{
"info": {
"nct_id": "NCT03644173",
"official_title": "Personal Resilience Empowerment Program (PREP) in the Perioperative Setting of Surgically Treated Cancer Patients",
"inclusion_criteria": "* Patients diagnosed with cancer of the thoracic (lung), hepatobiliary system (cholangiocarcinoma, pancreatic, liver) that will undergo a scheduled surgical procedure\n* Able to understand and sign the informed consent form\n* Willingness to participate in the study and comply with protocol requirements\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Unable to provide consent\n* Unable to participate at the discretion of the PI based on the ECOG survey (if ECOG >1). See section 5 and appendix 1 for details.\n* Non- English speaking patients .\n* Opioid use for non-malignant pain for greater than 7 days 6 Terminal or Stage 4 cancer.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Patients diagnosed with cancer of the thoracic (lung), hepatobiliary system (cholangiocarcinoma, pancreatic, liver) that will undergo a scheduled surgical procedure",
"criterions": [
{
"exact_snippets": "diagnosed with cancer of the thoracic (lung)",
"criterion": "thoracic cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "diagnosed with cancer of the ... hepatobiliary system (cholangiocarcinoma, pancreatic, liver)",
"criterion": "hepatobiliary cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "will undergo a scheduled surgical procedure",
"criterion": "scheduled surgical procedure",
"requirement": {
"requirement_type": "planned",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "diagnosed with cancer of the thoracic (lung)",
"criterion": "thoracic cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "will undergo a scheduled surgical procedure",
"criterion": "scheduled surgical procedure",
"requirement": {
"requirement_type": "planned",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "diagnosed with cancer of the ... hepatobiliary system (cholangiocarcinoma, pancreatic, liver)",
"criterion": "hepatobiliary cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "will undergo a scheduled surgical procedure",
"criterion": "scheduled surgical procedure",
"requirement": {
"requirement_type": "planned",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Able to understand and sign the informed consent form",
"criterions": [
{
"exact_snippets": "Able to understand",
"criterion": "understanding ability",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "sign the informed consent form",
"criterion": "ability to sign informed consent form",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Able to understand",
"criterion": "understanding ability",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "sign the informed consent form",
"criterion": "ability to sign informed consent form",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Willingness to participate in the study and comply with protocol requirements",
"criterions": [
{
"exact_snippets": "Willingness to participate in the study",
"criterion": "willingness to participate",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "comply with protocol requirements",
"criterion": "compliance with protocol requirements",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Willingness to participate in the study",
"criterion": "willingness to participate",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "comply with protocol requirements",
"criterion": "compliance with protocol requirements",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Unable to provide consent",
"criterions": [
{
"exact_snippets": "Unable to provide consent",
"criterion": "consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Unable to provide consent",
"criterion": "consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Unable to participate at the discretion of the PI based on the ECOG survey (if ECOG >1). See section 5 and appendix 1 for details.",
"criterions": [
{
"exact_snippets": "ECOG survey (if ECOG >1)",
"criterion": "ECOG score",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "ECOG survey (if ECOG >1)",
"criterion": "ECOG score",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "N/A"
}
}
},
"then_criteria": {
"exact_snippets": "Unable to participate at the discretion of the PI",
"criterion": "participation eligibility",
"requirement": {
"requirement_type": "discretion",
"expected_value": "PI"
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Non- English speaking patients .",
"criterions": [
{
"exact_snippets": "Non- English speaking",
"criterion": "language",
"requirement": {
"requirement_type": "proficiency",
"expected_value": "non-English"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Non- English speaking",
"criterion": "language",
"requirement": {
"requirement_type": "proficiency",
"expected_value": "non-English"
}
}
]
}
},
{
"identified_line": {
"line": "* Opioid use for non-malignant pain for greater than 7 days 6 Terminal or Stage 4 cancer.",
"criterions": [
{
"exact_snippets": "Opioid use for non-malignant pain for greater than 7 days",
"criterion": "opioid use for non-malignant pain",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 7,
"unit": "days"
}
}
},
{
"exact_snippets": "Terminal or Stage 4 cancer",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"Terminal",
"Stage 4"
]
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Opioid use for non-malignant pain for greater than 7 days",
"criterion": "opioid use for non-malignant pain",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 7,
"unit": "days"
}
}
},
{
"exact_snippets": "Terminal or Stage 4 cancer",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"Terminal",
"Stage 4"
]
}
}
]
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}