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"
"CYCORE: Cyberinfrastructure for Comparative Effectiveness Research - Feasibility Trial"
5 other identifiers
interventional
590
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 25, 2011
CompletedFirst Submitted
Initial submission to the registry
June 1, 2011
CompletedFirst Posted
Study publicly available on registry
June 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
January 7, 2026
January 1, 2026
16.1 years
June 1, 2011
January 5, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Study completion (defined as completing the final assessment)
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)
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.
Up to 2 weeks
Secondary Outcomes (10)
Correlation between PA data from the Actigraph and Fitbit
Up to 7 days
Correlation between patients' ECOG performance status scores and PA data
Up to 7 days
Correlation between PA data and Overall Survivor (OS)
Up to 7 days
Accrual of Diverse Sample of Cancer-Patients
Up to 2 weeks
Retention of using home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales) among participants.
Up to 2 weeks
- +5 more secondary outcomes
Study Arms (6)
Arm I (colorectal cancer patients)
EXPERIMENTAL(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.
Arm II (head and neck cancer patients)
EXPERIMENTAL(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)
EXPERIMENTAL(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)
EXPERIMENTAL(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.
PCS (pancreatic surgery patients)
EXPERIMENTALPatients 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.
TAPS (Technological Approach to Performance Status)
EXPERIMENTALPatients 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.
Interventions
Participate in walking and/or strengthening program
Use accelerometers, blood pressure monitor, heart rate monitor, GPS device, and smart phone
Ancillary studies
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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)
- +2 more criteria
You may not qualify if:
- 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)
- 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)
- 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)
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan K Peterson
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2011
First Posted
June 3, 2011
Study Start
May 25, 2011
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
January 7, 2026
Record last verified: 2026-01