Mobile Intervention - Physical Activity in Cancer Treatment
Phase: NA
Conditions: Carcinoma, Renal Cell
Sponsor: University of Texas Southwestern Medical Center

Mobile Intervention - Physical Activity in Cancer Treatment 
     
 
 
 
STU072018-088, Beg, FormA1-ResearchProtocol-V.2.0-02-03-2020, Mod_5, 06-17-20 (1) 
 
 
i 
Official title: Mobile Intervention - Physical Activity in Cancer Treatment  
 
NCT number: NCT03671304 
IRB approved date: 06/17/2020 
 
 
 

Mobile Intervention - Physical Activity in Cancer Treatment 
     
 
 
 
STU072018-088, Beg, FormA1-ResearchProtocol-V.2.0-02-03-2020, Mod_5, 06-17-20 (1) 
 
 
ii 
Protocol 
 
Mobile Intervention - Physical Activity in Cancer Treatment  
 
 
 
Principal Investigator(s): 
Muhammad Beg, MD 
 
 
 
 
 
 
 
 
 Version 2.0 - February 3, 2020 

Mobile Intervention - Physical Activity in Cancer Treatment 
     
 
 
 
STU072018-088, Beg, FormA1-ResearchProtocol-V.2.0-02-03-2020, Mod_5, 06-17-20 (1) 
 
 
iii 
TABLE OF CONTENTS 
1.0 
BACKGROUND ............................................................................................. 1 
2.0 
STUDY OBJECTIVES .................................................................................... 2 
3.0 
STUDY DESIGN............................................................................................. 2 
3.1 
Overview of Study Design .............................................................................................3 
4.0 
STUDY POPULATION.................................................................................... 4 
4.1 
Inclusion Criteria ............................................................................................................4 
4.2 
Exclusion Criteria ...........................................................................................................4 
4.3 
Participant Recruitment and Retention........................................................................4 
5.0 
STUDY PROCEDURES .................................................................................. 5 
5.1 
Informed Consent ...........................................................................................................5 
5.2 
Screening.........................................................................................................................5 
5.3 
Baseline ...........................................................................................................................5 
5.4 
Treatment and Study Intervention ................................... Error! Bookmark not defined. 
6.0 
STUDY ASSESSMENTS ................................................................................ 6 
6.1 
Schedule of Assessments .............................................................................................6 
6.1.1 
Study Assessments ..............................................................................................6 
7.0 
STATISTICAL ANALYSES ............................................................................. 7 
7.1 
Aim 1 ................................................................................................................................7 
7.2 
Aim 2 ................................................................................................................................7 
8.0 
REPORTING AND MONITORING ................................................................... 8 
8.1 
Statement of Compliance ..............................................................................................8 
8.2 
Regulatory Files ..............................................................................................................8 
8.3 
Informed Consent ...........................................................................................................8 
8.4 
Study Documentation.....................................................................................................9 
8.5 
Records Retention and Requirements .........................................................................9 
8.6 
Reporting to Sponsor .....................................................................................................9 
8.7 
Safety Monitoring ...........................................................................................................9 
8.7.1 
Data and Safety Monitoring ..................................................................................9 
8.7.2 
Protocol Violations Reporting and Management ..................................................9 
8.7.3 
Subject Confidentiality/Privacy ...........................................................................10 
8.7.4 
Adverse Events (AEs) and Serious Adverse Events (SAEs) .............................10 
8.7.5 
Definitions of Adverse Event and Serious Adverse Event .................................10 
8.7.6 
Non-Reportable Adverse Event and Serious Adverse Events...........................10 
9.0 
DATA MANAGEMENT AND PROCEDURES................................................. 11 
9.1 
Data Collection Forms..................................................................................................11 
9.2 
Data Acquisition and Entry..........................................................................................11 
 

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1.0 
BACKGROUND 
Recent analyses have indicated that physical activity reduces mortality risk among 
patients with renal cell carcinoma (RCC), and gastrointestinal cancer, particularly colon 
cancer 1. Physical activity also provides additional benefits for patients undergoing treatment for 
cancer such as improved quality of life and sleep, and reduced treatment-related fatigue . 
However, individuals receiving treatment for RCC and gastrointestinal cancer often fail to 
engage in sufficient physical activity. Many cancer survivors experience a decrease in their 
physical activity after diagnosis 2 and the majority of RCC and gastrointestinal cancer survivors 
do not meet the recommended guidelines for physical activity 3. Traditional physical activity 
interventions require significant resources and present substantial barriers for participants (travel, 
time commitments, etc.). In contrast, mobile technologies enable delivery of interventions with 
significantly fewer resources. These technologies also facilitate the delivery of just-in-time 
adaptive interventions (JITAIs) in which intervention support is provided at only at times when an 
opportunity for positive changes exists.4 The purpose of this support the development of a JITAI 
in RCC and gastrointestinal cancer patients. Evaluation of the acceptability and efficacy of three 
intervention strategies (affective framing, intention planning, goal-setting, and savoring) will 
determine their inclusion in the JITAI. 
 

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2.0 
STUDY OBJECTIVES 
Aim 1. Determine the feasibility and acceptability of the proposed mobile technology intervention 
to increase physical activity patients receiving treatment for renal cell carcinoma and 
gastrointestinal cancer. 
Aim 2. Evaluate the effect of the proposed intervention components (affective framing, intention 
planning, and goal-setting) on changes in physical activity. 

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3.0 
STUDY DESIGN 
3.1 
Overview of Study Design 
For this project, we will enroll 50 participants diagnosed with renal cell carcinoma or 
gastrointestinal cancer in an eight-week study. Using a micro-randomized design, participants 
will receive affective framing messages and intention planning prompts on a randomized 
schedule, such that participants will receive each message type on 50% of days.  
 

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4.0 
STUDY POPULATION 
4.1 
Inclusion Criteria 
1) Males and females 18 years to 89 years of age  
2) Diagnosed with renal cell carcinoma or gastrointestinal cancer  
3) < 150 minutes of weekly moderate-to-vigorous physical activity, as per PAVS survey 
4) Own a smartphone (required for syncing the Fitbit device). 
 
4.2 
Exclusion Criteria 
1) Medical condition contraindicating exercise participation 
2) Cognitively unable to give informed consent.  
3) Unable to read and communicate in English 
 
4.3 
Participant Recruitment and Retention 
We will recruit participants from the clinics in the UT Southwestern Harold C. Simmons 
Comprehensive Cancer Center (SCCC).  
 

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5.0 
STUDY PROCEDURES 
5.1 
Informed Consent 
Individuals will go through the informed consent process prior to completing any study activities. 
Study personnel will explain the details of the study to the potential participant and then give him 
or her time to read through the informed consent document. Study personnel will then go through 
the document with the potential participant and answer any questions he or she may have 
5.2 
Screening 
Potential participants will be screened for eligibility based on all inclusion and exclusion criteria, 
detailed in sections 5.1 and 5.2. All participants who are screened will complete the Demographics 
Form. 
5.3 
Baseline 
Study assessments (described in section 6.0) will be collected at initial visit.  
5.4 
Treatment and Study Intervention  
Participants will receive a Fitbit Versa and instructions on its use. Participants will be asked to 
wear the device for eight weeks, removing it only for charging and when engaging in activities in 
which the device could be submerged in water beyond its recommended depths (water 
resistant up to 50 meters).   
 
Manual Connection and Pre-Authorization: At baseline, a research staff member will create a 
unique email and password combination in order to create an account on Fitbit.com. 
During the account creation process the following information will be entered: 
• 
First Name: A de-identified placeholder name will be entered 
• 
Last Name: A de-identified placeholder name will be entered 
• 
Date of Birth: The first day of the month of birth will be entered OR The first day of the 
year of birth will be entered. 
• 
Gender/Sex: The participant's gender will be entered.  
• 
Height: The participant's height will be entered. 
• 
Weight: The participant's weight will be entered. 
It is important to note that the personal demographic details - date of birth, gender, height, and 
weight - are required for accurate estimation of data captured by the Fitbit Device.  
 
The Fitbit account will be connected to a research device. Once the device is connected to the 
study-generated and study-controlled Fitbit account it will be manually connected to the Fitabase 
platform and assigned a unique study ID so that data will be synced and available for viewing and 
downloading by research staff. All data associated with the Fitbit device will be linked to the 
chosen unique study ID in the Fitabase platform. 
 
Participants will be given the connected Fitbit device and be provided with the associated 
email/password so that they may login into the Fitbit.com user account, use the online dashboard, 
and associated mobile applications. They will be informed that research staff will be able to 
access, view, and download their data through the Fitabase platform. The participant will be given 
a copy of the Fitabase Terms of Use and the Privacy Policy for review during the consent process. 
By consenting to use the Fitbit device as part of this study the participants also signals an 
acceptance of the Fitabase Terms of Use and Privacy Policy.  
 
 
 

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At enrollment, participants will indicate a preferred time to receive affective framing messages 
and EMA prompts (morning), and intention planning prompts (evenings). 
 
Ecological momentary assessment.  
Each 
morning 
during 
the 
eight-week 
intervention, 
participants 
will 
receive 
questions about their current affect, intent to 
engage in physical activity, and self-efficacy 
for engaging in physical activity. At each 
request, participants will be given the option 
to “snooze” the request for up to one hour. 
The assessment questions will be viewed 
and responded to on the Fitbit Versa device. 
We will utilize the Fitabase Engage platform 
(see Figure 3), which utilizes the Fitbit SDK 
to 
deliver 
assessments 
and 
message 
prompts via the Fitbit Versa. Assessment 
questions have been validated for their use 
in EMA.5-7 Daily questions will include: 
 
Physical Activity Intention (One item; 1 strongly disagree to 5 strongly agree) 
“I intend to meet my goal of XXX steps today”  
 
Physical Activity Self-Efficacy (One item; 1 not confident at all to 5 completely confident) 
“I believe I can complete my goal of XXX steps today.”  
 
Affect (Nine items assessing positive and negative affect; 1 not at all to 5 extremely) 
“How (happy, cheerful, relaxed, stressed, anxious, angry, depressed, energetic, fatigued/tired) do 
you feel right now?”  
 
Affective Framing Messages. After completing the daily EMAs, participants may receive an 
affective framing message. Message delivery will occur on a 1:1 randomization schedule, such 
that participants will receive messages on 28 of the 56 intervention days. The study biostatistician 
will generate randomization schedules for each participant using block randomization with 
variable block sizes. Messages will be randomly selected from a pool of 14 messages, meaning 
each message will be received twice during the eight-week study. Messages will emphasize 
potential improvements in mood, energy, and calmness.8,9 Examples of these messages: 
“Research has shown that physical activity often results in improved mood.” 
“Most people report feeling happier and more relaxed after exercise.” 
 
Weekly Goal Setting. Each Sunday evening, participants will receive a prompt to select a step 
goal for the upcoming week. Along with this prompt, participants will receive feedback on their 
activity during the previous week. Participants will receive either: 1) the average daily number of 
steps taken during the previous week, or 2) the highest daily number of steps taken during the 
previous week. 
 
Intention Planning Prompts. Delivery of these messages will occur on a 1:1 randomization 
schedule, such that participants will receive messages on 28 of the 56 intervention days. Planning 
prompts will be delivered in the evening at a time preferred by the participant. At each request, 
participants will be given the option to “snooze” the request for up to one hour. Using a drop-down 
How’s your
energy
level
today?
Mild
Snooze.
I can’t today.
Ready.
Figure 3. Representations of messages delivered via 
the Fitabase Engage platform.  
 *Actual messages will be customized as described below. 

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menu, participants will be able to indicate the time, duration, and location to complete the following 
prompt: 
“Tomorrow, at (time), I will walk for (duration) minutes at (location).”  
 
Activity recognition. We will utilize Fitbit SmartTrack feature to automatically detect physical 
activity bouts. The SmartTrack settings will be customized to identify all physical activity bouts of 
> 10 minutes. Approximately one hour after completion of a physical activity bout, participants will 
be asked to report on their current affect and reflect upon their experience during the physical 
activity bout. Delivery of these assessments will occur after each activity bout; however, in the 
event of multiple activity bouts occurring in one day, assessments will be limited to the first activity 
bout of that day. Participants will be given the option to “snooze” for up to one hour if they are 
unavailable.  
 
Affect (Nine items assessing positive and negative affect; 1 not at all to 5 extremely) 
“How (happy, cheerful, relaxed, stressed, anxious, angry, depressed, energetic, fatigued/tired) do 
you feel right now?”  
 
Remembered Experience (One item; 1 very good to 5 very bad).  
 “Think back to how you felt during your physical activity today - How do you remember feeling?” 
 
Savoring – After completing the EMAs, participants will receive the savoring messages 
after 50% of their detected activity bouts (1:1 randomization schedule). Participants will 
receive imagery-based prompts, as those have been shown to elicit more positive affect 
responses compared to descriptive prompts (Nelis et al 2015). Delivery of the savoring 
prompts will occur over approximately 1-minute, with pauses interspersed between 
prompts to allow for the participant to imagine their experience (see below).  
“Thinking back to that physical activity bout, try to create an image of that in your mind. 
Spend a moment re-living the activity.”  
(10 seconds) 
“Replay that memory as if you were watching a movie in mind.” 
(10 seconds) 
“What could you see around you?” 
(10 seconds) 
“What could you hear?” 
(10 seconds)  
“How did you feel in that moment?” 
(10 seconds) 
“What was happening around you?” 
(10 seconds) 
“What did you do immediately after your activity?” 
 
 
 
5.5 
Participant Discontinuation 
In order to ensure safety, female participants who become pregnant during the study will be 
required to discontinue participation in the intervention. Participants may be asked to stop study 
intervention if any situation arises that, in the investigator’s judgment, poses a safety risk. 

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Participants who must stop the study intervention will still be asked to complete assessment visits 
as scheduled. 
5.6 
Participant Remuneration 
Participants will be paid up to a total of $40 for their participation in the trial to compensate for 
their time, travel arrangements, and the burden of participation. Participants will  be paid $20 for 
attending the each of the assessment visits (baseline and Week 8). Participants will be paid for 
each eligible visit using the UT Southwestern Greenphire ClinCard system. Participants will also 
receive instructions on how use the card.   

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6.0 
STUDY ASSESSMENTS 
6.1 
Schedule of Assessments 
Study assessments may have a window of +/- 2 weeks to allow visits to occur concurrent 
with standard of care visits. Week 8 and 10 can occur at the same visit if needed. 
Remote phone/video visits are allowed  
Assessment 
Baseline 
Week 8 
Week10 
Informed Consent  
X 
 
 
Demographics (age, gender, race, diagnosis, stage) 
X 
 
 
Weight, height, ECOG performance status 
X 
 
 
Physical Activity Vital Sign 
X 
 
 
Physical Activity Readiness Questionnaire 
X 
 
 
Eligibility Criteria 
X 
 
 
Completion of Fitbit Versa Registration  
X 
 
 
Physical Activity Stages of Change Questionnaire 
X 
X 
 
Physical Activity Self-Efficacy Questionnaire  
X 
X 
 
Multidimensional Outcome Expectation for Exercise Scale 
X 
X 
 
Affective Associations  
X 
X 
 
Affective Attitudes  
X 
X 
 
Anticipated Affect 
X 
X 
 
Functional Assessment of Cancer Therapy - Kidney Symptom Index*  X 
X 
 
Functional Assessment of Cancer Therapy - Gastric Cancer~ 
X 
X 
 
Quick Inventory of Depressive Symptomatology  
X 
X 
 
Brief Fatigue Inventory 
X 
X 
 
Generalized Anxiety Disorder  
X 
X 
 
Pittsburgh Sleep Quality Index 
X 
X 
 
Pain - Frequency, Intensity, and Burden Scale 
X 
X 
 
Dimensional Anhedonia Rating Scale  
X 
X 
 
Exercise Vital Sign 
X 
X 
 
Intervention Acceptability  
 
 
X 
* Only applicable for renal cell carcinoma patients 
~ Only applicable for any GI cancer patient 
6.1.1 
Study Assessments 
At baseline and at the end of the eight-week intervention, participants will complete assessments 
of: 1) potential moderators of physical activity behavior change, and 2) psychosocial outcomes.  
Primary outcome measurement: 
Fitbit Versa. The primary outcome measure will be daily step counts measured by the Fitbit Versa. 
Wrist-worn Fitbit devices demonstrate acceptable reliability and validity for measuring step 
counts.13 We will utilize Fitabase, a comprehensive data management platform that utilizes the 
Fitbit partner-level API, to capture near real-time participant activity data.  
 
Theoretical moderators of physical activity behavior change: 
Physical Activity Stages of Change Questionnaire: 4-item scale that assesses current stage 
of activity. 

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Physical Activity Self-Efficacy Questionnaire: 3-item scale that assesses self-efficacy for 
physical activity.  
Multidimensional Outcome Expectations for Exercise Scale: 15-item scale that assesses a 
multitude expectations for physical activity.  
Affective associations: 6-item scale that assesses feelings about exercise.  
Affective attitudes: 3-item scale that assesses feelings during exercise.  
Anticipated affect: 2-item scale that assesses the anticipated affect of regular physical 
activity. 
 
Psychosocial Outcomes: 
Functional Assessment of Cancer Therapy: 19-item scale that assesses quality of life in 
cancer patients.  
Quick Inventory of Depressive Symptomatology – Self-Rated (QIDS-SR): 16-item scale that 
assesses severity of depression-specific symptoms. 
Brief Fatigue Inventory (BFI): 9-item scale that assesses fatigue in cancer patients  
Generalized Anxiety Disorder 7 item Scale (GAD-7): 7-item scale that assesses anxiety 
symptoms.  
Pittsburgh Sleep Quality Index (PSQI): 19-item scale that assesses sleep quality and 
disturbances.  
Pain – Frequency, Intensity, and Burden Scale (P-FIBS): 4-item scale that assesses the 
frequency, intensity, and burden of pain. 
Dimensional Anhedonia Rating Scale (DARS): 21-item scale that assesses anhedonia.  
Exercise Vital Sign (EVS): 2-item scale that assesses an estimate of an individual’s physical 
activity.  
 
Intervention Acceptability: 
After completion of the study, at Week 10, participants will complete an intervention 
acceptability questionnaire. Using a series of 5-point Likert scale questions, we will evaluate 
overall intervention satisfaction and also satisfaction with specific components of the intervention 
(i.e., message content, message frequency, Fitbit ease of use, etc.) 
 

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7.0 
STATISTICAL ANALYSES 
 
Aim 1. Aim 1 of the proposed pilot study will evaluate the feasibility and acceptability of the 
proposed intervention. The feasibility of the study will be assessed by the following criteria 
displayed in Table 1. 
 
Table 1. Feasibility and acceptability measures and 
benchmarks. 
FEASIBILITY 
  
Measure 
Benchmark 
 Recruitment 
Enrollment rate 
7 participants/month 
 Intervention 
Adherence 
Response rate to intervention messages 
75% 
  
Response rate to EMA prompts 
75% 
  
Fitbit use (% of days with > 8 hours wear 
time) 
70% 
  Retention 
Completion of follow-up assessments 
90% 
ACCEPTABILITY 
  
  
  
Measure 
Benchmark 
 Intervention                   
satisfaction 
Satisfaction questionnaire 
75%  of participants rate  
> 4 on 5-point Likert 
scale 
  
  
 
Aim 2.  
Hypothesis 2a: Participants will have greater daily step counts on days receiving an affective 
framing message compared to non-message days.  
A repeated-measures mixed effects model will be used as described in Klasnja et al. (2015) 
with participant and time as random effects and other effects as fixed. Daily step count will be the 
dependent variable while main effects of affective framing intervention (message/no message) 
and linear time effects will be within-subjects factors, and an intervention by time interaction term 
will be included. We also will consider more complex effects of time (e.g., quadratic effects). We 
will include scores of the Physical Activity Intention, Physical Activity Self-Efficacy, and Affect as 
time-varying covariates. As described in Klasnja, et al. (2015) we will include the scores for the 
day prior to the intervention so the covariates will not be affected by the intervention. We will also 
classify each day as a cancer treatment day (i.e. day on which chemotherapy or radiation therapy 
is received) or not and presence/absence of cancer treatment will also be a time-varying 
covariate. A time lag is not needed for this covariate as the timing of cancer treatment will not be 
influenced by the intervention. Presence/absence of an implementation planning message on 
each day will also be included as a time-varying covariate and an affective framing by planning 
message interaction will be included to assess synergistic effects of the two messages. The 
baseline measurement of theoretical moderators of physical activity behavior change (Physical 
Activity Stage of Change, Physical Activity Self-Efficacy, Multidimensional Outcome Expectations 
for Exercise Scale) and psychosocial characteristics Functional Assessment of Cancer Therapy 
– General, Quick Inventory of Depressive Symptomatology – Self-Rated, Brief Fatigue Inventory) 
will be considered as covariates as will other baseline demographic and clinical variables 
determined to improve the fit of the final model. 
 
Hypothesis 2b: Participants will have greater daily step counts on days receiving the 
implementation planning message compared to non-message days.   

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The same repeated-measures mixed effects model described for Hypothesis 2a will be used 
for this hypothesis. Only the interpretation of the results will be different as the presence/absence 
of the implementation message will be the main effect and the affective framing intervention will 
be considered the covariate.  
 
Hypothesis 2c: Participants randomized to receive feedback prompts reporting their highest daily 
step count will achieve greater step counts compared to participants that receive feedback 
prompts reporting their average daily step counts.   
Participants will be randomized at baseline for the duration of the study because we expect 
that the intervention will have a cumulative effect over the course of the study.  The hypothesis 
will be tested using a repeated-measures mixed effects model with participant and time as random 
effects and other effects as fixed. Daily step count will be the dependent variable. The intervention 
(highest vs average steps feedback) will be a between-subjects factor and time the within-subjects 
factor and an intervention by time interaction term will be included. We also will consider more 
complex effects of time (e.g., quadratic effects). The baseline characteristics described in 
Hypothesis 2a will be considered to improve the fit of the final model. We will also consider the 
inclusion of time-varying covariates if a clinically meaningful imbalance between groups is found. 
 
Exploratory analyses 
For Aim 2a and 2b we will also evaluate the moderating effects of time-varying factors measured 
through daily EMA (Physical Activity Intention, Physical Activity Self-Efficacy, and Affect). Our 
ultimate goal is to be able to evaluate these factors to inform decision rules in the ultimate 
adaptable intervention. The proposed sample size limits the power to detect time-varying 
moderators of intervention effects and formal analysis of moderating effects will only be conducted 
in the subsequent clinical trial. These analyses will use a repeated-measures mixed effects model 
as described above for Hypotheses 2a and 2b, and the moderating effect will be represented by 
a 3-way interaction of intervention, covariate, and time.  
Power calculations 
The study design for Aims 2a and 2b will require subjects to be randomized each day to receive 
the intervention or not.  Each day there will be a 50% probability of receiving the intervention (1:1 
randomization schedule) so that the average subject will receive the intervention on 28 of the 56 
study days.  The sample size for Hypotheses 2a and 2b of 50 is based on the sample sizes in the 
table below which assume 80% power with an alpha=0.05. We also assume that the effect size 
(standardized difference between treatment groups, similar to Cohen’s d) is constant during the 
56-day study period. Note that for Cohen’s d an effect size of 0.2 or less is considered ‘small’ 
(Cohen, 1998) (small effect=0.2, medium effect=0.5, large effect=0.8), therefore, the proposed 
sample size of 50 will be able to detect effect sizes that are about half of a ‘small’ effect. 
The power analysis for Hypothesis 2c is based on a repeated measures analysis of variance 
comparison of two groups with 56 repeated observations assuming a correlation between 
repeated measurements of 0.5, 80% power, and alpha=0.05.  Given these assumptions, an effect 
size of 0.29 can be detected with the proposed sample size of 50.  Based on Cohen’s guidelines 
for an ANOVA f-test an effect size of 0.29 is slightly larger than a ‘medium’ effect (small effect=0.1, 
medium effect=0.25, large effect=0.4). 
 
 
 
 
 

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Table 1. Sample size calculations. 
Hypotheses 2a and 2b 
Hypothesis 2c 
Effect Size 
Sample Size to 
Obtain 80% 
Power 
Effect Size 
Sample Size to 
Obtain 80% 
Power 
0.200 
17 
0.290                         50    
0.109 
50 
0.265 
                       60  
0.099 
60 
0.245 
70  
0.091 
70 
0.203 
                     100 
0.076 
100 
0.100 
402 
 

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8.0 
REPORTING AND MONITORING 
8.1 
Statement of Compliance 
This trial will be conducted in compliance with the appropriate protocol, appropriate ICH guidelines 
(including current Good Clinical Practice [GCP]), the principles of the Declaration of Helsinki, and 
all other applicable regulatory requirements. The study team must obtain written approval of the 
study protocol, consent form, other supporting documents, and any advertising for participant 
recruitment from the UT Southwestern institutional review board (IRB) in order to participate in 
the study. Prior to study initiation, the protocol and the informed consent documents will be 
reviewed and approved by an appropriate UT Southwestern IRB. Any amendments to the protocol 
or consent materials must be approved before they are implemented. Annual progress reports 
and Serious Adverse Event (SAE) reports will be submitted to each IRB, according to its usual 
procedures. 
8.2 
Regulatory Files 
The regulatory files should contain all required regulatory documents, study-specific documents, 
and all important communications. Regulatory files will be reviewed at each participating site for 
regulatory document compliance prior to study initiation, throughout the study, as well as at the 
study closure. 
8.3 
Informed Consent 
Every study participant is required to sign a valid, IRB-approved current version of the study 
informed consent form prior to the initiation of any study related procedures.  
Prior to signing the informed consent form, research staff who are knowledgeable about the study 
will explain the study to the potential participant and provide the participant with a copy of the 
consent to read. If the participant is interested in participating in the study, a researcher who is 
authorized to obtain informed consent will review each section of the informed consent form in 
detail, answer any of the participant’s questions. The participant will consent by signing and dating 
the consent document. The person obtaining consent will also sign and date the consent 
document. Every study participant must be offered a copy of the signed consent form. The 
consent must be properly executed and complete to be valid. All persons obtaining consent must 
have completed appropriate training. 
The informed consent form must be updated or revised whenever important new safety 
information is available, or whenever the protocol is amended in a way that may affect a 
participants’ participation in the trial.  
Study participation is voluntary and there are no benefits lost if an individual declines participation. 
Individuals who refuse to participate or who withdraw from the study will be treated without 
prejudice. Study sites will be responsible for maintaining signed consent forms as source 
documents for quality assurance review and regulatory compliance. 
8.4 
Study Documentation 
Study documentation includes all case report forms, source documents, monitoring logs, 
Institutional Review Board correspondence and approved consent form and signed participant 
consent forms. 
Source documents include all recordings of observations or notations of clinical activities and all 
reports and records necessary for the evaluation and reconstruction of the clinical research study. 
Whenever possible, the original recording of an observation should be retained as the source 
document; however, a photocopy is acceptable provided that it is a clear, legible, and exact 
duplication of the original document. 

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8.5 
Records Retention and Requirements 
All research records for all subjects will be stored by the investigator in a secure location to be 
accessed only by authorized research personnel. Study records will be stored in accordance with 
local IRB, State, and Federal Regulations but, in any case, will be kept for a minimum of  
2 years following study completion. 
8.6 
Reporting to Sponsor 
The principal investigator will submit any and all required reports accurately to the sponsor in a 
timely manner. Reports may include any significant changes possibly affecting the safe and 
accurate conduct of the trial or its outcomes. The principal investigator will also submit to the 
sponsor a detailed final report on the study at its conclusion. 
8.7 
Safety Monitoring 
8.7.1 
Data and Safety Monitoring 
On a monthly basis, Dr. Beg will examine accumulating data to assure protection of participants’ 
safety while the study’s scientific goals are being met. These meetings will determine whether 
there is support for continuation of the trial, or evidence that study procedures should be changed, 
or if the trial should be halted, for reasons relating to the safety of the study participants, or 
inadequate trial performance (e.g., poor recruitment). 
8.7.2 
Protocol Violations Reporting and Management 
A protocol departure is any departure from procedures and requirements outlined in the protocol. 
Protocol departures may occur on two levels, deviation versus violation. The difference between 
a protocol deviation and violation has to do with the seriousness of the event and the corrective 
action required. A protocol deviation is considered an action (or inaction) that by itself is not likely 
to affect the scientific soundness of the investigation or seriously affect the safety, rights, or 
welfare of a study participant.  Protocol violations are departures that may compromise the 
participant safety, participant rights, inclusion/exclusion criteria or study data and could be cause 
for corrective actions if not rectified or prevented from re-occurrence. Protocol violations will be 
monitored for (1) significance, (2) frequency, and (3) impact on the study objectives, to ensure 
the integrity of the trial. The PI or designee will make the decision about whether a departure from 
the protocol will be designated as a protocol deviation or a protocol violation. All protocol violations 
and deviations will be reported to the IRB as required.  
8.7.3 
Subject Confidentiality/Privacy 
Participant records will be held confidential by the use of study codes for identifying participants 
on CRFs, secure and separate storage of any documents that have participant identifiers, and 
secure computing procedures for entering and transferring electronic data. 
All research information obtained on participants is confidential, and disclosure to any third parties 
without specific authorization is strictly prohibited. To maintain subject privacy, all study forms and 
reports will be identified by a coded study identification number only. No subject identifying 
information will be included in any presentations or publications resulting from the study. 
Study records may be inspected by the sponsor and its authorized representatives, other 
government agencies such as the U.S. Department of Health and Human Services (DHHS) Office 
for Human Research Protections (OHRP), authorized Node Staff, or the local IRB for quality 
assurance purposes. 

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8.7.4 
Adverse Events (AEs) and Serious Adverse Events (SAEs) 
The Primary Investigator (PI) will review or seek consultation for each Serious Adverse Event 
(SAE) as needed. These reviews will include an assessment of the possible relatedness of the 
event to the study intervention or other study procedures. The PI will also provide advice for 
decisions to exclude, refer, or withdraw participants as required. The study staff will be trained to 
monitor for and report Adverse Events and Serious Adverse Events. 
8.7.5 
Reporting Adverse Events and Serious Adverse Events 
Adverse Events 
Adverse events severe in nature (grade 3) will be documented from the time consent is 
signed through the end of study participation.  
For the purpose of this study, the following AEs will not require reporting in the participant's 
record and will not be captured: 
• 
Grade 1 (mild) unrelated event. 
• 
Grade 2 (moderate) unrelated event. 
Serious Adverse Events 
For the purpose of this study, all SAEs will be documented in the participant's record with the 
exception of the following: 
• 
Admission to a hospital/surgery center for preplanned/elective surgeries (captured in 
the Visit Summary/Progress Note). 
• 
Admission to a hospital for scheduled labor and delivery (captured in the Visit 
Checklist/Progress Note). 
Local documentation and reporting guidelines should also be followed based on local IRB 
requirements. 

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9.0 
DATA MANAGEMENT AND PROCEDURES 
9.1 
Data Collection Forms 
The data collection process consists of data entry into the CRFs according to the instructions 
provided and project specific training. The investigator is responsible for maintaining accurate, 
complete and up-to-date records, and for ensuring the completion of the CRFs for each research 
participant. CRFs will be monitored for completeness, accuracy, and attention to detail throughout 
the study. 
9.2 
Data Acquisition and Entry 
Data entry into an electronic database shall be performed by authorized individuals. 

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References 
 
1. 
Schmid D, Matthews CE, Leitzmann MF. Physical activity and sedentary 
behavior in relation to mortality among renal cell cancer survivors. PLoS One. 
2018;13(6):e0198995. 
2. 
Fassier P, Zelek L, Partula V, et al. Variations of physical activity and sedentary 
behavior between before and after cancer diagnosis: Results from the prospective 
population-based NutriNet-Sante cohort. Medicine (Baltimore). Oct 2016;95(40):e4629. 
3. 
Behrens G, Leitzmann M. The association between physical activity and renal 
cancer: systematic review and meta-analysis. Br. J. Cancer. 2013;108(4):798. 
4. 
Nahum-Shani I, Hekler EB, Spruijt-Metz D. Building health behavior models to 
guide the development of just-in-time adaptive interventions: A pragmatic framework. 
Health Psychol. Dec 2015;34S:1209-1219. 
5. 
Conroy DE, Elavsky S, Doerksen SE, Maher JP. A daily process analysis of 
intentions and physical activity in college students. J. Sport Exerc. Psychol. Oct 
2013;35(5):493-502. 
6. 
Maher JP, Dzubur E, Huh J, Intille S, Dunton GF. Within-Day Time-Varying 
Associations Between Behavioral Cognitions and Physical Activity in Adults. J. Sport 
Exerc. Psychol. Aug 2016;38(4):423-434. 
7. 
Pickering TA, Huh J, Intille S, Liao Y, Pentz MA, Dunton GF. Physical Activity 
and Variation in Momentary Behavioral Cognitions: An Ecological Momentary 
Assessment Study. J Phys Act Health. Mar 2016;13(3):344-351. 
8. 
Kwan BM, Stevens CJ, Bryan AD. What to expect when you're exercising: An 
experimental test of the anticipated affect-exercise relationship. Health Psychol. Apr 
2017;36(4):309-319. 
9. 
Helfer SG, Elhai JD, Geers AL. Affect and exercise: positive affective 
expectations can increase post-exercise mood and exercise intentions. Ann. Behav. 
Med. Apr 2015;49(2):269-279. 
10. 
Coleman KJ, Ngor E, Reynolds K, et al. Initial validation of an exercise "vital 
sign" in electronic medical records. Med. Sci. Sports Exerc. Nov 2012;44(11):2071-
2076. 
11. 
Ball TJ, Joy EA, Gren LH, Shaw JM. Concurrent Validity of a Self-Reported 
Physical Activity "Vital Sign" Questionnaire With Adult Primary Care Patients. Prev. 
Chronic Dis. Feb 4 2016;13:E16. 
12. 
Thomas S, Reading J, Shephard RJ. Revision of the physical activity readiness 
questionnaire (PAR-Q). Can. J. Sport Sci. 1992. 
13. 
Brewer W, Swanson BT, Ortiz A. Validity of Fitbit's active minutes as compared 
with a research-grade accelerometer and self-reported measures. BMJ Open Sport 
Exerc Med. 2017;3(1):e000254. 
14. 
Marcus BH, Forsyth L. Motivating people to be physically active. Human Kinetics; 
2003. 
15. 
Wojcicki TR, White SM, McAuley E. Assessing outcome expectations in older 
adults: the multidimensional outcome expectations for exercise scale. J. Gerontol. B 
Psychol. Sci. Soc. Sci. Jan 2009;64(1):33-40. 

Mobile Intervention - Physical Activity in Cancer Treatment  
 
STU072018-088, Beg, FormA1-ResearchProtocol-V.2.0-02-03-2020, Mod_5, 06-17-20 (1) 
19 
16. 
Cella DF, Tulsky DS, Gray G, et al. The Functional Assessment of Cancer 
Therapy scale: development and validation of the general measure. J. Clin. Oncol. 
1993;11(3):570-579. 
17. 
Trivedi MH, Rush AJ, Ibrahim HM, et al. The Inventory of Depressive 
Symptomatology, Clinician Rating (IDS-C) and Self-Report (IDS-SR), and the Quick 
Inventory of Depressive Symptomatology, Clinician Rating (QIDS-C) and Self-Report 
(QIDS-SR) in public sector patients with mood disorders: a psychometric evaluation. 
Psychol. Med. Jan 2004;34(1):73-82. 
18. 
Rush AJ, Trivedi MH, Ibrahim HM, et al. The 16-Item Quick Inventory of 
Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-
SR): a psychometric evaluation in patients with chronic major depression. Biol. 
Psychiatry. Sep 1 2003;54(5):573-583. 
19. 
Rush AJ, Carmody TJ, Reimitz PE. The Inventory of Depressive 
Symptomatology (IDS): Clinician (IDS C) and Self Report (IDS SR) ratings of 
depressive symptoms. Int. J. Methods Psychiatr. Res. 2000;9(2):45-59. 
20. 
Mendoza TR, Wang XS, Cleeland CS, et al. The rapid assessment of fatigue 
severity in cancer patients: use of the Brief Fatigue Inventory. Cancer. Mar 1 
1999;85(5):1186-1196.