{
"info": {
"nct_id": "NCT02050620",
"official_title": "A Pilot Study to Examine the Association Between Self-Reported Exercise Behavior and Short-Term Patient Outcomes in Women Undergoing Radiation Treatment for Operable Breast Cancer",
"inclusion_criteria": "* Women with a biopsy-proven diagnosis of ductal carcinoma in situ or invasive breast carcinoma\n* Definitive radiation treatment planned to the chest and/or regional nodes\n* 18 years of age or older\n* Signed study-specific informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Significant mental disorders making informed consent difficult or mental impairment leading to inability to cooperate\n* Karnofsky Performance Status (KPS) < 70%",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Women with a biopsy-proven diagnosis of ductal carcinoma in situ or invasive breast carcinoma",
"criterions": [
{
"exact_snippets": "Women",
"criterion": "gender",
"requirements": [
{
"requirement_type": "presence",
"expected_value": "female"
}
]
},
{
"exact_snippets": "biopsy-proven diagnosis of ductal carcinoma in situ",
"criterion": "ductal carcinoma in situ",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": true
}
]
},
{
"exact_snippets": "biopsy-proven diagnosis of ... invasive breast carcinoma",
"criterion": "invasive breast carcinoma",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": true
}
]
}
]
},
{
"line": "* Definitive radiation treatment planned to the chest and/or regional nodes",
"criterions": [
{
"exact_snippets": "Definitive radiation treatment planned to the chest",
"criterion": "radiation treatment to the chest",
"requirements": [
{
"requirement_type": "planned",
"expected_value": true
}
]
},
{
"exact_snippets": "Definitive radiation treatment planned to ... regional nodes",
"criterion": "radiation treatment to regional nodes",
"requirements": [
{
"requirement_type": "planned",
"expected_value": true
}
]
}
]
},
{
"line": "* 18 years of age or older",
"criterions": [
{
"exact_snippets": "18 years of age or older",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Signed study-specific informed consent",
"criterions": [
{
"exact_snippets": "Signed study-specific informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "signed",
"expected_value": true
},
{
"requirement_type": "specificity",
"expected_value": "study-specific"
}
]
}
]
},
{
"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": "* Significant mental disorders making informed consent difficult or mental impairment leading to inability to cooperate",
"criterions": [
{
"exact_snippets": "Significant mental disorders making informed consent difficult",
"criterion": "mental disorders",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "significant"
}
]
},
{
"exact_snippets": "mental impairment leading to inability to cooperate",
"criterion": "mental impairment",
"requirements": [
{
"requirement_type": "impact",
"expected_value": "inability to cooperate"
}
]
}
]
},
{
"line": "* Karnofsky Performance Status (KPS) < 70%",
"criterions": [
{
"exact_snippets": "Karnofsky Performance Status (KPS) < 70%",
"criterion": "Karnofsky Performance Status",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 70,
"unit": "%"
}
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}