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"CYCORE: Cyberinfrastructure for Comparative Effectiveness Research - Feasibility Trial"

NCT ID: NCT01365169Sponsor: M.D. Anderson Cancer CenterLast updated: 2026-01-07

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.

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.

Arms & interventions

  • BehavioralExercise Intervention

    Participate in walking and/or strengthening program

  • OtherHealth Telemonitoring

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

  • OtherHealth Telemonitoring

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

  • OtherHealth Telemonitoring

    Use smart phone

  • OtherHealth Telemonitoring

    Use CO monitor and smart phone

  • OtherHealth Telemonitoring

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

  • OtherQuality-of-Life Assessment

    Ancillary studies

  • OtherQuestionnaire Administration

    Ancillary studies

  • OtherHealth Telemonitoring

    Use Fitbit and Actigraph

Outcome measures

Primary

  • Study completion (defined as completing the final assessment)

    Time frame: Up to 7 months after baseline

  • 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

  • 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

  • Correlation between PA data from the Actigraph and Fitbit

    Time frame: Up to 7 days

  • Correlation between patients' ECOG performance status scores and PA data

    Time frame: Up to 7 days

  • Correlation between PA data and Overall Survivor (OS)

    Time frame: Up to 7 days

  • Accrual of Diverse Sample of Cancer-Patients

    Time frame: 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

  • Acceptability of using home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales) among participants.

    Time frame: 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

  • 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

  • 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

  • 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

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

M D Anderson Cancer Center

Houston, Texas, 77030

Recruiting
Susan K. Peterson · Contact
713-792-8267
Susan K. Peterson · Principal Investigator