Examining the link between physical activity and survival in advanced cancer patients
"CYCORE: Cyberinfrastructure for Comparative Effectiveness Research - Feasibility Trial"
This study is testing how physical activity affects survival and overall health in people with advanced cancer by using wearable devices to track their activity levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 590 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT01365169 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between healthcare provider-assessed ECOG performance status and objectively measured physical activity levels in patients with advanced cancer. It employs a variety of wearable devices to collect data on physical activity, health symptoms, and dietary habits over specified periods. The goal is to enhance the understanding of how physical activity impacts overall survival and performance status in this patient population. The study includes multiple arms focusing on different cancer types, utilizing technology for real-time data collection and monitoring.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with advanced stages of colorectal cancer or head and neck cancers who can engage with technology and live in the Houston area.
Not a fit: Patients with early-stage cancers or those unable to participate in physical activity assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights that improve the management and treatment outcomes for advanced cancer patients by integrating physical activity assessments into clinical practice.
How similar studies have performed: Other studies have shown promising results in using objective measures of physical activity to assess health outcomes in cancer patients, suggesting this approach has potential.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Susan K Peterson — M.D. Anderson Cancer Center
- Study coordinator: Susan Peterson
- Email: speterso@mdanderson.org
- Phone: 713-792-8267
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.