{
    "info": {
        "nct_id": "NCT06683482",
        "official_title": "Ethnographic Study on Advanced Breast Cancer Patients and Their Caregivers in Spain",
        "inclusion_criteria": "1. Informed consent to individual in the qualitative study and to allow the recording of the interview for analyses purposes (individual and/or caregiver).\n2. Women or men (individual and/or caregiver) over 18 years of age.\n3. Confirmed diagnosis of triple-negative breast cancer (TNBC), hormone receptor (HR)+/ human epidermal growth factor receptor 2 (HER2)-, HER2+ unresectable locally advanced breast cancer (ULABC) or metastatic breast cancer (mBC) (individual).\n4. Individuals must have initiated at least the firstline treatment.\n5. Functional status according to the Eastern Cooperative Oncology Group (ECOG) scale 0-2 (individual).\n6. Ability to conduct interviews from home (individual and/or caregiver) or remotely (ie, with technology available for an online interview).\n\nKey\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Individual unable to collaborate in the collection of necessary information (alteration in mental status, noncollaboration, limited language comprehension).\n2. Individual unable or unwilling to provide informed consent.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply",
        "miscellaneous_criteria": "Key"
    },
    "inclusion_lines": [
        {
            "line": "1. Informed consent to individual in the qualitative study and to allow the recording of the interview for analyses purposes (individual and/or caregiver).",
            "criterions": [
                {
                    "exact_snippets": "Informed consent to individual",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "allow the recording of the interview",
                    "criterion": "interview recording consent",
                    "requirements": [
                        {
                            "requirement_type": "permission",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Women or men (individual and/or caregiver) over 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "Women or men ... over 18 years of age.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Confirmed diagnosis of triple-negative breast cancer (TNBC), hormone receptor (HR)+/ human epidermal growth factor receptor 2 (HER2)-, HER2+ unresectable locally advanced breast cancer (ULABC) or metastatic breast cancer (mBC) (individual).",
            "criterions": [
                {
                    "exact_snippets": "Confirmed diagnosis of triple-negative breast cancer (TNBC)",
                    "criterion": "triple-negative breast cancer (TNBC)",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hormone receptor (HR)+/ human epidermal growth factor receptor 2 (HER2)-",
                    "criterion": "hormone receptor (HR)+/ human epidermal growth factor receptor 2 (HER2)-",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "HR+/HER2-"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2+ unresectable locally advanced breast cancer (ULABC)",
                    "criterion": "HER2+ unresectable locally advanced breast cancer (ULABC)",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "HER2+"
                        },
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic breast cancer (mBC)",
                    "criterion": "metastatic breast cancer (mBC)",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Individuals must have initiated at least the firstline treatment.",
            "criterions": [
                {
                    "exact_snippets": "initiated at least the firstline treatment",
                    "criterion": "firstline treatment",
                    "requirements": [
                        {
                            "requirement_type": "initiation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Functional status according to the Eastern Cooperative Oncology Group (ECOG) scale 0-2 (individual).",
            "criterions": [
                {
                    "exact_snippets": "Functional status according to the Eastern Cooperative Oncology Group (ECOG) scale 0-2",
                    "criterion": "functional status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": "Eastern Cooperative Oncology Group (ECOG)"
                        },
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Ability to conduct interviews from home (individual and/or caregiver) or remotely (ie, with technology available for an online interview).",
            "criterions": [
                {
                    "exact_snippets": "Ability to conduct interviews from home (individual and/or caregiver)",
                    "criterion": "interview conduction ability",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "home"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Ability to conduct interviews ... remotely (ie, with technology available for an online interview)",
                    "criterion": "interview conduction ability",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "remotely"
                            ]
                        },
                        {
                            "requirement_type": "technology availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. Individual unable to collaborate in the collection of necessary information (alteration in mental status, noncollaboration, limited language comprehension).",
            "criterions": [
                {
                    "exact_snippets": "unable to collaborate in the collection of necessary information",
                    "criterion": "collaboration ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "alteration in mental status",
                    "criterion": "mental status",
                    "requirements": [
                        {
                            "requirement_type": "alteration",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "noncollaboration",
                    "criterion": "collaboration",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "limited language comprehension",
                    "criterion": "language comprehension",
                    "requirements": [
                        {
                            "requirement_type": "comprehension level",
                            "expected_value": "limited"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Individual unable or unwilling to provide informed consent.",
            "criterions": [
                {
                    "exact_snippets": "unable or unwilling to provide informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: Other protocol defined Inclusion/Exclusion criteria may apply",
            "criterions": [
                {
                    "exact_snippets": "Other protocol defined Inclusion/Exclusion criteria",
                    "criterion": "protocol defined Inclusion/Exclusion criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [
        {
            "line": "Key",
            "criterions": [
                {
                    "exact_snippets": "Key",
                    "criterion": "key",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [
        {
            "line": "Key",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}