Clinical trial · Interventional
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"
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (48)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Head and Neck Neoplasm | Malignant Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Metastatic Malignant Neoplasm in the Neck | — | UNRESOLVED | — |
| Metastatic Malignant Neoplasm in the Uterine Cervix | — | UNRESOLVED | — |
| Metastatic or Locally Unresectable Solid Tumor | — | UNRESOLVED | — |
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Neuroendocrine Carcinoma | Pancreatic Neuroendocrine Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Colorectal Carcinoma | Colorectal Carcinoma | CURATED_BROADER | 0.78 |
| Stage I Colorectal Cancer AJCC v6 and v7 | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise Intervention | Behavioral | — | UNRESOLVED |
| Health Telemonitoring | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Arm I (colorectal cancer patients)
- description
- (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.
- interventionNames
- Other: Health Telemonitoring
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Arm II (head and neck cancer patients)
- description
- (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.
- interventionNames
- Other: Health Telemonitoring
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available