RECRUITING

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"

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Conditions

Malignant Head and Neck NeoplasmMalignant NeoplasmMetastatic Malignant Neoplasm in the NeckMetastatic Malignant Neoplasm in the Uterine CervixPancreatic AdenocarcinomaPancreatic Neuroendocrine CarcinomaRecurrent Colorectal CarcinomaStage I Colorectal Cancer AJCC v6 and v7Stage I Hypopharyngeal Carcinoma AJCC v7Stage I Major Salivary Gland Cancer AJCC v7Stage I Nasopharyngeal Carcinoma AJCC v7Stage I Oral Cavity Cancer AJCC v6 and v7Stage I Oropharyngeal Carcinoma AJCC v6 and v7Stage II Colorectal Cancer AJCC v7Stage II Hypopharyngeal Carcinoma AJCC v6 and v7Stage II Major Salivary Gland Cancer AJCC v7Stage II Nasopharyngeal Carcinoma AJCC v7Stage II Oral Cavity Cancer AJCC v6 and v7Stage II Oropharyngeal Carcinoma AJCC v6 and v7Stage IIA Colorectal Cancer AJCC v7Stage IIB Colorectal Cancer AJCC v7Stage IIC Colorectal Cancer AJCC v7Stage III Colorectal Cancer AJCC v7Stage III Hypopharyngeal Carcinoma AJCC v7Stage III Laryngeal Cancer AJCC v6 and v7Stage III Major Salivary Gland Cancer AJCC v7Stage III Nasopharyngeal Carcinoma AJCC v7Stage III Oral Cavity Cancer AJCC v6 and v7Stage III Oropharyngeal Carcinoma AJCC v7Stage IIIA Colorectal Cancer AJCC v7Stage IIIB Colorectal Cancer AJCC v7Stage IIIC Colorectal Cancer AJCC v7Stage IV Colorectal Cancer AJCC v7Stage IVA Colorectal Cancer AJCC v7Stage IVA Hypopharyngeal Carcinoma AJCC v7Stage IVA Laryngeal Cancer AJCC v7Stage IVA Major Salivary Gland Cancer AJCC v7Stage IVA Nasopharyngeal Carcinoma AJCC v7Stage IVA Oral Cavity Cancer AJCC v6 and v7Stage IVA Oropharyngeal Carcinoma AJCC v7Stage IVB Colorectal Cancer AJCC v7Stage IVB Hypopharyngeal Carcinoma AJCC v7Stage IVB Laryngeal Cancer AJCC v7Stage IVB Major Salivary Gland Cancer AJCC v7Stage IVB Nasopharyngeal Carcinoma AJCC v7Stage IVB Oral Cavity Cancer AJCC v6 and v7Stage IVB Oropharyngeal Carcinoma AJCC v7Metastatic or Locally Unresectable Solid Tumor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2011-05-25
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01365169

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of any stage I - IV colorectal cancer or recurrent colorectal cancer (Arm 1)
  2. * Able to speak, read, and write in English (Pre-pilot phase, Arms 1-4)
  3. * Able to provide informed consent (Pre-pilot phase, Arms 1-4, PCS study)
  4. * Lives in the Houston area (Harris county or a contiguous county) (Pre-pilot phase)
  5. * 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)
  6. * 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)
  7. * History of any cancer, other than non-melanoma skin cancer (Arm 4)
  8. * Admitted to being a current smoker or recent quitter upon admission to MD Anderson Cancer Center (MDACC) (Arm 4)
  9. * Has a valid home address and functioning home telephone number (Arm 4)
  10. * 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)
  11. * Patients who will undergo curative pancreatectomy for pancreatic adenocarcinoma, pancreatic neuroendocrine tumors, or pancreatic cysts (malignant or benign) (PCS study)
  12. * Fluent in English (PCS study)
  13. * Must have telephone access and agree to engage with research personnel using telephone (PCS study)
  14. * Diagnosis of a metastatic or locally unresectable solid tumor (TAPS study)
  15. * Fluent in English (TAPS study)
  16. * Age 18 years or older (TAPS study)
  17. * ECOG performance status score between 0-3 (TAPS study)
  1. * Major surgery in the past 8 weeks (Arms 1 and 4)
  2. * 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)
  3. * Overt cognitive difficulty demonstrated by not being clearly oriented to time or person or place (Arms 1-4)
  4. * Orthopedic, neurologic, or musculoskeletal disability that would interfere with the functional task of standing on a weight scale (Pre-pilot phase, Arm 2)
  5. * Not currently receiving radiation treatment for a cancer listed in the arm-specific inclusion criteria (Arms 2 and 3)
  6. * 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)
  7. * 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)
  8. * History of current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g. dysphagia due to underlying neurogenic disorder) (Arm 3 only)
  9. * Active substance use disorder (diagnosed or strongly suspected) (Arm 4)
  10. * Currently enrolled in protocol 2014-0712 (PCS study)
  11. * No home access to internet (PCS study)
  12. * No home WiFi connection (PCS study)
  13. * During clinician's pre-surgical evaluation, presents with high risk for non-therapeutic resection related to cancer diagnosis (PCS study)
  14. * Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV) (PCS study)
  15. * 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)
  16. * Poorly-controlled pain with a self-reported pain score of 7/10 at the time of enrollment (PCS study)
  17. * Myopathic or rheumatologic disease that impacts physical function (PCS study)
  18. * Has a pacemaker or other internal medical device, or reports being pregnant (PCS study)
  19. * Currently enrolled in protocol 2017-0198 (PCS study)
  20. * Demonstration of overt cognitive difficulty as demonstrated by not being clearly oriented to time or person or place (TAPS study)

Contacts and Locations

Study Contact

Susan Peterson
CONTACT
713-792-8267
speterso@mdanderson.org

Principal Investigator

Susan K Peterson
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Susan K Peterson, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2011-05-25
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2011-05-25
Study Completion Date2027-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • 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