Pilot Test of an mHealth Intervention for Reducing Alcohol Use Among Adolescent and Young Adult Cancer Survivors
Phase: NA
Conditions: Cancer, Alcohol Use
Sponsor: Carolyn Lauckner

Document Coversheet 
 
 Study Title: Pilot Test of an mHealth Intervention for Reducing Alcohol Use Among Rural 
Adolescent and Young Adult Cancer Survivors 
Institution/Site:  
University of Kentucky 
Document (Approval/Update) Date: 
6/2/2025 
NCT Number: 
NCT05087875 
IRB Number 
67410 
Coversheet created: 
7/1/25 
 
 

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Section 9 Page 2 of 2

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Section 10 Page 1 of 17

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Section 10 Page 2 of 17

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1.1
STATISTICAL HYPOTHESES
Primary Endpoint: We hypothesize that at least 60% of eligible patients approached will enroll in 
the TRAC-AYA study. 
1.2
SAMPLE SIZE DETERMINATION
The sample size of 40 is based on the goal of estimating the probabilities and means for 3 
feasibility outcome measures enrollment  60% >primary@ retention  60% adherence >defined 
as ! 0% completing at least 60% of sessions@. Assuming a negatiYe binomial distribution and 
true probability of enrollment of 60% the probability that we would haYe to approach  or more 
people to recruit 40 is 0.0. ,f we approach  AYAs to enroll 40 it is unliNely the true 
probability of enrollment is 60% or greater concluding a future efficacy study may not be 
feasible. 2ut of 40 AYAs if the true probability of retention is 60% we e[pect at least  AYAs 
will be retained (i.e. probability of n retained giYen true retention probability of 60% is 
0.0 so if more than  AYAs are not retained an efficacy study may not be feasible. We 
haYe 0% power (using a -tailed alpha of 0.0 to detect an adherence proportion of 0. if we 
assume a null hypothesis adherence proportion of 0.0.
1.3
POPULATIONS FOR ANALYSES
The sample from Aim  (n =  will be used to refine procedures and the interYention protocol. 
The sample from Aim  (n = 40 will be used to analyze feasibility and acceptability data and 
describe pre-post changes in patient-reported outcomes. 
1.4
STATISTICAL ANALYSES
AIM 1 ANALYSES
For Aim  all interYiews will be audio recorded and transcribed using a transcription serYice. 
Study staff will annotate transcripts to identify which aspects of TRAC were the focus of 
comments. Annotated transcripts will be reYiewed to refine proposed coding categories and 
create a coding categories dictionary. Coders will meet to compare results and resolYe any 
discrepancies through consensus. Proposed initial coding categories are: 8sability of deliYery 
(e.g. perceiYed efficiency ease /ength (appropriateness acceptability Content 
(appropriateness helpfulness releYance and AYA specific education (e.g. AYA surYiYorship 
and risNs of alcohol use for AYAs. ,f needed data will be managed in 19iYo software and we 
will engage the 0arNey Shared Resource Facility for additional coding support.
AIM 2 ANALYSES
1.4.2.1
FEASIBILITY 

Enrollment: the number of AYAs enrolled diYided by the number of eligible AYAs approached 
(hypothesized Yalue = 60%.  
Retention the percentage of AYAs who complete baseline and follow-up Tuestionnaires (T0 T; 
hypothesized Yalue = 60%.  
Adherence: the percentage of AYAs who complete at least % of sessions in  weeNs 
(hypothesized Yalue = 0%; alcohol monitoring hypothesized Yalue = 0%.  
 
We will calculate % C,s for feasibility measures to determine the range of estimates that are 
consistent with our data. We will use one-sample negatiYe binomial probabilities and tests of 
binomial proportions to compare to hypothesized Yalues. We will summarize reasons for 
ineligibility and refusal and compare AYAs who drop out or do not adhere by demographic and 
clinical characteristics and baseline scores of the measures (e.g. PR20,S- alcohol use. 
We will inYestigate differences in AYA enrollment retention or adherence by sociodemographic 
and clinical characteristics (e.g. cancer type to identify populations for a future study.  
1.4.2.2 PRELIMINARY DATA ON FUTURE TRIAL-RELATED OUTCOMES.  
The primary outcome Yariable related to a future efficacy trial is alcohol use (as measured by 
the PR20,S Alcohol 8se a and number of drinNing days. The primary intermediate Yariables 
are self-efficacy and readiness to change drinNing. We will describe pre-post changes in 
intermediate and outcome Yariables using descriptiYe statistics. T-tests will e[amine whether 
pre-post changes in TRAC differ significantly from pre-post changes in control. The goal of 
these analyses will be to estimate standard deYiations for use in future studies. ,n e[ploratory 
analyses we will include intermediate Yariables as coYariates to model the relation between 
outcome Yariables and hypothesized mediators. 
1.4.2.3 FIDELITY 
We will calculate inter-rater reliability for fidelity scores between raters of interYention fidelity. 
 

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Consent and Authorization to Participate in a Research Study 
 
KEY INFORMATION FOR Tracking and Reducing Alcohol Consumption for Adolescent and 
Young Adult Survivors of Cancer (TRAC-AYA): 
 
We are asking you to choose whether or not to volunteer for a research study testing a health promotion program 
for survivors of adolescent and young adult (AYA) cancer. The goal of this program is to help AYA survivors 
reduce their alcohol use, as research has found that drinking alcohol can have negative consequences for cancer 
survivors. The study will provide free alcohol reduction counseling during a 4-week program delivered using cell 
phones, called TRAC-AYA. You are being asked to participate in this study because you are: 1) a survivor of 
childhood, adolescent, or young adult cancer, 2) between the ages of 18 years and 39, 3) someone who 
consumes at least a moderate amount of alcohol, as identified by your responses on an earlier questionnaire. 
This page aims to give you key information to help you decide whether to participate. We have included detailed 
information after this page. Ask the research team questions. If you have questions later, the contact information 
for the research investigator in charge of the study is below. 
WHAT IS THE STUDY ABOUT AND HOW LONG WILL IT LAST?   
If you agree to participate, you will be asked to complete a 4-week alcohol reduction program delivered using cell 
phones. You will be randomly placed into one of two groups (Group A and Group B). Group A will receive the 
TRAC-AYA program, while Group B will receive alcohol monitoring and education. Using two groups allows the 
researchers to better examine the effects of the program. You will also complete several questionnaires regarding 
your health behaviors, mental health, and attitudes. Overall, your participation in this research will span 10 weeks. 
WHAT ARE KEY REASONS YOU MIGHT CHOOSE TO VOLUNTEER FOR THIS STUDY? 
If you choose to participate and are placed in Group A, you will receive free alcohol reduction counseling, which 
may reduce your alcohol use and impact your overall health. Participants in Group B may benefit from monitoring 
their alcohol use by having increased self-awareness as to levels of alcohol use and triggers for drinking. For a 
complete description of benefits, refer to the Detailed Consent. 
WHAT ARE KEY REASONS YOU MIGHT CHOOSE NOT TO VOLUNTEER FOR THIS STUDY? 
There is a potential risk of discomfort or distress when completing the questionnaires or program sessions. You 
have the right to skip any questions and you may leave the study at any time without penalty. There is also a risk 
of loss of confidentiality, as identifying information will be collected in order to monitor your data throughout the 
course of the planned research. However, this is unlikely considering the careful plans in place regarding data 
management and protection. For a complete description of risks, refer to the Detailed Consent. 
DO YOU HAVE TO TAKE PART IN THE STUDY? 
If you decide to take part in the study, it should be because you really want to volunteer. You will not lose any 
services, benefits or rights you would normally have if you choose not to volunteer.  
WHAT IF YOU HAVE QUESTIONS, SUGGESTIONS OR CONCERNS? 
If you have questions, suggestions, or concerns regarding this study or you want to withdraw from the study 
contact Carolyn Lauckner, PhD of the University of Kentucky, Department of Behavioral Science at 859-562-3335 
or carolyn.lauckner@uky.edu. 
If you have any concerns or questions about your rights as a volunteer in this research, contact staff in the 
University of Kentucky (UK) Office of Research Integrity (ORI) between the business hours of 8am and 5pm EST, 
Monday-Friday at 859-257-9428 or toll free at 1-866-400-9428. 
IRB Approval
1/17/2024
IRB # 67410
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DETAILED CONSENT: 
ARE THERE REASONS WHY YOU WOULD NOT QUALIFY FOR THIS STUDY? 
You will not qualify to participate if you are not a survivor of childhood, adolescent, or young adult cancer, are not 
3 months-15 years post-treatment, are not currently between the ages of 18 and 39, do not reside in the United 
States, do not use any alcohol or use alcohol only at low levels, and/or do not speak English. 
WHERE WILL THE STUDY TAKE PLACE AND WHAT IS THE TOTAL AMOUNT OF TIME INVOLVED? 
The study will be conducted remotely through phone sessions and Internet-based questionnaires. Study 
equipment and materials will be shipped to your home address. The total amount of time you will be asked to 
volunteer for this study is approximately 10-13 hours, depending on which group you are assigned to. 
WHAT WILL YOU BE ASKED TO DO? 
If you decide to participate, you will be asked to complete the 4-week TRAC-AYA alcohol reduction program or 
engage in alcohol monitoring and education. This program is not considered standard of care; it is intended to be 
an optional supplemental activity. You will be randomly placed into one of two groups (Group A or Group B). We 
will use a random number generator to determine which group you will be placed into. Group A will receive the 4-
week TRAC-AYA program and complete alcohol monitoring, while Group B will receive education and alcohol 
monitoring. Both Group A and Group B will complete alcohol monitoring for 6 weeks. 
All participants will be shipped a mobile breathalyzer, cell phone (if needed), and program materials. These 
materials will contain instructions for downloading and finding the breathalyzer app. You will be trained to use the 
breathalyzer, which you will use to monitor your alcohol use during the study. The breathalyzer will connect 
wirelessly to your cell phone and transmit your blood alcohol level to an app. If you do not own a cell phone 
compatible with the breathalyzer app, you will be provided a study phone to use. On each day of the 6-week study 
period, you will be texted in the morning to complete a short survey about your alcohol use, and once in the 
evening and asked to complete a breathalyzer reading before you go to bed that night. The breathalyzer reading 
and survey should take you no more than 5 minutes. Once the 6 weeks of monitoring are completed, you will 
return your cell phone via mail (if you used a study phone). You will be able to keep your breathalyzer. 
Additionally, all participants will complete two electronic questionnaires that ask a variety of questions, including 
some about your alcohol consumption, drug use, mental health, and your attitudes toward technology. These 
questionnaires will take approximately 45-60 minutes each and can be done online using a computer, tablet, or 
mobile phone. You will take this questionnaire at the beginning of your enrollment and at the 6-week point. Once 
you have completed the follow-up questionnaire, the study coordinator will contact you to schedule a 20-30-
minute exit interview. This interview will be audio recorded and transcribed and will be concern your experiences 
with monitoring your alcohol use. Group A participants will also be asked for feedback regarding the TRAC-AYA 
program. At the 10-week point, you will complete an additional follow-up questionnaire, which will take 
approximately 45-60 minutes and can be done online using a computer, tablet, or mobile phone. 
In addition to these monitoring and assessment tasks, if you are placed into Group A, you will meet weekly via 
phone or videoconference with a counselor to discuss alcohol use. Each of these sessions will be recorded. You 
will also complete a short 5-minute questionnaire after each session to provide feedback and a short survey after 
your first session about your expectations regarding TRAC-AYA. 
See Appendix for a detailed overview of the primary study activities. 
WHAT ARE THE POSSIBLE RISKS AND DISCOMFORTS? 
For all participants, there is the potential risk of discomfort or emotional distress when completing questionnaires 
or program sessions. To protect against distress, you have the freedom to skip any questions in assessments that 
make you uncomfortable. You are also free to conclude any ongoing program session without penalty. 
You will be required to provide contact information for at least one emergency contact. We also will ask that you 
provide one “back-up” contact who we will reach out to if we are unable to reach you at any point during the study, 
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however, this is optional. We will not specify the nature of this research study to these individuals. In cases of 
extreme distress, adverse events, or threats of self-harm, the researchers will contact your emergency contact 
and your medical care team if you are a patient at UK HealthCare. Your medical care team will be required to 
refer you if you show signs that you may hurt yourself or others. If they believe it is necessary and immediate 
harm to yourself or others is possible, they will contact emergency services to provide transportation to your local 
emergency department for assessment and intake. You and/or your insurance plans will be responsible for all 
costs incurred related to emergency transportation. 
There is a risk of loss of confidentiality, as identifying information will be collected to monitor your data throughout 
the course of the planned research. There are also risks associated with using mobile phones for health, as they 
are less secure methods of communication. By agreeing to participate in this study, you are stating that you 
understand the risks associated with discussing health information over mobile connections and with to participate 
in spite of these risks. If identifying information is released to an unauthorized party, your alcohol use or other 
health information could be revealed to unwanted individuals. This could potentially cause harm, but is unlikely 
considering the careful plans in place regarding data management and protection. 
Unknown risks. Though the procedures used in this study have been used before, there may be risks, 
discomforts, or side effects that are not yet known. 
WILL YOU BENEFIT FROM TAKING PART IN THIS STUDY? 
If you participate in this research and are placed in Group A, you may benefit from receiving free alcohol reduction 
counseling, which could reduce your alcohol use and impact your overall health. Group B participants may benefit 
from monitoring alcohol use, which could increase your own awareness of your level of consumption and triggers 
for drinking. All participants will receive these benefits with minimal effort, as the program can be entirely 
delivered via mobile phone. 
IF YOU DON’T WANT TO TAKE PART IN THE STUDY, ARE THERE OTHER CHOICES? 
You do not have to be in this study to continue receiving treatment at your healthcare facility. 
As an alternative to participating in this study there are other options available to you: medications and counseling 
such as cognitive behavioral therapy, 12-step facilitation and motivational interviewing have been found to aid in 
the treatment of unhealthy alcohol use. If you are not eligible to participate or decline to participate you may still 
receive treatment and other services to which you are otherwise entitled. Additionally, you can call the SAMSHA’s 
National Helpline at 1-800-662-HELP (4357). This Helpline is a confidential, free, 24-hours-a-day service that can 
help you to find community resources and treatment for reducing your alcohol use. 
WHAT WILL IT COST YOU TO PARTICIPATE? 
There are no costs to participate, however, participation requires access to the Internet and a smartphone. We 
will loan a smartphone to those who need one to complete study tasks. If you choose to use your personal phone, 
you will be responsible for the cost of the data, minutes, and texts used during the study. Should medical care be 
necessary during the study, you and/or your insurance plans will be responsible for all costs incurred related to 
your treatment. 
WHO WILL SEE THE INFORMATION THAT YOU GIVE? 
When we write about or share the results from the study, we will write about the combined information. We will 
keep your name and other identifying information private. 
We will make every effort to prevent anyone who is not on the research team from knowing that you gave us 
information, or what that information is. During this program, we will collect your contact information to use for 
scheduling, delivering program materials, and monitoring your data. This identifying information will be kept 
separately from any and all data you provide us—linked only by an ID number. Only the researchers will have 
access to a code key, which will link your ID number to your contact information. Once data collection is complete, 
this key will be permanently deleted and all identifying information will be removed from records. The study staff 
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will keep any paper copies of study files locked in a file cabinet in a private office. We will use a study number 
rather than your name on study records when we can. 
To secure data on mobile phones, you will be taught how to delete messages if you are worried about your 
information being compromised. Both you and your counselor will be trained and required to secure your phones 
using a password. A web-based service that allows complete control over data will be chosen to deliver your self-
monitoring reminders, and any data collected during this process will be downloaded to a secure computer and 
deleted from the website following the completion of data collection. 
If you choose to use a study phone instead of your own smartphone: These phones will be capable of being 
remotely wiped in the case of loss or theft to protect your information. If at any point you lose your phone or have 
it stolen, notify the researchers IMMEDIATELY at 502-240-2119. After you conclude the program, the phone you 
used will undergo a factory reset to remove any traces of data or identifying information. 
To ensure the study is conducted properly, officials at the National Cancer Institute or the University of Kentucky 
may look at or copy pertinent portions of records that identify you. 
We will make every effort to safeguard your data, but as with anything online, we cannot guarantee the security of 
data obtained by way of the Internet. Third-party applications used in this study may have Terms of Service and 
Privacy Policies outside of the control of the University of Kentucky. 
REDCap is a secure, web-based program to capture and store data at the University of Kentucky. We will make 
every effort to safeguard your data in REDCap. However, given the nature of online surveys, we cannot 
guarantee the security of data obtained by way of the Internet.   
Certificates of Confidentiality (CoC): 
To help us protect your privacy, this research has a Certificate of Confidentiality. The researchers can use this 
Certificate to refuse to disclose information that may identify you to anyone not connected with this study, or in 
any legal proceedings. The exceptions to this rule are release of information: 
x 
you have requested us to provide, for instance, to your insurance company or doctor; 
x 
to the sponsor (e.g., National Institutes of Health) or agency auditing the research (e.g., Food and 
Drug Administration); 
x 
about child or elder abuse, neglect, or harm to yourself or others; and 
x 
about you if it involves a reportable disease. 
This policy does not prevent you from releasing information about your own participation in this study. By signing 
this consent, you agree that your healthcare providers and associated staff affiliated, contracted with, or with 
access to records of the University of Kentucky (UK) may see your information from research studies and 
consider and use that information in the course of medical care and related activities. 
You will need to provide your social security number. This is in order for you to be compensated for your time. If 
you do not provide this number, you will not be compensated. If you earn $600 or more by participating in any 
research, it is potentially reportable for tax purposes. 
All research records and/or identifiers will be stored for at least 6 years following the end of the study, per IRB 
requirements. 
CAN YOU CHOOSE TO WITHDRAW FROM THE STUDY EARLY? 
You can choose to leave the study at any time. You will not be treated differently if you decide to stop taking part 
in the study. If you choose to leave the study early, data collected until that point will remain in the study database 
and may not be removed.  
The investigators conducting the study may need to remove you from the study. You may be removed from the 
study if: 
x 
you are not able to follow the directions, 
x 
you communicate inappropriately with or harass study staff (e.g. sending messages unrelated to the 
study, sending personal photos), 
x 
we find that your participation in the study is more risk than benefit to you, or  
x 
the agency paying for the study chooses to stop the study early for a number of scientific reasons.  
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The study intervention, medication, and/or device will no longer be provided to you and may not be available for 
purchase. This may occur for a number of reasons. 
If at any point during the study you lose or damage the provided phone (if applicable), you will be dismissed and 
unable to earn any further incentive payments. However, you will be entitled to the payments you earned prior to 
the loss of or damage to the equipment. 
ARE YOU PARTICIPATING, OR CAN YOU PARTICIPATE, IN ANOTHER RESEARCH STUDY AT THE SAME 
TIME AS PARTICIPATING IN THIS ONE? 
You may take part in this study if you are currently involved in another research study. It is important to let the 
investigator/your doctor know if you are in another research study. You should discuss this with the 
investigator/your doctor before you agree to participate in another research study while you are in this study. 
WHAT HAPPENS IF YOU GET HURT OR SICK DURING THE STUDY? 
If you believe you are hurt or if you get sick because of something that is due to the study, you should call Carolyn 
Lauckner, PhD at 859-562-3335 immediately. Dr. Lauckner will determine what time of treatment, if any, is best 
for you at that time. 
It is important for you to understand that the University of Kentucky does not have funds set aside to pay for the 
cost of any care or treatment that might be necessary because you get hurt or sick while taking part in this study. 
Also, the University of Kentucky will not pay for any wages you may lose if you are harmed by this study.   
Medical costs related to your care and treatment because of study-related harm will be your responsibility. 
You do not give up your legal rights by signing this form. 
WILL YOU RECEIVE ANY REWARDS FOR TAKING PART IN THIS STUDY? 
Throughout the study, you will receive Amazon e-gift cards on the following schedule. On the rare occurrence that 
a program session is delayed (Group A), you may receive additional compensation equivalent to the monitoring 
tasks completed, but no more than $30. 
x 
After baseline questionnaire: $20 
x 
At 6 weeks: Up to $230 for completing daily monitoring tasks 
x 
After follow-up questionnaire: $25 
x 
After exit interview: $10 
x 
After delayed follow-up questionnaire (at 10 weeks): $30 
TOTAL POSSIBLE: $315 
These incentives will be paid to you via Amazon e-gift card. The link to redeem e-gift cards will be emailed or 
texted directly to you. Money on the e-gift card will be available as soon as you redeem it. 
WHAT IF NEW INFORMATION IS LEARNED DURING THE STUDY THAT MIGHT AFFECT YOUR DECISION 
TO PARTICIPATE? 
We will tell you if we learn new information that could change your mind about staying in the study. We may ask 
you to sign a new consent form if the information is provided to you after you have joined the study.  
WILL WE CONTACT YOU WITH INFORMATION ABOUT PARTICIPATING IN FUTURE STUDIES? 
The research staff would like to contact you in the future with information about participating in additional studies. 
If so, it will be limited to 1-2 times per year.   
Do you give your permission to be contacted in the future by Carolyn Lauckner, PhD regarding your willingness 
to participate in future research studies?   
   Yes 
   No  
Initials_________ 
 
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WHAT ELSE DO YOU NEED TO KNOW? 
If you volunteer to take part in this study, you will be one of about 50 people to do so at the University of 
Kentucky. 
The National Cancer Institute is providing financial support and/or material for this study. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov as required by U.S. Law. This 
Web site will not include information that can identify you. At most, the Web site will include a summary of the 
results. You can search this Web site at any time. 
WILL YOUR INFORMATION BE USED FOR FUTURE RESEARCH? 
All identifiable information (e.g., your name, medical record number, or date of birth) will be removed from the 
information or samples collected in this study. This means that no link or code to your identity will be kept. 
After all identifiers have been removed, the information or samples may be used for future research or shared 
with other researchers without your additional informed consent. Once you give your permission to have your 
de-identified information or samples stored, they will be available indefinitely and cannot be removed due to 
the inability to identify them. 
 
AUTHORIZATION TO USE OR DISCLOSE YOUR IDENTIFIABLE HEALTH INFORMATION 
The privacy law, HIPAA (Health Insurance Portability and Accountability Act), requires researchers to protect your 
health information. The following sections of the form describe how researchers may use your health information. 
Your health information that be accessed, used, and/or released includes: 
x 
Name 
x 
Medical record number 
x 
Email address 
x 
Phone number 
x 
Mailing address 
x 
Cancer treatment date of initiation and completion 
x 
Date of upcoming cancer care appointment 
x 
Age 
x 
ZIP code 
x 
Race/Ethnicity 
x 
Gender 
x 
Amount of alcohol consumed 
The researchers may use and share your health information with: 
x 
The University of Kentucky’s Institutional Review Board/Office of Research Integrity; 
x 
Law enforcement agencies when required by law; 
x 
University of Kentucky representatives; 
x 
UK HealthCare and their representatives; 
x 
Health systems outside of UK for which you have a patient relationship; 
x 
National Institutes of Health (NIH); 
x 
National Cancer Institute (NCI). 
The researchers agree to only share your health information with the people listed in this document. Should your 
health information be released to anyone that is not regulated by the privacy law, your health information may be 
 
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shared with others without your permission; however, the use of your health information may still be regulated by 
applicable federal and state laws. 
You may not be allowed to participate in the research study if you do not sign this form. If you decide not to sign 
this form, it will not affect your: 
x 
Current or future healthcare at the University of Kentucky; 
x 
Current or future payments to the University of Kentucky; 
x 
Ability to enroll in any health plans (if applicable); or 
x 
Eligibility for benefits (if applicable). 
After signing the form, you can change your mind and NOT let the researcher(s) collect or release your 
health information (revoke the Authorization). If you revoke the Authorization: 
x 
Send a written letter to Carolyn Lauckner, PhD at 467 Healthy Kentucky Research Building, University of 
Kentucky, 760 Press Avenue, Lexington, KY 40536 to inform her of your decision. 
x 
Researchers may use and release your health information already collected for this research study. 
x 
Your protected health information may still be used and released should you have a bad reaction 
(adverse event). 
The use and sharing of your information has no time limit. 
If you have not already received a copy of the Privacy Notice, you may request one. If you have any 
questions about your privacy rights, you should contact the University of Kentucky’s Privacy Officer 
between the business hours of 8am and 5pm EST, Monday-Friday at (859) 323-1184. 
 
 
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APPENDIX A 
DETAILED OVERVIEW OF THE PRIMARY STUDY ACTIVITIES 
GROUP A (TRAC-AYA Group): 
 
Tasks 
Maximum Time Commitment 
Questionnaire #1 
45 min 
Orientation Session 
1 hr 
Session 1 
1 hr 
Treatment expectations survey 
10 min 
Sessions 2-4 
30 min each; 1.5 hrs total 
Post-session questionnaires 
5 min each; 20 min total 
Daily monitoring (42 days) 
10 min/day; 7 hrs total 
Questionnaire #2 
45 min 
Exit interview 
30 min 
Questionnaire #3 
45 min 
TOTAL TIME 
13 hrs, 45 min 
 
GROUP B (Education and Monitoring Only): 
 
Tasks 
Maximum Time Commitment 
Questionnaire #1 
45 min 
Orientation Session 
1 hr 
Daily monitoring (42 days) 
10 min/day; 7 hrs total 
Questionnaire #2 
45 min 
Exit interview 
30 min 
Questionnaire #3 
45 min 
TOTAL TIME 
10 hrs, 45 min 
 
 
 
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INFORMED CONSENT SIGNATURES 
 
This consent includes the following: 
x Key Information Page 
x Detailed Consent  
x Appendix A: Detailed overview of the primary study activities  
 
You will receive a copy of this consent form after it has been signed. 
 
 
 
___________________________________________                      _____________________ 
Signature of research subject                                                          Date 
 
 
 
 
 
___________________________________________ 
 
 
 
Printed name of research subject  
 
 
 
________________________________________________________________          ___________ 
Printed name of [authorized] person obtaining informed consent   
 
          Date 
 
 
 
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