CYCORE Feasibility
This study is ongoing, but not recruiting participants.
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: February 13, 2015
Last verified: February 2015
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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:
Genetic and Rare Diseases Information Center resources:
Hypopharyngeal Cancer
Laryngeal Cancer
Nasopharyngeal Carcinoma
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 2016 (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
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
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
Investigators
| Principal Investigator: | Susan Peterson, PHD, MPH | M.D. 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, NCI-2014-02468, RC2 CA148263 |
| Study First Received: | June 1, 2011 |
| Last Updated: | February 13, 2015 |
| 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 Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site |
Rectal Diseases Complement Factor H Antimetabolites Complement Inactivating Agents Gasotransmitters Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on February 27, 2015