Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: CYCORE: Cyberinfrastructure for Comparative Effectiveness Research - Feasibility Trial

Summary: Objectives:
  To explore the feasibility and acceptability in diverse samples of cancer patients of wireless collection and transmission of data for transfer into the open-source cyberinfrastructure (CI) called CYCORE.

Detailed description: Pilot Phase - Arm 1:
  If participant agrees to take part in this study, participant will attend a 30-minute training session about how to use 8 devices:
  -  2 Accelerometers; each will monitor participant's activity levels.
  -  Blood pressure monitor; this will monitor participant's blood pressure at different times in the day.
  -  Heart rate monitor; this will monitor participant's heart rate.
  -  Cellular modem and hub; these devices will be plugged into a wall at participant's 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 participant goes throughout the day.
  -  Phone; Participant 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, participant 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 participant of this before we start the recording. Participant 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 participant's 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 participant returns the phone to MD Anderson research staff.
  If participant is one of the first 10 people in this study, a member of the study staff may go to participant's home to set up these devices because researchers would like to learn about the problems people have with home set-up. If participant does not have a regularly scheduled appointment at MD Anderson, a member of the study staff can go to participant's home to drop-off and collect these devices.
  Participant 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, participant will:
  -  Wear 2 different accelerometers, each about the size of a matchbox. One accelerometer participant only will wear while awake, and the second one participant will try to wear while awake and sleeping (strapped to participant's waist).
  -  Measure participant's 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 participant's chest while participant is awake. This should be put on right after participant wakes up in the morning and worn all day unless participant goes swimming or take a shower.
  -  Carry a GPS device with participant while participant is 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 participant wakes up in the morning and worn all day unless participant goes swimming or take a shower.
  -  Carry a phone and when prompted by the phone at multiple times during the day, participant 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 participant after participant takes participant's equipment home to check transmission of participant's 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 participant questions about how usable and acceptable the devices are to participant, as well as questions about any problems participant 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 participant has any immediate medical problems, please contact participant's regular doctor in the normal manner.
  Information from participant's 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, participant will return all devices to study staff at MD Anderson when participant next returns to MD Anderson. Once more, participant will complete a 36-question health survey. If participant is unable to return within 2 weeks, the study staff can go to participant's home to pick up the devices.
  Length of Study:
  Participant will be off study after participant returns the devices and completes the second health survey. Participant will be taken off study if participant is 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 participant agrees to take part in this study, participant will attend a 30-minute training session about how to use 7 devices:
  -  2 Accelerometers; each will monitor participant's activity levels.
  -  Blood pressure monitor; this will monitor participant's blood pressure when participant gets up in the morning.
  -  Weight scale; this will monitor participant's weight.
  -  Cellular modem and hub; these devices will be plugged into a wall at participant's 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; participant will use this to type in answers about participant's diet and about health-related symptoms, and may receive reminders from the phone.
  After the training, participant 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 participant 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 participant's 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 participant returns the phone to MD Anderson research staff.
  If participant is one of the first 10 people in this study, a member of the study staff may go to participant's home to set up these devices because researchers would like to learn about the problems people have with home set-up. If participant does not have a regularly scheduled appointment at MD Anderson, a member of the study staff can go to participant's home to drop-off and collect these devices.
  Participant 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, participant will:
  -  Wear 2 different accelerometers, each about the size of a matchbox. One accelerometer participant only will wear while awake, and the second one participant will try to wear while awake and sleeping (strapped to participant's waist).
  -  Weigh participant on a scale once a day right after getting out of bed in the morning.
  -  Measure participant's blood pressure 2 times after getting out of bed in the morning.
  -  Carry a phone and when prompted by the phone in the morning, participant will type in responses to questions about participant's diet and about health-related symptoms. Answering the questions should take about 1-6 minutes each time.
  The study staff will call participant after participant takes participant's equipment home to check transmission of participant's 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 participant questions about how usable and acceptable the devices are to participant, as well as questions about any problems participant 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 participant has any immediate medical problems, please contact participant's regular doctor in the normal manner.
  Information from participant's 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, participant will return all devices to study staff at MD Anderson when participant next return to MD Anderson. If participant is unable to return within 2 weeks, the study staff can go to participant's home to pick up the devices.
  Length of Study:
  Participant will be off study after participant returns all devices. Participant will be taken off study if participant is 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 participant agrees to take part in this study, participant will attend a 15-minute training session about how to use a smart phone. Participant will use this to type in answers about participant's diet, health-related symptoms, and swallowing exercises. The phone will also be used to video-record participant's swallowing exercises. Participant also may receive reminders from the phone.
  After the training, participant 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 participant 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 participant's survey answers, which will be saved to an MD Anderson computer, and then deleted from participant's 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 participant is one of the first 10 people in this study, a member of the study staff may go to participant's home to set up these devices because researchers would like to learn about the problems people have with home set-up. If participant does not have a regularly scheduled appointment at MD Anderson, a member of the study staff can go to participant's home to drop-off and collect these devices.
  Participant 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, participant will:
  °Carry the phone and when prompted by the phone every morning, participant will type in responses to questions about participant's diet, about health-related symptoms, and about participant's swallowing exercises. Answering the questions should take about 1-6 minutes each time. Additionally, using the video camera in the phone, participant will take video recordings of participant's neck while performing swallowing exercises as prescribed during normal medical care.
  The study staff will call participant after participant takes participant's equipment home to check transmission of participant's 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 participant questions about how usable and acceptable the devices are to participant, as well as questions about any problems participant 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 participant has any immediate medical problems, please contact participant's regular doctor in the normal manner.
  Information from participant's 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, participant will return all devices to study staff at MD Anderson when participant next returns to MD Anderson. If participant is unable to return within 2 weeks, our staff may go to participant's home to pick up the devices.
  Length of Study:
  Participant will be off study after participant returns all devices. Participant will be taken off study if participant is 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 participant agrees to take part in this study, participant will attend a 15-minute training session about how to use 4 devices:
  -  Carbon monoxide (CO) monitor, participant will exhale (breath out) into this device to check carbon monoxide levels.
  -  Phone, participant will use this to type in answers about smoking and to video-record when participant exhales into the CO monitor. Participant also will receive reminders from the phone.
  -  Cellular modem and hub; these devices will be plugged into a wall at participant's 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, participant will answer questions about the training and about participant's smoking history. It should take about 15 minutes to answer the questions. The session will be audio-recorded, and we will remind participant of this before we start the recording. Participant 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 participant's 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 participant returns the phone to MD Anderson research staff.
  If participant is one of the first 10 people in this study, a member of the study staff may go to participant's home to set up these devices because researchers would like to learn about the problems people have with home set-up. If participant does not have a regularly scheduled appointment at MD Anderson, a member of the study staff can go to participant's home to drop-off and collect these devices.
  Participant 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, participant will:
  -  Exhale into the CO monitor 3 times a day (once in the morning, once mid-day, and once before bedtime). Participant 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, participant will type in responses to questions about smoking. Answering the questions should take about 1-4 minutes each time.
  The study staff will call participant after participant takes participant's equipment home to check transmission of participant's 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 participant questions about how usable and acceptable the devices are to participant, as well as questions about any problems participant 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 participant has any immediate medical problems, please contact participant's regular doctor in the normal manner.
  Information from participant's 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, participant will return all devices to study staff at MD Anderson when participant next returns to MD Anderson. Once more, participant will be weighed. If participant is unable to return within 2 weeks, the study staff can go to participant's home to pick up the devices.
  Length of Study:
  Participant will be off study after participant returns the devices and complete the second weight measurement. Participant will be taken off study if participant is 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.
  Pancreas Study:
  If participant agrees to take part in this study, participant will complete physical fitness tests, questionnaires, and training sessions at 4 different time points:
  -  Before surgery, either during participant's clinic visit or by phone. This session will take about 75 minutes.
  -  About 1 week after participant is discharged from the hospital following surgery, the study staff will meet participant at participant's clinic appointment. This session will take about 30 minutes.
  -  About 4-7 weeks after participant is discharged from the hospital following surgery, participant will come into the clinic. This session will take about 45 minutes.
  -  Between 3 and 7 months after surgery, the study staff will meet participant at participant's clinic appointment. This session will take about 45 minutes.
  If participant is physically able, participant will also take part in nutrition and exercise programs that include strengthening exercises and walking. Additionally, participant will wear 2 activity monitors; and at night, participant will use a weight scale and an electronic reporting system to provide information about participant's physical activity, symptoms, and appetite.
  A study staff member will get approval from participant's doctor or a doctor specializing in physical medicine and rehabilitation before participant begins either exercise program (walking or strength) described in this study.
  At-Home Device Use and Electronic Reporting System:
  Below is more information about the devices and reporting system participant will use or wear during the study:
  -  Participant will wear a Fitbit monitor on participant's wrist all day and night starting from the day participant receives the monitor (up to 4 weeks before participant's surgery) until participant's final study visit (3-7 months after participant's surgery). Participant authorizes the research staff to receive the data from participant's Fitbit starting at the date of participant's study enrollment and ending once participant has completed the study. When participant completes the study, this Fitbit will be participant's to keep.
  -  Participant will receive a second activity monitor to wear on participant's wrist for 7 days beginning about 1 week after participant is discharged from the hospital for this surgery. After the 7 days, participant will return this monitor using a postage-paid envelope provided to participant.
  -  Participant will receive a weight scale to weigh participant each day starting about 1 week after participant is discharged from the hospital and ending with participant's final study visit (3-7 months after participant's surgery). Participant will return the scale to us at the final study visit.
  At the end of each day and before participant goes to bed, participant will weigh participant and use an electronic reporting system to report participant's physical activity, symptoms and desire to eat. Participant will report this information to us either by completing an emailed survey or by using an application uploaded to participant's personal phone. This should take about 5 minutes each day.
  Nutrition:
  A registered dietitian (RD) will be monitoring responses from participant's daily electronic reports. If any report indicates that participant's appetite is unusually poor, the RD will contact participant to provide nutrition counseling aimed at improving participant's food and nutrient intake. The length of each session will be determined by participant's need for this counseling.
  At-Home Exercise Program:
  A rehabilitation specialist and other study staff will teach participant about participant's exercise program. An MD Anderson rehabilitation doctor will oversee this training.
  At participant's first clinic visit after participant is discharged from the hospital, research staff will discuss participant's walking program with participant. The program will consist of walking briskly for 20-30 minutes per day at least 5 times each week until participant's final study visit (3-7 months after participant's surgery). If participant is unable to walk at a brisk pace, participant will be asked to walk at a slower pace.
  Between 4 and 7 weeks after your surgery, research staff will discuss participant's strengthening exercise program with participant. The strengthening exercises will be done using resistance bands. Participant will be asked to perform these exercises for 30 minutes at least 2 times a week. Participant also will be asked to perform an additional 5 minutes of stretching exercises each time to help prevent soreness. Strengthening certain muscle groups will help with upper body control and balance, which the study team believes may help with participant's ability to move before and after surgery. Also, strengthening the shoulder, back, and leg muscles is important for activities like getting into and out of bed, which is important after pancreas surgery.
  Physical Fitness Tests:
  Participant's strength will be checked using a hand-held grip test. Participant's walking speed will be checked with a 6-minute walking test. Participant will perform 3 other tests to check the function of participant's lower body. Those tests will check participant's balance, walking speed, and participant's ability to stand from a seated position. All of these tests will be done 3 times: (1) before participant's surgery, (2) 4-7 weeks after surgery, and (3) 3-7 months after surgery.
  Questionnaires:
  Participant will be asked to complete questionnaires about participant's physical ability, health, and quality-of-life 3 times: (1) before participant's pancreatic surgery, (2) 4-7 weeks after that surgery, and (3) 3-7 months after that surgery. Answering these questionnaires should take about 20 minutes each time. About 1 week after participant leaves the hospital for participant's surgery, participant will again complete the physical ability and quality-of-life questionnaires. This should take about 10 minutes. Participant will be asked to re-take the quality-of-life questionnaire 7-10 days after each of the 4 time-points noted above. This will take about 7-10 minutes each time.
  Participant will also asked to complete a questionnaire about the usefulness of the devices participant uses at home. Participant will complete this questionnaire 2 times: the first will be 1 week after participant starts using the weight scale and the second will be 3-7 months after participant's surgery.
  Lean Body Mass Assessment:
  If computerized tomography (CT) scans are performed as part of participant's routine medical care, the study staff will look at 3 of those scans to estimate participant's lean body mass. If available, the study staff will also look at participant's CT scans at 3 time points: before participant's surgery, at about 4-7 weeks after participant is discharged from the hospital for that surgery, and 3-7 months after participant's surgery.
  Equipment Provided to Participant:
  During the study, participant will be issued a Fitbit wrist monitor, a second activity monitor, a weight scale, and exercise bands. When participant completes the study, participant will keep the Fitbit wrist monitor and the exercise bands. Participant will return the second activity monitor to the study team about 7 days after it is issued to participant. Participant will return the weight scale to study team at the end of the study.
  Other Medical Information:
  Information from participant's medical record will be collected and stored in an electronic password-protected research database, which will be accessible only by research staff.
  Length of Study:
  Participant will begin this study prior to participant's pancreas surgery, which may be up to 4 weeks before that surgery. Participant will continue the device use, exercise and nutrition programs, and evaluations for up to 3-7 months after participant's surgery. If participant has a side effect or the disease gets worse, the study team will decide if continuing the exercise program is in participant's best interest.
  This is an investigational study. Up to 50 patients who are scheduled to have pancreatic surgery will take part in the pancreas study. The pancreas study is one of many smaller studies that, when added together, will enroll up to 290 participants at MD Anderson.

Eligibility: 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, PCS study)
  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)
  12. Patients who will undergo curative pancreatectomy for pancreatic adenocarcinoma, pancreatic neuroendocrine tumors, or pancreatic cysts (malignant or benign) (PCS study)
  13. Fluent in English (PCS study)
  14. Must have telephone access and agree to engage with research personnel using telephone (PCS study)
  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)
  10. Currently enrolled in protocol 2014-0712 (PCS study)
  11. No home access to internet (PCS study)
  12. No home WiFi connection (PCS study)
  13. Presents with high risk for non-therapeutic resection related to cancer diagnosis (PCS study)
  14. During clinician's pre-surgical evaluation, presents with high risk for non-therapeutic resection related to cancer diagnosis (PCS study)
  15. Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV) (PCS study)
  16. Recent fracture or acute musculoskeletal injury that precludes the ability to fully bear weight on all 4 limbs in order to participate in an exercise intervention (PCS study)
  17. Poorly-controlled pain with a self-reported pain score of ≥ 7/10 at the time of enrollment (PCS study)
  18. Myopathic or rheumatologic disease that impacts physical function (PCS study)

Relevance to patient case: not relevant