{
    "info": {
        "nct_id": "NCT02216162",
        "official_title": "PROACTIVE Study Evaluation of the Impact of a Multidimensional Geriatric Intervention Program Including a Regular Physical Training, a Medical and Nutritional Follow-up, on Adjuvant Hormonal Treatment Compliance in Breast Cancer Patients Over 70 Years.",
        "inclusion_criteria": "* Age ≥ 70 years old\n* Non metastatic breast cancer, with or without node metastases\n* Hormone Receptor (HR) positive breast cancer patients\n* Women with breast adenocarcinoma, confirmed by a pathologist and who underwent surgery or radiotherapy\n* Introduce an hormonal therapy during 5 years\n* Life expectancy > 6 months (at the discretion of the investigator)\n* Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research\n* Patient must be available for follow-up\n* Having given written informed consent prior to any procedure related to the study\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 70 Years",
        "exclusion_criteria": "* No other primary malignant tumor < 5-years old except cured in situ cancer of the cervix, in situ urothelial cancer, or basocellular cancer\n* Patient with an experimental treatment in the 30 days prior to the enrollment\n* Evidence of metastatic disease\n* Not under any administrative or legal supervision",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age ≥ 70 years old",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 70 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Non metastatic breast cancer, with or without node metastases",
            "criterions": [
                {
                    "exact_snippets": "Non metastatic breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "metastasis",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "with or without node metastases",
                    "criterion": "node metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "with or without"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hormone Receptor (HR) positive breast cancer patients",
            "criterions": [
                {
                    "exact_snippets": "Hormone Receptor (HR) positive",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "breast cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "breast cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women with breast adenocarcinoma, confirmed by a pathologist and who underwent surgery or radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "Women with breast adenocarcinoma",
                    "criterion": "breast adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed by a pathologist",
                    "criterion": "pathologist confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "underwent surgery or radiotherapy",
                    "criterion": "treatment history",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": [
                                "surgery",
                                "radiotherapy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Introduce an hormonal therapy during 5 years",
            "criterions": [
                {
                    "exact_snippets": "Introduce an hormonal therapy during 5 years",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy > 6 months (at the discretion of the investigator)",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy > 6 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research",
            "criterions": [
                {
                    "exact_snippets": "Covered by a Health System",
                    "criterion": "health system coverage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in compliance with the recommendations of the national laws in force relating to biomedical research",
                    "criterion": "compliance with national laws",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must be available for follow-up",
            "criterions": [
                {
                    "exact_snippets": "Patient must be available for follow-up",
                    "criterion": "patient availability",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Having given written informed consent prior to any procedure related to the study",
            "criterions": [
                {
                    "exact_snippets": "given written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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 be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 70 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* No other primary malignant tumor < 5-years old except cured in situ cancer of the cervix, in situ urothelial cancer, or basocellular cancer",
            "criterions": [
                {
                    "exact_snippets": "No other primary malignant tumor < 5-years old",
                    "criterion": "primary malignant tumor",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cured in situ cancer of the cervix",
                    "criterion": "in situ cancer of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "cured"
                        }
                    ]
                },
                {
                    "exact_snippets": "in situ urothelial cancer",
                    "criterion": "in situ urothelial cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "basocellular cancer",
                    "criterion": "basocellular cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient with an experimental treatment in the 30 days prior to the enrollment",
            "criterions": [
                {
                    "exact_snippets": "experimental treatment in the 30 days prior to the enrollment",
                    "criterion": "experimental treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "Evidence of metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not under any administrative or legal supervision",
            "criterions": [
                {
                    "exact_snippets": "Not under any administrative or legal supervision",
                    "criterion": "administrative or legal supervision",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}