RecruitingNot ApplicableNCT01365169

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"


Sponsor

M.D. Anderson Cancer Center

Enrollment

590 participants

Start Date

May 25, 2011

Study Type

INTERVENTIONAL

Conditions

Stage I Colorectal Cancer AJCC v6 and v7Stage II Colorectal Cancer AJCC v7Stage III Colorectal Cancer AJCC v7Stage IV Colorectal Cancer AJCC v7Pancreatic AdenocarcinomaRecurrent Colorectal CarcinomaMalignant NeoplasmPancreatic Neuroendocrine CarcinomaMalignant Head and Neck NeoplasmMetastatic Malignant Neoplasm in the NeckMetastatic Malignant Neoplasm in the Uterine CervixStage I Hypopharyngeal Carcinoma AJCC v7Stage I Major Salivary Gland Cancer AJCC v7Stage I Nasopharyngeal Carcinoma AJCC v7Stage I Oral Cavity Cancer AJCC v6 and v7Stage I Oropharyngeal Carcinoma AJCC v6 and v7Stage II Hypopharyngeal Carcinoma AJCC v6 and v7Stage II Major Salivary Gland Cancer AJCC v7Stage II Nasopharyngeal Carcinoma AJCC v7Stage II Oral Cavity Cancer AJCC v6 and v7Stage II Oropharyngeal Carcinoma AJCC v6 and v7Stage IIA Colorectal Cancer AJCC v7Stage IIB Colorectal Cancer AJCC v7Stage IIC Colorectal Cancer AJCC v7Stage III Hypopharyngeal Carcinoma AJCC v7Stage III Laryngeal Cancer AJCC v6 and v7Stage III Major Salivary Gland Cancer AJCC v7Stage III Nasopharyngeal Carcinoma AJCC v7Stage III Oral Cavity Cancer AJCC v6 and v7Stage III Oropharyngeal Carcinoma AJCC v7Stage IIIA Colorectal Cancer AJCC v7Stage IIIB Colorectal Cancer AJCC v7Stage IIIC Colorectal Cancer AJCC v7Stage IVA Colorectal Cancer AJCC v7Stage IVA Hypopharyngeal Carcinoma AJCC v7Stage IVA Laryngeal Cancer AJCC v7Stage IVA Major Salivary Gland Cancer AJCC v7Stage IVA Nasopharyngeal Carcinoma AJCC v7Stage IVA Oral Cavity Cancer AJCC v6 and v7Stage IVA Oropharyngeal Carcinoma AJCC v7Stage IVB Colorectal Cancer AJCC v7Stage IVB Hypopharyngeal Carcinoma AJCC v7Stage IVB Laryngeal Cancer AJCC v7Stage IVB Major Salivary Gland Cancer AJCC v7Stage IVB Nasopharyngeal Carcinoma AJCC v7Stage IVB Oral Cavity Cancer AJCC v6 and v7Stage IVB Oropharyngeal Carcinoma AJCC v7Metastatic or Locally Unresectable Solid Tumor

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

Min Age: 18 Years

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

BEHAVIORALExercise Intervention

Participate in walking and/or strengthening program

OTHERHealth Telemonitoring

Use accelerometers, blood pressure monitor, heart rate monitor, GPS device, and smart phone

OTHERHealth Telemonitoring

Use accelerometers, blood pressure monitor, weight scale, and smart phone

OTHERHealth Telemonitoring

Use smart phone

OTHERHealth Telemonitoring

Use CO monitor and smart phone

OTHERHealth Telemonitoring

Use Fitbit, weight scale and iPhone- or web-based app for self-reported data

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

OTHERHealth Telemonitoring

Use Fitbit and Actigraph


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT01365169


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