{
    "info": {
        "nct_id": "NCT05331391",
        "official_title": "A Brief Mobile SMART Exercise Support Program to Improve Fatigue in Patients With Advanced Lung Cancer - A Pragmatic Randomized Controlled Trial With Outcome and Process Evaluation",
        "inclusion_criteria": "* Aged 18 years and above;\n* Diagnosis of Stage III or IV non-small cell lung cancer;\n* Edmonton Symptom Assessment System Scale fatigue symptom score ≥4 out of 10\n* Self-reported engagement of <150 minutes of moderate intensity PA each week,\n* Ambulatory and capable of all self-care activities (European Co-operative Oncology Group (ECOG) Performance Status of ≤2)\n* Either undergoing or finished oncology therapy, biological agents and/or support care;\n* Mentally, cognitively and physically fit to join the trial as determined by the doctor in-charge and responsible clinical investigators;\n* Able to speak and read Chinese;\n* Willing to complete the patient-reported outcome questionnaire;\n* Completion of the Physical Activity Readiness Questionnaire; and\n* Possession of a smartphone with instant messaging functions such as WhatsApp or WeChat.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 100 Years",
        "exclusion_criteria": "* Those preparing for lung operation;\n* Skeletal fragility;\n* Serious active infection;\n* Inability to walk;\n* Previously untreated symptomatic brain metastases;\n* Severe respiratory insufficiency;\n* Uncontrolled pain; or\n* Diagnosed psychiatric illness with or without medication such as major depressive disorder.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Aged 18 years and above;",
            "criterions": [
                {
                    "exact_snippets": "Aged 18 years and above",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of Stage III or IV non-small cell lung cancer;",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of Stage III or IV non-small cell lung cancer",
                    "criterion": "non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "Stage III",
                                "Stage IV"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Edmonton Symptom Assessment System Scale fatigue symptom score ≥4 out of 10",
            "criterions": [
                {
                    "exact_snippets": "Edmonton Symptom Assessment System Scale fatigue symptom score ≥4 out of 10",
                    "criterion": "fatigue symptom score",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": "Edmonton Symptom Assessment System Scale"
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "out of 10"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Self-reported engagement of <150 minutes of moderate intensity PA each week,",
            "criterions": [
                {
                    "exact_snippets": "Self-reported engagement of <150 minutes of moderate intensity PA each week",
                    "criterion": "moderate intensity physical activity (PA)",
                    "requirements": [
                        {
                            "requirement_type": "engagement",
                            "expected_value": {
                                "operator": "<",
                                "value": 150,
                                "unit": "minutes per week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Either undergoing or finished oncology therapy, biological agents and/or support care;",
            "criterions": [
                {
                    "exact_snippets": "undergoing or finished oncology therapy",
                    "criterion": "oncology therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "undergoing",
                                "finished"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "undergoing or finished ... biological agents",
                    "criterion": "biological agents",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "undergoing",
                                "finished"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "undergoing or finished ... support care",
                    "criterion": "support care",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "undergoing",
                                "finished"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Mentally, cognitively and physically fit to join the trial as determined by the doctor in-charge and responsible clinical investigators;",
            "criterions": [
                {
                    "exact_snippets": "Mentally, cognitively and physically fit",
                    "criterion": "mental fitness",
                    "requirements": [
                        {
                            "requirement_type": "fitness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Mentally, cognitively and physically fit",
                    "criterion": "cognitive fitness",
                    "requirements": [
                        {
                            "requirement_type": "fitness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Mentally, cognitively and physically fit",
                    "criterion": "physical fitness",
                    "requirements": [
                        {
                            "requirement_type": "fitness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to speak and read Chinese;",
            "criterions": [
                {
                    "exact_snippets": "Able to speak and read Chinese",
                    "criterion": "language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "languages",
                            "expected_value": [
                                "Chinese"
                            ]
                        },
                        {
                            "requirement_type": "skills",
                            "expected_value": [
                                "speak",
                                "read"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing to complete the patient-reported outcome questionnaire;",
            "criterions": [
                {
                    "exact_snippets": "Willing to complete the patient-reported outcome questionnaire",
                    "criterion": "completion of patient-reported outcome questionnaire",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Completion of the Physical Activity Readiness Questionnaire; and",
            "criterions": [
                {
                    "exact_snippets": "Completion of the Physical Activity Readiness Questionnaire",
                    "criterion": "Physical Activity Readiness Questionnaire",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Possession of a smartphone with instant messaging functions such as WhatsApp or WeChat.",
            "criterions": [
                {
                    "exact_snippets": "Possession of a smartphone",
                    "criterion": "smartphone possession",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "instant messaging functions such as WhatsApp or WeChat",
                    "criterion": "instant messaging functions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "examples",
                            "expected_value": [
                                "WhatsApp",
                                "WeChat"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 100 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 100 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Those preparing for lung operation;",
            "criterions": [
                {
                    "exact_snippets": "preparing for lung operation",
                    "criterion": "lung operation",
                    "requirements": [
                        {
                            "requirement_type": "preparation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Skeletal fragility;",
            "criterions": [
                {
                    "exact_snippets": "Skeletal fragility",
                    "criterion": "skeletal fragility",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious active infection;",
            "criterions": [
                {
                    "exact_snippets": "Serious active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to walk;",
            "criterions": [
                {
                    "exact_snippets": "Inability to walk",
                    "criterion": "ability to walk",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previously untreated symptomatic brain metastases;",
            "criterions": [
                {
                    "exact_snippets": "Previously untreated symptomatic brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        },
                        {
                            "requirement_type": "symptom presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe respiratory insufficiency;",
            "criterions": [
                {
                    "exact_snippets": "Severe respiratory insufficiency",
                    "criterion": "respiratory insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled pain; or",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled pain",
                    "criterion": "pain",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosed psychiatric illness with or without medication such as major depressive disorder.",
            "criterions": [
                {
                    "exact_snippets": "Diagnosed psychiatric illness",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "major depressive disorder",
                    "criterion": "major depressive disorder",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Ambulatory and capable of all self-care activities (European Co-operative Oncology Group (ECOG) Performance Status of ≤2)",
            "criterions": [
                {
                    "exact_snippets": "Ambulatory",
                    "criterion": "ambulatory status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "capable of all self-care activities",
                    "criterion": "self-care capability",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ECOG Performance Status of ≤2",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}