Pancreatic Adenocarcinoma Clinical Trial
Official title:
"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.
Status | Recruiting |
Enrollment | 590 |
Est. completion date | June 30, 2027 |
Est. primary completion date | June 30, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Study completion (defined as completing the final assessment) | Up to 7 months after baseline | ||
Primary | 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) | Up to 7 days | |
Primary | 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. | Up to 2 weeks | |
Secondary | Correlation between PA data from the Actigraph and Fitbit | Association between PA measured using a Fitbit and PA measured using Actigraph | Up to 7 days | |
Secondary | 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 | Up to 7 days | |
Secondary | Correlation between PA data and Overall Survivor (OS) | Association between Physical Activity (PA) data and the Overall Survivor (OS) rate | Up to 7 days | |
Secondary | Accrual of Diverse Sample of Cancer-Patients | Up to 2 weeks | ||
Secondary | Retention of using home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales) among participants. | Up to 2 weeks | ||
Secondary | Acceptability of using home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales) among participants. | Up to 2 weeks | ||
Secondary | Participants ability to activate, set-up, and use the home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales). | Up to 2 weeks | ||
Secondary | 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. | Up to 2 weeks | ||
Secondary | Successful upload of data from the home-based health monitor devices to the Cyberinfrastructure for Comparative effectiveness Research (CYCORE) for future analysis. | Up to 2 weeks | ||
Secondary | 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). | Up to 2 weeks |
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