Narrative Visualization for Breast Cancer Survivors' Physical Activity
Phase: NA
Conditions: Breast Cancer
Sponsor: The University of Texas Medical Branch, Galveston

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Title:  
 
 
Narrative Visualization for Breast Cancer Survivors’ Physical Activity 
 
 
 
Principal Investigator:  
Elizabeth J. Lyons, PhD, MPH 
 
 
 
 
301 University Blvd., Galveston, Texas 77555 - 1124 
Phone: (409) 772-2575, Fax: (409)772-2577  
Email: ellyons@utmb.edu 
 
 
 
 
Funding Sponsor:   
National Cancer Institute 
 
 
 
 
 
Clinicaltrials.gov ID:  
NCT03612596 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1. SUMMARY 
Women breast cancer survivors are at increased risk for several negative health outcomes. Physical activity 
can reduce these risks, but activity levels in this population are low. Standard interventions that use self-
regulation techniques (goal setting, self-monitoring, and feedback) are successful in the short term but do not 
produce the long-term activity maintenance needed for optimal health benefits. Their effectiveness might be 
improved by better connecting activity feedback to individuals’ real-life experiences and values. Integrated 
regulation is a form of motivation related to personal values and identity and is strongly related to physical 
activity over time. Increasing this form of motivation could improve upon current intervention strategies, 
particularly in this population. Narrative visualization uses photographic, visual, and text annotation to tell a 
meaningful story with a data chart. This form of visualization can increase reflection, which in turn can predict 
integrated regulation and physical activity. We hypothesize that an intervention that encourages participants to 
create narrative visualizations from their step self-monitoring data will produce greater increases in physical 
activity than a self-regulation intervention. To test this hypothesis, we must first investigate the feasibility and 
acceptability of the narrative visualization intervention in a pilot randomized controlled trial. We will recruit 60 
women breast cancer survivors (aged 55 – 79, < 150 minutes of physical activity per week) in two phases. In 
Phase I, 20 women will use prototype materials for one week and undergo cognitive interviewing to investigate 
feasibly and acceptability. Materials will be revised based on responses for use in the subsequent trial. In 
Phase II, we will randomize 40 participants to receive either the narrative visualization intervention or a 
standard self-regulation intervention for 12 weeks (with 12 weeks of no-intervention follow-up). Both groups will 
receive a wearable activity monitor and feedback app for use during the intervention period as well as an initial 
orientation/goal setting meeting and workbook. In the self-regulation group, participants will receive a workbook 
in which they will write and log their weekly goals. The narrative visualization group will also receive extended 
workbook content, a photo printer, and art supplies. The expanded workbooks will include spaces for posting 
daily photos and drawing explanations of step charts as well as reflection prompts relating the photos and 
charts to personal values and identity. Participants will be assessed at baseline, 12 weeks, and 24 weeks on 
changes to their activity, reflection, and integrated regulation. Feasibility indicators will include wear of the 
monitor and usage of the workbooks. Results from this study will be used to refine the intervention and to 
develop a follow-up study powered to investigate the relationships between reflection, motivation, and activity. 
Our overarching goal is to reduce the burden of cancer and improve quality of life among breast cancer 
survivors. This project represents a critical step towards this goal. Insights from the study will impact research 
and practice by testing a highly novel, scalable, and motivating intervention in a population at unique risk. 
2. BACKGROUND AND RATIONALE 
Breast cancer survivors are at risk for negative health outcomes related to both cancer and its treatment.1,2 
Sustained habitual physical activity (PA) can reduce these risks,3,4 but PA levels are low in this population.5,6 
Self-regulation interventions that use techniques such as goal setting, self-monitoring, and feedback can 
produce short-term PA increases7 but have rarely demonstrated long-term behavior change.8  
A major limitation of self-regulation interventions is the lack of focus on motivation related to personal values 
and identity, which is called integrated regulation.9 Increasing evidence suggests that integrated regulation is 
strongly associated with PA over time.10,11 Individuals who self-monitor PA have reported that their adherence 
decreases over time because the feedback they are provided is inadequate: without an emotional connection 
to their values and everyday experiences, individuals are unsure of how to use and interpret reports of their 
step progress.12,13 Older breast cancer survivors in particular face issues related to the impact of treatment on 
their identities14,15 and desire their step goals and progress to be placed in the context of their broader values.16  
Thus, a method for connecting step data to values, identity, and real-life experiences is needed. Reflection is 
the process of transforming experience into meaning.17 Brief experiments have found that self-monitoring alone 
did not produce reflection,18 and adding reflection prompts to self-regulatory PA programs increased PA.19 
Using visuals to prompt reflection may be even more successful than written prompts.20 Narrative visualization 
consists of using drawings, photographs, and text to annotate data charts to better tell a compelling personal 
story.21,22 This procedure could address limitations of current step self-regulation interventions and promote 
reflection and integrated regulation.  
 
 

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3. SPECIFIC AIMS AND OUTCOMES 
3.1. SPECIFIC AIMS 
Aim 1. Develop and refine reflection materials among a sample of sedentary breast cancer survivors.  
Aim 2. Conduct a pilot randomized controlled trial comparing the self-monitoring + narrative visualization 
intervention to standard self-monitoring. 
• 
2a. Determine the feasibility and acceptability of intervention procedures and materials.  
• 
2b. Compare the effects of the interventions on objectively-assessed PA and psychological outcomes 
at 12 and 24 weeks.  
3.2. Primary outcomes will be feasibility and acceptability. Specifically, indicators of feasibility and 
acceptability will include: 
• 
Attrition per intervention condition as measured by study records 
• 
Adherence to wear of the activity monitor as measured by daily step information in the Fitbit app 
• 
Adherence to use of the workbook as measured by observation of photographs of each workbook 
page (number of photographs taken for values clarification activity, completion of written portion of 
values clarification activity, number of days with written entries, number of days with graphic entries, 
photos pasted into workbook, number of stickers pasted into workbook, number of additional drawings, 
number of “tag” annotations added to graphs, coded level of reflection of written entries) 
• 
Dose delivered as measured by study logs of materials provision 
• 
Dose received as measured by self-report 
• 
Adverse events as measured by self-report and study records 
• 
Acceptability will be measured using quantitative items in the 12 week and 24 week questionnaires as 
well as in the brief interview during the 12 week assessment 
3.3. Secondary outcomes 
• 
Steps. PA will be measured objectively using Actigraph wGT3X BT monitors. Wear time will be seven 
days at 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. Because the emphasis of the intervention content is on walking, steps will be the 
primary measure of PA. We will also investigate minutes of moderate-vigorous intensity PA. 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.23 
• 
Anthropometric measurements will include height (SECA stadiometer; baseline only), weight (Tanita 
research-grade scale), and waist circumference.  
• 
Additional psychological variables. Table 1 shows the variables to be included in questionnaires at 
each time point.  
Table 1. Measures 
Variable 
Measure 
Sub-scales 
Alpha 
References 
Motivation 
Behavioral Regulation in 
Exercise Questionnaire-3 
Intrinsic motivation, amotivation, and integrated, 
identified, introjected, and external regulation 
0.73 to 
0.86 
24,25 
Self-reflection 
Self Reflection and Insight 
Scale 
Engaging in self-reflection, need for self-reflection, 
insight 
0.71 – 
0.91 
26 
Engaged living 
Engaged Living Scale 
Valued living, life fulfillment 
0.78 – 
0.88 
27 
Values 
Chronic Pain Values 
Inventory 
Family, intimate relations, friends, work, health, growth 
0.82 
28 
Basic psychological 
needs 
Basic Psychological Needs 
in Exercise questionnaire 
Autonomy, competence, relatedness 
0.75 to 
0.86 
29 
Exercise identity 
Exercise Identity Scale 
Exercise role identity, exercise beliefs 
0.94 
30 
Body image 
Body Image Scale 
N/A 
0.86+ 
31 
Quality of life 
Functional Assessment of 
Cancer Therapy – Breast 
Physical, social, breast, functional ,emotional 
0.90 
32 
4. STUDY DESIGN 

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This study will combine an initial formative, qualitative study with a pilot randomized controlled trial. The target 
population is breast cancer survivors aged 55 – 79 who are sedentary (< 150 minutes of physical activity per 
week), and who completed their primary cancer treatments at least 6 months prior to enrollment. This trial 
corresponds approximately to phases Ib (formative research to refine the intervention) and IIb (pilot 
randomized controlled trial to investigate feasibility and effect sizes) in the ORBIT model of behavioral 
intervention development. The trial itself will occur at a single center, but recruitment will occur at both UTMB 
and MD Anderson.  
We anticipate that the duration of the Aim 1 phase will be approximately four months. From the beginning of 
recruitment to the final data collection point, we expect the trial to take one year to complete. The trial will 
consist of two arms: the narrative visualization intervention condition and an attention control intervention that 
includes only standard self-monitoring. 
5. Study enrollment and withdrawal 
5.1. Inclusion criteria for Aim 1 
1. Age between 55 and 79 
2. Female 
3. Self-reported diagnosis of breast cancer 
4. Participant is inactive (reports less than 150 minutes of moderate-vigorous intensity activity per week)  
5. Able to read and understand English 
6. Daily access to a smartphone or similar device compatible with Garmin or Fitbit app 
5.2. Exclusion criteria for Aim 1 
No exclusion criteria for the Aim 1 study will be used. 
5.3. Inclusion criteria for RCT 
1. Age between 55 and 79 
2. Female 
3. Self-reported diagnosis of breast cancer 
4. BMI is between 18 kg/m2 and 40 kg/m2 
5. Willingness to be randomized to any condition 
6. Participant is able to walk for exercise 
7. Able to read and understand English 
8. Daily access to a smartphone or similar device compatible with Fitbit app  
9. PAR-Q+ indicates that physical activity would be safe (with note from physician required if any heart-
related questions are endorsed) 
During the COVID-19 pandemic, the following inclusion criteria will be implemented 
10. Must have access to teleconference capability from home (i.e. Skype, FaceTime, Zoom or other 
teleconference programs with smart phone or webcam technology). 
 
5.4. Exclusion criteria for RCT 
1. Participant is active (150 or more minutes of moderate-vigorous intensity activity per week)  
2. Major health interventions such as surgery, radiation, or chemotherapy within the past 6 months 
(adjuvant treatments such as tamoxifen are okay) 
3. Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months 
4. Report a history of orthopedic complications that would prevent optimal participation in the physical 
activities prescribed (e.g., heel spurs, severe arthritis) 
5. Current evidence of cancer  
6. Self-reported smoker 
7. Participant reports psychological issues that would interfere with study completion. Examples will be 
provided to illustrate potential psychological issues, such as dementia or schizophrenia. 
8. Participant reports hospitalization within the past year due to psychiatric problem(s) 
9. Clinical judgment concerning safety 
10. Currently participating in an organized commercial or research exercise program 
11. Another member of the household is a participant or staff member on this trial 
12. Current use of a wearable activity monitor  
5.5. Rationale for inclusion/exclusion criteria 

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We will not recruit individuals who cannot speak English due to the need to understand the app, which is in 
English.  
Participants will likely be moderate risk as designated by the American College of Sports Medicine, and thus 
we want to be conservative in our eligibility criteria. If participants endorse any question on the PAR-Q+, they 
will automatically be ineligible due to unacceptably high risk unless they produce a note from their physician 
clearing them for participation. 
We will focus specifically on cancer survivors who are at least six months post major treatment to ensure that 
complications do not impact the safety of exercises. 
Other exclusion criteria exist to exclude variables that could potentially affect participation in the trial. We will 
also exclude those with a BMI indicating that they are underweight as we are interested in adults of normal 
weight, overweight, and obese status. Underweight may indicate other health problems that could compromise 
participant safety. We will include obese adults up to a BMI of 40, but those over 40 are likely to be 
substantially different from our target population and will require independent study in the future. 
Other health exclusions are for the purposes of safety and unbiased data (e.g., substance use disorder).  
No exclusion criteria or quotas will be related to race, ethnicity, or gender. 
5.6. Recruitment strategies 
Participants will be recruited using several methods: 
1. In-person recruitment at UTMB and MD Anderson clinics 
2. Phone and email screening of eligible patients at MD Anderson clinics 
3. Referrals from practitioners at both institutions 
4. Flyers and brochures available in treatment and waiting areas of both institutions, community clinics in 
Galveston and surrounding areas.  
5. Mailed letters and emails to members of research and cancer registries at both institutions 
6. Targeted Facebook advertisements 
7. Emails to local organization listservs (each institution, local cancer support groups, etc.) 
8. Presentations at local cancer and wellness events 
9. As necessary, newspaper and radio advertisement 
 
Specifically, recruitment of MD Anderson patients may occur by flyer, in-person, by email, or by phone. Study 
staff at MD Anderson will review upcoming patient appointments in the clinic via EPIC. Participants who look to 
be eligible will be called over the phone to explain to them the study procedures and see if they are interested 
in participating. This procedure is regularly used successfully by our collaborators at MD Anderson. Whereas 
at UTMB we must obtain practitioner permission to approach patients, all MD Anderson patients have provided 
consent to be approached by research-related phone calls. Reciprocal approval of all screening materials, 
protocols, etc by the MD Anderson IRB will be obtained prior to any recruitment. Participants will also be 
screened at that time to ensure that they are eligible to participate in the study. If the patient is interested and 
eligible, UTMB study staff will call to set up an appointment for informed consent, baseline assessment, and 
randomization/study orientation. MD Anderson staff will assist with this pre-screening but will not be involved in 
intervention or assessment procedures. MD Anderson clinics will be a recruitment site only, not an intervention 
site (i.e., UTMB consent forms will be used, MD Anderson personnel will not have access to any non-
screening-related study data, etc.). 
 
5.7. Randomization 
A random number generator will be used to create a list of group assignments by ID number. Sheets 
containing group assignments (intervention or comparison group) will be placed in envelopes that are labeled 
with the corresponding ID number. The envelopes will be opaque, and foil will be placed inside to ensure that 
the randomizer cannot see inside. Carbon paper will also be included to provide an audit trail. ID numbers will 
be assigned in the order participants arrive to their randomization visit. Upon opening the envelope, the staff 
member undertaking the randomization will sign and write the date on the envelope. The inner paper that lists 
the group assignment, with the ID, signature, and date written on it via carbon paper, will be kept in the 
participant’s file. 
5.8. Blinding 

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Because of the nature of this behavioral study, participants and interventionists cannot be blinded to their 
group assignment. 
5.9. Participant withdrawal 
Participants may withdraw from the study at any time. Withdrawal prior to the end of the study will not affect the 
safety of participants. The consent form lists the following potential reasons that participants may be removed 
by the investigators: 
• The researchers believe that participation in the research is no longer safe for you. 
• The researchers believe that other treatment may be more helpful. 
• The sponsor stops the research for the safety of the participants. 
• The sponsor cancels the research. 
• You are unable to keep appointments or to follow the researcher’s instructions. 
5.10. Premature termination or suspension of study 
There is no reason to believe that the proposed intervention would produce increased risk as compared to 
standard self-monitoring. Because anticipated risks and benefits to individual participants are small, we do not 
anticipate early termination of the study due to excessive risk or differences in anticipated benefits. 
5.11. Participant remuneration 
For the initial formative study, participants (n = 20) will receive $50 for their participation. Participants in this 
study do not get to keep any of the study materials. For the RCT, participants will receive $50 incentive for 
attending assessments ($25 at 12 weeks and $25 at 24 weeks) and will be able to keep the activity monitors 
and other supplies provided. Parking will also be provided. 
 
6. INTERVENTIONS 
6.1. Description of the active control group intervention 
This group will receive only a wearable activity monitor, app, and workbook. We will use Fitbit. The workbook 
will contain a weekly calendar with prompts to write in that week’s goal and whether each daily goal was 
achieved. Basic pen supplies will be provided for writing in the workbook. At orientation, instruction will be 
provided on the use of the materials, and participants will set long-term (24 weeks) goals and their goals for the 
first week. Goals are based on estimates of appropriate step counts for older adults with chronic illness.33 
Goals will be negotiated with each participant, based on their baseline totals. The suggested progression will 
be from 2 days per week at 8,000 steps (week 1) to 5 days per week at 8,000 or more steps (from week 6 on). 
Negotiated goals are critical in an autonomy-promoting study, to ensure that participants do not feel controlled. 
The standard protocol will include daily reminders to log progress in the workbook negotiated with participants 
and expected to occur via automated phone reminders set to occur every day at a time they choose). After 
their final assessment, participants in this condition will receive the additional supplies given to the narrative 
visualization intervention participants. 
In summary, the active control group will receive an activity monitor, mobile app, and a workbook. This 
workbook will include simple diary-like calendar pages. Participants will be instructed to enter their step count 
into these calendars every night. 
6.2. Description of the narrative visualization intervention 
This intervention builds upon the standard intervention by expanding the workbook and providing art supplies 
and an instant camera for more detailed reflection activities. The orientation meeting will include extended 
instructions on using the additional materials as well as tips and examples for creating narrative visualizations. 

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The workbook will include two pages for each calendar day.      Figure C.1. Example narrative visualization  
One page will include a blank chart for drawing their 
interpretation of their step chart for the day. Ample space will 
be provided for writing, drawing, and placing stickers or 
photos at various points in the chart to represent things that 
happened that day. The workbooks will have sufficient pages 
for 12 weeks of entries. Figure C.1. shows an example of 
narrative visualization, though participants will be 
encouraged to be creative in how they annotate their charts. 
In this very simple example, a standard step chart (taken from the Nike Fuelband app) was annotated with 
emojis to show what was going on that day. Without the annotations, the user would know that she met her 
step goal, but would not know why PA dropped off late in the day. Here, it is clear that a planned running bout 
and a trip to the beach to play with the wharf cats were the causes of the early activity. The lack of activity at 
the end of the day coincided with attending a party, drinking too much, and getting sick. This narrative clearly 
offers a starting point for reflection: perhaps in the future, more pleasant trips to do fun things could be 
planned, and the participant could limit drinking at parties. These visuals also relate the steps to personal 
values, such as spending time outdoors and socializing. Visual triggers provide a foundation for figuring out 
how to interpret PA data and what to do to change behavior in the context of one’s values and identity.  
Table C.1 shows examples of daily and weekly reflection questions that can be answered with a combination 
of text and visuals (please note that these prompts may change based on the results of the Aim 1 interviews). 
We will also include additional one-time prompts to provide context for these reflections. For example, we will 
ask participants in their first week to take photos that represent how they feel about themselves and photos 
that represent their values, following the procedures of a published photo values clarification activity.20 
Art supplies will include 
adequate film for one photo 
per day for 12 weeks, 
decorative tape for pasting 
photos into the workbook, 
writing materials, and stickers 
(e.g., emojis or other 
potentially explanatory pictures).  
In summary, the narrative visualization group will receive an activity monitor, a mobile app, a workbook, and an 
art supply kit. This art supply kit will include an instant camera, writing materials, stickers, photo paper, and 
photo corners for pasting photos into the workbook. The workbook will differ from that of the active control 
group. This workbook will contain a values clarification exercise, which will involve participants taking 10 
photos over a period of about one week. These photos will be of things the participant values and will be used 
as a jumping-off point for connecting personal values to reasons to be physically active. The daily pages for 
entering steps will also be more elaborate than those of the active control group. These pages will include a 
blank graph on which participants will draw their step graph and add text, drawing, and sticker annotations that 
explain what they were doing at different times. There will also be space for including photos of interesting 
things seen on walks (and sufficient photo paper will be provided for daily photos). Daily and weekly reflection 
questions will encourage participants to think about why they were active each day and how their behavior 
changed over time.  
 
Element 
Active control 
Narrative 
visualization 
Activity monitor 
x 
x 
Mobile app 
x 
x 
Reminders to log steps nightly 
x 
x 
Art supply kit (camera, writing 
materials, stickers, photo corners, 
photo paper) 
 
x 
Workbook pages: 
 
 
Daily diary calendar pages 
x 
 
Table 1. Reflection prompts 
Timing 
Prompt 
Daily 
How were you active today? 
 
Why do you think you were (or were not) active today? 
 
What impacted your decisions about activity today? 
Weekly 
Looking back, do you see any patterns in your activity? 
 
How can you take this knowledge and use it to be more active next week? 
 
How do you feel about your progress this week? Do you feel closer to your goals?  

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Values clarification activity 
 
x 
Daily blank graphs 
 
x 
Daily reflection questions 
 
x 
Weekly reflection questions 
 
x 
 
6.3. Administration of intervention 
The interventions are primarily self-guided, with minimal personal attention from interventionists. Participant 
contact with interventionists will occur at the orientation visit only.  
Daily texts/emails that serve to remind participants to complete their workbook page that day will be generic 
and not considered personal intervention. 
6.4. Procedures for training interventionists and monitoring intervention fidelity 
Interventionists will be trained by the Principal Investigator to conduct the orientation visit. Intervention fidelity is 
itself an outcome of this study and as such is detailed in the measures and statistical analysis sections of this 
protocol. 
6.5. Assessment of participant compliance with study intervention 
Participant compliance is an outcome of this study and as such is detailed in the measures and statistical 
analysis sections of this protocol. 
7. STUDY SCHEDULE – AIM 1 FORMATIVE STUDY 
7.1. Screening 
We have collaborated with oncologists at various clinics to expand our effort in recruitment. A HIPAA waiver 
request form has been completed. With the oncologist’s 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 
oncologist’s and patient’s permission. 
Research staff will use the Aim 1 screening guide, either in person or by phone, to determine eligibility in the 
study. Should the participant be found eligible, the staff member will schedule an appointment for informed 
consent and enrollment. 
7.2. Enrollment and provision of materials 
Research staff will conduct the informed consent interview. Once the interview is complete and participants 
have asked any questions they may have, the participant and staff member will each sign two copies of the 
consent form. One copy will be provided to the participant and the other kept for study records.  
The staff member will then use the Aim 1 visit 1 checklist to go through study procedures for this visit. S/he will 
provide participants with materials (activity monitor, workbook, camera, film, writing materials, photo corners, 
stickers) and go over instructions for their use. At the conclusion of the visit, the staff member will schedule an 
appointment for the return visit after approximately one week. 
• 
Obtain and document consent from participant on study consent form 
• 
Administer Aim 1 Visit 1 checklist/interview guide 
• 
Provide and document the following materials: 
o Activity monitor 
o Instant camera 
o Workbook (binder with pre-printed instruction pages for 7 days + values activity + 
troubleshooting guide) 
o Writing materials 
o Stickers 
o Film for camera 
o Photo corners for pasting photos in workbook 
o Bag to hold materials 
• 
Set up activity monitor app on the participants’ mobile device & daily reminder 
7.3. Cognitive interviewing visit 

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An interviewer, who will receive training in cognitive interviewing, will guide participants through orientation to 
the workbook and using the wearable device, mobile app, and photo printer at this initial meeting. Interviews 
one week later will use a combination of think-aloud and probing procedures from a semi-structured guide, as 
has been used in development of other behavioral interventions.34-36 
• 
Collect and document returned materials 
• 
Prepare audio recorder 
• 
Administer Aim 1 Cognitive Interviewing checklist and guide 
• 
Provide participant gift card and document 
 
8. STUDY SCHEDULE - RCT  
 
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. 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.   
 
8.1. Screening 
We have collaborated with oncologists at various clinics to expand our effort in recruitment. A HIPAA waiver 
request form has been completed. With the oncologist’s approval, we will pre-screen patients via medical 
records for eligibility. The oncologists will refer their patients. We will not approach UTMB patients unless we 
have oncologist’s and patient’s permission. 
For patients at MD Anderson clinics, as discussed above in section x, staff will review upcoming patient 
appointments in the clinic via EPIC and call potentially eligible participants. Whereas at UTMB we must obtain 
practitioner permission to approach patients, all MD Anderson patients have provided consent to be 
approached by research-related phone calls and emails. If the patient is interested and eligible, UTMB study 
staff will later call to set up an appointment for informed consent, baseline assessment, and 
randomization/study orientation.  
Research staff will use the RCT screening guide, either in person or by phone, to determine eligibility in the 
study. Should the participant be found eligible, the staff member will schedule an appointment for informed 
consent and enrollment. 
8.2. Enrollment and provision of accelerometer 
Research staff will conduct the informed consent interview. Once the interview is complete and participants 
have asked any questions they may have, the participant and staff member will each sign two copies of the 
consent form. One copy will be provided to the participant and the other kept for study records. The staff 
member will take the participant’s height, weight and waist circumference at this visit and ask several 
demographic questions (age, gender, race) for the purposes of calibrating the accelerometer. Once calibrated 
and activated, the staff member will provide instructions as to wearing the accelerometer for one week. At the 
conclusion of this visit, the staff member will schedule a follow-up appointment for approximately one week 
after the enrollment appointment. 
• 
Obtain and document consent from participant on study consent form 
• 
Obtain height, weight and waist circumference measurements 
• 
Calibrate and activate accelerometer 
COVID-19 adjustments for consenting/enrollment: 
 
• 
The visit will be conducted using teleconference communication (examples: via phone, skype, zoom)  
• 
Consent will be obtained via teleconference call and the study subjects will scan or photograph and 
transmit the signed consent form to us via email or text.  

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• 
Height, weight, and waist measurements- we will obtain self-reported height, weight, and waist 
measurements. If possible, we will obtain measurements at a future face to face visit if available.  
• 
We will drop off and pick up the activity monitor. For the participant to wear for 7 days, for at least 10 
hours per day.  
• 
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.  
• 
We will give participants paper forms of the questionnaires to complete prior to the baseline visit. 
8.3. Baseline and orientation visit 
Participants will return after approximately one week to engage in baseline assessment, be randomized to a 
condition, and to begin the intervention. Baseline assessments will include height, weight and waist 
circumference, collection of the accelerometer and questionnaires. A staff member will randomize the 
participant and then, based on their condition, provide them with appropriate materials. The staff member will 
go over these materials in detail, following a specific checklist. S/he will also check off materials provided on a 
separate log sheet. Participants will engage in a brief goal-setting activity before leaving. 
• 
Collect and document accelerometer 
• 
Check accelerometer data to ensure that they include at least 10 hours on at least 4 days 
• 
*If not enough days are found, request that participant wear an accelerometer for an additional 7 days 
and return for their randomization afterwards 
• 
Administer questionnaires 
• 
Randomize participant 
For the narrative visualization intervention: 
• 
Follow RCT visit 2 checklist to document each step 
• 
Provide activity monitor 
• 
Download activity monitor app onto participant’s mobile device and provide orientation 
• 
Provide workbook 
• 
Orient participant to contents of the workbook 
• 
Provide camera, film, writing materials, stickers, photo corners, film, and bag and provide orientation 
• 
Administer goal-setting activity 
For the self-monitoring only intervention: 
• 
Follow RCT visit 2 checklist to document each step 
• 
Provide activity monitor 
• 
Download activity monitor app onto participant’s mobile device and provide orientation 
• 
Provide workbook 
• 
Orient participant to contents of the workbook 
• 
Provide writing materials 
• 
Administer goal-setting activity 
COVID-19 adjustments for baseline/orientation: 
 
• 
The initial portion of the visit will occur in-person. Study staff will wear personal protective equipment and 
follow safety precautions, such as sanitizing equipment. The in-person portion will consist of obtaining 
measurements, retrieving the activity monitor, providing participant materials, and assisting with 
downloading the Fitbit app onto participant phones. 
• 
The rest of the orientation portion of the visit will be conducted using teleconference communication 
(examples: via phone, skype, zoom)  
8.4. 12 week follow-up 
After approximately 10 weeks, a staff member will document and mail the participant a calibrated 
accelerometer and questionnaires. The staff member will call the participant to ensure receipt and to make 
sure it is fitted correctly. At approximately 12 weeks, the participant will meet with an assessor to measure 
height, weight, waist circumference and collect the accelerometer and questionnaires. A brief interview will also 
occur. Study staff will follow a guide with a checklist to ensure the interview proceeds as planned. 

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• 
Mail accelerometer and questionnaires (approximately 2 weeks before), call to inform participant, and 
document. 
• 
Phone/email/text reminder to bring workbook to appointment (day before) 
• 
Collect accelerometer 
• 
Check accelerometer data to ensure that they include at least 10 hours on at least 4 days 
• 
*If not enough days are found, request that participant wear an accelerometer for an additional 7 days 
and return it in a provided padded, pre-stamped envelope 
• 
Administer or collect questionnaires 
• 
Make copies/take pictures of workbook pages 
• 
Conduct interview according to RCT interview guide and checklist 
• 
Provide gift card and document 
COVID-19 adjustments for consenting/enrollment: 
 
• 
We will collect the activity monitor and questionnaires during a brief in-person visit. Study staff will wear 
personal protective equipment and sanitize equipment as needed. The gift card will be provided at the 
conclusion of this visit. 
 
8.5. 24 week follow-up 
After approximately 22 weeks, a staff member will mail the participant a calibrated accelerometer and possibly 
questionnaires. The staff member will call the participant to ensure receipt and to make sure it is fitted 
correctly. At approximately 24 weeks, the participant will meet with an assessor to measure height, weight, 
waist circumference, collect the accelerometer, and administer or collect questionnaires. 
• 
Mail accelerometer and possibly questionnaires (approximately 2 weeks before), call to confirm receipt, 
and document 
• 
Phone/email/text reminding participant to bring the workbook to appointment (day before) 
• 
Collect accelerometer 
• 
Check accelerometer data to ensure that they include at least 10 hours on at least 4 days 
• 
*If not enough days are found, request that participant wear an accelerometer for an additional 7 days 
and return it in a provided padded, pre-stamped envelope 
• 
Administer or collect questionnaires 
• 
Make copies/take pictures of workbook pages 
• 
Provide gift card and document 
COVID-19 adjustments for consenting/enrollment: 
 
• 
We will collect the activity monitor and questionnaires during a brief in-person visit. Study staff will wear 
personal protective equipment and sanitize equipment as needed. The gift card will be provided at the 
conclusion of this visit. 
• 
While reviewing data in January of 2021, we noticed that many follow-up assessments scheduled after 
March of 2020 were missing. We suspect many of these missing visits were due to COVID-19 in some 
form and wish to investigate and gather as much information as possible from these participants. Thus, 
we are amending our procedures for follow-up to include the possibility of contacting participants more 
than one month after their indicated follow-up time. These visits will be amended to consist only of 
questionnaire, interview, and if possible collection/photography of materials. We have added several 
questions about COVID-19 to our interview guide to find out more about whether or not participants used 
intervention materials during the pandemic. The consent form has been updated to include these 
procedures. When we contact participants with no follow-up data, we will conduct a new consent interview 
and re-consent them using the new form to ensure that they are fully aware of the updated procedures. 
 
8.6. Additional communications with participants by phone, email/text, and in person  
Study staff will ensure that participants have contact information for the research team and knows how to call 
after hours in the case of a question or problem. 

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Participants will be asked (but may decline) to provide alternative contacts to the study staff. At each study 
visit, participants will be asked if there have been any changes in their contact information or that of their 
alternative contacts. 
Attempts at contact will be documented in each participants’ contact log. Information discussed, provided to, or 
obtained from the participant will be documented in the log.  
Study staff will provide basic technical troubleshooting with study devices (Fitbit monitor, app, camera) during 
business hours by text or phone. If necessary, we will set up one meeting per participant to replace broken or 
lost equipment. We will allow one other meeting for technical support of other kinds, if necessary.  
Study staff will contact participants by phone, text or email the day before each appointment. If emailed or text 
regarding the appointment and scheduling, staff will respond. Study staff will also send generic cards at 
approximately 5 months in to the intervention period to remind the participants of their participation in the study 
and that they will be contacted to schedule another appointment at a later date.  
Prior to determining that a participant is lost to follow up form, we will attempt to contact the participant at least 
3 times, attempt contacting the alternative contact(s), and attempt a final contact by mail. A form documenting 
all mailed correspondence will be stored in the participants’ file. 
Participants will be notified that study staff may not respond to non-emergency contacts outside of normal 
business hours. 
Additional contact may occur for the purposes of picking up/dropping off accelerometers or questionnaires. 
Due to difficulties from COVID19 additional contact may occur for the purpose of collecting final 
questionnaires, interview, and collection/photography of material. The following steps will take place if we 
contact a subject for this purpose: 
We will ask for their permission to re-consent for the purpose of collection/photography of material, 
questionnaires, and interview. This visit may be completed by using a teleconference call or in person.  
  
9. ASSESSMENT OF SAFETY 
9.1. Plan for monitoring and safety review 
The Principal Investigator (PI) will be responsible for monitoring the safety environment of participants and 
ensuring that appropriate medical care and coverage is provided to all participants if necessary.  
The PI is also responsible for monitoring procedures during conduct of the study for each participant, including 
eligibility, enrollment, data collection, evaluation of study outcomes, problems with informed consent, and 
subject safety and well-being.  
The plan will include: 
1. Review of screening results by PI 
2. Immediate reporting of adverse events by interventionists to PI 
3. Quarterly review of collected data by PI 
4. Annual review by PI and UTMB IRB 
Screening data will be reviewed during recruitment periods by the PI. Ensuring that any values indicating 
ineligibility and/or unsafe practices are flagged. Flagged participants may be excused from the study or 
instructed on safer practices, as needed. These decisions will be made in consultation with Dr. Volpi.  
In the case of adverse events, standard protocol for reported adverse events will be used. Study data will be 
reviewed by the PI or Co-I, as needed. Finally, the UTMB IRB will review study progress yearly.  
We do not anticipate a strong ethical imperative to cease one of the arms prior to the planned end of the study, 
and thus we will not perform full statistical analysis during these periodic reviews. The reviews will focus on 
indicators of safety for participants, such as large decreases in quality of life or strength, or large weight gains.  
We will not convene an external Data Safety and Monitoring Board. Should the NCI request that we do so, we 
will take advantage of protocols used in the past by investigators associated with the Claude D. Pepper Older 

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Americans Independence Center at UTMB. The center has previously convened external DSMBs for its 
investigators from its external advisory board. 
Anticipated non-serious adverse events include musculoskeletal pain or mild injuries, other non-serious injuries 
(e.g., bruises), minor discomfort, cardiac events, fatigue, and possible loss of confidentiality. If an anticipated 
adverse event occurs, the PI will discuss as soon as possible and determine whether the event requires 
reporting to the IRB and/or to the NCI. The attribution and impact of each event on the overall project’s 
risk/benefit ratio will then be determined in consultation with the Co-Is. 
All unanticipated, serious, fatal, and/or life-threatening adverse events will be immediately reported to the 
UTMB IRB within 24 hours of occurrence. All serious, fatal, and/or life-threatening adverse events will be 
reported to the program officer as well. The IRB and PI are responsible for determining if modifications are 
needed to the consent form and/or protocol based on the event. If a determination is made that participants are 
exposed to unacceptably high risk in comparison to benefit, the study will be suspended until proper 
modifications are made for participant safety. Aggregate reports of adverse events will be prepared in 
consultation with the regulatory key resource of the Institute for Translational Sciences at UTMB and forwarded 
to the IRB for review. 
Should cessation of study activities be required (temporarily or permanently), the program officer will be 
notified immediately. 
9.2. Unexpected problems 
Unexpected problems involve risks to participants that meet all of the following criteria: 
• 
Unexpected in terms of nature, severity, or frequency given the nature of the research and population 
• 
Related or possibly related to participation in the study 
• 
Suggests that the research places participants at a greater risk of harm than was previously known or 
recognized 
Incidents that meet these criteria will require documentation in an unanticipated problem report form submitted 
to the IRB within 1 week. The Principal Investigator will also contact the Program Officer at NCI to determine 
next steps. 
9.3. Expected adverse events 
An adverse event is an unfavorable medical occurrence in a human subject. This population consists of 
women susceptible to adverse events related to age, cancer, cancer treatment, comorbidities, 
overweight/obesity, and sedentary lifestyle. Based on these factors and adverse events that occurred in 
previous similar studies, we anticipate the following potential adverse events: 
• 
Acute mild activity-related injuries 
• 
Acute musculoskeletal pain 
• 
Minor discomfort 
• 
Fatigue 
• 
Cardiac events 
• 
Mild, acute illness 
• 
Complications of ongoing chronic illness(es) 
• 
Acute hospitalization for a specific, unrelated illness (e.g., flu) 
9.4. Characteristics and severity of an adverse event 
• 
Mild events include discomfort without disruption of daily activities. No therapy or only symptomatic 
therapy is required. This level is equivalent to the National Cancer Institute’s Common Terminology 
Criteria for Adverse Events version 4.03 Grade 1 adverse events (mild; asymptomatic or mild 
symptoms; intervention not indicated). 
• 
Moderate events include discomfort sufficient to modify daily normal activity. Specific therapy is 
required. Laboratory test alterations indicate injury without long-term risk. This level is equivalent to NCI 
Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate 
activities of daily living). 

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• 
Severe events include incapacity, inability to work, inability to perform normal daily activity, 
hospitalization required, prolonged emergency treatment required, life-threatening events, laboratory 
tests indicating a serious health threat or permanent injury, and death. This level is equivalent to NCI 
Grades 3 (severe/medically significant but not immediately life-threatening), 4 (life-threatening, urgent 
intervention indicated), and 5 (death). 
9.4.1. Relationship to study participation 
Attribution will be assessed by the PI on a scale used by CRC investigators: 1) not related, 2) possibly related, 
3) probably related, and 4) definitely related to the study interventions. 
9.4.2. Expectedness 
The Principal Investigator will be responsible for determining whether adverse events are expected or 
unexpected. An adverse event will be considered unexpected if the nature, severity, or frequency of the event 
is not consistent with risk information previously described. We may use de-identified photographic copies of 
workbook pages in publications and/or presentations. Photographs including an individual’s face will be 
obscured.  
9.5. Reporting 
All unanticipated, serious, fatal, and/or life-threatening adverse events will be immediately reported to the 
UTMB IRB within 24 hours of occurrence. All serious, fatal, and/or life-threatening adverse events will be 
reported to the program officer as well. The IRB and PI are responsible for determining if modifications are 
needed to the consent form and/or protocol based on the event. If a determination is made that participants are 
exposed to unacceptably high risk in comparison to benefit, the study will be suspended until proper 
modifications are made for participant safety. Aggregate reports of adverse events will be prepared in 
consultation with the regulatory key resource of the Institute for Translational Sciences at UTMB and forwarded 
to the IRB for review. 
Should cessation of study activities be required (temporarily or permanently), the program officer will be 
notified immediately. 
The PI will hold responsibility for monitoring and reporting adverse events of any kind. We do not anticipate 
severe adverse events, though mild and moderate events are possible. The scale to be used is the UTMB 
Clinical Research Center Adverse Event Grading Scale. Examples of each level of adverse event on the scale 
are provided below.  
Table 1. Reporting of adverse events to IRB  
NCI Adverse Event Grade 
Expected 
Unexpected 
Grade 1 
Reporting not required 
Report within 10 days 
Grade 2 
Reporting not required 
Report within 10 days 
Grade 3 (UTMB level 3) 
Report by phone within 24 hours 
Report by phone within 24 hours 
Grade 4 (UTMB level 3) 
Report by phone within 24 hours 
Report by phone within 24 hours 
Grade 5 (UTMB level 3) 
Report by phone within 24 hours 
Report by phone within 24 hours 
The PI will follow the reporting requirements for serious and unexpected adverse events outlined in the UTMB 
IRB Adverse Event Policy. All unanticipated, serious, fatal, and/or life-threatening adverse events will be 
reported to the UTMB IRB within 24 hours of occurrence or recognition. Aggregate reports of adverse events 
will be prepared on an annual basis and forwarded to the IRB at annual review. 
10. STATISTICAL CONSIDERATIONS 
10.1. Study hypotheses 
Aim 1. Participants will… 
• 
Complete >80% of values clarification activities 
• 
Complete >80% of daily workbook entries 
• 
Participants will wear the activity monitor <80% of days 
• 
Report no serious adverse events related to the study 
Aim 2. The narrative visualization intervention will produce, as compared to the self-monitoring intervention at 
12 weeks… 

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• 
Greater physical activity  
• 
Greater intrinsic motivation for activity 
• 
Greater integrated regulation for activity 
• 
Greater perceived autonomy 
• 
Greater perceived competence 
• 
Greater engagement in self-reflection  
• 
Greater insight 
• 
Greater need for self-reflection 
• 
Greater perceived valued living 
• 
Greater perceived life fulfillment 
• 
Greater exercise role identity 
• 
Greater exercise beliefs 
• 
Greater physical quality of life 
• 
Greater social quality of life 
• 
Greater functional quality of life 
• 
Greater emotional quality of life 
Aim 2 feasibility and acceptability hypotheses: 
• 
Participants will complete >80% of values clarification activities 
• 
Participants will complete >80% of daily workbook entries 
• 
Participants will wear the activity monitor <80% of days 
• 
Participants will report no serious adverse events related to the study 
• 
Study records will indicate attrition did not differ by group assignment 
• 
Study records will indicate that all intervention materials were provided as intended 
• 
Study records will indicate that >90% of intervention materials were reported received as intended 
• 
Participants will rate intervention materials >4 out of 5 
10.2. Sample size considerations 
As a Phase Ia evidentiary study, hypothesis tests are not powered to detect statistical significance. A study of 
40 individuals would have 80% power to detect a large effect size of approximately F = 0.45 for an ANCOVA 
model, but we will not interpret statistical significance. Rather, we have set a priori cut points for effect sizes to 
which we will compare our outcomes. These effect sizes represent points at which we can conclude that the 
intervention components adequately impact psychosocial and behavioral outcomes to proceed to further 
testing. For the comparison to the standard group, the intervention group must produce at least a small effect 
size difference in integrated regulation to allow us to proceed to Phase Ib. 
10.3. Final analysis plan 
10.3.1. Qualitative analyses 
Qualitative investigations of interview transcripts and workbook content will be performed using NVivo. We will 
use thematic analysis to create codes to better understand how participants reacted to specific aspects of the 
intervention.37  
Interviews will be recorded and transcribed with interviewer field notes, then the investigators will refine any 
materials or procedures that were flagged by participants. Once the investigators have come to a consensus, 
we will apply insights from this sub-study to orientation procedures and intervention materials as needed. 
We will use Fleck’s procedures for coding reflection levels in the workbook text.38 These procedures involve 
creating “chunks” of content surrounding a particular theme, then rating these chunks against a framework of 
reflection levels. We will count the number of instances of each level of reflection within the text workbook 
responses. Artistic content will be analyzed using standard thematic analysis, as Fleck’s procedures 
investigate reflective text or verbal responses to art rather than reflection in the art itself.  
10.3.2. Quantitative 
All quantitative analyses will be performed by the study statistician, who will be blinded to group allocation. For 
tests of feasibility and acceptability, we will use descriptive statistics only.  

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A priori benchmark indicators will be used from a variety of similar studies (e.g., 80% completion, no serious 
related adverse events) to indicate whether feasibility or acceptability were achieved.  
For quantitative hypotheses, we will use analyses of covariance, controlling for baseline values of the 
dependent variable as well as time since diagnosis. We will follow the intent to treat principle, and imputation 
methods will be used as necessary to account for missing data. As indicated above, these outcomes will be 
used primarily for the purposes of shaping a fully powered follow-up study. 
 
11. ETHICS AND PROTECTION OF HUMAN SUBJECTS 
11.1. Institutional Review Board and ethical standard 
The protocol, informed consent forms, recruitment materials, screening materials, and copies of all written or 
spoken materials/communication provided to participants will be submitted to the UTMB IRB for review and 
approval. Approval of both the protocol and the consent form must be obtained before any participant is 
enrolled. Any amendment to the protocol will require review and approval by the IRB before any changes are 
implemented. 
The investigator will ensure that this study is conducted in full conformity with the principles set forth in the 
Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects Research, as drafted 
by the US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 
(April 18, 1979) and codified in 45 CFR Part 46 and/or the ICH E6. 
11.2. Informed consent process 
All study personnel have attended required courses on human subject protection and HIPAA regulations, and 
certificates of Institutional Review Board training completion are on file at UTMB. Participants that are eligible 
based on initial telephone screening will be invited to attend an initial session. They will be given an individual 
orientation to the study, including information on all aspects of the study. They will be able to ask questions at 
any time. Following this explanation, potential participants will be given informed consent information and 
forms to sign. Only then will participants engage in assessments, be randomized to a group, and proceed with 
orientation to their study group. 
11.3. Exclusion of women, minorities, children, and vulnerable populations 
We will not recruit children, pregnant women, or prisoners for this study. 
11.4. Participant risks 
Risks in this study are moderate and include breaches of confidentiality, minor injuries, and safety. The steps 
taken to reduce these risks include surveillance of exercise patterns (by “friending” participants on the apps 
they are using and reviewing their activity patterns weekly). We acknowledge that, in addition to these related 
risks, many unrelated and/or random adverse events may occur during the study period. Participants may 
catch colds, flu, or other similar sicknesses and may be injured in ways unrelated to exercise. 
All known related risks will be described in the protocol and consent form. 
Confidentiality could be breached, as is a risk in all human subjects research. Sensitive personal health 
information or other sensitive information could be divulged inappropriately to outside sources. 
Injury, pain, fatigue. Participants may experience joint discomfort, muscle soreness, or other minor injuries due 
to increased physical activity. There is a low risk of cardiac events during exercise among deconditioned 
adults, particularly those who are overweight/obese and/or older. 
Psychological stress. Participants may feel uncomfortable due to some of the questions included in the 
questionnaires. 
There is no reason to believe that the proposed intervention would produce increased risk as compared to 
standard self-monitoring. Because anticipated risks and benefits to individual participants are small, we do not 
anticipate early termination of the study due to excessive risk or differences in anticipated benefits. 
11.5. Protection against risks 

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General. Inclusion/exclusion criteria will allow us to exclude from the study anyone who is potentially at higher 
risk for developing complications due to research procedures. Participants will be able to withdraw from the 
study at any time if study procedures are upsetting or painful for them. We will closely monitor all participants 
for adverse events (see data safety and monitoring plan below). 
Confidentiality. All data collected will be confidential. The risk of breached confidentiality of potentially sensitive 
data is minimal and comparable to the risk inherent in any human subjects research project. We will take 
standard precautions to ensure that personal health information is not identifiable, including: 
o Paper copies of questionnaires and screening forms will be kept in a locked file cabinet in the 
research coordinator’s locked office. ID numbers will be used on these forms to match them to 
individual participants. The database matching ID numbers to identifying information will be 
individually password-protected and kept separately on the password-protected server. We will 
abstract wear and step data from their Fitbit app accounts weekly into a database kept on this 
server, but we will not otherwise collect data from the app. 
o Data collected on measurement equipment will be uploaded to the server as soon as possible after 
collection. Then, it will be erased from the equipment. ID numbers will be used for participant 
identification on all physiologic measurement equipment as an added layer of protection. No 
identifying data will be kept on measurement equipment or on portable data storage devices such 
as laptops or USB drives. 
o Transcripts and scans of workbook pages will be saved by ID number, with any identifying 
information redacted. These files will be kept on a password-protected server. 
Injury, pain, fatigue. Exercise may produce minor injuries or, much less likely, adverse cardiac events. Though 
starting an exercise program can be minimally to moderately risky, depending on the individual, when 
participants are properly screened the benefits outweigh the risks. Exercise can improve fitness, quality of life, 
cardiometabolic indicators of health, mood, fatigue, and a number of other outcomes (see research plan for 
references). The goals that we will suggest will increase slowly to ensure safety. Dr. Volpi is a physician. She 
will review all adverse events and data abstracted from the apps that indicate potentially dangerous activities. 
Psychological stress. Participants may refuse to answer any of the questions, take a break, or stop their 
participation. 
11.5. Potential benefits 
Participants may experience improvements in mood and energy levels due to increased physical activity.   
11.6 Future used of stored identifiable data 
No identifiable data will be stored for future research use. 
12. DATA HANDLING AND RECORD KEEPING 
12.1. Data management responsibilities 
The PI is responsible for collection and storage of data on paper, in pdfs of workbook scans, and saved in 
recording equipment. All data of interest will be abstracted into a computer database located on a secure 
UTMB server. Data saved in recording equipment will be erased after transfer to the server.  
Questionnaire data will not be personally identifiable. All questionnaires will use ID numbers for identification 
purposes, and the correspondence of ID numbers to names will be kept in a password-protected file on a 
password-protected, secure server. Databases will use ID numbers for identification of data and will also be 
stored on the secure, password-protected server. 
For non-UTMB study personnel we will use UTMB SharePoint link to provide de-identified information.  
The PI is responsible for collection and storage of all data on paper questionnaires as well as in subsequent 
computer databases.  
12.2. Sources of data 
Participants will provide verbal and written data specifically for research purposes. We will also scan their 
narrative visualizations and reflections in their workbooks for analysis. Research-grade measurement 
equipment (activity monitors, etc.) will capture physiological data. The wearable devices and mobile apps will 

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collect limited data on physical activity as well as manually entered data by the participant. Procedures for 
ensuring the confidentiality and anonymity of these data are discussed below. Only trained study staff will have 
access to written study data. These data will be confidential. 
12.3. Study records retention 
Study documents will be retained for a minimum of 3 years from the date of the final financial report is sent to 
the NCI. No records will be destroyed without written consent of the sponsor, if applicable. 
12.4. Protocol deviations 
A protocol deviation will be considered any noncompliance with the clinical study protocol or good clinical 
practice requirements. The noncompliance may be on the part of the participant, the investigator, or study staff. 
Deviations will be reported to the IRB and corrective actions will be taken and documented as necessary. 
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