{
"info": {
"nct_id": "NCT02934880",
"official_title": "Study of Impact of Adapted Physical Activity on Cognitive Functions and Quality of Life in Patients Treated for Locally Advanced Breast Cancer",
"inclusion_criteria": "* Women\n* More than 18 years old\n* Locally advanced breast cancer\n* Patient who undergone surgery\n* Cognitive complaint (FACT-COG inferior or equal to 8/16)\n* No metastasis at the inclusion\n* Patient who received adjuvant therapy by chemotherapy\n* Patient with a social protection\n* Barbizet scale Superior or equal to 3\n* No neurological history\n* No medical contraindication to APA\n* Inform consent signed\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Metastatic breast cancer\n* History of other cancer (in 5 years before inclusion)\n* Current chemotherapy or radiotherapy\n* Chemotherapy or radiotherapy ended for more than 6 months\n* Current APA program\n* Blood transfusion for less than 6 mois\n* Minimal mental score inferior to normal\n* Patient no able to respond to the cognitive test\n* Patient no able to realize APA program\n* Drug use\n* Alcohol abuse\n* Patient Under guardianship or curatorship or deprived of liberty",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Women",
"criterions": [
{
"exact_snippets": "Women",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "female"
}
]
}
]
},
{
"line": "* More than 18 years old",
"criterions": [
{
"exact_snippets": "More than 18 years old",
"criterion": "age",
"requirements": [
{
"requirement_type": "age",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Locally advanced breast cancer",
"criterions": [
{
"exact_snippets": "Locally advanced breast cancer",
"criterion": "breast cancer",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "locally advanced"
}
]
}
]
},
{
"line": "* Patient who undergone surgery",
"criterions": [
{
"exact_snippets": "undergone surgery",
"criterion": "surgery",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* Cognitive complaint (FACT-COG inferior or equal to 8/16)",
"criterions": [
{
"exact_snippets": "Cognitive complaint (FACT-COG inferior or equal to 8/16)",
"criterion": "cognitive complaint",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 8,
"unit": "16"
}
}
]
}
]
},
{
"line": "* No metastasis at the inclusion",
"criterions": [
{
"exact_snippets": "No metastasis",
"criterion": "metastasis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Patient who received adjuvant therapy by chemotherapy",
"criterions": [
{
"exact_snippets": "Patient who received adjuvant therapy by chemotherapy",
"criterion": "adjuvant therapy",
"requirements": [
{
"requirement_type": "treatment type",
"expected_value": "chemotherapy"
}
]
}
]
},
{
"line": "* Patient with a social protection",
"criterions": [
{
"exact_snippets": "Patient with a social protection",
"criterion": "social protection",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Barbizet scale Superior or equal to 3",
"criterions": [
{
"exact_snippets": "Barbizet scale Superior or equal to 3",
"criterion": "Barbizet scale",
"requirements": [
{
"requirement_type": "score",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* No neurological history",
"criterions": [
{
"exact_snippets": "No neurological history",
"criterion": "neurological history",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* No medical contraindication to APA",
"criterions": [
{
"exact_snippets": "No medical contraindication to APA",
"criterion": "medical contraindication to APA",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Inform consent signed",
"criterions": [
{
"exact_snippets": "Inform consent signed",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "signed",
"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": "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": "* Metastatic breast cancer",
"criterions": [
{
"exact_snippets": "Metastatic breast cancer",
"criterion": "breast cancer",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "metastatic"
}
]
}
]
},
{
"line": "* History of other cancer (in 5 years before inclusion)",
"criterions": [
{
"exact_snippets": "History of other cancer (in 5 years before inclusion)",
"criterion": "history of other cancer",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* Current chemotherapy or radiotherapy",
"criterions": [
{
"exact_snippets": "Current chemotherapy",
"criterion": "chemotherapy",
"requirements": [
{
"requirement_type": "current status",
"expected_value": true
}
]
},
{
"exact_snippets": "Current ... radiotherapy",
"criterion": "radiotherapy",
"requirements": [
{
"requirement_type": "current status",
"expected_value": true
}
]
}
]
},
{
"line": "* Chemotherapy or radiotherapy ended for more than 6 months",
"criterions": [
{
"exact_snippets": "Chemotherapy ... ended for more than 6 months",
"criterion": "chemotherapy",
"requirements": [
{
"requirement_type": "end time",
"expected_value": {
"operator": ">",
"value": 6,
"unit": "months"
}
}
]
},
{
"exact_snippets": "radiotherapy ended for more than 6 months",
"criterion": "radiotherapy",
"requirements": [
{
"requirement_type": "end time",
"expected_value": {
"operator": ">",
"value": 6,
"unit": "months"
}
}
]
}
]
},
{
"line": "* Current APA program",
"criterions": [
{
"exact_snippets": "Current APA program",
"criterion": "APA program",
"requirements": [
{
"requirement_type": "current participation",
"expected_value": true
}
]
}
]
},
{
"line": "* Blood transfusion for less than 6 mois",
"criterions": [
{
"exact_snippets": "Blood transfusion for less than 6 mois",
"criterion": "blood transfusion",
"requirements": [
{
"requirement_type": "time since last transfusion",
"expected_value": {
"operator": "<",
"value": 6,
"unit": "months"
}
}
]
}
]
},
{
"line": "* Minimal mental score inferior to normal",
"criterions": [
{
"exact_snippets": "Minimal mental score inferior to normal",
"criterion": "mental score",
"requirements": [
{
"requirement_type": "comparison",
"expected_value": {
"operator": "<",
"value": 0,
"unit": "normal"
}
}
]
}
]
},
{
"line": "* Patient no able to respond to the cognitive test",
"criterions": [
{
"exact_snippets": "Patient no able to respond to the cognitive test",
"criterion": "cognitive test response ability",
"requirements": [
{
"requirement_type": "ability",
"expected_value": false
}
]
}
]
},
{
"line": "* Patient no able to realize APA program",
"criterions": [
{
"exact_snippets": "Patient no able to realize APA program",
"criterion": "ability to realize APA program",
"requirements": [
{
"requirement_type": "ability",
"expected_value": false
}
]
}
]
},
{
"line": "* Drug use",
"criterions": [
{
"exact_snippets": "Drug use",
"criterion": "drug use",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Alcohol abuse",
"criterions": [
{
"exact_snippets": "Alcohol abuse",
"criterion": "alcohol abuse",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Patient Under guardianship or curatorship or deprived of liberty",
"criterions": [
{
"exact_snippets": "Patient Under guardianship",
"criterion": "guardianship status",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "curatorship",
"criterion": "curatorship status",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "deprived of liberty",
"criterion": "liberty status",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}