Clinical trial NCT01365169: 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"
Official title: "CYCORE: Cyberinfrastructure for Comparative Effectiveness Research - Feasibility Trial"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malignant Head and Neck Neoplasm
Malignant Neoplasm
Metastatic Malignant Neoplasm in the Neck
Metastatic Malignant Neoplasm in the Uterine Cervix
Pancreatic Adenocarcinoma
Pancreatic Neuroendocrine Carcinoma
Recurrent Colorectal Carcinoma
Stage I Colorectal Cancer AJCC v6 and v7
Stage I Hypopharyngeal Carcinoma AJCC v7
Stage I Major Salivary Gland Cancer AJCC v7
Stage I Nasopharyngeal Carcinoma AJCC v7
Stage I Oral Cavity Cancer AJCC v6 and v7
Stage I Oropharyngeal Carcinoma AJCC v6 and v7
Stage II Colorectal Cancer AJCC v7
Stage II Hypopharyngeal Carcinoma AJCC v6 and v7
Stage II Major Salivary Gland Cancer AJCC v7
Stage II Nasopharyngeal Carcinoma AJCC v7
Stage II Oral Cavity Cancer AJCC v6 and v7
Stage II Oropharyngeal Carcinoma AJCC v6 and v7
Stage IIA Colorectal Cancer AJCC v7
Stage IIB Colorectal Cancer AJCC v7
Stage IIC Colorectal Cancer AJCC v7
Stage III Colorectal Cancer AJCC v7
Stage III Hypopharyngeal Carcinoma AJCC v7
Stage III Laryngeal Cancer AJCC v6 and v7
Stage III Major Salivary Gland Cancer AJCC v7
Stage III Nasopharyngeal Carcinoma AJCC v7
Stage III Oral Cavity Cancer AJCC v6 and v7
Stage III Oropharyngeal Carcinoma AJCC v7
Stage IIIA Colorectal Cancer AJCC v7
Stage IIIB Colorectal Cancer AJCC v7
Stage IIIC Colorectal Cancer AJCC v7
Stage IV Colorectal Cancer AJCC v7
Stage IVA Colorectal Cancer AJCC v7
Stage IVA Hypopharyngeal Carcinoma AJCC v7
Stage IVA Laryngeal Cancer AJCC v7
Stage IVA Major Salivary Gland Cancer AJCC v7
Stage IVA Nasopharyngeal Carcinoma AJCC v7
Stage IVA Oral Cavity Cancer AJCC v6 and v7
Stage IVA Oropharyngeal Carcinoma AJCC v7
Stage IVB Colorectal Cancer AJCC v7
Stage IVB Hypopharyngeal Carcinoma AJCC v7
Stage IVB Laryngeal Cancer AJCC v7
Stage IVB Major Salivary Gland Cancer AJCC v7
Stage IVB Nasopharyngeal Carcinoma AJCC v7
Stage IVB Oral Cavity Cancer AJCC v6 and v7
Stage IVB Oropharyngeal Carcinoma AJCC v7
Metastatic or Locally Unresectable Solid Tumor
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-06-03
Enrollment: 590
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Study completion (defined as completing the final assessment)
timeFrame: Up to 7 months after baseline
measure: Physical Activity (PA) Assessment
timeFrame: Up to 7 days
measure: ECOG Performance Status
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Correlation between PA data from the Actigraph and Fitbit
timeFrame: Up to 7 days
measure: Correlation between patients' ECOG performance status scores and PA data
timeFrame: Up to 7 days
measure: Correlation between PA data and Overall Survivor (OS)
timeFrame: Up to 7 days
measure: Accrual of Diverse Sample of Cancer-Patients
timeFrame: Up to 2 weeks
measure: Retention of using home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales) among participants.
timeFrame: Up to 2 weeks
measure: Acceptability of using home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales) among participants.
timeFrame: Up to 2 weeks
measure: Participants ability to activate, set-up, and use the home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales).
timeFrame: Up to 2 weeks
measure: 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.
timeFrame: Up to 2 weeks
measure: Successful upload of data from the home-based health monitor devices to the Cyberinfrastructure for Comparative effectiveness Research (CYCORE) for future analysis.
timeFrame: Up to 2 weeks
measure: 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).
timeFrame: Up to 2 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Susan K Peterson
role: PRINCIPAL_INVESTIGATOR
References: