{
    "info": {
        "nct_id": "NCT03712176",
        "official_title": "Descriptive Observational Study of the Evolution of the Lifestyle Alteration in Patients With Breast Cancer",
        "inclusion_criteria": "* Women between 18 and 65 years old\n* Breast invasive or in situ cancer (all histology), unilocal or multilocal tumor\n* Treatment by first surgery and adjuvant radiotherapy validated at the multidisciplinary consultation meeting with +/- adjuvant chemotherapy (all chemotherapy)\n* Patient reading and understanding the French language\n* Non-opposition of patient\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 65 Years",
        "exclusion_criteria": "* Patient with a history of treated breast cancer\n* Presence of metastasis\n* Other cancer or severe disease under evaluation or treatment at baseline (to avoid selection bias)\n* Patient with psychiatric disorders\n* Patient under protection status\n* Pregnant or nursing women or absence of contraception in a patient of childbearing age\n\nWithdrawal Criteria :\n\n- Other cancer or severe illness diagnosed during the study",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Women between 18 and 65 years old",
            "criterions": [
                {
                    "exact_snippets": "Women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "between 18 and 65 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 65,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Breast invasive or in situ cancer (all histology), unilocal or multilocal tumor",
            "criterions": [
                {
                    "exact_snippets": "Breast invasive or in situ cancer (all histology)",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "invasive",
                                "in situ"
                            ]
                        },
                        {
                            "requirement_type": "histology",
                            "expected_value": "all"
                        }
                    ]
                },
                {
                    "exact_snippets": "unilocal or multilocal tumor",
                    "criterion": "tumor location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "unilocal",
                                "multilocal"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment by first surgery and adjuvant radiotherapy validated at the multidisciplinary consultation meeting with +/- adjuvant chemotherapy (all chemotherapy)",
            "criterions": [
                {
                    "exact_snippets": "Treatment by first surgery",
                    "criterion": "treatment",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "first surgery"
                        }
                    ]
                },
                {
                    "exact_snippets": "adjuvant radiotherapy validated at the multidisciplinary consultation meeting",
                    "criterion": "adjuvant radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "validation",
                            "expected_value": "multidisciplinary consultation meeting"
                        }
                    ]
                },
                {
                    "exact_snippets": "+/- adjuvant chemotherapy (all chemotherapy)",
                    "criterion": "adjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": "all chemotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient reading and understanding the French language",
            "criterions": [
                {
                    "exact_snippets": "Patient reading and understanding the French language",
                    "criterion": "French language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": [
                                "reading",
                                "understanding"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Non-opposition of patient",
            "criterions": [
                {
                    "exact_snippets": "Non-opposition of patient",
                    "criterion": "patient opposition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "FEMALE"
                        }
                    ]
                }
            ]
        },
        {
            "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 65 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 65 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 65,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patient with a history of treated breast cancer",
            "criterions": [
                {
                    "exact_snippets": "history of treated breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of metastasis",
            "criterions": [
                {
                    "exact_snippets": "Presence of metastasis",
                    "criterion": "metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other cancer or severe disease under evaluation or treatment at baseline (to avoid selection bias)",
            "criterions": [
                {
                    "exact_snippets": "Other cancer ... under evaluation or treatment at baseline",
                    "criterion": "other cancer",
                    "requirements": [
                        {
                            "requirement_type": "evaluation or treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "severe disease under evaluation or treatment at baseline",
                    "criterion": "severe disease",
                    "requirements": [
                        {
                            "requirement_type": "evaluation or treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient with psychiatric disorders",
            "criterions": [
                {
                    "exact_snippets": "psychiatric disorders",
                    "criterion": "psychiatric disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient under protection status",
            "criterions": [
                {
                    "exact_snippets": "Patient under protection status",
                    "criterion": "protection status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or nursing women or absence of contraception in a patient of childbearing age",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing women",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "absence of contraception",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patient of childbearing age",
                    "criterion": "childbearing age",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "- Other cancer or severe illness diagnosed during the study",
            "criterions": [
                {
                    "exact_snippets": "Other cancer ... diagnosed during the study",
                    "criterion": "other cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "severe illness diagnosed during the study",
                    "criterion": "severe illness",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "Withdrawal Criteria :",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}