and widely used self-report 
measure (CHAMPS) will also be used to estimate total caloric expenditure at all time points, including follow-
up. The objective measure of minutes per week  (measured by the armband) at 6 months will be the primary 
endpoint of the study, with the self-report measure providing additional insight into activity types and overall 
caloric expenditure. 
Specific quality of life-related outcomes (depression, pain interference, anxiety, self-reported function, and 
sleep disturbance) will be measured using PROMIS computer adapted testing at 0, 6, and 12 months.135 
Participants will be emailed links to the assessment website (which stores information by ID number on a 
secure server). All item banks for each construct include a number of items. The computer adapted testing 
procedure uses item response theory to determine which items are shown to participants based upon their 
previous responses. No more than 12 items per construct will ever need to be answered by participants.Table 
6.5. Measurement of outcomes 
Variable 
Measure 
Specific measurement 
Months 
Assessed 
References 
Physical 
activity 
Actigraph wGT3X BT 
Minutes of moderate-vigorous PA over 7 
days 
0, 6, 12 
136 
Objective measurement from application  
Frequency and duration of MVPA, 
steps, miles walked per day 
weekly 
N/A 
CHAMPS self-report questionnaire 
Kilocalorie expenditure from physical 
activity per week 
0, 6, 12 
137 
Physical 
function 
Senior Fitness Test 
Chair stand, back scratch, chair sit and 
reach, 8 foot up and go 
0, 6, 12 
138 
Fitness 
Six-minute walk test 
Yards walked in 6 minutes on standard, 
marked track area 
0, 6, 12 
139 
Anthropo-
metrics 
Height , weight (Tanita, Arlington 
Heights, IL), waist circumference 
Centimeters, kilograms 
0, 6, 12 
N/A 
Quality of 
life 
Functional Assessment of Cancer 
Therapy - Breast 
Physical, social, functional, emotional, 
breast specific  
0, 6, 12 
140 
Intermediate outcomes 
We hypothesize in our conceptual model that several motivational and identity variables may mediate 
the relationship between group assignment and physical activity. Exercise identity will be measured using the 
Exercise Identity Scale,141 a 9-item scale with subscales of exercise role identity (“Others see me as someone 
who exercises regularly”) and exercise beliefs (“Exercise is something I think about often”). Responses range 
from 1 (“Strongly disagree”) to 7 (“Strongly agree”). This measure is widely used with a reported Cronbach’s 
alpha of .94, and several factor analyses have confirmed this factor structure.142,143 
 
Motivation will be measured using the 19-item Behavioral Regulation in Exercise Questionnaire-2, 
which measures external (“I exercise because other people say I should”), introjected (“I feel guilty when I don’t 
exercise”), and identified regulation (“I value the benefits of exercise”), amotivation (“I don’t see why I should 
have to exercise”), and intrinsic motivation (“I exercise because it’s fun”).144 We will also include four items to 
measure integrated regulation (“I consider exercise a fundamental part of who I am”), which is not traditionally 
included in exercise measures but which has been found to be an important predictor of exercise behavior.145 
Responses are provided on a 5-point Likert scale from 0 (“Not true for me”) to 4 (“Very true for me”). The 
complete questionnaire with integrated regulation questions has shown reliability (between 0.70 and 0.93 for 
the subscales) and predictive validity.145 A psychometric investigation showed discriminant validity between 
integrated regulation and exercise identity; though similar, these measures represent conceptually different 
latent constructs.143 
Other variables  
We will measure several other variables in the conceptual model that relate to games and narrative. 
Narrative transportation will be measured using Green and colleagues’ Narrative Transportation Scale.146 A 15-
item version will be used, which will include four items related to “imagery” that are specific to characters in the 
game (“While playing the game, I had a vivid image of Sam Yao”) as well as the standard 11 items relating to 
cognitive (“I was mentally involved with the game while playing it”) and affective (“The game affected me 

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emotionally”) aspects of transportation. Responses will be provided on a seven-point Likert scale with anchors 
“very much” and “not at all.” This scale is widely used and has demonstrated reliability (alpha > .70) in previous 
experiments using video games147 and diverse samples of adult women viewing cancer-related narratives.148  
Only participants in the narrative game group will complete this scale, as its questions do not make sense in 
the absence of a storyline.  
We will pilot test use of the Presence Self-Assessment Manikin as a crude indicator of immersion 
applicable to both applications. This measure consists of a row of five pictures corresponding to a nine-point 
Likert scale and has demonstrated predictive validity in a previous study of narrative video games.149 The 
pictures show a figure at various distances from a TV screen. Respondents are told that “the pictures go from a 
person who feels he or she is inside the picture, a part of the story, a part of the action on the left end, to a 
person who feels he or she is outside the picture, removed or separated from the story, not part of the action 
on the right end.”  
The Exercise Imagery Questionnaire is a widely-used measure that includes three subscales: 
appearance (“I imagine a leaner-me from exercising”), techniques (“When I think about exercising, I imagine 
my form and body position”), and energy (“To get me energized, I imagine exercising”).150 An additional 
subscale related to enjoyment (“When I think about exercise, I imagine myself having fun while exercising”) will 
be included.151 The resulting scale has 12 items and responses range from 1 (“Never”) to 9 (“Always”). 
Cronbach’s alphas ranged between 0.79 and 0.93 for the four subscales151. Tests of predictive validity have 
found relationships in the expected directions; for example, appearance imagery predicted controlled 
motivation, whereas enjoyment and technique imagery predicted autonomous motivation151. 
Character identification cannot be accurately compared across groups, as the monitoring app does not 
include characters. To provide a proxy for character identification, we will use the procedure described by 
Przybylski and colleagues for investigating discrepancy between the ideal self and self while playing the 
game/using the app.61 Participants will complete the Ten Item Personality Inventory with reference to their ideal 
self (at baseline), then regarding themselves while using the app (other time points). Correlations between 
ideal self and game-self for each of the items will be averaged, with neuroticism items reverse-coded, to create 
a number between -1 and 1 that indicates ideal-self and walking-self convergence. This convergence will be 
considered a proxy measure of the extent to which identification with the player character led to “trying on” of 
her characteristics. 
The Play Experience Scale is a 16-item scale made up of four subscales: freedom (“I was able to make 
the game do what I wanted it to”), no extrinsic (“I was not worried about someone judging how I performed in 
the game”), play-direct (“I would characterize my experience with the game as playing”), and autotelic-focus 
(“When I was using the game, I was focused on the task at hand”). Responses range from 1 (“Strongly 
disagree”) to 6 (“Strongly agree”). This is a relatively new scale with few published studies using it, but it has 
demonstrated reliability (alpha > .80) and convergent validity with intrinsic motivation (r = .79).152 
The Basic Psychological Needs in Exercise Scale will measure autonomy (“I feel that the way I exercise 
is the way I want to”), competence (“I feel that exercise is an activity which I do very well”), and relatedness 
(“My relationships with the people I exercise with are very friendly”). Responses to this 11-item scale use a 1 – 
5 Likert scale (“I don’t agree at all” to “I completely agree”). Reported alphas for the subscales were 0.75 or 
higher.153 This scale has been used similarly in past studies, for example to investigate the relationship 
between perceived competence and exercise role identity (partial r = 0.20).142 
At baseline, demographic information will be collected regarding gender, race, and age. Cancer-specific 
information will also be collected regarding time since diagnosis, type/stage of breast cancer, and type of 
treatment. Participants will complete the Transportability Scale to investigate their tendency towards narrative 
transportation.154 We will include treatment status as a covariate in our outcomes models to take into account 
any variability associated with treatment status. 
 
Acceptability and process measures 
 
 
 
Acceptability and usability items will be adapted from Vandelanotte and colleagues.155,156 Process measures 
for both groups will include logs of completed counseling phone calls, attrition, and adverse events. Objective 
process measures will also be recorded from the two apps. Zombies, Run! and Runkeeper will  send exercise 
session information to the Runkeeper service, where an interventionist account will “friend” the participant’s 
account. (Participants will not have access to the Runkeeper account.) Number of walks per week, total 
minutes per week, and steps during walks per week will be abstracted from the website.  

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For the self-reported measures, participants will have the option to complete them on paper or on a secure 
website. The same website that houses PROMIS measures can be adapted to include our other questionnaire 
items for those who choose the Internet option. 
At the 6 month assessment or 12 month assessment (if not collected at 6 months), participants will discuss 
intervention acceptability and individualization during in-depth interviews, which have been recommended as a 
method for improving the cultural sensitivity of interventions.157 The interview guide will include questions 
related to how well the app met their individual needs and if they felt it could be tailored to their preferences. 
We will concentrate on personal barriers to physical activity and how apps could be individualized to better 
address those barriers. The questions about narrative, for the enhanced group only, will qualitatively 
investigate potential effects of narrative transportation on attitudes, motivation, and behavior. In addition to 
interviews with participants, we will also recruit 10 stakeholders from the community and ask them the same 
questions after a brief orientation to the study materials to be discussed. Stakeholders will be identified via pre-
existing stakeholder networks and previous participants who have expressed interest in helping with 
intervention adaptation. Results of these interviews will be used to further adapt the intervention for better 
cultural sensitivity. Table 6.7 shows example questions. 
Table 6.7. Selected questions from interview guide 
Topic 
Question 
Individualization 
Did you feel that the app was something you could easily adapt to fit your needs and preferences? 
 
Is there a way the app could have been better designed to be more appropriate for you or someone like you? 
Narrative 
How much did you feel like the characters in the game resembled you? 
 
Did playing as the main character make you feel differently about yourself? 
F.7. Power and sample size 
This study is powered to detect differences between the two groups in minutes of moderate-vigorous physical 
activity at 6 months. We used G*Power to calculate sample size based on several studies that are similar to 
this one. Similar trials of telephone counseling and activity monitoring among BC survivors produced effect 
sizes ranging from 0.53 to 0.82.158-160 Because our study includes a low-intensity control group that we 
anticipate will produce a weak effect at 6 months, we have powered for a conservative effect size for physical 
activity at 6 months of approximately d = 0.65, which would require an N of 78 for 80% power at an alpha of 
0.05. This effect size translates to a between groups difference of approximately 20 minutes per week (SD = 
30 minutes). An N of 120 would allow a fully powered test of physical activity even in the case of 20% attrition 
and higher variability than expected (i.e., lower effect size).  
Similar studies that investigated maintenance are so few (three to our knowledge) and show such disparate 
results that power was difficult to calculate for this effect. For example, Rogers et al. report large differences in 
change scores between groups from baseline to the end of maintenance (79 vs. -22 minutes per week; 3 
month follow-up),161 whereas Vallance et al. report smaller differences (24 vs. -14 minutes per week; 6 month 
follow-up).162 Even assuming large standard deviations for these change scores, our sample should be 
sufficient to detect group differences during the maintenance period as well. 
F.8. Statistical analysis  
The primary endpoint of this study will be behavioral change in physical activity at 6 months (Aim 1). Our 
primary hypothesis is: Participants who receive the enhanced intervention will spend more minutes per week in 
moderate-vigorous physical activity at 6 months than will those in the standard group. To test this hypothesis, 
we will use an analysis of covariance to test the difference between groups at 6 months, controlling for 
baseline. Missing data will be imputed. As a secondary analysis, we will use linear mixed modeling to 
investigate changes in physical activity over time at baseline, 6, and 12 months. This procedure will provide 
necessary information for powering a subsequent larger trial that will require complex modeling of multiple time 
points. We will also use multiple imputation techniques prior to all analyses to ensure that missing data due to 
attrition do not bias our results. Analyses will be performed using SAS 9.2 (SAS, Inc., Cary, NC). Dr. Lyons and 
the research assistants will conduct all analyses in collaboration with biostatisticians from the biostatistics key 
resource in the Institute for Translational Sciences. Outcomes and effect sizes for other variables will be 
assessed using the same protocol. 
Interviews with participants and stakeholders will be transcribed and coded by two trained coders. Code lists 
will initially be derived from Self-Determination Theory and theories of narrative transportation. Then, coders 
will use grounded theory to derive codes based on themes brought up by participants.163 We have successfully 
used this procedure in the past.92 NVivo qualitative software will be used to code and compare codes across 

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multiple coders.  
F.10. Potential limitations and alternative approaches 
Several limitations might hinder the project’s progress.  
F.10.a. Recruitment difficulties. First, we may have difficulty recruiting a sufficiently large sample.  We will 
approach appropriate cancer and volunteer registries for recruitment such as the UTMB cancer registry and 
MD Anderson registries (email and/or phone calls). We have partnered with several area volunteer groups 
through which we plan to recruit, and we have budgeted for continuous newspaper, radio, and television 
advertisements throughout the three year data collection period. UTMB has extensive resources for assisting 
with recruitment, including volunteer registries and a recruitment core. If we fell behind schedule in recruitment 
progress, we would increase our efforts and expand recruitment to include neighboring counties (including 
southern Harris County, location of Houston, and up to Victoria County) and additional UTMB and M.D. 
Anderson clinics. Recruitment from M.D. Anderson clinics is feasible, as long drives are very common in the 
Houston-Galveston area. Recruitment of MD Anderson patients will occur in person at MD Anderson and joint 
MD Anderson/UTMB clinics as well as by phone (following the same procedures used to identify UTMB 
patients to approach, except by phone rather than in-person). For the two pilot studies Dr. Lyons is currently 
conducting, many participants live in surrounding areas ≥ 30 minutes’ drive away from UTMB but are still 
willing to come in for assessments. The Breast Health Center at UTMB’s mainland facility (approximately 30 
minutes from Galveston and 30 minutes from downtown Houston) offers the opportunity to conduct 
assessments closer to Houston. We will accommodate based on location and travel convenience. We have 
collaborated with oncologists at various clinics to expand our effort in recruitment. A HIPAA waiver request 
form has been completed. With the oncologists approval, we will pre-screen patients via medical records for 
eligibility. The oncologists will refer their patients. We will not approach patients unless we have oncologists 
and patients permission.   
We have allowed additional time during the five-year award period such that if recruitment is not complete in 
the first three years, we can continue data collection through the fourth year and still have one year for analysis 
and dissemination. If absolutely necessary, we can expand our inclusion criteria to include women with other 
cancers; we do not anticipate this being necessary, however. 
F.10.b. Retention difficulties. The intervention and maintenance periods of the study together equal 12 
months of follow-up. We have developed procedures, both within the lab and on a larger scale in the Clinical 
Research Core of the Claude Pepper Older Americans Independence Center at UTMB, for regular participant 
contact to ensure continued participation. These contacts include reminder postcards, brief phone 
confirmations of contact information, and collection of information on friends/family who can be listed as 
secondary contacts in case contact information for a participant changes unexpectedly. We will send a Thank 
you/holiday card during the study participation.  
F.10.c. Technical difficulties. The monitors and/or application may present technical obstacles to some less 
tech-savvy participants. We will provide extensive technical assistance as needed. We will be available by 
email and phone for technical consultation (which we will log and measure), and will provide in-depth illustrated 
instructions with troubleshooting tips and frequently asked questions as part of the manual. We will allow up to 
one in-person meeting for technical support. We will reschedule an assessment visit twice if necessary. Based 
on our interventions thus far with older adults using tablets and smartphones, we believe that technical issues 
will not be so great as to reduce feasibility or acceptability. In case of a broken/lost ipod, we will lend one ipod 
for the duration of the study. We will also replace a lost charging cord one time if necessary. 
F.10.d. Phone Calls/Communication. The calls will be generated by the research staff weekly for 3 months 
and monthly until 6 months (we will call two times within 15 minutes of weekly counseling phone call and 
arrange one make-up per week if necessary) from their randomization date. Staff will view the list on a weekly 
basis to make sure that calls are made on time. Once the call has been successful and the forms completed, 
or after 3 attempts are made, we will document the number of attempts made, the date of the last phone call 
and if it was successful. If a counseling call lasts longer than 20 minutes, we will end the call as quickly as 
possible. We will reply to texts/emails/phone calls during business hours for technical problems or to schedule 
calls/assessments. After hours texts or calls will only occur if pre-arranged for the purposes of picking up study 
materials or after-hours counseling calls. We may contact participants via phone, text, or email to schedule 
appointments, the day before an appointment as a reminder, and if we have a question or concern regarding 
their participation such as following up on questionnaire responses or adverse events. Additional 
calls/texts/emails may occur to schedule dropping off accelerometers prior to 6 month and 12 month 

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assessments. Text messages are optional. Message and data rates may apply. Any in-person contact that 
occurs to drop off an accelerometer will be minimal and only for the purposes of providing the monitor and 
instructions for its wear. 
F.11. Timeline 
We anticipate that data collection for this project will occur during the first 4 years of the award period, with the 
final year dedicated to data cleaning, evaluation, dissemination, and intervention protocol refinement (or, in the 
case of delays, completing data collection as well). The timeline for the award period is displayed in Table 6.8. 
Table 6.8. Timeline 
 
Year  1 
Year 2 
Year 3 
Year 4 
Year 5 
 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
Materials purchasing and preparation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
RCT participant contact period  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
RCT maintenance observational period 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
RCT evaluation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Results dissemination (manuscripts, grants) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Deliverables for this project include conference presentations, published manuscripts, counseling scripts, study 
protocols, and grant applications. We anticipate at least one publication related to the study per year, with 
potential examples shown in Table 6.9. Because this trial uses novel technology-based methods, is one of few 
studies that includes a maintenance period, and is fully powered on its primary behavioral outcome, we expect 
the outcomes papers to be published in high-impact journals. Targeting high-impact medical journals that are 
read by practitioners in addition to researchers (e.g., JAMA Internal Medicine, J Clin Oncol,) is part of our 
strategy for speeding dissemination. Ancillary papers on motivation, qualitative results, and methodology will 
be submitted to well-regarded discipline-specific journals. Data or specimens collected in this research might 
be de-identified and used for future research or distributed to another investigator for future research without 
your consent.   
Table 6.9. Examples of potential manuscripts based on study findings 
Upon completion of data collection for the randomized controlled trial, we will draft an application for an 
independent research award (e.g., R01, Research Scholar Award, etc.) to fund a follow-up project. The 
intervention content will be modified based on process and outcome evaluation findings. The larger sample 
and funding of such an award will allow adequate power to detect differences in more distal health outcomes 
over longer intervention and maintenance periods, to formally test mediation, and to investigate moderation by 
race/ethnicity. Our overarching goal is to create a successful program that can eventually be incorporated into 
survivorship care plans and implemented on a large scale. The preliminary data provided by this research 
project, in combination with the training activities discussed elsewhere in this application, will provide the 
necessary foundation upon which a truly disseminable program can be built.   
Year 
Paper subject 
1 
Protocol and rationale for the study  
2 
Review/meta-analysis related to video game intervention studies 
3 
Lessons learned paper regarding recruitment, retention, and process evaluation 
4 
6-month outcomes paper  
5 
12-month outcomes paper  
 
Quality of life and psychological outcomes paper 
 
Qualitative cultural appropriateness and acceptability paper 

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G. EXPERIMENTAL DETAILS  
Randomization details 
Participants will be randomized using sequentially numbered opaque sealed envelopes. Group assignments 
will be written on pieces of paper, placed under a piece of carbon paper, wrapped in aluminum foil, and then 
sealed one per opaque envelope. The envelopes will be then thoroughly shuffled and numbered sequentially. 
Envelopes will be assigned to participants after baseline assessment (which will occur after orientation) in 
order of presentation by a member of the research team blinded to the original randomization process. The 
participant’s ID number will be written on the envelope to ensure that the carbon paper serves as an audit trail. 
Questionnaire content 
Tables 6.9 and 6.10 display the content of several of the questionnaires to be used in this intervention, to 
provide context as to the nature of the theoretical constructs measured. All of the measures shown below use 
Likert-type response scales 
Table 6.9. Questionnaire items related to Self-Determination Theory  
The nature of narrative transportation scales renders comparisons across groups difficult. Thus, we have 
included several different scales to measure different aspects of the construct. For measurement within the 
enhanced group, we will use the Transportation Scale,146 which is widely used in the literature, and the 
Narrative Engagement Scale,164 which provides subscales that may point to interesting areas for future work 
(narrative understanding, attentional focus, narrative presence, and emotional engagement). To compare the 
two groups, it was necessary to use a more general measure of presence (also known as engagement or 
immersion). Table 6.10 shows the items from the two narrative-related scales. Below the table, we have 
included a self-assessment manikin that is commonly used for brief but valid investigations of a general sense 
of engagement during a mediated experience (using an app, watching TV, playing a game, etc.).165 
Motivation 
I exercise because other people say I should 
I feel guilty when I don’t exercise 
I value the benefits of exercise 
I exercise because it’s fun 
I don’t see why I should have to exercise 
I take part in exercise because my friends/family/partner say I should 
I feel ashamed when I miss an exercise session 
It’s important to me to exercise regularly 
I can’t see why I should bother exercising 
I enjoy my exercise sessions 
I exercise because others will not be pleased with me if I don’t 
I don’t see the point in exercising 
I feel like a failure when I haven’t exercised in a while 
I think it is important to make the effort to exercise regularly 
I find exercise a pleasurable activity 
I feel under pressure from my friends/family to exercise 
I get restless if I don’t exercise regularly 
I get pleasure and satisfaction from participating in exercise 
I think exercising is a waste of time 
Basic 
psychological 
needs 
I feel I have made a lot of progress in relation to the goal I want to achieve 
The way I exercise is in agreement with my choices and interests 
I feel I perform successfully the activities of my exercise program 
My relationships with the people I exercise with are very friendly 
I feel that the way I exercise is the way I want to 
I feel exercise is an activity which I do very well 
I feel I have excellent communication with the people I exercise with 
I feel that the way I exercise is a true expression of who I am 
I am able to meet the requirement of my exercise program 
My relationships with the people I exercise with are close 
I feel that I have the opportunity to make choices with regard to the way I exercise 

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Table 6.10. Questionnaire items related to Narrative Transportation 
Below is the presence Self Assessment Manikin, with the instructions provided to participations: 
Please use the figures below to indicate your feelings or emotional response to the game. The pictures go from 
a person who feels he or she is INSIDE THE PICTURE, A PART OF THE STORY, A PART OF THE ACTION 
on the left end, to a person who feels he or she is OUTSIDE THE PICTURE, REMOVED OR SEPARATED 
FROM THE STORY, NOT PART OF THE ACTION on the right end. Please circle the number for the picture, 
or the space between any two pictures, that best represents how you felt while using the app. 
 
 
 
         1          2         3         4         5          6        7          8         9 
Transportation 
Scale 
While I was playing the game, I could easily picture the events in it taking place. 
While I was playing the game, activity going on in the room/space around me was on my mind. 
I could picture myself in the scene of the events described in the game. 
I was mentally involved in the game while playing it. 
After finishing the game, I found it easy to put it out of my mind. 
I wanted to learn how the game ended. 
The game affected me emotionally. 
I found myself thinking of ways the game could have turned out differently. 
I found my mind wandering while playing the game. 
The events in this game are relevant to my everyday life. 
The events of the game have changed my life. 
While playing the game I had a vivid image of my character. 
Narrative 
Engagement 
Scale 
At points, I had a hard time making sense of what was going on in the game. 
My understanding of the characters is unclear. 
I had a hard time recognizing the thread of the story. 
I found my mind wandering while using the game. 
While using the game I found myself thinking about other things. 
I had a hard time keeping my mind on the game. 
While using the game, my body was in the room, but my mind was inside the world created by the story. 
The game created a new world, and then that world suddenly disappeared when the game ended. 
At times during the game, the story world was closer to me than the real world. 
The story affected me emotionally. 
During the game, when a main character succeeded, I felt happy, and when they suffered in some way, I felt sad 
I felt sorry for some of the characters in the game. 

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Counseling content example 
Below, we present an example from our weekly brief counseling guides. The content and structure of the 
guides was taken from previous studies performed by co-mentor Karen Basen-Engquist. The themes for each 
week reflect standard behavior change counseling content and techniques, such as stimulus control, problem-
solving, goal-setting, etc. 
Week 3. Uncovering Barriers  
[Discuss exercise progress report abstracted from application – ask for totals from the feedback screen(s)] 
Last session we discussed finding times to fit in exercise. You mentioned that you wanted to try fitting in exercise 
______________. Did you try it? Did you develop plans for the rest of the week? (YES NO) Were you able to fit 
in exercise in times that you hadn’t before? What were they?_________________________________ 
We are going to use something called the IDEA process to examine ways to overcome barriers to exercise. The 
IDEA process stands for Identify, Develop, Evaluate, and Analyze. Let’s choose one barrier and problem-solve 
that barrier.  
I-Identify problem.____________________________________________________ 
D- Develop creative solutions. What are some possible solutions? (just brainstorm as many as you possibly can) 
____________________________________________________________________ 
E- Evaluate the solutions and select the one you are most likely to implement and develop a specific plan to 
implement._____________________________________________________________________ 
Which solution do you think would be the easiest for you to implement? This week try implement _____________ 
and we can review next week. 
A- After implementing, analyze how well it worked and revise if necessary.  
HMWK: This week, think about the barrier that you chose and implement the plan. Next week we will analyze 
how the plan went. 
 

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