e-Motivación: Developing and Pilot Testing an App to Improve Latinos' Screening Colonoscopy Rates
Phase: NA
Conditions: Colorectal Cancer
Sponsor: Icahn School of Medicine at Mount Sinai

e-Motivación: Developing and Pilot Testing an App to Improve Latinos' Screening 
Colonoscopy Rates 
PI: Sarah J Miller, Psy.D.
NCT04987788
Document Date: 3-14-2024

e-Motivación: Developing and Pilot Testing an App to Improve Latinos’ Screening Colonoscopy 
Rates [Aim III, RCT]
Principal Investigator:
Sarah Miller, PsyD
Department of Population Health Science and Policy, Center for 
Behavioral Oncology
1 Gustave L. Levy Place, Box 1077 
212.824.7783
Sarah.miller@mssm.edu
Sub-Investigator:
Lina Jandorf, MA
Department of Population Health Science and Policy in the Center for 
Behavioral Oncology
Sub-Investigator:
Karen S. Ingersoll, Ph.D.
University of Virginia, School of Medicine/Department of Psychiatry and 
Neurobehavioral Sciences
200 Jeanette Lancaster Way, Charlottesville, VA 22903
Phone: (434) 243-0581
Fax: (434) 973-7031
Email: kes7a@virginia.edu
Study Drug:
N/A
IND Number:
N/A
IND Holder Name:
N/A
Funding Source: 
National Institute On Aging/NIH/DHHS (R34AG059705)
Initial version:
October 21, 2020
Amended:
July 11, 2022
Effective Date: 3/14/2024
End Date:3/13/2025

Signature Page
The signature below constitutes the approval of this protocol and the attachments, and provides the 
necessary assurances that this trial will be conducted according to all stipulations of the protocol, including 
all statements regarding confidentiality, and according to local legal and regulatory requirements and 
applicable U.S. federal regulations and ICH guidelines.
Principal Investigator (PI) Name: Sarah Miller
PI Sign
Date: July 11, 2022
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TABLE OF CONTENTS
LIST OF ABBREVIATIONS ............................................................................................................1
STUDY SCHEMA ............................................................................................................................2
STUDY SUMMARY .........................................................................................................................2
1.0
BACKGROUND AND RATIONALE....................................................................................4
1.1
Disease Background .......................................................................................................4
1.2
Study Agent(s) Background and Associated Known Toxicities.......................................4
1.3
Other Agents ...................................................................................................................5
1.4
Rationale .........................................................................................................................5
1.5
Correlative Studies ..........................................................................................................6
2.0
STUDY OBJECTIVES .........................................................................................................6
2.1
Primary Objectives ..........................................................................................................6
2.2
Secondary Objectives......................................................................................................6
2.3
Exploratory Objectives.....................................................................................................6
2.4
Endpoints.........................................................................................................................6
3.0
PATIENT ELIGIBILITY........................................................................................................6
3.1
Inclusion Criteria..............................................................................................................7
3.2
Exclusion Criteria.............................................................................................................7
4.0
TREATMENT PLAN ............................................................................................................7
4.1
Administration..................................................................................................................7
4.2
Toxicities and Dosing Delays/Dose Modifications...........................................................7
4.3
Concomitant Medications/Treatments.............................................................................7
4.4
Other Modalities or Procedures.......................................................................................7
4.5
Duration of Therapy.........................................................................................................7
4.6
Duration of Follow Up......................................................................................................7
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4.7
Removal of Patients from Protocol Therapy....................................................................7
4.8
Patient Replacement .......................................................................................................8
5.0
STUDY PROCEDURES.......................................................................................................8
5.1
Screening/Baseline Procedures ......................................................................................8
5.2
Procedures During Treatment .........................................................................................8
5.3
Follow-up Procedures......................................................................................................9
5.4
Time and Events Table....................................................................................................9
5.5
Removal of Subjects from Study ...................................................................................10
6.0
Measurement of Effect.....................................................................................................10
6.1
Antitumor Effect- Solid Tumors......................................................................................10
6.2
Antitumor Effect- Hematologic Tumors..........................................................................10
6.3
Safety/tolerability ...........................................................................................................10
7.0
ADVERSE EVENTS ..........................................................................................................10
7.1
Experimental Therapy ...................................................................................................11
7.2
Adverse Event Monitoring .............................................................................................10
7.3
Definitions......................................................................................................................11
7.4
Steps to Determine If an Adverse Event Requires Expedited Reporting ......................12
7.5
Reporting Requirements for Adverse Events ................................................................12
7.6
Unblinding Procedures ..................................................................................................13
7.7
Stopping Rules ..............................................................................................................13
8.0
DRUG INFORMATION ......................................................................................................13 
9.0
CORRELATIVES/SPECIAL STUDIES..............................................................................13
9.1
Sample Collection Guidelines........................................................................................13
9.2
Assay Methodology .......................................................................................................13
9.3
Specimen Banking.........................................................................................................13
10.0
STATISTICAL CONSIDERATIONS ..............................................................................13
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10.1
Study Design/Study Endpoints......................................................................................13
10.2
Sample Size and Accrual ..............................................................................................13
10.3
Data Analyses Plans .....................................................................................................14
11.0
STUDY MANAGEMENT................................................................................................14
11.1
Conflict of Interest..........................................................................................................14
11.2
Institutional Review Board (IRB) Approval and Consent...............................................14
11.3
Required Documentation...............................................................................................14
11.4
Registration Procedures................................................................................................14
11.5
Data Management and Monitoring/Auditing ..................................................................15
11.6
Adherence to the Protocol.............................................................................................18
11.7
Amendments to the Protocol .........................................................................................18
11.8
Record Retention...........................................................................................................18
11.9
Obligations of Investigators ...........................................................................................19
12.0
REFERENCES...............................................................................................................19
13.0
APPENDICES................................................................................................................25
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LIST OF ABBREVIATIONS
AE
Adverse Event
CRC
Colorectal Cancer
DHHS
Department of Health and Human Services
DSMB
Data and Safety Monitoring Board
FDA
US Food & Drug Administration
GCP
Good Clinical Practice
HCP
Healthcare Provider
IRB
Institutional Review Board
ISMMS
Icahn School of Medicine at Mount Sinai
MI
Motivational Interviewing
NIH
National Institute of Health
PPHS
Program for the Protection of Human Subjects
RCT
Randomized Control Study
SAE
Serious Adverse Event
UPR/UPIRSO
Unanticipated Problems Involving Risk to Subjects or Others
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STUDY SCHEMA
HCPs (e.g., physician, navigator, nurse) introduce the study to eligible patients. If patients are 
interested and agreed to be contacted – HCP will provide research team with patients’ contact 
information or will connect the parts in person, after an in-clinic appointment
Research Coordinators reach out to patients to describe the study, confirm 
eligibility, and enroll interested patients over the phone or in person
Control group (n=40): Participants receive a 
link to watch a general health information video 
on their personal device
Condition group (n=40): Participants 
receive a link to the App to use on their 
personal device
Inform Future RCT
Research Coordinators review patients’ medical charts to 
determine completion status of screening colonoscopy
Research Coordinators consent participants over the phone or in person using  
REDCap and gather baseline data (demographics and medical history)
RANDOMIZATION (stratified for language)
FOLLOW-UP (6 months following the consent)
Study team gets access to patient lists (i.e. CERNER, Pool of Direct Access for Colonoscopies 
referrals, MSHS EPIC screening colonoscopy lists) and medical records to identify and screen for 
potential participants. The research team informs members of the HCPs (e.g., patient navigators, 
schedulers, physicians, medical assistants) which patients may be eligible for the study.
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STUDY SUMMARY
Title
e-Motivación: Developing and Pilot Testing an App to Improve Latinos’ 
Screening Colonoscopy Rates: Aim III
Short Title
N/A
Protocol Number
IRB-18-00344
Phase
N/A 
Methodology
Pilot Randomized Control Trial 
Study Duration
9 months to conduct pilot study, 6 months to analyze pilot study data and 
disseminate results. 
Study Center(s)
Single-center
Objectives
To begin to examine the efficacy of the e-Motivación app for improving 
screening colonoscopy uptake among Latinos (results of the pilot study 
will inform power calculations for a future randomized clinical trial that will 
formally test the efficacy of the app).
Number of Subjects
80 subjects total (N=40 in control group, N=40 in condition group)
Diagnosis and Main 
Inclusion Criteria
1.
Self-identified as Latino,a,x
2.
English or Spanish-speaking
3.
Received a physician referral for a screening colonoscopy
4.
Has access to a tablet, smartphone, or computer with working internet  
Study Product(s), Dose, 
Route, Regimen
N/A
Duration of administration
N/A
Reference therapy
N/A
Statistical Methodology
Contingency tables and t-tests will be performed to determine any 
differences between the two groups. Using a p value of ≤ 0.15, any 
consistent pattern of correlation for any of the covariates would suggest 
their inclusion in the primary data analysis model. Effect size estimate: 
Logistic regression analyses will be used to evaluate an estimate of the 
efficacy. The model will include any covariates that differentiate the 
intervention and control groups. The effect size of the treatment group will 
be used as an indicator to inform power calculations for a future RCT. The 
power calculations will inform the appropriate sample size needed for the 
RCT.
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1.0
BACKGROUND AND RATIONALE
1.1
Disease Background
Colorectal Cancer and Aging.  The risk of developing colorectal cancer (CRC) directly 
increases with age, with 89% of all CRC occurring in individuals over the age of 50.1 The 
median age of a colon cancer diagnosis is 68 in men and 72 in women; the median age for 
rectal cancer is 63 in both men and women.1 Given the link between age and CRC, the 
American Cancer Society, the U.S. Multi-Society Task Force on Colorectal Cancer, and 
the American College of Radiology recommend that average risk people begin screening 
for CRC at the age of 50 and continue until at least the age of 75.2 Of the recommended 
CRC screening tests, a colonoscopy is considered the gold standard because it allows for 
both the detection and removal of precancerous and cancerous growths.3,4 Epidemiological 
research has found an association between increased screening colonoscopy rates and 
reduced mortality rates.5 
Colorectal Cancer and Latinos. Among Latinos, a fast growing population, CRC remains 
the third leading cause of cancer death in the U.S. Compared to non-Latino whites, Latinos 
are less likely to be diagnosed with localized CRC and more likely to be diagnosed with 
advanced stage disease.1 Given this disparity, it is critical to increase this population’s 
participation in CRC prevention efforts. Although screening colonoscopies can detect and 
prevent CRC, more than half of Latinos have not received a screening colonoscopy within 
the recommended time frame (one colonoscopy per ten years).6 Among uninsured Latinos, 
only a staggering 11% have received any type of recent CRC screening.7 It is critical to 
increase Latinos’ screening colonoscopy rates in order to the unequal burden of CRC in 
the Latino community. 
Motivational Interviewing. Motivational Interviewing (MI), a brief client-centered 
behavioral intervention, may improve Latinos’ screening colonoscopy uptake. Drawing from 
Self-Determination Theory (SDT),8-10 MI helps increase competence, autonomy, and 
relatedness in order to promote behavioral change. MI involves four sequential processes: (1) 
engaging the patient in the intervention; (2) focusing the goal of the intervention; (3) evoking 
motivations for change; and, (4) planning for change.11 Within this framework, MI implements 
techniques (e.g., decisional balance) to support behavior change.12 MI was originally 
developed to treat substance use, and extensive research supports its efficacy for treating 
drug, alcohol, and nicotine use.13-16 More recently, MI has proven efficacious for improving 
health behaviors such as diet,17-19 exercise,17 and medication adherence.20 A meta-
analysis found that MI had a significant, moderate effect (d=0.53) for improving health 
behaviors when compared to a no treatment/placebo control group.21 Moreover, research 
has found that the effects of MI are long-lasting (>2 year follow up).21 Extensive evidence 
supports the use of MI with Latinos. For example, research with exclusively or 
predominantly Latinos/Hispanic samples have found MI efficacious for managing 
diabetes,22 decreasing drug use/needle sharing,23,24 quitting smoking,25 and decreasing 
alcohol use.26 In fact, a 2005 review found MI to yield larger effect sizes with minorities, 
compared to non-minority whites.15  
MI for Colonoscopy. Preliminary research has found MI to be efficacious for improving 
screenings for HIV,27,28 breast cancer,29,30 skin cancer,31 and cervical cancer.29 A recently 
published study examining the efficacy of MI to improve CRC screening uptake produced 
promising results, though non-significant (OR=1.6, CI=0.9, 3.0). Notable problems with this 
study may have limited the effects of MI. Most critical, not all MI interventionists were 
proficient in MI in the beginning stages of the study. Additionally, the intervention 
implemented techniques (e.g., discussing ambivalence when it was not clinically indicated) 
that may have been counterproductive.32 A systematic review of the literature yielded that 
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MI shows strong promise for improving health screening behaviors, including several 
cancer screenings. 33
1.2
Study Agent(s) Background and Associated Known Toxicities
N/A
1.3
Other Agents
N/A
1.4
Rationale
MI as an E-Health Intervention. Traditionally, MI is delivered live, where individuals meet 
with a professional either in person or over the telephone. Although efficacious, live-MI is 
not without limitations. Of greatest concern, live-MI requires staffing and economic 
resources, limiting its potential for wide dissemination. As such, many studies have 
examined the efficacy of e-MI, that is MI interventions delivered via electronic media (e.g., 
smartphone). This line of research began with the “Drinker’s Checkup”, an e-MI 
intervention designed to reduce alcohol use in problem drinkers. Extensive research 
supports the efficacy of this intervention34,35 and it is currently listed in the Substance Abuse 
and Mental Health Administration (SAMSHA)’s National Registry of Evidenced-based 
Protocols and Programs (NREPP). Due to its proven efficacy, the Drinker’s Checkup can 
be accessed online for clinical use and it has been widely disseminated both nationally and 
internationally.36
Although e-MI cannot replicate the nuances of live-MI, with advancing technology (e.g., 
algorithm based tailoring), e-MI is able to capture many of the essential components of 
live-MI, thus contributing to its widely proven efficacy.
Advantages of e-MI versus live-MI. There are both clinical and research advantages to 
using e-Health interventions, such as e-MI, as compared to live interventions. The clinical 
advantages of e-Health interventions include: (1) High Technology Use: E-health 
interventions are timely given the ubiquity of technology use in the U.S. According to a 
recent report from the U.S. Census, in 2015, 78% of households had a computer and 75% 
had a handheld computer (e.g., smartphone).46 The PEW Internet & American Life 
Project’s 2015 statistics reported that 84% of Latino adults use the Internet and 80% of 
Latino adults access the Internet via smartphone or tablet.47  In recent years, the digital 
divide between Latinos and non-Latino whites has significantly narrowed, largely due to 
the increases in Internet use among immigrant Latinos and Spanish-speaking dominant 
Latinos. In fact, from 2009 to 2015, the rate of immigrant Latinos who use the Internet 
increased from 51% to 78% and the rate of Spanish-speaking dominant Latinos who use 
the Internet increased from 36% to 74%.48  (2) High Reach: E-Health interventions have 
the potential for wide dissemination because they can be accessed from multiple locations 
and at convenient times, thus overcoming common barriers to receiving health 
interventions (e.g., limited transportation). E-Health interventions may be particularly useful 
for individuals of low socioeconomic status as they are often confronted with access 
barriers such as having limited transportation.49 (3) Privacy: E-Health interventions can be 
accessed in private locations, maximizing anonymity and privacy. Research has found that 
individuals are more willing to disclose personal information when interacting with a 
computerized device versus a person.50-52 Privacy may be particularly important with 
regard to potentially embarrassing health content, such as that surrounding a colonoscopy. 
(4) Low Cost: E-Health interventions do not require the hiring or training of staff thus 
reducing costs.53 The research advantages to e-Health interventions include: (1) 
Standardization: E-Health interventions are highly standardized, thereby minimizing 
variance and maximizing internal validity.53 (2) Storage and Backup: E-Health 
interventions can be linked to secure online databases that are regularly backed up thereby 
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eliminating errors in data entry and maximizing data security.53 (3) Tailored by Language:  
E-health interventions can be programmed to be offered in multiple languages (e.g., 
Spanish and English) to address a wide range of patient populations. 
e-MI to Improve Latinos’ Screening Colonoscopy Uptake. Despite the strong promise 
of MI for improving screening colonoscopy uptake, and the advantages of e-MI, no study 
to date has examined the efficacy of e-MI to improve Latinos’ screening colonoscopy 
uptake. This study pilot tests an e-MI intervention, e-Motivación (e-Motivation), to help 
improve Latinos’ screening colonoscopy uptake. This line of research will increase our 
understanding of efficacious interventions to improve Latinos’ CRC screening rates. It will 
also provide power calculations for a future RCT that will formally examine the efficacy of 
the e-Motivación app for improving Latinos’ screening colonoscopy uptake. This program 
of research can help increase Latinos’ colonoscopy uptake and, in doing so, reduce CRC 
screening disparities. 
1.5
Correlative Studies
N/A
2.0
STUDY OBJECTIVES
2.1
Primary Objectives
2.1.1
To obtain an estimate of the efficacy of the e-Motivación app for improving 
screening colonoscopy uptake among Latinos
[For details, please see section 5.2.2; a detailed flowchart of the App is attached – 
please see Appendix B]
2.2
Secondary Objectives 
N/A
2.3
Exploratory Objectives
N/A
2.4
Endpoints
2.4.1
Screening colonoscopy completion status in medical charts six months after t 
participants complete the consent for the study  will be used as a proxy for efficacy 
of the e-Motivación app in improving screening colonoscopy uptake among 
Latinos. In our previous study with a similar sample, less than 10 of 900+ 
participants reported completing the colonoscopy at a different hospital. As such, 
for the proposed project, if the medical chart does not report that a colonoscopy 
was completed, the colonoscopy will be documented as “not completed”.
3.0
PATIENT ELIGIBILITY
Eligibility waivers are not permitted. Subjects must meet all of the inclusion and exclusion criteria 
to be registered to the study. Study treatment may not begin until a subject is registered.
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3.1
Inclusion Criteria
3.1.1
Self-identified as Latino,a,x
3.1.2
English or Spanish-speaking
3.1.3
Received a physician referral for a screening colonoscopy
3.1.4
Has access to a tablet, smartphone, or computer with working Internet
3.2
Exclusion Criteria
3.2.1
Hearing or vision impaired
3.2.2
Aim 1 or 2 participant
4.0
TREATMENT PLAN
4.1
Administration
Participants will be randomly assigned to one of two groups: e-Motivación (N=40) or control 
group (N=40). Participants assigned to the e-Motivación condition will complete the e-
Motivación app on a personal device of their choice (for details, please see section 5.2.2; 
a detailed flowchart of the App is attached – please see Appendix B). Participants assigned 
to the control group will watch a general health video on a personal device of their choice. 
4.2
Toxicities and Dosing Delays/Dose Modifications
N/A
4.3
Concomitant Medications/Treatments
N/A
4.4
Other Modalities or Procedures
N/A
4.5
Duration of Therapy
N/A
4.6
Duration of Follow Up
Six months following the consent to take part into the study, medical charts will be reviewed 
to determine colonoscopy completion status.
4.7
Removal of Patients from Protocol Therapy
Patients can be taken off the study at any time at their own request, or they may be 
withdrawn at the discretion of the investigator for safety, behavioral or administrative 
reasons. The reason(s) for discontinuation will be documented and may include:
4.7.1
Patient voluntarily withdraws from the study (follow-up permitted); 
4.7.2
Patient withdraws consent (termination of treatment and follow-up);
4.7.3
Patient is unable to comply with protocol requirements;
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4.7.4
Continuation on the study would not be in the patient’s best interest based on the 
judgement of the treating physician, study PI, study doctor, sponsor or study 
institutions
4.8
Patient Replacement
N/A
5.0
STUDY PROCEDURES
5.1
Screening/Baseline Procedures
A HIPAA waiver will be requested to access patient lists and medical records to screen for 
study eligibility. Patients’ lists (i.e. CERNER, Pool of Direct Access for Colonoscopies 
referrals, MSHS EPIC screening colonoscopy lists) and medical records will be obtained 
to identify and screen for potential participants. A member of the research team will inform 
members of the healthcare team (e.g., patient navigators, schedulers, physicians, medical 
assistants) which patients may be eligible for the study.  
Members of the healthcare team, including patient navigators and primary care providers, 
will introduce the study to eligible patients (e.g., identify as Latino, received a primary care 
referral for a screening colonoscopy).  If patients are interested in learning more about the 
study, and agree to be contacted, the member of the healthcare team will provide the 
research staff with the patient’s contact information.  If patients are being recruited in 
person, the member of the healthcare team will introduce the patient to the member of the 
research team, in person, after an in-clinic appointment. 
The research staff will then contact (via email/over the phone/in person) the eligible patient 
to provide the patient with more details about the study.  If the patient is interested in 
participating in the study and meets eligibility criteria, the patient will complete the consent 
form on RedCAP (emailed/texted/shown on the device of the person obtaining consent).  
The screening procedures include:
5.1.1
Obtaining Informed Consent
5.1.2
Reviewing Subject Eligibility Criteria
5.1.3
Collecting Demographics 
[Age;; Length of permanence in the US; Ethnicity; Race; Preferred language; Territory of 
identity; Gender; Highest level of education; Marital Status; Estimated total income for the 
household for the past year]
5.1.4
Collecting Medical History
[Referral for a screening colonoscopy (Yes/No); Previous experience of colonoscopy 
before (Yes/No) - If yes: year of last colonoscopy; Diagnosis of colorectal cancer (Yes/No); 
Diagnosis of a gastrointestinal disease (Yes/No); Family history of colorectal cancer 
(Yes/No) - If yes: Mother, Father, Brother, Sister, Child, Other; PRIMARY type of health 
insurance]
5.2
Procedures During Treatment
Consented participants will first complete a demographics questionnaire administered over 
the phone or in-person. Then, the participant will be randomly assigned to either the 
intervention condition (e-motivacion) or the control condition (general health video).  The 
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participants will be emailed or texted a hyperlink.  The hyperlink will either direct the 
participants to the app or to a general health video (see Appendices A and B, for details).
5.2.1
Completing an interviewer-administered baseline questionnaire
[Age; Length of permanence in the US; Ethnicity; Race; Preferred language; Territory of 
identity; Referral for a screening colonoscopy (Yes/No); Previous experience of 
colonoscopy before (Yes/No) - If yes: year of last colonoscopy; Diagnosis of colorectal 
cancer (Yes/No); Diagnosis of a gastrointestinal disease (Yes/No); Family history of 
colorectal cancer (Yes/No) - If yes: Mother, Father, Brother, Sister, Child, Other; Gender; 
Highest level of education; PRIMARY type of health insurance; Marital Status; Estimated 
total income for the household for the past year, before taxes]
5.2.2
Interacting with the App (condition group)
The app is designed to be used in English or Spanish, based on participant preference. 
The content of the app is drawn from our preliminary studies and the current MI literature, 
with particular emphasis on the most recently published MI guidelines (MI-III).11,15,81-83 The 
e-Motivación app is designed to be user-friendly and to require low computer literacy. 
Consistent with the published MI guidelines, the e-Motivación app involves four sequential 
phases: (1) Engaging:  During the engaging phase, participants will watch a video 
welcoming them to the intervention. Drawing from other e-MI interventions,42 a live video 
coach will be used. (2) Focusing: During the focusing phase, participants will reaffirm their 
willingness to discuss the decision to have a screening colonoscopy. Then, using the “elicit-
provide-elicit” MI technique, through touch screen multiple-choice questions, participants’ 
knowledge about CRC prevention will be assessed. If participants lack knowledge 
regarding certain aspects of the colonoscopy or CRC in general, they will be given the 
option to view information videos (e.g., how to prepare for a screening colonoscopy). (3) 
Evoking: During the evoking phase of the intervention, participants will rate their perceived 
importance of having a colonoscopy and their level of confidence in their ability to complete 
the procedure. Based on their responses, participants will complete interactive MI 
exercises (e.g., decisional balance, values clarification) to help improve their perceived 
importance and confidence. (4) Planning: During the planning phase of the intervention,  
participants will be offered the option to watch a video designed to orient them to complete 
an action plan (e.g., scheduling the colonoscopy, planning for an escort). 
[A detailed flowchart of the App is attached – please see Appendix B]
5.2.3
The study team will have access to back end information that will allow 
authorized members to know which parts of the App were utilized by the user and how. 
That information will be linked to each participant by the ID that users are required to enter 
to log into the app. Watching a General Health Information Video (control group)
For the control group, the investigators will not be able to know if the video was watched 
by the participant or not.
5.3
Follow-up Procedures
5.3.1 Reviewing Medical Charts to Determine Colonoscopy Completion Status and 
relevant medical information [Screening colonoscopy referral and scheduling 
date; Screening colonoscopy completion (yes/no); Screening colonoscopy 
completion date; bowel prep quality; number of cancelations and no-shows; 
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Received patient navigation/care coordination(yes/no); reasons for not 
completion (if applicable)]
6 months following consent to participate in the study 
5.4
Time and Events Table
Research Timeline
[Aim III]
Months
1-3
Months
4-6
Months
7-9
Months
10-12
Months
13-15
Recruitment
X
X
X
Informed Consent
X
X
X
Baseline data
(demographics & medical history)
X
X
X
Review of medical charts
(colonoscopy completion status)
X
X
X
Analyze pilot study data
X
Disseminate results
X
 
5.5
Removal of Subjects from Study
Patients can be taken off the study at any time at their own request, or they may be 
withdrawn at the discretion of the investigator for safety, behavioral or administrative 
reasons. The reasons for discontinuation will be documented and may include:
5.5.1
Patient voluntarily withdraws from the study (follow-up permitted); 
5.5.2
Patient withdraws consent (termination of treatment and follow-up);
5.5.3
Patient is unable to comply with protocol requirements;
5.5.4
Continuation on the study would not be in the patient’s best interest based on the 
judgement of the treating physician, study PI, study doctor, sponsor or study 
institution
6.0
Measurement of Effect
Screening colonoscopy completion status (in medical charts) six months after the patient expressed 
informed consent to participate in the study will be the proxy for efficacy of the e-Motivación app in 
improving screening colonoscopy uptake among Latinos. If the medical chart does not report that 
a colonoscopy was completed, the colonoscopy will be documented as “not completed”. This 
decision is informed by a study that we have conducted with a similar sample, where less than 10 
out of 900+ participants reported completing the colonoscopy at a different hospital.
6.1
Antitumor Effect- Solid Tumors
N/A
6.2
Antitumor Effect- Hematologic Tumors
N/A
6.3
Safety/tolerability
N/A
7.0
ADVERSE EVENTS
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7.1
Experimental Therapy
N/A
7.2
Adverse Event Monitoring
Adverse event data collection and reporting, which are required as part of every clinical 
trial, are done to ensure the safety of Subjects enrolled in the studies as well as those who 
will enroll in future studies. Adverse events are reported in a routine manner at scheduled 
times during a trial. Additionally, certain adverse events must be reported in an expedited 
manner to allow for optimal monitoring of patient safety and care. 
All patients experiencing an adverse event, regardless of its relationship to the study, will 
be monitored until: 

the adverse event resolves or the symptoms or signs that constitute the adverse 
event return to baseline; 

any abnormal laboratory values have returned to baseline; 

there is a satisfactory explanation other than the study for the changes observed; 
or

death.
7.3
Definitions
7.3.1
Definition of Adverse Event
An adverse event (AE) is any untoward medical occurrence in a patient receiving 
study treatment and which does not necessarily have a causal relationship with 
this treatment. An AE can therefore be any unfavorable and unintended sign 
(including an abnormal laboratory finding), symptom, or disease temporally 
associated with the use of an experimental intervention, whether or not related to 
the intervention. 
7.3.2
Severity of Adverse Events
The severity of an AE is graded as follows:
Mild (grade 1): the event causes discomfort without disruption of normal daily 
activities.
Moderate (grade 2): the event causes discomfort that affects normal daily 
activities.
Severe (grade 3): the event makes the patient unable to perform normal daily 
activities or significantly affects his/her clinical status.
Life-threatening (grade 4): the patient was at risk of death at the time of the event.
Fatal (grade 5): the event caused death.
7.3.3
Serious Adverse Events
A “serious” adverse event is defined in regulatory terminology as any untoward 
medical occurrence that:
7.3.3.1
Results in death.
If death results from (progression of) the disease, the disease should 
be reported as event (SAE) itself.
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7.3.3.2
Is life-threatening.
(the patient was at risk of death at the time of the event; it does not refer 
to an event that hypothetically might have caused death if it were more 
severe).
7.3.3.3
Requires in-patient hospitalization or prolongation of existing 
hospitalization for ≥ 24 hours.
7.3.3.4
Results in persistent or significant disability or incapacity.
7.3.3.5
Is an important medical event
Any event that does not meet the above criteria, but that in the 
judgment of the investigator jeopardizes the patient, may be considered 
for reporting as a serious adverse event. The event may require 
medical or surgical intervention to prevent one of the outcomes listed 
in the definition of “Serious Adverse Event“.
7.4
Steps to Determine If an Adverse Event Requires Expedited Reporting
Step 1: Identify the type of adverse event using the aforementioned scale (7.3.2). 
Step 2: Grade the adverse event using the aforementioned scale (7.3.2).
Step 3: Determine whether the adverse event is related to the study protocol
Attribution categories are as follows:
-
Definite – The AE is clearly related to the study.
-
Probable – The AE is likely related to the study.
-
Possible – The AE may be related to the study.
-
Unrelated – The AE is clearly NOT related to the study.
Note: This includes all events that occur within 30 days of the last participation of patient 
in the study. Any event that occurs more than 30 days after the last participation and is 
attributed (possibly, probably, or definitely) to the agent(s) must also be reported 
accordingly.
Step 4: Determine the prior experience of the adverse event. 
Expected events are those that have been previously identified as resulting from 
administration of the intervention.
7.5
Reporting Requirements for Adverse Events
7.5.1
Expedited Reporting

The Principal Investigator must be notified within 24 hours of learning of any 
serious adverse events, regardless of attribution, occurring during the study 
or within 30 days of the last participation of patient in the study. 

The IRB/PPHS must be notified within 5 business days of “any 
unanticipated problems involving risk to subjects or others” (UPR/UPIRSO).
The following events meet the definition of UPR
a.
Any new information that indicates a new or increased risk, or 
safety issue (e.g., interim analysis, safety monitoring report, 
publication, updated sponsor safety report), that indicates an 
unexpected change to the risk/benefit ratio for the research.
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b.
Protocol deviation or violation that harmed subjects or others or 
that indicated subjects or others might be at increased risk of 
harm.
c.
Complaint of subject that indicates subjects or others might be at 
increased risk of harm or at risk of a new harm
d.
Any breach in confidentiality that may involve risk to the subject or 
others.
e.
Any harm experienced by a subject or other individual that in the 
opinion of the investigator is unexpected and at least probably 
related to the research procedures.
7.5.2
Routine Reporting
All other adverse events- such as those that are expected, or are unlikely or 
definitely not related to the study participation- are to be reported annually as part 
of regular data submission.
7.6
Unblinding Procedures
N/A
7.7
Stopping Rules 
N/A
8.0
DRUG INFORMATION
8.1
N/A
9.0
CORRELATIVES/SPECIAL STUDIES
9.1
Sample Collection Guidelines
N/A
9.2
Assay Methodology
N/A
9.3
Specimen Banking
N/A
10.0
STATISTICAL CONSIDERATIONS
10.1
Study Design/Study Endpoints
This pilot study is a behavioral research Randomized Control Trial. A previously used 
English/Spanish questionnaire90, 91 is administered to assess demographics and medical 
history of participants. Stratified randomization (per language, English or Spanish) assigns 
participants to either the e-Motivación condition arm or control arm.
Participants in both groups will be asked to complete their respective tasks on their 
personal device of choice (going through the e-Motivación App or watching the general 
health informative video). To determine colonoscopy completion status, patients’ medical 
charts are to be reviewed six months following patient’s consent to participate in the study.
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10.2
Sample Size and Accrual
The sample includes 80 participants: 40 in the e-Motivación condition arm and 40 in the 
control arm. Based on previous studies, this sample will provide a large enough sample to 
determine the effect of the intervention. We also expect the ratio of male to female 
participation to be 4 to 6.
10.3
Data Analyses Plans
Analyses of covariates: Due to the use of randomization, significant baseline differences 
(e.g., gender, age) between condition and control groups are not expected. However, 
contingency tables and t-tests will be performed to determine any differences between the 
two arms. Using a p value of ≤ 0.15, any consistent pattern of correlation for any of the 
covariates would suggest their inclusion in the primary data analysis model.
Effect size estimate: Logistic regression analyses will be used to evaluate an estimate of 
the efficacy. The model will include any covariates that differentiate the intervention and 
control groups. The effect size of the treatment group will be used as an indicator to inform 
power calculations for a future RCT. The power calculations will inform the appropriate 
sample size needed for the RCT.
Missing data: The e-Motivación app is a one-time intervention and the questionnaire to 
assess demographics and medical history of participants will be conducted as an interview. 
Therefore, we anticipate minimal missing data.
11.0
STUDY MANAGEMENT
11.1
Conflict of Interest
Any research personnel who has a conflict of interest with this study (patent ownership, 
intellectual property, royalties, or financial gain greater than the minimum allowable by their 
institution, etc.) must declare their conflict of interest to the appropriate institutional review 
bodies. Local institutional conflict of interest policies will be followed for all research 
personnel associated with the research project.  
11.2
Institutional Review Board (IRB) Approval and Consent 
It is expected that the IRB will have the proper representation and function in accordance 
with federally mandated regulations. The IRB should approve the consent form and 
protocol.
In obtaining and documenting informed consent, the investigator should comply with the 
applicable regulatory requirement(s), and should adhere to Good Clinical Practice (GCP) 
and to ethical principles that have their origin in the Declaration of Helsinki.
Before recruitment and enrollment onto this study, the patient will be given a full 
explanation of the study and will be given the opportunity to review the consent form. Each 
consent form must include all the relevant elements currently required by the FDA 
Regulations and local or state regulations. Once this essential information has been 
provided to the patient and the investigator is assured that the patient understands the 
implications of participating in the study, the patient will be asked to give consent to 
participate in the study by signing an IRB-approved consent form.
Prior to a patient’s participation in the trial, the written informed consent form should be 
signed and personally dated (in person or electronic via RedCAP) by the patient and by 
the person who conducted the informed consent discussion.
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11.3
Required Documentation 
N/A
11.4
Registration Procedures
All patients must be enrolled onto trial through the Cancer Clinical Trials Office Central 
Registration process. Prior to registration, a member of the study staff must scan and email 
the following documents as individual PDF files to the Central Registration Mailbox 
(central.registration@mssm.edu) with a cc to the Central Registrars. 
•
Signed Informed Consent(s)
•
Signed CCTO Registration Form
•
Signed Eligibility Checklist
•
Additional supporting documentation (i.e. lab/scan reports) may be included at the 
study teams’ discretion. 
The designated Central Registrar will review all received documents for consistency and 
completeness.
•
If there is any concern or discrepancy noted, the study staff member who originated 
the central registration request will be contacted immediately for clarification.
If the patient is deemed eligible for study enrollment based on a thorough review 
by the Central Registrar, the patient will be entered into the CTMS system and a 
Registration Confirmation Letter is generated and sent to the following individuals:
•
Study team
•
Treating Physician
•
Research Infusion Nurse designee 
•
Research Pharmacy
11.5
Data Management and Monitoring/Auditing
11.5.1 Elements of a Data and Safety Monitoring Plan
1.
List the name(s) of the individual(s) at the Icahn School of Medicine at Mount Sinai 
(ISMMS) who will be responsible for data and safety monitoring of this study. For each 
individual, indicate their role, name, title, and department information. 
ISMMS Principal Monitor:
Principal Investigator
Last Name: Miller
First Name: Sarah
Academic Title: 
Department: Oncological Sciences
Mailing Address: 1 Gustave L. Levy Place, Box 1130 
Phone: 212.824.7783
E-mail: Sarah.miller@mssm.edu 
ISMMS Additional Monitor:
Team Member
Last Name: Jandorf
First Name: Lina
Academic Title: MA
Department: Population Health Science and Policy, Oncological Sciences
Mailing Address: 1425 Madison Ave, New York, NY 10029
Phone: 212-659-5506
E-mail: lina.jandorf@mssm.edu
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2.
Justify your choice of principal monitor in terms of the assessed risk to the research 
subject‘s health and wellbeing.
Participants could experience mild to moderate emotional discomfort from 1) failed 
attempts to use the App, 2) engaging with an App that is focused on colorectal cancer 3) 
breach in confidentiality. In the event a patient requires a higher level of care or assistance 
than provided in this study, a Licensed Clinical Psychologist (Dr. Sarah Miller, PI) will be 
consulted and the participant will be referred to the appropriate level of care. If additional 
intervention is necessary, Dr. Miller will coordinate with Mount Sinai’s Psychiatry 
Department.
As per ISMMS PPHS policies, the PI is required to notify PPHS of any unanticipated 
problems involving risks to participants or others that occur. If an adverse event is due to 
the intervention and is unexpected, the PI will draft a safety report and send a copy to 
PPHS. The PPHS committee will serve as an objective review mechanism. This 
policy/procedure means that any potential conflict of interest inherent in the PI being the 
sole reviewer of serious adverse advents is avoided.
3.
List the specific items that will be monitored for safety (e.g., adverse events, subject 
compliance with the protocol, drop outs, etc.).

Informed Consent

Subject compliance with the protocol

Research Staff compliance with the protocol

Adverse Events

Drop outs
4.
Indicate the frequency at which ACCUMULATED safety and data information (items 
listed in number 3 above and interim analysis of efficacy outcomes) will be reviewed 
by the monitor(s) or the Data Monitoring Committee (DMC). Although this information 
must be reviewed at least annually, the higher the study risks, the more frequently 
reviews must be scheduled.
The PI will monitor the progress of the trial and the safety of participants on an ongoing 
basis. The procedures of this study, such as regular meetings with research staff and the 
entire study team, will ensure prompt discussion and reporting of all study conduct issues, 
including adverse events. During these meetings, the PI will focus on participant safety by 
reviewing adverse events, study progress (e.g. recruitment, retention, protocol adherence), 
data integrity and study outcomes. Additionally, we anticipate that risk-benefit ratio will 
remain favorable throughout the study. However, if at any point it is not, we will stop the 
study and re-evaluate study procedures in order to ensure a positive risk-benefit ratio for 
participants. 
The table below describes each data monitoring activity, responsible staff person, and 
frequency of review. Tracking forms will be developed to document the occurrence of all 
reviews. The PI will review all reports as they are generated. 
Activity
Report
Timing of review
Informed Consent
Quality control of each new 
consent by Research 
Coordinators
PI reviews all consents 
upon receipt
Protocol Adherence (both 
Subjects and Research Staff)
Weekly report generated by 
Research Coordinators
Weekly PI review
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Adverse Events
Weekly report generated by 
Research Coordinators
Weekly PI review
Study Retention
Weekly report generated by 
Research Coordinators
Weekly PI review
Review of Medical Charts to 
Assess Colonoscopy 
Completion Status
Weekly report generated by 
Research Coordinators
Weekly PI review
Self-Report Information
PI and other study staff will 
review all self-report materials 
and complete fidelity checklist
PI will review data weekly 
for completeness and 
accurate entry into a 
database for analysis
5.
Where applicable, describe rules which will guide interruption or alteration of the study 
design.
N/A
6.
Where applicable, indicate dose selection procedures that will be used to minimize 
toxicity.
N/A
7.
List any specialized grading system that will be used to evaluate adverse events (e.g., 
National Cancer Institute Common Toxicity Criteria).
The severity of an adverse event is graded as follows:

Mild (grade 1): the event causes discomfort without disruption of normal daily 
activities.

Moderate (grade 2): the event causes discomfort that affects normal daily 
activities.

Severe (grade 3): the event makes the patient unable to perform normal daily 
activities or significantly affects his/her clinical status.

Life-threatening (grade 4): the patient was at risk of death at the time of the event.

Fatal (grade 5): the event caused death.
8.
Describe procedures that will be used to assure data accuracy and completeness.
Study data will be entered by a Research Coordinator trained to enter data into a password-
protected, secure database on REDCap. To ensure the validity and integrity of study data, 
the PI will oversee all data management responsibilities. Data entry, level of accuracy and 
percentage of error in data entry will be discussed with the study team on a regular basis. 
Monthly meetings (either in person or via video/telephone conference) will be held with the 
entire study team.
Thorough training of Research Coordinators is also designed to ensure adequate 
protection of human subjects. All Research Coordinators will receive all required training 
and certification in Mount Sinai’s human subjects in research. Research Coordinators will 
be required to participate in a training program designed to ensure that they administer the 
interviews and evaluate participant responses in a sensitive manner. Research 
Coordinators will be trained to speak clearly and audibly and let participants determine the 
pace of the interview.
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Protocol compliance will be monitored at the weekly research staff meetings. The PI will 
meet with the study staff on a weekly basis to train and ensure adherence to the intended 
protocol. The PI will be responsible for updating all investigators regarding any study 
related issues that arise of that need to be addressed.
The medical chart abstraction will be conducted by a research team member.  A second 
research team member will review 20% of the medical charts to confirm accuracy.  
9.
Should a temporary or permanent suspension of your study occur, in addition to the 
PPHS, to whom (NIH, FDA, sponsor, IRB) will you report the occurrence? 
IRB and Program Officer of the National Institute On Aging/NIH/DHHS
11.5.2  Data Monitoring Committee/Data Safety Monitoring Board (DMC/DSMB)
N/A
11.6
Adherence to the Protocol
Except for an emergency situation in which proper care for the protection, safety, and well-
being of the study patient requires alternative treatment, the study shall be conducted 
exactly as described in the approved protocol. 
11.6.1
Emergency Modifications
Investigators may implement a deviation from, or a change of, the protocol to 
eliminate an immediate hazard(s) to trial subjects without prior IRB approval.
11.6.2
Other Reportable New Information and Protocol Deviations/Violations
In accordance with local IRB requirements, the following information must be reported 
within five (5) business days. 

Non-compliance with federal regulations governing human research or with the 
requirements or determinations of the IRB, or an allegation of such non-compliance

Failure to follow the protocol due to the action or inaction of the investigator or 
research staff.

Breach of confidentiality

Premature suspension or termination of the research by the sponsor or 
investigator.
11.7
Amendments to the Protocol 
Should amendments to the protocol be required, the amendments will be originated and 
documented by the Principal Investigator. It should also be noted that when an amendment 
to the protocol substantially alters the study design or the potential risk to the patient, a 
revised consent form might be required. 
The written amendment, and if required the amended consent form, must be sent to the 
IRB for approval prior to implementation. 
11.8
Record Retention
Study documentation includes all Case Report Forms, data correction forms or queries, 
source documents, Sponsor-Investigator correspondence, monitoring logs/letters, and 
regulatory documents (e.g., protocol and amendments, IRB correspondence and approval, 
signed patient consent forms).
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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.
Government agency regulations and directives require that the study investigator must 
retain all study documentation pertaining to the conduct of a clinical trial. In the case of a 
study with a drug seeking regulatory approval and marketing, these documents shall be 
retained for at least two years after the last approval of marketing application in an 
International Conference on Harmonization (ICH) region. In all other cases, study 
documents should be kept on file until three years after the completion and final study 
report of this investigational study.
11.9
Obligations of Investigators
The Principal Investigator is responsible for the conduct of the clinical trial at the site in 
accordance with Title 21 of the Code of Federal Regulations and/or the Declaration of 
Helsinki. The Principal Investigator is responsible for personally overseeing the treatment 
of all study patients. The Principal Investigator must assure that all study site personnel, 
including sub-investigators and other study staff members, adhere to the study protocol 
and all FDA/GCP/NCI regulations and guidelines regarding clinical trials both during and 
after study completion.
The Principal Investigator at each institution or site will be responsible for assuring that all 
the required data will be collected and entered onto the Case Report Forms. Periodically, 
monitoring visits will be conducted and the Principal Investigator will provide access to 
his/her original records to permit verification of proper entry of data. At the completion of 
the study, all case report forms will be reviewed by the Principal Investigator and will require 
his/her final signature to verify the accuracy of the data.
12.0
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13.0
APPENDICES
A.
Shortlisted General Health Information Videos


Acabe con los microbios. ¡Lávese las manos! [Spanish version]

Fight Germs. Wash Your Hands [English version]
Note: The shortlisted videos are CDC’s materials; If approved by the IRB, the research team will 
make sure to follow the Agency’s requirements to utilize CDC’s public domain content. .
B.
App Flowchart - Field Testing II
Effective Date: 3/14/2024
End Date:3/13/2025