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"

  • STATUS
    Recruiting
  • End date
    Jun 30, 2027
  • participants needed
    590
  • sponsor
    M.D. Anderson Cancer Center
Updated on 3 November 2021
radiation oncology
cancer
cyst
non-melanoma skin cancer
dental caries
cavity
metastasis
cancer diagnosis
advanced cancer
primary cancer
adenocarcinoma
oropharyngeal
neuroendocrine 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.

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.

Details
Condition Cancer (Pediatric), Noncancerous Growth, Ewing's Family Tumors, Stage IIIC Colorectal Cancer AJCC v7, Stage IVB Laryngeal Cancer AJCC v7, Stage III Laryngeal Cancer AJCC v6 and v7, Stage III Major Salivary Gland Cancer AJCC v7, malignancies, Pancreatic Adenocarcinoma, recurrent colorectal cancer, malignant tumors, islet cell cancer, Stage IIB Colorectal Cancer AJCC v7, Head and Neck Cancer, Stage IVB Nasopharyngeal Carcinoma AJCC v7, Pancreatic disorder, Stage IVA Nasopharyngeal Carcinoma AJCC v7, Stage I Oropharyngeal Carcinoma AJCC v6 and v7, Advanced Cancers, Stage I Major Salivary Gland Cancer AJCC v7, Stage IVB Hypopharyngeal Carcinoma AJCC v7, Pancreatic Disorders, Stage I Colorectal Cancer AJCC v6 and v7, Stage IVA Colorectal Cancer AJCC v7, Stage IVB Oral Cavity Cancer AJCC v6 and v7, Stage IIA Colorectal Cancer AJCC v7, Stage II Colorectal Cancer AJCC v7, Colorectal Cancer, Colon Cancer Screening, Colon cancer; rectal cancer, Neoplasms, Islet cell carcinoma, Pancreatic Cyst, Stage IVA Laryngeal Cancer AJCC v7, Stage II Major Salivary Gland Cancer AJCC v7, Stage II Nasopharyngeal Carcinoma, Stage IVB Oropharyngeal Carcinoma AJCC v7, Metastatic or Locally Unresectable Solid Tumor, Stage III Colorectal Cancer AJCC v7, Cancer, Stage IIIB Colorectal Cancer AJCC v7, Stage IVA Oropharyngeal Carcinoma AJCC v7, Stage IVB Colorectal Cancer AJCC v7, Stage II Oral Cavity Cancer AJCC v6 and v7, Stage IVA Hypopharyngeal Carcinoma AJCC v7, malignancy, malignant tumor, head and neck cancer, Cancer Survivor, primary malignant neoplasm, Cancer Survivors, Current Smoker, Stage I Nasopharyngeal Carcinoma AJCC v7, Cyst, Stage IVA Oral Cavity Cancer AJCC v6 and v7, Stage II Nasopharyngeal Carcinoma AJCC v7, Stage II Oropharyngeal Carcinoma AJCC v6 and v7, Metastatic Malignant Neoplasm in the Uterine Cervix, cancer of the head and neck, Metastatic Malignant Neoplasm in the Neck, Stage IVA Major Salivary Gland Cancer AJCC v7, Stage IIC Colorectal Cancer AJCC v7, Stage III Oral Cavity Cancer AJCC v6 and v7, Stage IV Colorectal Cancer AJCC v7, Stage III Nasopharyngeal Carcinoma AJCC v7, Recurrent Colorectal Carcinoma, Stage I Oral Cavity Cancer AJCC v6 and v7, cancers, Stage I Hypopharyngeal Carcinoma AJCC v7, pancreatic cysts, Cancer/Tumors, Stage III Oropharyngeal Carcinoma AJCC v7, Stage III Hypopharyngeal Carcinoma AJCC v7, Former Smoker, primary cancer, Stage IIIA Colorectal Cancer AJCC v7, Stage IVB Major Salivary Gland Cancer AJCC v7, Stage II Hypopharyngeal Carcinoma AJCC v6 and v7
Treatment questionnaire administration, quality-of-life assessment, Questionnaires, surveys, exercise intervention, Home Visit, Smart phone, Accelerometers, Blood Pressure Monitor, Blood Pressure Monitor, Telephone Surveys, Home Health Hub and Modem, Carbon Monoxide (CO) Monitor, Heat Rate Monitor, Global Positioning System (GPS) Device, Weight Scale, Fitbit Monitor, At-Home Exercise Program, Physical Fitness Tests, Lean Body Mass Assessment, Health Telemonitoring
Clinical Study IdentifierNCT01365169
SponsorM.D. Anderson Cancer Center
Last Modified on3 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

the study does not exclude those receiving treatment for non-melanoma skin cancer) (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 Criteria

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)
Not currently receiving radiation treatment for a cancer listed in the arm-specific inclusion criteria (Arms 2 and 3)
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)
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