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"

January 5, 2026 updated by: M.D. Anderson Cancer Center

"CYCORE: Cyberinfrastructure for Comparative Effectiveness Research - Feasibility 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Estimated)

590

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
          • Susan K. Peterson
          • Phone Number: 713-792-8267
        • Principal Investigator:
          • Susan K. Peterson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)
  • Eastern Cooperative Oncology Group (ECOG) status of 0 - 2, or self-reports being up and about more than 50% of waking hours and able to provide self-care (Arm 1)
  • Diagnosis of any of the following cancers: stage 1-4b oropharyngeal, hypopharyngeal, nasopharyngeal, salivary gland or oral cavity; stage 3-4b laryngeal; any unknown primary head and neck cancer with cervical metastasis that will be addressed with treatment to bilateral necks and mucosa; or other head and neck cancers medically approved by one of our Radiation Oncology collaborating medical doctors (MDs) (Arms 2 and 3)
  • History of any cancer, other than non-melanoma skin cancer (Arm 4)
  • Admitted to being a current smoker or recent quitter upon admission to MD Anderson Cancer Center (MDACC) (Arm 4)
  • Has a valid home address and functioning home telephone number (Arm 4)
  • Lives in the Houston or surrounding area, or resides in this same area during the time period that coincides with this study (Arms 1-4)
  • Patients who will undergo curative pancreatectomy for pancreatic adenocarcinoma, pancreatic neuroendocrine tumors, or pancreatic cysts (malignant or benign) (PCS study)
  • Fluent in English (PCS study)
  • Must have telephone access and agree to engage with research personnel using telephone (PCS study)
  • Diagnosis of a metastatic or locally unresectable solid tumor (TAPS study)
  • Fluent in English (TAPS study)
  • Age 18 years or older (TAPS study)
  • ECOG performance status score between 0-3 (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)
  • Currently receiving treatment for a cancer other than those listed in the arm-specific inclusion criteria (exception: 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Questionnaire Administration
Ancillary studies
Other: Health Telemonitoring
Use accelerometers, blood pressure monitor, heart rate monitor, GPS device, and smart phone
Other: Health Telemonitoring
Use accelerometers, blood pressure monitor, weight scale, and smart phone
Other: Health Telemonitoring
Use smart phone
Other: Health Telemonitoring
Use CO monitor and smart phone
Other: Health Telemonitoring
Use Fitbit, weight scale and iPhone- or web-based app for self-reported data
Other: Health Telemonitoring
Use Fitbit and Actigraph
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.
Other: Questionnaire Administration
Ancillary studies
Other: Health Telemonitoring
Use accelerometers, blood pressure monitor, heart rate monitor, GPS device, and smart phone
Other: Health Telemonitoring
Use accelerometers, blood pressure monitor, weight scale, and smart phone
Other: Health Telemonitoring
Use smart phone
Other: Health Telemonitoring
Use CO monitor and smart phone
Other: Health Telemonitoring
Use Fitbit, weight scale and iPhone- or web-based app for self-reported data
Other: Health Telemonitoring
Use Fitbit and Actigraph
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.
Other: Questionnaire Administration
Ancillary studies
Other: Health Telemonitoring
Use accelerometers, blood pressure monitor, heart rate monitor, GPS device, and smart phone
Other: Health Telemonitoring
Use accelerometers, blood pressure monitor, weight scale, and smart phone
Other: Health Telemonitoring
Use smart phone
Other: Health Telemonitoring
Use CO monitor and smart phone
Other: Health Telemonitoring
Use Fitbit, weight scale and iPhone- or web-based app for self-reported data
Other: Health Telemonitoring
Use Fitbit and Actigraph
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.
Other: Questionnaire Administration
Ancillary studies
Other: Health Telemonitoring
Use accelerometers, blood pressure monitor, heart rate monitor, GPS device, and smart phone
Other: Health Telemonitoring
Use accelerometers, blood pressure monitor, weight scale, and smart phone
Other: Health Telemonitoring
Use smart phone
Other: Health Telemonitoring
Use CO monitor and smart phone
Other: Health Telemonitoring
Use Fitbit, weight scale and iPhone- or web-based app for self-reported data
Other: Health Telemonitoring
Use Fitbit and Actigraph
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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Health Telemonitoring
Use accelerometers, blood pressure monitor, heart rate monitor, GPS device, and smart phone
Other: Health Telemonitoring
Use accelerometers, blood pressure monitor, weight scale, and smart phone
Other: Health Telemonitoring
Use smart phone
Other: Health Telemonitoring
Use CO monitor and smart phone
Other: Health Telemonitoring
Use Fitbit, weight scale and iPhone- or web-based app for self-reported data
Other: Health Telemonitoring
Use Fitbit and Actigraph
Behavioral: Exercise Intervention
Participate in walking and/or strengthening program
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.
Other: Health Telemonitoring
Use accelerometers, blood pressure monitor, heart rate monitor, GPS device, and smart phone
Other: Health Telemonitoring
Use accelerometers, blood pressure monitor, weight scale, and smart phone
Other: Health Telemonitoring
Use smart phone
Other: Health Telemonitoring
Use CO monitor and smart phone
Other: Health Telemonitoring
Use Fitbit, weight scale and iPhone- or web-based app for self-reported data
Other: Health Telemonitoring
Use Fitbit and Actigraph

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study completion (defined as completing the final assessment)
Time Frame: Up to 7 months after baseline
Up to 7 months after baseline
Physical Activity (PA) Assessment
Time Frame: Up to 7 days
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)
Up to 7 days
ECOG Performance Status
Time Frame: Up to 2 weeks
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.
Up to 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between PA data from the Actigraph and Fitbit
Time Frame: Up to 7 days
Association between PA measured using a Fitbit and PA measured using Actigraph
Up to 7 days
Correlation between patients' ECOG performance status scores and PA data
Time Frame: Up to 7 days
Association between performance status (PS) assesses by the patient's medical oncologist, and PA data
Up to 7 days
Correlation between PA data and Overall Survivor (OS)
Time Frame: Up to 7 days
Association between Physical Activity (PA) data and the Overall Survivor (OS) rate
Up to 7 days
Accrual of Diverse Sample of Cancer-Patients
Time Frame: Up to 2 weeks
Up to 2 weeks
Retention of using home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales) among participants.
Time Frame: Up to 2 weeks
Up to 2 weeks
Acceptability of using home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales) among participants.
Time Frame: Up to 2 weeks
Up to 2 weeks
Participants ability to activate, set-up, and use the home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales).
Time Frame: Up to 2 weeks
Up to 2 weeks
Adherence to procedures for home-based health monitor devices activation (e.g. Fitbit, Actigraph, CO monitor, weight scales) self-monitoring (e.g. PA, weight), and self-reported data capture by the devices.
Time Frame: Up to 2 weeks
Up to 2 weeks
Successful upload of data from the home-based health monitor devices to the Cyberinfrastructure for Comparative effectiveness Research (CYCORE) for future analysis.
Time Frame: Up to 2 weeks
Up to 2 weeks
CYCORE Data availability for clinicians and researchers in order to be able to daily monitor patients using home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales).
Time Frame: Up to 2 weeks
Up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Susan K Peterson, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2011

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

June 1, 2011

First Submitted That Met QC Criteria

June 1, 2011

First Posted (Estimated)

June 3, 2011

Study Record Updates

Last Update Posted (Estimated)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-0955 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2014-02468 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • R01CA243554 (U.S. NIH Grant/Contract)
  • RC2CA148263 (U.S. NIH Grant/Contract)
  • R01CA177996 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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