CYCORE Feasibility
This study is currently recruiting participants.
Verified April 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01365169
First received: June 1, 2011
Last updated: April 5, 2013
Last verified: April 2013
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Advanced Cancers Colorectal Cancer Head And Neck Cancer Cancer Survivors |
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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | CYCORE: Cyberinfrastructure for Comparative Effectiveness Research - Feasibility Trial |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
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. ] [ Designated as safety issue: No ]Primary feasibility endpoint is study completion represented as number of participants who complete study final assessment.
| Estimated Enrollment: | 240 |
| Study Start Date: | June 2011 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Exercise Adherence Arm (Arm 1) |
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: 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.
|
| Dehydration Risk Arm (Arm 2) |
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.
Other: Surveys
After training about each device, completion of a survey about that training.
|
| Swallowing Exercise Adherence Arm (Arm 3) |
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).
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.
Other: Surveys
After training about each device, completion of a survey about that training.
|
| Smoking Cessation Adherence Arm (Arm 4) |
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).
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.
Other: Surveys
After training about each device, completion of a survey about that training.
|
| Pre-Pilot |
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.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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)
- 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)
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365169
Contacts
| Contact: Susan Peterson, PHD, MPH | 713-792-8267 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Susan Peterson, PHD, MPH | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Susan Peterson, PHD, MPH | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01365169 History of Changes |
| Other Study ID Numbers: | 2010-0955 |
| Study First Received: | June 1, 2011 |
| Last Updated: | April 5, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Head and Neck Neoplasms Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Carbon Monoxide Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013