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Clinical Trial 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.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To explore the feasibility and acceptability in diverse samples of cancer patients of wireless collection and transmission of data for transfer into the open-source cyberinfrastructure (CI) called Cyberinfrastructure for Comparative Effectiveness Research (CYCORE). OUTLINE: Patients are assigned to 1 of 4 arms. ARM I (COLORECTAL CANCER PATIENTS) (CLOSED TO ACCRUAL AS OF 01/30/14): Patients use two accelerometers, a blood pressure monitor, a heart rate monitor, a global positioning system (GPS) device, and a smart phone that prompts patients to electronically answer questions about exercise and health-related symptoms and feelings. The devices are used for 5 consecutive days. After a 2 week period, patients resume use of the devices for an additional 5 days. ARM II (HEAD AND NECK CANCER PATIENTS) (CLOSED TO ACCRUAL AS OF 01/30/14): Patients use two accelerometers, a blood pressure monitor, a weight scale, and a smart phone that prompts patients to electronically answer questions about diet and health-related symptoms. The devices are used for 5 consecutive days. After a 2 week period, patients resume use of the devices for an additional 5 days. ARM III (HEAD AND NECK CANCER PATIENTS) (CLOSED TO ACCRUAL AS OF 01/30/14): Patients use a smart phone that prompts patients to electronically answer questions about diet, health-related symptoms, and swallowing exercises. Patients also take video recordings of their neck while performing swallowing exercises. The device is used for 5 consecutive days. After a 2 week period, patients resume use of the device for an additional 5 days. ARM IV (CANCER SURVIVORS THAT ARE CURRENT/FORMER SMOKERS) (CLOSED TO ACCRUAL AS OF 01/30/14): Patients use a carbon monoxide (CO) monitor and a smart phone that prompts patients to electronically answer questions about smoking. Patients also take video recordings of themselves while exhaling into the CO monitor. The devices are used for 5 consecutive days. After a 2 week period, patients resume use of the devices for an additional 5 days. PANCREATIC CANCER STUDY (PCS): Patients receive post-surgical wellness program consisting of physical activity, nutrition counseling, and daily monitoring (physical activity, weight, and self-reported data) for up to 7 months post-op. Technological Approach to Performance Status (TAPS) Study: Patients use two Physical Activity monitor devices, the wrist-worn device (Fitbit) continuously and the Actigraph during waking hours. Patients use the devices for 7 consecutive days. ;


Study Design


Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Islet Cell
  • Carcinoma, Neuroendocrine
  • Colorectal Neoplasms
  • Head and Neck Neoplasms
  • Laryngeal Neoplasms
  • Malignant Head and Neck Neoplasm
  • Malignant Neoplasm
  • Metastatic Malignant Neoplasm in the Neck
  • Metastatic Malignant Neoplasm in the Uterine Cervix
  • Metastatic or Locally Unresectable Solid Tumor
  • Mouth Neoplasms
  • Nasopharyngeal Carcinoma
  • Neoplasms
  • Neoplasms, Second Primary
  • Oropharyngeal Neoplasms
  • Pancreatic Adenocarcinoma
  • Pancreatic Neuroendocrine Carcinoma
  • Recurrent Colorectal Carcinoma
  • Salivary Gland Neoplasms
  • Stage I Colorectal Cancer AJCC v6 and v7
  • Stage I Hypopharyngeal Carcinoma AJCC v7
  • Stage I Major Salivary Gland Cancer AJCC v7
  • Stage I Nasopharyngeal Carcinoma AJCC v7
  • Stage I Oral Cavity Cancer AJCC v6 and v7
  • Stage I Oropharyngeal Carcinoma AJCC v6 and v7
  • Stage II Colorectal Cancer AJCC v7
  • Stage II Hypopharyngeal Carcinoma AJCC v6 and v7
  • Stage II Major Salivary Gland Cancer AJCC v7
  • Stage II Nasopharyngeal Carcinoma AJCC v7
  • Stage II Oral Cavity Cancer AJCC v6 and v7
  • Stage II Oropharyngeal Carcinoma AJCC v6 and v7
  • Stage IIA Colorectal Cancer AJCC v7
  • Stage IIB Colorectal Cancer AJCC v7
  • Stage IIC Colorectal Cancer AJCC v7
  • Stage III Colorectal Cancer AJCC v7
  • Stage III Hypopharyngeal Carcinoma AJCC v7
  • Stage III Laryngeal Cancer AJCC v6 and v7
  • Stage III Major Salivary Gland Cancer AJCC v7
  • Stage III Nasopharyngeal Carcinoma AJCC v7
  • Stage III Oral Cavity Cancer AJCC v6 and v7
  • Stage III Oropharyngeal Carcinoma AJCC v7
  • Stage IIIA Colorectal Cancer AJCC v7
  • Stage IIIB Colorectal Cancer AJCC v7
  • Stage IIIC Colorectal Cancer AJCC v7
  • Stage IV Colorectal Cancer AJCC v7
  • Stage IVA Colorectal Cancer AJCC v7
  • Stage IVA Hypopharyngeal Carcinoma AJCC v7
  • Stage IVA Laryngeal Cancer AJCC v7
  • Stage IVA Major Salivary Gland Cancer AJCC v7
  • Stage IVA Nasopharyngeal Carcinoma AJCC v7
  • Stage IVA Oral Cavity Cancer AJCC v6 and v7
  • Stage IVA Oropharyngeal Carcinoma AJCC v7
  • Stage IVB Colorectal Cancer AJCC v7
  • Stage IVB Hypopharyngeal Carcinoma AJCC v7
  • Stage IVB Laryngeal Cancer AJCC v7
  • Stage IVB Major Salivary Gland Cancer AJCC v7
  • Stage IVB Nasopharyngeal Carcinoma AJCC v7
  • Stage IVB Oral Cavity Cancer AJCC v6 and v7
  • Stage IVB Oropharyngeal Carcinoma AJCC v7

NCT number NCT01365169
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Susan Peterson
Phone 713-792-8267
Email speterso@mdanderson.org
Status Recruiting
Phase N/A
Start date May 25, 2011
Completion date June 30, 2027

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