{
"info": {
"nct_id": "NCT00564694",
"official_title": "Validation of an EORTC Quality of Life Questionnaire Module for Patients With Colorectal Cancer",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the colon or rectum\n* No brain metastases or intracranial tumor extension with cognitive impairment\n\nPATIENT CHARACTERISTICS:\n\n* No limit on performance status\n* Able to understand the language of the questionnaire\n* No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n* No other concurrent malignancies except basal cell carcinoma of the skin\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior participation in this study (in a different subgroup)\n* No concurrent participation in other quality of life studies that might interfere with this study"
},
"inclusion_lines": [
{
"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": [],
"miscellaneous_lines": [
{
"line": "DISEASE CHARACTERISTICS:",
"criterions": [
{
"exact_snippets": "DISEASE CHARACTERISTICS",
"criterion": "disease characteristics",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Histologically confirmed adenocarcinoma of the colon or rectum",
"criterions": [
{
"exact_snippets": "Histologically confirmed adenocarcinoma",
"criterion": "adenocarcinoma",
"requirements": [
{
"requirement_type": "confirmation method",
"expected_value": "histologically"
}
]
},
{
"exact_snippets": "adenocarcinoma of the colon or rectum",
"criterion": "adenocarcinoma location",
"requirements": [
{
"requirement_type": "location",
"expected_value": [
"colon",
"rectum"
]
}
]
}
]
},
{
"line": "* No brain metastases or intracranial tumor extension with cognitive impairment",
"criterions": [
{
"exact_snippets": "No brain metastases",
"criterion": "brain metastases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "intracranial tumor extension",
"criterion": "intracranial tumor extension",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "cognitive impairment",
"criterion": "cognitive impairment",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* No limit on performance status",
"criterions": [
{
"exact_snippets": "No limit on performance status",
"criterion": "performance status",
"requirements": [
{
"requirement_type": "limit",
"expected_value": "none"
}
]
}
]
},
{
"line": "* Able to understand the language of the questionnaire",
"criterions": [
{
"exact_snippets": "Able to understand the language of the questionnaire",
"criterion": "language comprehension",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
}
]
},
{
"line": "* No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule",
"criterions": [
{
"exact_snippets": "No psychological ... condition potentially hampering compliance",
"criterion": "psychological condition",
"requirements": [
{
"requirement_type": "potential to hamper compliance",
"expected_value": false
}
]
},
{
"exact_snippets": "No ... familial ... condition potentially hampering compliance",
"criterion": "familial condition",
"requirements": [
{
"requirement_type": "potential to hamper compliance",
"expected_value": false
}
]
},
{
"exact_snippets": "No ... sociological ... condition potentially hampering compliance",
"criterion": "sociological condition",
"requirements": [
{
"requirement_type": "potential to hamper compliance",
"expected_value": false
}
]
},
{
"exact_snippets": "No ... geographical condition potentially hampering compliance",
"criterion": "geographical condition",
"requirements": [
{
"requirement_type": "potential to hamper compliance",
"expected_value": false
}
]
}
]
},
{
"line": "* No other concurrent malignancies except basal cell carcinoma of the skin",
"criterions": [
{
"exact_snippets": "No other concurrent malignancies",
"criterion": "concurrent malignancies",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "except basal cell carcinoma of the skin",
"criterion": "basal cell carcinoma of the skin",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "PRIOR CONCURRENT THERAPY:",
"criterions": [
{
"exact_snippets": "PRIOR CONCURRENT THERAPY",
"criterion": "prior concurrent therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* No prior participation in this study (in a different subgroup)",
"criterions": [
{
"exact_snippets": "No prior participation in this study (in a different subgroup)",
"criterion": "prior participation in this study",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* No concurrent participation in other quality of life studies that might interfere with this study",
"criterions": [
{
"exact_snippets": "No concurrent participation in other quality of life studies",
"criterion": "concurrent participation in other quality of life studies",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"line": "PATIENT CHARACTERISTICS:",
"criterions": []
}
]
}