{
"info": {
"nct_id": "NCT03857620",
"official_title": "Improving Surgical Care and Outcomes in Older Cancer Patients Through Implementation of an Efficient Pre-Surgical Toolkit (OPTI-Surg)",
"inclusion_criteria": "* Patients must have known or suspected cancer diagnosis and have one of the following cancer-directed operations planned:\n\n * Gastrectomy\n * Colectomy\n * Proctectomy\n * Esophagectomy\n * Pancreatectomy\n * Hepatectomy\n * Total cystectomy\n * Partial or total nephrectomy\n * Lung lobectomy/pneumonectomy\n* Patients with known metastatic disease with a plan for curative intent resection are eligible (e.g. curative liver resection for metastatic colorectal cancer).\n* Patients with double primaries undergoing planned curative operation for both are eligible (e.g. synchronous colon cancers undergoing colectomy to treat both).\n* Patients must be able to speak and complete questionnaires in English.\nHealthy volunteers allowed\nMust have minimum age of 70 Years",
"exclusion_criteria": "* Patients undergoing emergent surgery are not eligible.\n* Patients under active treatment such as chemotherapy, targeted therapy, immunotherapy, radiation treatment, etc. for second primary, are not eligible.\n* Patients with second primary are not eligible.\n* Patients with known metastatic disease who are undergoing palliative resection are not eligible.\n* Patients with psychiatric illness or other mental impairment that would preclude their ability to give informed consent or to participate in the prehabilitation program are not eligible.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Patients must have known or suspected cancer diagnosis and have one of the following cancer-directed operations planned:",
"criterions": [
{
"exact_snippets": "known or suspected cancer diagnosis",
"criterion": "cancer diagnosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "one of the following cancer-directed operations planned",
"criterion": "cancer-directed operations",
"requirement": {
"requirement_type": "planned",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "known or suspected cancer diagnosis",
"criterion": "cancer diagnosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "one of the following cancer-directed operations planned",
"criterion": "cancer-directed operations",
"requirement": {
"requirement_type": "planned",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Gastrectomy",
"criterions": [
{
"exact_snippets": "Gastrectomy",
"criterion": "gastrectomy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Gastrectomy",
"criterion": "gastrectomy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Colectomy",
"criterions": [
{
"exact_snippets": "Colectomy",
"criterion": "colectomy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Colectomy",
"criterion": "colectomy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Proctectomy",
"criterions": [
{
"exact_snippets": "Proctectomy",
"criterion": "proctectomy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Proctectomy",
"criterion": "proctectomy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Esophagectomy",
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{
"exact_snippets": "Esophagectomy",
"criterion": "esophagectomy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Esophagectomy",
"criterion": "esophagectomy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Pancreatectomy",
"criterions": [
{
"exact_snippets": "Pancreatectomy",
"criterion": "pancreatectomy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Pancreatectomy",
"criterion": "pancreatectomy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Hepatectomy",
"criterions": [
{
"exact_snippets": "Hepatectomy",
"criterion": "hepatectomy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Hepatectomy",
"criterion": "hepatectomy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Total cystectomy",
"criterions": [
{
"exact_snippets": "Total cystectomy",
"criterion": "total cystectomy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Total cystectomy",
"criterion": "total cystectomy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Partial or total nephrectomy",
"criterions": [
{
"exact_snippets": "Partial or total nephrectomy",
"criterion": "nephrectomy",
"requirement": {
"requirement_type": "type",
"expected_value": [
"partial",
"total"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Partial or total nephrectomy",
"criterion": "nephrectomy",
"requirement": {
"requirement_type": "type",
"expected_value": [
"partial",
"total"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Lung lobectomy/pneumonectomy",
"criterions": [
{
"exact_snippets": "Lung lobectomy/pneumonectomy",
"criterion": "lung surgery",
"requirement": {
"requirement_type": "type",
"expected_value": [
"lobectomy",
"pneumonectomy"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Lung lobectomy/pneumonectomy",
"criterion": "lung surgery",
"requirement": {
"requirement_type": "type",
"expected_value": [
"lobectomy",
"pneumonectomy"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with known metastatic disease with a plan for curative intent resection are eligible (e.g. curative liver resection for metastatic colorectal cancer).",
"criterions": [
{
"exact_snippets": "known metastatic disease",
"criterion": "metastatic disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "plan for curative intent resection",
"criterion": "curative intent resection plan",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
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"exact_snippets": "known metastatic disease",
"criterion": "metastatic disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "plan for curative intent resection",
"criterion": "curative intent resection plan",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with double primaries undergoing planned curative operation for both are eligible (e.g. synchronous colon cancers undergoing colectomy to treat both).",
"criterions": [
{
"exact_snippets": "Patients with double primaries",
"criterion": "double primaries",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "undergoing planned curative operation for both",
"criterion": "planned curative operation",
"requirement": {
"requirement_type": "status",
"expected_value": "planned"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients with double primaries",
"criterion": "double primaries",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "undergoing planned curative operation for both",
"criterion": "planned curative operation",
"requirement": {
"requirement_type": "status",
"expected_value": "planned"
}
}
]
}
},
{
"identified_line": {
"line": "* Patients must be able to speak and complete questionnaires in English.",
"criterions": [
{
"exact_snippets": "Patients must be able to speak ... in English.",
"criterion": "language ability",
"requirement": {
"requirement_type": "language",
"expected_value": "English"
}
},
{
"exact_snippets": "Patients must be able to ... complete questionnaires in English.",
"criterion": "questionnaire completion ability",
"requirement": {
"requirement_type": "language",
"expected_value": "English"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients must be able to speak ... in English.",
"criterion": "language ability",
"requirement": {
"requirement_type": "language",
"expected_value": "English"
}
},
{
"exact_snippets": "Patients must be able to ... complete questionnaires in English.",
"criterion": "questionnaire completion ability",
"requirement": {
"requirement_type": "language",
"expected_value": "English"
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
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"expected_value": "healthy"
}
}
]
},
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"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
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"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 70 Years",
"criterions": [
{
"exact_snippets": "minimum age of 70 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 70,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "minimum age of 70 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 70,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
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"criterion": "metastatic disease",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "undergoing palliative resection",
"criterion": "palliative resection",
"requirement": {
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"expected_value": true
}
}
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"logical_structure": {
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"and_criteria": [
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"criterion": "metastatic disease",
"requirement": {
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"expected_value": true
}
},
{
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"expected_value": true
}
}
]
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "* Patients undergoing emergent surgery are not eligible.",
"criterions": [
{
"exact_snippets": "Patients undergoing emergent surgery are not eligible.",
"criterion": "emergent surgery",
"requirement": {
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"expected_value": false
}
}
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"expected_value": true
}
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},
{
"identified_line": {
"line": "* Patients under active treatment such as chemotherapy, targeted therapy, immunotherapy, radiation treatment, etc. for second primary, are not eligible.",
"criterions": [
{
"exact_snippets": "Patients under active treatment such as chemotherapy",
"criterion": "active chemotherapy treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Patients under active treatment such as ... targeted therapy",
"criterion": "active targeted therapy treatment",
"requirement": {
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"expected_value": false
}
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{
"exact_snippets": "Patients under active treatment such as ... immunotherapy",
"criterion": "active immunotherapy treatment",
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"expected_value": false
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{
"exact_snippets": "Patients under active treatment such as ... radiation treatment",
"criterion": "active radiation treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": false
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},
{
"exact_snippets": "for second primary",
"criterion": "second primary cancer",
"requirement": {
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}
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"and_criteria": [
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"exact_snippets": "Patients under active treatment such as chemotherapy",
"criterion": "active chemotherapy treatment",
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}
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{
"exact_snippets": "Patients under active treatment such as ... targeted therapy",
"criterion": "active targeted therapy treatment",
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"expected_value": true
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{
"exact_snippets": "Patients under active treatment such as ... immunotherapy",
"criterion": "active immunotherapy treatment",
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"expected_value": true
}
},
{
"exact_snippets": "Patients under active treatment such as ... radiation treatment",
"criterion": "active radiation treatment",
"requirement": {
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"expected_value": true
}
}
]
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{
"exact_snippets": "for second primary",
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"expected_value": true
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}
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}
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"identified_line": {
"line": "* Patients with second primary are not eligible.",
"criterions": [
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"exact_snippets": "Patients with second primary are not eligible.",
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"expected_value": false
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"exact_snippets": "Patients with second primary are not eligible.",
"criterion": "second primary",
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with psychiatric illness or other mental impairment that would preclude their ability to give informed consent or to participate in the prehabilitation program are not eligible.",
"criterions": [
{
"exact_snippets": "psychiatric illness",
"criterion": "psychiatric illness",
"requirement": {
"requirement_type": "presence",
"expected_value": false
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},
{
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}
},
{
"exact_snippets": "ability to give informed consent",
"criterion": "ability to give informed consent",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "ability ... to participate in the prehabilitation program",
"criterion": "ability to participate in the prehabilitation program",
"requirement": {
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"expected_value": true
}
}
]
},
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"and_criteria": [
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{
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{
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"expected_value": true
}
},
{
"exact_snippets": "ability ... to participate in the prehabilitation program",
"criterion": "ability to participate in the prehabilitation program",
"requirement": {
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"expected_value": false
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"and_criteria": [
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{
"exact_snippets": "ability to give informed consent",
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{
"and_criteria": [
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"expected_value": true
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},
{
"exact_snippets": "ability ... to participate in the prehabilitation program",
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"requirement": {
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"expected_value": false
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}
]
}
]
}
]
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}
],
"failed_miscellaneous": []
}