NCT01365169Recruiting
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"
"CYCORE: Cyberinfrastructure for Comparative Effectiveness Research - Feasibility Trial"
Source: ClinicalTrials.gov · Last updated 15 Jul 2026
Brief summary (registry, in English)
The main goal of this phase of the study is to determine if objectively assessed Physical Activity (PA) levels in advanced-cancer patients are associated with health care provider (HCP)-assessed ECOG performance status and overall survival. The purpose is to advance the evidence-base for incorporating objective assessment of Physical Activity (PA) in the context of performance status assessment in advanced cancer patients.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 590 (estimated)
- First submitted
- 1 Jun 2011
- Start date
- 25 May 2011
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- M.D. Anderson Cancer Center
- NCT number
- NCT01365169
What you commit to
- Study type: Interventional
- Planned participants: 590
- From 25 May 2011 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major surgery in the past 8 weeks (Arms 1 and 4)
- Not currently receiving radiation treatment for a cancer listed in the arm-specific inclusion criteria (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)
Other illness
- 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)
- 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)
- 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)
- Myopathic or rheumatologic disease that impacts physical function (PCS study)
Other
- 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)
- 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 enrolled in protocol 2014-0712 (PCS study)
- No home access to internet (PCS study)
- No home WiFi connection (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)
- Has a pacemaker or other internal medical device, or reports being pregnant (PCS study)
- Currently enrolled in protocol 2017-0198 (PCS study)
- Demonstration of overt cognitive difficulty as demonstrated by not being clearly oriented to time or person or place (TAPS study)
Who the study is looking for
- 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)
- Eastern Cooperative Oncology Group (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 medical doctors (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 MD Anderson Cancer Center (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)
- Diagnosis of a metastatic or locally unresectable solid tumor (TAPS study)
- Fluent in English (TAPS study)
- Age 18 years or older (TAPS study)
- ECOG performance status score between 0-3 (TAPS study)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.