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"
M.D. Anderson Cancer Center
590 participants
May 25, 2011
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria31
- 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)
- 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)
- 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)
- Currently enrolled in protocol 2014-0712 (PCS study)
- No home access to internet (PCS study)
- No home WiFi connection (PCS study)
- 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)
- 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)
- Myopathic or rheumatologic disease that impacts physical function (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)
Exclusion Criteria4
- 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)
Interventions
Participate in walking and/or strengthening program
Use accelerometers, blood pressure monitor, heart rate monitor, GPS device, and smart phone
Use accelerometers, blood pressure monitor, weight scale, and smart phone
Use smart phone
Use CO monitor and smart phone
Use Fitbit, weight scale and iPhone- or web-based app for self-reported data
Ancillary studies
Ancillary studies
Use Fitbit and Actigraph
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT01365169