Actively Recruiting
CYCORE: Cyberinfrastructure for Comparative Effectiveness Research - Feasibility Trial
Led by M.D. Anderson Cancer Center · Updated on 2026-01-07
590
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the relationship between objectively measured physical activity levels and health care provider-assessed performance status, as well as overall survival in patients with advanced cancer. The goal is to enhance understanding of how physical activity can be used in assessing performance status in these patients. This trial includes diverse cancer types and explores the use of wearable devices and technology to collect data. Participants are assigned to one of several groups, some of which are closed to new participants. These groups involve various monitoring devices such as accelerometers, blood pressure monitors, heart rate monitors, GPS devices, CO monitors, smart phones, and wearable physical activity trackers like Fitbit and Actigraph. In some groups, participants complete exercise programs, nutrition counseling, and daily monitoring for up to seven months post-surgery. Device usage periods vary from consecutive 5-day intervals to 7-day continuous monitoring. Throughout the study, participants use devices to track physical activity, vital signs, and self-reported health data. They respond to electronic questionnaires about exercise, diet, symptoms, and smoking habits. Researchers assess outcomes including study completion, physical activity levels, and performance status. Data upload success, device acceptability, adherence, and correlations between different measurements are also evaluated to support future clinical use. Participation may last up to seven months depending on the assigned group.
CONDITIONS
Brief Title
Association Between Health Care Provider (HCP)-Assessed ECOG Performance Status (PS) and Overall Survival, and Objectively Measure of Physical Activity (PA) Levels in Advance-cancer Patients"
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of 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 or contiguous counties (Pre-pilot phase)
- ECOG status of 0-2 or reports being up and about more than 50% of waking hours and able to provide self-care (Arm 1)
- Diagnosis of certain head and neck cancers including stages 1-4b oropharyngeal, hypopharyngeal, nasopharyngeal, salivary gland, oral cavity, and others approved by medical doctors (Arms 2 and 3)
- History of any cancer except non-melanoma skin cancer (Arm 4)
- Current smoker or recent quitter admitted at MD Anderson Cancer Center (Arm 4)
- Valid home address and functioning home telephone number (Arm 4)
- Resides in Houston or surrounding area during study period (Arms 1-4)
- Scheduled for curative pancreatectomy for pancreatic adenocarcinoma, neuroendocrine tumors, or cysts (PCS study)
- Fluent in English and has telephone access for research contact (PCS study)
- Diagnosis of metastatic or locally unresectable solid tumor (TAPS study)
- Age 18 years or older (TAPS study)
- ECOG performance status score between 0-3 (TAPS study)
You will not qualify if you...
- Major surgery within the past 8 weeks (Arms 1 and 4)
- Unmonitored or unmanaged hypertension (Pre-pilot phase, Arms 1-3)
- Cognitive difficulties with orientation to time, person, or place (Arms 1-4)
- Orthopedic, neurologic, or musculoskeletal disability interfering with standing on weight scale (Pre-pilot phase, Arm 2)
- Not currently receiving radiation treatment for included cancers (Arms 2 and 3)
- Zubrod performance status greater than 2 or unable to be up and about more than 50% of waking hours or unable to provide self-care (Arms 2 and 3)
- Receiving treatment for cancers other than those included except non-melanoma skin cancer (Arms 2 and 3)
- History of oropharyngeal dysphagia unrelated to cancer (Arm 3 only)
- Active or suspected substance use disorder (Arm 4)
- Enrollment in certain protocols (PCS study)
- No home internet or WiFi access (PCS study)
- High risk for non-therapeutic resection based on pre-surgical evaluation (PCS study)
- Unstable or symptomatic cardiac or pulmonary disease (PCS study)
- Recent fracture or injury preventing weight bearing on limbs (PCS study)
- Poorly controlled pain score of 7/10 at enrollment (PCS study)
- Myopathic or rheumatologic disease affecting physical function (PCS study)
- Presence of pacemaker, internal medical device, or pregnancy (PCS study)
- Cognitive difficulties with orientation (TAPS study)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 5 consecutive days, followed by a 2 week break, then another 5 consecutive days
Participants use various home-based health monitor devices such as accelerometers, blood pressure monitors, heart rate monitors, GPS devices, weight scales, CO monitors, smart phones, Fitbit, and Actigraph to electronically answer questions and record health-related data.
Device use during these periods with electronic prompts; no specific in-person visits required
Duration - Up to 7 months post-operation
Participants who have undergone pancreatic surgery receive a program including physical activity, nutrition counseling, and daily monitoring of physical activity, weight, and self-reported data.
Daily monitoring with scheduled counseling sessions; visit frequency varies
Duration - 7 consecutive days
Participants use physical activity monitoring devices (Fitbit continuously and Actigraph during waking hours) to assess activity levels.
Continuous device use during this period; no specific in-person visits required
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Susan Peterson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
6
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