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

Plain Language Summary

Simplified for easier understanding

This study examines whether a doctor's assessment of a cancer patient's physical function (called ECOG performance status) matches what can be objectively measured by activity monitors, and whether physical activity levels predict survival in patients with advanced cancer. **You may be eligible if...** - You have been diagnosed with colorectal cancer (any stage, including recurrent) and have good daily functioning (ECOG 0-2) - You have head and neck cancer scheduled for radiation treatment - You have any cancer history (other than non-melanoma skin cancer) and are a current or recent smoker - You are scheduled for pancreatic surgery - You have a metastatic or locally advanced solid tumor and are 18 or older (ECOG 0-3) - You can speak, read, and write English and live in or near Houston, TX (for most arms) **You may NOT be eligible if...** - You had major surgery in the past 8 weeks - You have unmonitored high blood pressure - You have significant cognitive impairment - You have an orthopedic or neurological disability affecting your ability to stand or exercise - You have poorly controlled pain (7/10 or higher) - You have a pacemaker or are pregnant (for the pancreatic surgery sub-study) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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