{
    "info": {
        "nct_id": "NCT05454280",
        "official_title": "A Randomized Controlled Trial of Post-Discharge Risk-Based Management in Patients Undergoing High-Risk Elective Major Cancer Operations (PRS II)",
        "inclusion_criteria": "* Age > 18 years at diagnosis\n* ECOG performance status 0, 1, or 2, defined as\n\nGrade ECOG 0 Fully active, able to carry on all pre-disease performance without restriction\n\n1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work\n2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours\n\n   * Patients must have probable (i.e., clinically suspicious) or histologically/cytologically confirmed, primary or recurrent, malignant neoplasm, malignant neuroendocrine tumor, or carcinoma in situ (any stage).\n\nPatients undergoing major operations to resect or treat known or suspected malignancies of the head and neck, chest, abdomen, genitourinary tract, or extremities are eligible. Patients undergoing biopsies, outpatient procedures, superficial resections of cutaneous malignancies, or purely palliative operations are not eligible.\n\nThese procedures are commonly performed in patients with malignant neoplasms, malignant neuroendocrine tumors, or carcinomas in situ, and are commonly \"tracked\" by hospitals and cancer centers participating in the ACS NSQIP Procedure Targeted option because they are often associated with higher rates of postoperative morbidity and mortality (compared to other, less complex cancer procedures).\n\n* Patient must be scheduled for elective major cancer surgery (as listed in 4.1.4) at FCCC < 30 days after First Registration.\n\nElective surgery is defined as:\n\n* Patient is scheduled to be brought from their home (or normal living environment) to FCCC on the day of the index surgery (or day prior as scheduled admission) AND\n* Surgery is not scheduled as urgent or emergent\n\n  * Ability to understand and willingness to sign a written informed consent and HIPAA consent document\n  * Geographical accessibility and willingness to return to FCCC for all preoperative and postoperative study assessments.\n\nFirst Registration\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Any condition that might interfere with the subject's participation in the study, compliance with study requirements, or in the evaluation of the study results.\n\nSecond Registration Inclusion Criteria:\n\nA patient will be eligible for continued inclusion in this study only if ALL of the following criteria apply at the time of Second Registration (one to two days prior to anticipated discharge). No exceptions or waivers will be granted for patients who do not meet the eligibility criteria.\n\n* Post\n\n  * Elective (curative or palliative) major cancer surgery (as listed in 4.1.4 above) at the time of the index surgery (patient may have undergone more than one of these procedures) OR\n  * Elective surgical procedure(s) listed as an option (i.e., CPT code) in the Surgical Risk Calculator webpage (patient may have undergone more than one of these procedures)\n\nFor the purposes of this study, the procedure that was performed with the highest estimated risk of DSC (as predicted by the Surgical Risk Calculator) will be denoted at the time of Second Registration as the \"index procedure\" performed during the \"index surgery\".\n\n* Elective surgery < 30 days after First Registration.\n\nSecond Registration Exclusion Criteria:\n\n* Status post elective surgical procedure(s) not listed as options in the Surgical Risk Calculator webpage. This includes patients whose scheduled procedure was suspended due to unexpected findings, such as carcinomatosis.",
        "miscellaneous_criteria": "First Registration"
    },
    "inclusion_lines": [
        {
            "line": "* Age > 18 years at diagnosis",
            "criterions": [
                {
                    "exact_snippets": "Age > 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0, 1, or 2, defined as",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0, 1, or 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Grade ECOG 0 Fully active, able to carry on all pre-disease performance without restriction",
            "criterions": [
                {
                    "exact_snippets": "Grade ECOG 0",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": "0"
                        }
                    ]
                },
                {
                    "exact_snippets": "Fully active, able to carry on all pre-disease performance without restriction",
                    "criterion": "activity level",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fully active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work",
            "criterions": [
                {
                    "exact_snippets": "Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature",
                    "criterion": "physical activity level",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": "ambulatory"
                        },
                        {
                            "requirement_type": "work capability",
                            "expected_value": [
                                "light",
                                "sedentary"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours",
            "criterions": [
                {
                    "exact_snippets": "Ambulatory",
                    "criterion": "ambulatory status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "ambulatory"
                        }
                    ]
                },
                {
                    "exact_snippets": "capable of all self-care",
                    "criterion": "self-care capability",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": "capable of all self-care"
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to carry out any work activities",
                    "criterion": "work activity capability",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": "unable to carry out any work activities"
                        }
                    ]
                },
                {
                    "exact_snippets": "Up and about more than 50% of waking hours",
                    "criterion": "activity level during waking hours",
                    "requirements": [
                        {
                            "requirement_type": "activity level",
                            "expected_value": "> 50% of waking hours"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have probable (i.e., clinically suspicious) or histologically/cytologically confirmed, primary or recurrent, malignant neoplasm, malignant neuroendocrine tumor, or carcinoma in situ (any stage).",
            "criterions": [
                {
                    "exact_snippets": "probable (i.e., clinically suspicious) or histologically/cytologically confirmed",
                    "criterion": "neoplasm confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": [
                                "probable",
                                "histologically confirmed",
                                "cytologically confirmed"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "primary or recurrent",
                    "criterion": "neoplasm occurrence",
                    "requirements": [
                        {
                            "requirement_type": "occurrence",
                            "expected_value": [
                                "primary",
                                "recurrent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "malignant neoplasm",
                    "criterion": "malignant neoplasm",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "malignant neuroendocrine tumor",
                    "criterion": "malignant neuroendocrine tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinoma in situ (any stage)",
                    "criterion": "carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": "any"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Patients undergoing major operations to resect or treat known or suspected malignancies of the head and neck, chest, abdomen, genitourinary tract, or extremities are eligible. Patients undergoing biopsies, outpatient procedures, superficial resections of cutaneous malignancies, or purely palliative operations are not eligible.",
            "criterions": [
                {
                    "exact_snippets": "Patients undergoing major operations to resect or treat known or suspected malignancies of the head and neck, chest, abdomen, genitourinary tract, or extremities",
                    "criterion": "major operations for malignancies",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "head and neck",
                                "chest",
                                "abdomen",
                                "genitourinary tract",
                                "extremities"
                            ]
                        },
                        {
                            "requirement_type": "purpose",
                            "expected_value": [
                                "resect",
                                "treat"
                            ]
                        },
                        {
                            "requirement_type": "malignancy_status",
                            "expected_value": [
                                "known",
                                "suspected"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients undergoing biopsies, outpatient procedures, superficial resections of cutaneous malignancies, or purely palliative operations are not eligible",
                    "criterion": "type of operation",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "biopsies",
                                "outpatient procedures",
                                "superficial resections of cutaneous malignancies",
                                "purely palliative operations"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "These procedures are commonly performed in patients with malignant neoplasms, malignant neuroendocrine tumors, or carcinomas in situ, and are commonly \"tracked\" by hospitals and cancer centers participating in the ACS NSQIP Procedure Targeted option because they are often associated with higher rates of postoperative morbidity and mortality (compared to other, less complex cancer procedures).",
            "criterions": [
                {
                    "exact_snippets": "malignant neoplasms",
                    "criterion": "malignant neoplasms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "malignant neuroendocrine tumors",
                    "criterion": "malignant neuroendocrine tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinomas in situ",
                    "criterion": "carcinomas in situ",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must be scheduled for elective major cancer surgery (as listed in 4.1.4) at FCCC < 30 days after First Registration.",
            "criterions": [
                {
                    "exact_snippets": "Patient must be scheduled for elective major cancer surgery",
                    "criterion": "elective major cancer surgery",
                    "requirements": [
                        {
                            "requirement_type": "scheduled",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at FCCC < 30 days after First Registration",
                    "criterion": "time from First Registration to surgery",
                    "requirements": [
                        {
                            "requirement_type": "time",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Elective surgery is defined as:",
            "criterions": [
                {
                    "exact_snippets": "Elective surgery is defined as",
                    "criterion": "elective surgery",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient is scheduled to be brought from their home (or normal living environment) to FCCC on the day of the index surgery (or day prior as scheduled admission) AND",
            "criterions": [
                {
                    "exact_snippets": "Patient is scheduled to be brought from their home (or normal living environment) to FCCC on the day of the index surgery (or day prior as scheduled admission)",
                    "criterion": "transportation to FCCC",
                    "requirements": [
                        {
                            "requirement_type": "scheduled",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Surgery is not scheduled as urgent or emergent",
            "criterions": [
                {
                    "exact_snippets": "Surgery is not scheduled as urgent",
                    "criterion": "surgery urgency",
                    "requirements": [
                        {
                            "requirement_type": "urgency",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Surgery is not scheduled as ... emergent",
                    "criterion": "surgery emergence",
                    "requirements": [
                        {
                            "requirement_type": "emergence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to understand and willingness to sign a written informed consent and HIPAA consent document",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent",
                    "criterion": "willingness to sign informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign ... HIPAA consent document",
                    "criterion": "willingness to sign HIPAA consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Geographical accessibility and willingness to return to FCCC for all preoperative and postoperative study assessments.",
            "criterions": [
                {
                    "exact_snippets": "Geographical accessibility",
                    "criterion": "geographical accessibility",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to return to FCCC for all preoperative and postoperative study assessments",
                    "criterion": "willingness to return to FCCC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "First Registration",
            "criterions": [
                {
                    "exact_snippets": "First Registration",
                    "criterion": "registration status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "first"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Any condition that might interfere with the subject's participation in the study, compliance with study requirements, or in the evaluation of the study results.",
            "criterions": [
                {
                    "exact_snippets": "Any condition that might interfere with the subject's participation in the study",
                    "criterion": "condition interfering with study participation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Any condition that might interfere with ... compliance with study requirements",
                    "criterion": "condition interfering with compliance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Any condition that might interfere with ... evaluation of the study results",
                    "criterion": "condition interfering with evaluation of study results",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "A patient will be eligible for continued inclusion in this study only if ALL of the following criteria apply at the time of Second Registration (one to two days prior to anticipated discharge). No exceptions or waivers will be granted for patients who do not meet the eligibility criteria.",
            "criterions": [
                {
                    "exact_snippets": "Second Registration (one to two days prior to anticipated discharge)",
                    "criterion": "second registration timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "one to two days prior to anticipated discharge"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Post",
            "criterions": [
                {
                    "exact_snippets": "Post",
                    "criterion": "postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Elective (curative or palliative) major cancer surgery (as listed in 4.1.4 above) at the time of the index surgery (patient may have undergone more than one of these procedures) OR",
            "criterions": [
                {
                    "exact_snippets": "Elective (curative or palliative) major cancer surgery",
                    "criterion": "major cancer surgery",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "elective",
                                "curative",
                                "palliative"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "at the time of the index surgery",
                    "criterion": "timing of surgery",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "at the time of the index surgery"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Elective surgical procedure(s) listed as an option (i.e., CPT code) in the Surgical Risk Calculator webpage (patient may have undergone more than one of these procedures)",
            "criterions": [
                {
                    "exact_snippets": "Elective surgical procedure(s) listed as an option (i.e., CPT code) in the Surgical Risk Calculator webpage",
                    "criterion": "elective surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "listing",
                            "expected_value": "option in the Surgical Risk Calculator webpage"
                        }
                    ]
                }
            ]
        },
        {
            "line": "For the purposes of this study, the procedure that was performed with the highest estimated risk of DSC (as predicted by the Surgical Risk Calculator) will be denoted at the time of Second Registration as the \"index procedure\" performed during the \"index surgery\".",
            "criterions": [
                {
                    "exact_snippets": "procedure that was performed with the highest estimated risk of DSC",
                    "criterion": "procedure with highest estimated risk of DSC",
                    "requirements": [
                        {
                            "requirement_type": "risk estimation",
                            "expected_value": "highest"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Elective surgery < 30 days after First Registration.",
            "criterions": [
                {
                    "exact_snippets": "Elective surgery < 30 days after First Registration.",
                    "criterion": "elective surgery",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "days after First Registration"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Status post elective surgical procedure(s) not listed as options in the Surgical Risk Calculator webpage. This includes patients whose scheduled procedure was suspended due to unexpected findings, such as carcinomatosis.",
            "criterions": [
                {
                    "exact_snippets": "Status post elective surgical procedure(s) not listed as options in the Surgical Risk Calculator webpage.",
                    "criterion": "elective surgical procedure status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "patients whose scheduled procedure was suspended due to unexpected findings, such as carcinomatosis.",
                    "criterion": "suspended scheduled procedure",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "unexpected findings"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [
        {
            "line": "First Registration",
            "criterions": [
                {
                    "exact_snippets": "First Registration",
                    "criterion": "registration status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "first registration"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "Second Registration Inclusion Criteria:",
            "criterions": []
        },
        {
            "line": "Second Registration Exclusion Criteria:",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}