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CYCORE: Cyberinfrastructure for Comparative Effectiveness Research - Feasibility Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01365169
First received: June 1, 2011
Last updated: April 19, 2016
Last verified: April 2016
History of Changes
  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:

U.S. FDA Resources

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 2017 (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   (Adult, Senior)
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:

  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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365169

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
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
  More Information

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01365169     History of Changes
Other Study ID Numbers: 2010-0955  NCI-2014-02468  RC2CA148263 
Study First Received: June 1, 2011
Last Updated: April 19, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by M.D. Anderson Cancer Center:
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:
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
Complement Factor H
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gasotransmitters
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 27, 2016