CYCORE Feasibility

The goal of this study is to test the acceptability and usefulness of certain home-based health care devices in specific groups of cancer survivors (those who are being treated for head and neck or colorectal cancer, or who are current or former smokers).

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.

MD Anderson Cancer Center patients from Head and Neck clinics, Colorectal clinics, and Smoking Cessation groups.

• Advanced Cancers
• Colorectal Cancer
• Head And Neck Cancer
• Cancer Survivors

• Device: Smart phone
  Answer questions sent by the phone (all study groups). Some participants will video-record swallowing exercises or device usage (Pre-Pilot, Arms 3 and 4).
• Device: Accelerometers (Arms 1 and 2)
  These devices are worn on a belt around the waist, and record activity.
• Device: Blood Pressure Monitor (Arms 1 and 2)
  This device is used at home to measure blood pressure and pulse rate.
• Other: Telephone Surveys
  On days 1, 3, and 6 of each 5-day sensor usage period, study personnel will call participants to ascertain functionality, acceptability, and overall satisfaction regarding use of sensing devices.
• Other: Home Visit
  For the first 10 patients enrolled in the trial, a home visit to be made on day 2, to ascertain if there were any problems related to home set-up.
• Device: Home Health Hub and Modem (All study groups)
  These devices collect data from other home devices, and send this data (over the internet) to study researchers.
• Device: Carbon Monoxide (CO) Monitor (Arm 4)
  This device captures the CO level expelled in one breath.
• Device: Heat Rate Monitor (Arm 1)
  This device is worn on a chest strap, and measures heart rate.
• Device: Global Positioning System (GPS) Device (Arm 1)
  This device describes location on a map, but not location within a building.
  Other Name: GPS
• Other: Surveys
  After training about each device, completion of a survey about that training.

• Exercise Adherence Arm (Arm 1)
  Interventions:

  • Device: Accelerometers (Arms 1 and 2)
  • Device: Blood Pressure Monitor (Arms 1 and 2)
  • Other: Telephone Surveys
  • Other: Home Visit
  • Device: Home Health Hub and Modem (All study groups)
  • Device: Heat Rate Monitor (Arm 1)
  • Device: Global Positioning System (GPS) Device (Arm 1)
  • Other: Surveys
• Dehydration Risk Arm (Arm 2)
  Interventions:

  • Device: Accelerometers (Arms 1 and 2)
  • Device: Blood Pressure Monitor (Arms 1 and 2)
  • Other: Telephone Surveys
  • Other: Home Visit
  • Device: Home Health Hub and Modem (All study groups)
  • Other: Surveys
• Swallowing Exercise Adherence Arm (Arm 3)
  Interventions:

  • Device: Smart phone
  • Other: Telephone Surveys
  • Other: Home Visit
  • Device: Home Health Hub and Modem (All study groups)
  • Other: Surveys
• Smoking Cessation Adherence Arm (Arm 4)
  Interventions:

  • Device: Smart phone
  • Other: Telephone Surveys
  • Other: Home Visit
  • Device: Home Health Hub and Modem (All study groups)
  • Device: Carbon Monoxide (CO) Monitor (Arm 4)
  • Other: Surveys
• Pre-Pilot
  Interventions:

  • Device: Smart phone
  • Device: Accelerometers (Arms 1 and 2)
  • Device: Blood Pressure Monitor (Arms 1 and 2)
  • Other: Telephone Surveys
  • Other: Home Visit
  • Device: Home Health Hub and Modem (All study groups)
  • Device: Carbon Monoxide (CO) Monitor (Arm 4)
  • Device: Heat Rate Monitor (Arm 1)
  • Device: Global Positioning System (GPS) Device (Arm 1)
  • Other: Surveys

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)