CYCORE: Cyberinfrastructure for Comparative Effectiveness Research - Feasibility Trial
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| ClinicalTrials.gov Identifier: NCT01365169 |
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Recruitment Status
:
Recruiting
First Posted
: June 3, 2011
Last Update Posted
: January 23, 2018
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Sponsor:
M.D. Anderson Cancer Center
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
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Brief Summary:
The goal of this study of this study is to test the acceptability and usefulness of certain home-based health care devices for people who have been diagnosed with pancreatic cancer or other abnormal growth of tissue in the pancreas.
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Advanced Cancers Colorectal Cancer Head And Neck Cancer Cancer Survivors | Device: Smart phone Device: Accelerometers Device: Blood Pressure Monitor Other: Telephone Surveys Other: Home Visit Device: Home Health Hub and Modem Device: Carbon Monoxide (CO) Monitor Device: Heat Rate Monitor Device: Global Positioning System (GPS) Device Other: Surveys Device: Weight Scale Device: Fitbit Monitor Behavioral: At-Home Exercise Program Behavioral: Physical Fitness Tests Behavioral: Questionnaires Behavioral: Lean Body Mass Assessment |
Show Detailed Description
| Study Type : | Observational |
| Estimated Enrollment : | 290 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | CYCORE: Cyberinfrastructure for Comparative Effectiveness Research - Feasibility Trial |
| Actual Study Start Date : | June 2011 |
| Estimated Primary Completion Date : | June 2019 |
| Estimated Study Completion Date : | June 2019 |
Resource links provided by the National Library of Medicine
Genetic and Rare Diseases Information Center resources:
Nasopharyngeal Carcinoma
Laryngeal Cancer
Hypopharyngeal Cancer
U.S. FDA Resources
| Group/Cohort | Intervention/treatment |
|---|---|
| Exercise Adherence Arm (Arm 1) |
Device: Smart phone
Answer questions sent by the phone . Some participants will video-record swallowing exercises or device usage.
Device: Accelerometers
These devices are worn on a belt around the waist, and record activity.
Device: Blood Pressure Monitor
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
These devices collect data from other home devices, and send this data (over the internet) to study researchers.
Device: Heat Rate Monitor
This device is worn on a chest strap, and measures heart rate.
Device: Global Positioning System (GPS) Device
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.
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| Dehydration Risk Arm (Arm 2) |
Device: Smart phone
Answer questions sent by the phone . Some participants will video-record swallowing exercises or device usage.
Device: Accelerometers
These devices are worn on a belt around the waist, and record activity.
Device: Blood Pressure Monitor
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
These devices collect data from other home devices, and send this data (over the internet) to study researchers.
Other: Surveys
After training about each device, completion of a survey about that training.
Device: Weight Scale
Weight scale will monitor weight.
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| Swallowing Exercise Adherence Arm (Arm 3) |
Device: Smart phone
Answer questions sent by the phone . Some participants will video-record swallowing exercises or device usage.
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
These devices collect data from other home devices, and send this data (over the internet) to study researchers.
Other: Surveys
After training about each device, completion of a survey about that training.
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| Smoking Cessation Adherence Arm (Arm 4) |
Device: Smart phone
Answer questions sent by the phone . Some participants will video-record swallowing exercises or device usage.
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
These devices collect data from other home devices, and send this data (over the internet) to study researchers.
Device: Carbon Monoxide (CO) Monitor
This device captures the CO level expelled in one breath.
Other: Surveys
After training about each device, completion of a survey about that training.
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| Pre-Pilot |
Device: Smart phone
Answer questions sent by the phone . Some participants will video-record swallowing exercises or device usage.
Device: Accelerometers
These devices are worn on a belt around the waist, and record activity.
Device: Blood Pressure Monitor
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
These devices collect data from other home devices, and send this data (over the internet) to study researchers.
Device: Carbon Monoxide (CO) Monitor
This device captures the CO level expelled in one breath.
Device: Heat Rate Monitor
This device is worn on a chest strap, and measures heart rate.
Device: Global Positioning System (GPS) Device
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.
Device: Weight Scale
Weight scale will monitor weight.
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| Pancreas Cancer Group |
Device: Accelerometers
These devices are worn on a belt around the waist, and record activity.
Device: Weight Scale
Weight scale will monitor weight.
Device: Fitbit Monitor
Participants wear a Fitbit monitor on wrist all day and night starting from the day they receive the monitor (up to 4 weeks before surgery) until final study visit (3-7 months after surgery).
Behavioral: At-Home Exercise Program
Participants participate in a walking program and strengthening exercise program at home guided by a rehabilitation specialist.
Behavioral: Physical Fitness Tests
Participants strength checked using a hand-held grip test. Walking speed will be checked with a 6-minute walking test. Tests to check your balance, walking speed, and ability to stand from a seated position also performed. Tests to be done 3 times: (1) before surgery, (2) 4-7 weeks after surgery, and (3) 3-7 months after surgery.
Behavioral: Questionnaires
Questionnaires completed about physical ability, health, and quality-of-life 3 times: (1) before pancreatic surgery, (2) 4-7 weeks after surgery, and (3) 3-7 months after surgery. About 1 week after participant leaves the hospital for surgery, participant again completes the physical ability and quality-of-life questionnaires. Participant 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 completes a questionnaire about the usefulness of the devices used at home. Questionnaires completed 2 times: the first will be 1 week after starting using the weight scale and the second will be 3-7 months after surgery. Other Name: Surveys
Behavioral: Lean Body Mass Assessment
If computerized tomography (CT) scans are performed as part of 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 CT scans at 3 time points: before surgery, at about 4-7 weeks after discharge from hospital for that surgery, and 3-7 months after surgery.
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Primary Outcome Measures
:
- Study Completion as Evidenced by Completion of Final Assessment [ Time Frame: Participant survey data collection over 10 days, study data collection one year. ]Primary feasibility endpoint is study completion represented as number of participants who complete study final assessment.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
MD Anderson Cancer Center patients from Head and Neck clinics, Colorectal clinics, and Smoking Cessation groups.
Criteria
Inclusion Criteria:
- Diagnosis of any stage I - IV colorectal cancer or recurrent colorectal cancer (Arm 1)
- Able to speak, read, and write in English (Pre-pilot phase, Arms 1-4)
- Able to provide informed consent (Pre-pilot phase, Arms 1-4, PCS study)
- Lives in the Houston area (Harris county or a contiguous county) (Pre-pilot phase)
- Age 18 years or older (Pre-pilot phase, Arms 1-4)
- 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)
- 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)
- History of any cancer, other than non-melanoma skin cancer (Arm 4)
- Admitted to being a current smoker or recent quitter upon admission to MDACC (Arm 4)
- Has a valid home address and functioning home telephone number (Arm 4)
- 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)
- Patients who will undergo curative pancreatectomy for pancreatic adenocarcinoma, pancreatic neuroendocrine tumors, or pancreatic cysts (malignant or benign) (PCS study)
- Fluent in English (PCS study)
- Must have telephone access and agree to engage with research personnel using telephone (PCS study)
Exclusion Criteria:
- Major surgery in the past 8 weeks (Arms 1 and 4)
- 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)
- Overt cognitive difficulty demonstrated by not being clearly oriented to time or person or place (Arms 1-4)
- Orthopedic, neurologic, or musculoskeletal disability that would interfere with the functional task of standing on a weight scale (Pre-pilot phase, Arm 2)
- Not currently receiving radiation treatment for a cancer listed in the Arm-specific inclusion criteria (Arms 2 and 3)
- 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)
- 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)
- History of current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g. dysphagia due to underlying neurogenic disorder) (Arm 3 only)
- Active substance use disorder (diagnosed or strongly suspected) (Arm 4)
- Currently enrolled in protocol 2014-0712 (PCS study)
- No home access to internet (PCS study)
- No home WiFi connection (PCS study)
- During clinician's pre-surgical evaluation, presents with high risk for non-therapeutic resection related to cancer diagnosis (PCS study)
- Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV) (PCS study)
- 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)
- Poorly-controlled pain with a self-reported pain score of ≥ 7/10 at the time of enrollment (PCS study)
- Myopathic or rheumatologic disease that impacts physical function (PCS study)
- Has a pacemaker or other internal medical device, or reports being pregnant (PCS study)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365169
Contacts
| Contact: Susan Peterson, PHD, MPH | 713-792-8267 |
Locations
| United States, Texas | |
| University of Texas MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Susan Peterson, PHD, MPH | M.D. Anderson Cancer Center |
Additional Information:
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01365169 History of Changes |
| Other Study ID Numbers: |
2010-0955 NCI-2014-02468 ( Registry Identifier: NCI CTRP ) RC2CA148263 ( U.S. NIH Grant/Contract ) R01CA177996 ( U.S. NIH Grant/Contract ) |
| First Posted: | June 3, 2011 Key Record Dates |
| Last Update Posted: | January 23, 2018 |
| Last Verified: | January 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by M.D. Anderson Cancer Center:
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Carbon Monoxide Cyberinfrastructure CI CYCORE Quality of Life QOL Head and Neck H&N |
CO Colorectal Cancer Oropharyngeal Cancer Laryngeal Cancer Hypopharyngeal Cancer Nasopharyngeal Cancer Smoker Recent Smoking Cessation |
Additional relevant MeSH terms:
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Carbon Monoxide Colorectal Neoplasms Head and Neck Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Antimetabolites Molecular Mechanisms of Pharmacological Action Gasotransmitters Neurotransmitter Agents Physiological Effects of Drugs |