{
"info": {
"nct_id": "NCT02909062",
"official_title": "Beyond Performance Status: Electronic Activity Monitoring to Assess Functional Activity of Patients With Gastrointestinal Malignancy During Chemotherapy",
"inclusion_criteria": "* Clinical diagnosis of gastrointestinal malignancy.\n* Age ≥ 18 years\n* Planned to receive systemic chemotherapy, either adjuvant chemotherapy, or neoadjuvant chemotherapy, or any new line of chemotherapy in the setting of advanced disease. Subjects may enroll prior to chemotherapy or during the first cycle of treatment.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Restricted mobility defined as dependence or anytime use of a walker or wheelchair in the past three months.\n* Refusing systemic chemotherapy.\n* Concurrent radiotherapy with chemotherapy\n* Have received at least one cycle of chemotherapy in the current chemotherapy regimen.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Clinical diagnosis of gastrointestinal malignancy.",
"criterions": [
{
"exact_snippets": "Clinical diagnosis of gastrointestinal malignancy",
"criterion": "gastrointestinal malignancy",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": true
}
]
}
]
},
{
"line": "* Age ≥ 18 years",
"criterions": [
{
"exact_snippets": "Age ≥ 18 years",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Planned to receive systemic chemotherapy, either adjuvant chemotherapy, or neoadjuvant chemotherapy, or any new line of chemotherapy in the setting of advanced disease. Subjects may enroll prior to chemotherapy or during the first cycle of treatment.",
"criterions": [
{
"exact_snippets": "Planned to receive systemic chemotherapy",
"criterion": "systemic chemotherapy",
"requirements": [
{
"requirement_type": "planned",
"expected_value": true
}
]
},
{
"exact_snippets": "either adjuvant chemotherapy, or neoadjuvant chemotherapy, or any new line of chemotherapy",
"criterion": "type of chemotherapy",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"adjuvant",
"neoadjuvant",
"new line of chemotherapy"
]
}
]
},
{
"exact_snippets": "in the setting of advanced disease",
"criterion": "disease stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "advanced"
}
]
},
{
"exact_snippets": "Subjects may enroll prior to chemotherapy or during the first cycle of treatment",
"criterion": "enrollment timing",
"requirements": [
{
"requirement_type": "timing",
"expected_value": [
"prior to chemotherapy",
"during the first cycle of treatment"
]
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Restricted mobility defined as dependence or anytime use of a walker or wheelchair in the past three months.",
"criterions": [
{
"exact_snippets": "Restricted mobility defined as dependence or anytime use of a walker or wheelchair",
"criterion": "restricted mobility",
"requirements": [
{
"requirement_type": "definition",
"expected_value": "dependence or anytime use of a walker or wheelchair"
}
]
},
{
"exact_snippets": "in the past three months",
"criterion": "time frame for restricted mobility",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": "past three months"
}
]
}
]
},
{
"line": "* Refusing systemic chemotherapy.",
"criterions": [
{
"exact_snippets": "Refusing systemic chemotherapy",
"criterion": "systemic chemotherapy",
"requirements": [
{
"requirement_type": "refusal",
"expected_value": true
}
]
}
]
},
{
"line": "* Concurrent radiotherapy with chemotherapy",
"criterions": [
{
"exact_snippets": "Concurrent radiotherapy with chemotherapy",
"criterion": "concurrent treatment",
"requirements": [
{
"requirement_type": "treatment types",
"expected_value": [
"radiotherapy",
"chemotherapy"
]
}
]
}
]
},
{
"line": "* Have received at least one cycle of chemotherapy in the current chemotherapy regimen.",
"criterions": [
{
"exact_snippets": "received at least one cycle of chemotherapy",
"criterion": "chemotherapy cycles received",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "cycle"
}
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}