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"

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01365169
Status
Recruiting
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Conditions

  • 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
  • Pancreatic Adenocarcinoma
  • Pancreatic Neuroendocrine Carcinoma
  • Recurrent Colorectal Carcinoma
  • 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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Exercise Intervention — BEHAVIORAL
    Participate in walking and/or strengthening program
  • Health Telemonitoring — OTHER
    Use accelerometers, blood pressure monitor, heart rate monitor, GPS device, and smart phone
  • Health Telemonitoring — OTHER
    Use accelerometers, blood pressure monitor, weight scale, and smart phone
  • Health Telemonitoring — OTHER
    Use smart phone
  • Health Telemonitoring — OTHER
    Use CO monitor and smart phone
  • Health Telemonitoring — OTHER
    Use Fitbit, weight scale and iPhone- or web-based app for self-reported data
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Health Telemonitoring — OTHER
    Use Fitbit and Actigraph

Study Details

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.

Key Dates

Start date
May 25, 2011
Status verified
Jan 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
590 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: 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 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: Arm IV (cancer survivors that are current/former smokers)
    (CLOSED TO ACCRUAL AS OF 01/30/14) Patients use a 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.
  • Experimental: PCS (pancreatic surgery patients)
    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.
  • Experimental: TAPS (Technological Approach to Performance Status)
    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.

Primary Outcome Measure

Study completion (defined as completing the final assessment) [ Time Frame: Up to 7 months after baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Susan K. Peterson
713-792-8267
Susan K. Peterson (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
M D Anderson Cancer Center· Houston, TX

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