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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"

ConditionsMalignant Head and Neck NeoplasmMalignant NeoplasmMetastatic Malignant Neoplasm in the NeckMetastatic Malignant Neoplasm in the Uterine CervixPancreatic AdenocarcinomaPancreatic Neuroendocrine CarcinomaRecurrent Colorectal CarcinomaStage I Colorectal Cancer AJCC v6 and v7Stage 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 Colorectal Cancer AJCC 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 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 IV 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
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise Intervention

    Behavioral

    Participate in walking and/or strengthening program

  • Health Telemonitoring

    Other intervention

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

  • Health Telemonitoring

    Other intervention

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

  • Health Telemonitoring

    Other intervention

    Use smart phone

  • Health Telemonitoring

    Other intervention

    Use CO monitor and smart phone

  • Health Telemonitoring

    Other intervention

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

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Health Telemonitoring

    Other intervention

    Use Fitbit and Actigraph

Treatment groups

590 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Arm I (colorectal cancer patients)Experimental treatment 2 interventions
Group B: Arm II (head and neck cancer patients)Experimental treatment 2 interventions
Group C: Arm III (head and neck cancer patients)Experimental treatment 2 interventions
Group D: Arm IV (cancer survivors that are current/former smokers)Experimental treatment 2 interventions
Group E: PCS (pancreatic surgery patients)Experimental treatment 4 interventions
Group F: TAPS (Technological Approach to Performance Status)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Study completion (defined as completing the final assessment)

Time frame
Up to 7 months after baseline
2

Physical Activity (PA) Assessment

PA will be measured by two different devices, (1) a consumer-grade wrist-worn device that collects continuous PA data (Fitbit), and (2) a research-grade, hip-worn accelerometer (Actigraph)

Time frame
Up to 7 days
3

ECOG Performance Status

Eastern Cooperation Oncology Group (ECOG) is a 6-point performance status scale used to assess performance using PA as a key indicator (e.g., 0 = fully active, 2 = up and about more than 50% of walking hours, 5 = dead) Performance status will be assessed per usual clinical practice and will be recorded in the medical record.

Time frame
Up to 2 weeks

Secondary outcomes

1

Correlation between PA data from the Actigraph and Fitbit

Association between PA measured using a Fitbit and PA measured using Actigraph

Time frame
Up to 7 days
2

Correlation between patients' ECOG performance status scores and PA data

Association between performance status (PS) assesses by the patient's medical oncologist, and PA data

Time frame
Up to 7 days
3

Correlation between PA data and Overall Survivor (OS)

Association between Physical Activity (PA) data and the Overall Survivor (OS) rate

Time frame
Up to 7 days
4

Accrual of Diverse Sample of Cancer-Patients

Time frame
Up to 2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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