{
    "info": {
        "nct_id": "NCT06415266",
        "official_title": "Multicentric Randomized Study eValuating the sExual Quality of Life in Breast Cancer Patients Receiving oncoSexology Supportive Care on Proactive Versus On-request",
        "inclusion_criteria": "* Woman or man at least 18 years old\n* Diagnosis of infiltrating breast cancer regardless of the biological characteristics of the tumor\n* Standard treatment by surgery, radiotherapy and/or chemotherapy, completed a maximum of 3 months ago with the exception of post-neoadjuvant treatments (chemotherapy, poly(ADP-ribose) polymerase (PARP) inhibitor, immunotherapy, targeted treatment, ...) which must have been started less than 3 months previously\n* Patient with sufficient command of the French language to be able to answer the questionnaires\n* Patient having given informed, written and express consent.\n* Affiliation to the French Social Security System\n* Willingness and ability to comply with scheduled visits, treatment plan and other study procedures\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patient already taken cared of in oncosexology. The following are not criteria for non-inclusion (a previous single consultation without treatment, use of local vaginal treatments)\n* Metastatic disease\n* Patient under guardianship, curatorship or safeguard of justice",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Woman or man at least 18 years old",
            "criterions": [
                {
                    "exact_snippets": "Woman or man",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "woman",
                                "man"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of infiltrating breast cancer regardless of the biological characteristics of the tumor",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of infiltrating breast cancer",
                    "criterion": "infiltrating breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Standard treatment by surgery, radiotherapy and/or chemotherapy, completed a maximum of 3 months ago with the exception of post-neoadjuvant treatments (chemotherapy, poly(ADP-ribose) polymerase (PARP) inhibitor, immunotherapy, targeted treatment, ...) which must have been started less than 3 months previously",
            "criterions": [
                {
                    "exact_snippets": "Standard treatment by surgery, radiotherapy and/or chemotherapy, completed a maximum of 3 months ago",
                    "criterion": "standard treatment completion",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "post-neoadjuvant treatments (chemotherapy, poly(ADP-ribose) polymerase (PARP) inhibitor, immunotherapy, targeted treatment, ...) which must have been started less than 3 months previously",
                    "criterion": "post-neoadjuvant treatment initiation",
                    "requirements": [
                        {
                            "requirement_type": "time since initiation",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient with sufficient command of the French language to be able to answer the questionnaires",
            "criterions": [
                {
                    "exact_snippets": "sufficient command of the French language",
                    "criterion": "command of the French language",
                    "requirements": [
                        {
                            "requirement_type": "proficiency",
                            "expected_value": "sufficient"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient having given informed, written and express consent.",
            "criterions": [
                {
                    "exact_snippets": "Patient having given informed, written and express consent.",
                    "criterion": "consent",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "informed",
                                "written",
                                "express"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Affiliation to the French Social Security System",
            "criterions": [
                {
                    "exact_snippets": "Affiliation to the French Social Security System",
                    "criterion": "affiliation to the French Social Security System",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willingness and ability to comply with scheduled visits, treatment plan and other study procedures",
            "criterions": [
                {
                    "exact_snippets": "Willingness and ability to comply with scheduled visits",
                    "criterion": "compliance with scheduled visits",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willingness and ability to comply with ... treatment plan",
                    "criterion": "compliance with treatment plan",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willingness and ability to comply with ... other study procedures",
                    "criterion": "compliance with other study procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Patient already taken cared of in oncosexology. The following are not criteria for non-inclusion (a previous single consultation without treatment, use of local vaginal treatments)",
            "criterions": [
                {
                    "exact_snippets": "Patient already taken cared of in oncosexology",
                    "criterion": "oncosexology care",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "a previous single consultation without treatment",
                    "criterion": "previous single consultation without treatment",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "use of local vaginal treatments",
                    "criterion": "use of local vaginal treatments",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "Metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient under guardianship, curatorship or safeguard of justice",
            "criterions": [
                {
                    "exact_snippets": "Patient under guardianship, curatorship or safeguard of justice",
                    "criterion": "legal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "guardianship",
                                "curatorship",
                                "safeguard of justice"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}