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CYCORE: Cyberinfrastructure for Comparative Effectiveness Research - Feasibility Trial


N/A
18 Years
N/A
Open (Enrolling)
Both
Advanced Cancers, Colorectal Cancer, Head And Neck Cancer, Cancer Survivors

Thank you

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.


Inclusion Criteria:



1. Diagnosis of any stage I - IV colorectal cancer or recurrent colorectal cancer (Arm
1)

2. Able to speak, read, and write in English (Pre-pilot phase, Arms 1-4)

3. Able to provide informed consent (Pre-pilot phase, Arms 1-4)

4. Lives in the Houston area (Harris county or a contiguous county) (Pre-pilot phase)

5. Age 18 years or older (Pre-pilot phase, Arms 1-4)

6. ECOG status of 0 - 2, or self reports being up and about more than 50% of waking
hours and able to provide self care (Arm 1)

7. Diagnosis of any of the following cancers: stage 1-4b oropharyngeal, hypopharyngeal,
nasopharyngeal, salivary gland or oral cavity; stage 3-4b laryngeal; any unknown
primary head and neck cancer with cervical metastasis that will be addressed with
treatment to bilateral necks and mucosa; or other head and neck cancers medically
approved by one of our Radiation Oncology collaborating MDs (Arms 2 and 3)

8. History of any cancer, other than non-melanoma skin cancer (Arm 4)

9. Admitted to being a current smoker or recent quitter upon admission to MDACC (Arm 4)

10. Has a valid home address and functioning home telephone number (Arm 4)

11. Lives in the Houston or surrounding area, or resides in this same area during the
time period that coincides with this study (Arms 1-4)

Exclusion Criteria:

1. Major surgery in the past 8 weeks (Arms 1 and 4)

2. Self-reports hypertension that is not being monitored by a physician and is not being
managed with either medication, observation, or lifestyle change (Pre-pilot phase,
Arms 1-3)

3. Overt cognitive difficulty demonstrated by not being clearly oriented to time or
person or place (Arms 1-4)

4. Orthopedic, neurologic, or musculoskeletal disability that would interfere with the
functional task of standing on a weight scale (Pre-pilot phase, Arm 2)

5. Not currently receiving radiation treatment for a cancer listed in the Arm-specific
inclusion criteria (Arms 2 and 3)

6. Zubrod Performance Status >2, or self reports either not being up and about more than
50% of waking hours or unable to provide self care (Arms 2 and 3)

7. Currently receiving treatment for a cancer other than those listed in the
Arm-specific inclusion criteria (exception: the study does not exclude those
receiving treatment for non-melanoma skin cancer) (Arms 2 and 3)

8. History of current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g.
dysphagia due to underlying neurogenic disorder) (Arm 3 only)

9. Active substance use disorder (diagnosed or strongly suspected) (Arm 4)

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Study Completion as Evidenced by Completion of Final Assessment

Outcome Description:

Primary feasibility endpoint is study completion represented as number of participants who complete study final assessment.

Outcome Time Frame:

Participant survey data collection over 10 days, study data collection one year.

Safety Issue:

No

Principal Investigator

Susan Peterson, PHD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2010-0955

NCT ID:

NCT01365169

Start Date:

June 2011

Completion Date:

Related Keywords:

  • Advanced Cancers
  • Colorectal Cancer
  • Head and Neck Cancer
  • Cancer Survivors
  • Cyberinfrastructure
  • CI
  • CYCORE
  • Quality of Life
  • QOL
  • Head and Neck
  • H&N
  • Carbon Monoxide
  • CO
  • Colorectal Cancer
  • Oropharyngeal Cancer
  • Laryngeal Cancer
  • Hypopharyngeal Cancer
  • Nasopharyngeal Cancer
  • Smoker
  • Recent Smoking Cessation
  • Colorectal Neoplasms
  • Head and Neck Neoplasms
  • Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030