{
"info": {
"nct_id": "NCT03847220",
"official_title": "Prospective Study of the Utility of the BOMET-QOL Questionnaire Patients With Breast Cancer and Bone Metastasis",
"inclusion_criteria": "* Patient over 18 years of age.\n* Patient diagnosed with BC and BM.\n* Patient who has granted informed consent in writing to participate in the study.\n* Patient capable of understanding and completing the questionnaires\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Patient with another type of disease that, in the investigator's opinion, could mask the study results.\n* Patients with a life expectancy of less than 8 months.\n* Patient who is participating in a clinical trial with an unregistered drug at the start of the study.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Patient over 18 years of age.",
"criterions": [
{
"exact_snippets": "Patient over 18 years of age.",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Patient diagnosed with BC and BM.",
"criterions": [
{
"exact_snippets": "Patient diagnosed with BC",
"criterion": "BC diagnosis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Patient diagnosed with ... BM",
"criterion": "BM diagnosis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Patient who has granted informed consent in writing to participate in the study.",
"criterions": [
{
"exact_snippets": "Patient who has granted informed consent in writing",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Patient capable of understanding and completing the questionnaires",
"criterions": [
{
"exact_snippets": "Patient capable of understanding",
"criterion": "understanding capability",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "completing the questionnaires",
"criterion": "questionnaire completion capability",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected_value",
"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"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Patient with another type of disease that, in the investigator's opinion, could mask the study results.",
"criterions": [
{
"exact_snippets": "another type of disease",
"criterion": "other disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Patients with a life expectancy of less than 8 months.",
"criterions": [
{
"exact_snippets": "life expectancy of less than 8 months",
"criterion": "life expectancy",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": "<",
"value": 8,
"unit": "months"
}
}
]
}
]
},
{
"line": "* Patient who is participating in a clinical trial with an unregistered drug at the start of the study.",
"criterions": [
{
"exact_snippets": "Patient who is participating in a clinical trial with an unregistered drug",
"criterion": "participation in a clinical trial with an unregistered drug",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}