Trial Information

CYCORE: Cyberinfrastructure for Comparative Effectiveness Research - Feasibility Trial

Pilot Phase - Arm 1:

If you agree to take part in this study, you will attend a 30-minute training session about
how to use 8 devices:

- 2 Accelerometers; each will monitor your activity levels.

- Blood pressure monitor; this will monitor your blood pressure at different times in the
day.

- Heart rate monitor; this will monitor your heart rate.

- Cellular modem and hub; these devices will be plugged into a wall at your home and will
allow for transmission of encrypted data from the devices to the study staff at MD
Anderson and the University of California at San Diego.

- Global positioning device (GPS); this will monitor where you go throughout the day.

- Phone; you will use this to type in answers about exercise and health-related symptoms
and feelings, and may also receive reminders from the phone.

After the training, you will answer questions about the training. It should take about 15
minutes to answer the questions. The session will be audio-recorded, and we will remind you
of this before we start the recording. You will also complete a 36-question health survey.

All the devices, except for one of the accelerometers, will electronically send information
to the study staff at the University of California at San Diego (UCSD), and will be
available to researchers at MD Anderson. The phone will store a back-up copy of your survey
answers that will be downloaded, and then deleted. These will be deleted either
automatically after the phone sends the answers to UCSD computers, or when you return the
phone to MD Anderson research staff.

If you are one of the first 10 people in this study, a member of the study staff may go to
your home to set up these devices because researchers would like to learn about the problems
people have with home set-up. If you do not have a regularly scheduled appointment at MD
Anderson, a member of the study staff can go to your home to drop-off and collect these
devices.

You will use each device at home for 5 days, wait 2 weeks, then use the devices again for 5
more days. During each 5-day period, you will:

- Wear 2 different accelerometers, each about the size of a matchbox. One accelerometer
you only will wear while awake, and the second one you will try to wear while awake and
sleeping (strapped to your waist).

- Measure your blood pressure 2 times after getting out of bed in the morning and 2 more
times before going to bed.

- Wear a heart rate monitor (about the size of a matchbox) fastened to a soft belt around
your chest while you are awake. This should be put on right after you wake up in the
morning and worn all day unless you go swimming or take a shower.

- Carry a GPS device with you while you are awake. The device is about the size of a
pager, and can be clipped to a belt or carried in a pocket, backpack or purse. It
should be put on right after you wake up in the morning and worn all day unless you go
swimming or take a shower.

- Carry a phone and when prompted by the phone at multiple times during the day, you will
type in responses to questions about exercise and health-related symptoms and feelings.
Answering the questions should take about 1-10 minutes each time.

The study staff will call you after you take your equipment home to check transmission of
your equipment (this call will take about 10-15 minutes). On Days 2, 4, and 6 of each 5-day
device-usage period, staff will call again to ask you questions about how usable and
acceptable the devices are to you, as well as questions about any problems you might have
had when using any device (a total of 6 survey phone calls). On Days 2 and 4, these calls
will take about 10 minutes. On Day 6, the call will take about 20 minutes. Once more, all
of these telephone sessions will be audio-recorded.

During the study, if you have any immediate medical problems, please contact your regular
doctor in the normal manner.

Information from your medical record will be collected and stored in an electronic
password-protected research database, which will be accessible only by research staff.

After the study, you will return all devices to study staff at MD Anderson when you next
return to MD Anderson. Once more, you will complete a 36-question health survey. If you are
unable to return within 2 weeks, the study staff can go to your home to pick up the devices.

Length of Study:

You will be off study after you return the devices and complete the second health survey.
You will be taken off study if you are unable to follow study directions.

This is an investigational study.

Up to 240 participants will take part in this study. All will be enrolled at MD Anderson. Up
to 50 patients with colorectal cancer will take part in this portion of the study.

Pilot Phase - Arm 2:

If you agree to take part in this study, you will attend a 30-minute training session about
how to use 7 devices:

- 2 Accelerometers; each will monitor your activity levels.

- Blood pressure monitor; this will monitor your blood pressure when you get up in the
morning.

- Weight scale; this will monitor your weight.

- Cellular modem and hub; these devices will be plugged into a wall at your home and will
allow for transmission of encrypted data from the devices to the study staff at MD
Anderson and the University of California at San Diego.

- Phone; you will use this to type in answers about your diet and about health-related
symptoms, and may receive reminders from the phone.

After the training, you will answer questions about the training. It should take about 15
minutes to answer the questions. The session will be audio-recorded, and we will remind you
of this before we start the recording.

All the devices, except for one of the accelerometers, will electronically send information
to the study staff at the University of California at San Diego (UCSD), and will be
available to researchers at MD Anderson. The phone will store a back-up copy of your survey
answers that will be downloaded, and then deleted. These will be deleted either
automatically after the phone sends the answers to UCSD computers, or when you return the
phone to MD Anderson research staff.

If you are one of the first 10 people in this study, a member of the study staff may go to
your home to set up these devices because researchers would like to learn about the problems
people have with home set-up. If you do not have a regularly scheduled appointment at MD
Anderson, a member of the study staff can go to your home to drop-off and collect these
devices.

You will use each device at home for 5 days, wait 2 weeks, then use the devices again for 5
more days. During each 5-day period, you will:

- Wear 2 different accelerometers, each about the size of a matchbox. One accelerometer
you only will wear while awake, and the second one you will try to wear while awake and
sleeping (strapped to your waist).

- Weigh yourself on a scale once a day right after getting out of bed in the morning.

- Measure your blood pressure 2 times after getting out of bed in the morning.

- Carry a phone and when prompted by the phone in the morning, you will type in responses
to questions about your diet and about health-related symptoms. Answering the
questions should take about 1-6 minutes each time.

The study staff will call you after you take your equipment home to check transmission of
your equipment (this call will take about 10-15 minutes). On Days 2, 4, and 6 of each 5-day
device-usage period, staff will call again to ask you questions about how usable and
acceptable the devices are to you, as well as questions about any problems you might have
had when using any device (a total of 6 survey phone calls). On Days 2 and 4, these calls
will take about 10 minutes. On the Day 6, the call will take about 20 minutes. Once more,
all of these telephone sessions will be audio-recorded.

During the study, if you have any immediate medical problems, please contact your regular
doctor in the normal manner.

Information from your medical record will be collected and stored in an electronic
password-protected research database, which will be accessible only by research staff.

After the study, you will return all devices to study staff at MD Anderson when you next
return to MD Anderson. If you are unable to return within 2 weeks, the study staff can go to
your home to pick up the devices.

Length of Study:

You will be off study after you return all devices. You will be taken off study if you are
unable to follow study directions.

This is an investigational study.

Up to 240 participants will take part in this study. All will be enrolled at MD Anderson. Up
to 75 patients with head and neck cancer will take part in this portion of the study.

Pilot Phase Arm 3:

If you agree to take part in this study, you will attend a 15-minute training session about
how to use a smart phone. You will use this to type in answers about your diet,
health-related symptoms, and swallowing exercises. The phone will also be used to
video-record your swallowing exercises. You also may receive reminders from the phone.

After the training, you will answer questions about the training. It should take about 10
minutes to answer the questions. The session will be audio-recorded, and we will remind you
of this before we start the recording.

The phone will electronically send information to the study staff at the University of
California at San Diego (UCSD), and will be available to researchers at MD Anderson. The
phone will store a back-up copy of your survey answers, which will be saved to an MD
Anderson computer, and then deleted from your phone, once the phone is returned to MD
Anderson. After videos are sent to a UCSD computer, they will be automatically or manually
deleted from your phone.

If you are one of the first 10 people in this study, a member of the study staff may go to
your home to set up these devices because researchers would like to learn about the problems
people have with home set-up. If you do not have a regularly scheduled appointment at MD
Anderson, a member of the study staff can go to your home to drop-off and collect these
devices.

You will use each device at home for 5 days, wait 2 weeks, then use the devices again for 5
more days. During each 5-day period, you will:

-Carry the phone and when prompted by the phone every morning, you will type in responses to
questions about your diet, about health-related symptoms, and about your swallowing
exercises. Answering the questions should take about 1-6 minutes each time. Additionally,
using the video camera in the phone, you will take video recordings of your neck while
performing swallowing exercises as prescribed during normal medical care.

The study staff will call you after you take your equipment home to check transmission of
your equipment (this call will take about 10-15 minutes). On Days 2, 4, and 6 of each 5-day
device-usage period, staff will call again to ask you questions about how usable and
acceptable the devices are to you, as well as questions about any problems you might have
had when using any device (a total of 6 survey phone calls). On Days 2 and 4, these calls
will take about 10 minutes; on Day 6, the call will take about 15 minutes. Once more, all
of these telephone sessions will be audio-recorded.

During the study, if you have any immediate medical problems, please contact your regular
doctor in the normal manner.

Information from your medical record will be collected and stored in an electronic
password-protected research database, which will be accessible only by research staff.

After the study, you will return all devices to study staff at MD Anderson when you next
return to MD Anderson. If you are unable to return within 2 weeks, our staff may go to your
home to pick up the devices.

Length of Study:

You will be off study after you return all devices. You will be taken off study if you are
unable to follow study directions.

This is an investigational study.

Up to 240 participants will take part in this study. All will be enrolled at MD Anderson. Up
to 50 patients with head and neck cancer will take part in this portion of the study.

Pilot Phase Arm 4:

If you agree to take part in this study, you will attend a 15-minute training session about
how to use 4 devices:

- Carbon monoxide (CO) monitor, you will exhale (breath out) into this device to check
carbon monoxide levels.

- Phone, you will use this to type in answers about smoking and to video-record when you
exhale into the CO monitor. You also will receive reminders from the phone.

- Cellular modem and hub; these devices will be plugged into a wall at your home and will
allow for transmission of encrypted data from devices to the study staff at MD Anderson
and the University of California at San Diego.

After the training, you will answer questions about the training and about your smoking
history. It should take about 15 minutes to answer the questions. The session will be
audio-recorded, and we will remind you of this before we start the recording. You will also
be weighed.

The devices will electronically send information to the study staff at the University of
California at San Diego (UCSD), and will be available to researchers at MD Anderson. The
phone will store a back-up copy of your survey answers and videos that will be downloaded,
and then deleted. These will be deleted either automatically after the phone sends the
answers or videos to UCSD computers, or when you return the phone to MD Anderson research
staff.

If you are one of the first 10 people in this study, a member of the study staff may go to
your home to set up these devices because researchers would like to learn about the problems
people have with home set-up. If you do not have a regularly scheduled appointment at MD
Anderson, a member of the study staff can go to your home to drop-off and collect these
devices.

You will use each device at home for 5 days, wait 2 weeks, then use the devices again for 5
more days. During each 5-day period, you will:

- Exhale into the CO monitor 3 times a day (once in the morning, once mid-day, and once
before bedtime). You will use the phone's video-recorder to record these measurements.

- Carry the phone and before breathing into the CO monitor three times a day, you will
type in responses to questions about smoking. Answering the questions should take
about 1-4 minutes each time.

The study staff will call you after you take your equipment home to check transmission of
your equipment (this call will take about 10-15 minutes). On Days 2, 4, and 6 of each 5-day
device-usage period, staff will call again to ask you questions about how usable and
acceptable the devices are to you, as well as questions about any problems you might have
had when using any device (a total of 6 survey phone calls). On Days 2 and 4, these calls
will take about 10 minutes; on Day 6, the call will take about 15 minutes. Once more, all
of these telephone sessions will be audio-recorded.

During the study, if you have any immediate medical problems, please contact your regular
doctor in the normal manner.

Information from your medical record will be collected and stored in an electronic
password-protected research database, which will be accessible only to research staff.

After the study, you will return all devices to study staff at MD Anderson when you next
return to MD Anderson. Once more, you will be weighed. If you are unable to return within 2
weeks, the study staff can go to your home to pick up the devices.

Length of Study:

You will be off study after you return the devices and complete the second weight
measurement. You will be taken off study if you are unable to follow study directions.

This is an investigational study.

Up to 240 participants will take part in this study. All will be enrolled at MD Anderson. Up
to 50 survivors of a cancer other than non-melanoma skin cancer, and who were treated for
their cancer at MD Anderson, will take part in this portion of the study.