{
"info": {
"nct_id": "NCT03787966",
"official_title": "Attenuating Cancer Treatment-related Toxicity in Oncology Patients With a Tailored Physical Exercise Program: Study Protocol of the ATOPE Trial in Women Recently Diagnosed With Breast Cancer",
"inclusion_criteria": "* 18 years or older\n* Breast cancer diagnosis I-III stage\n* On the waiting list to anticancer medical treatment (at least surgery, chemotherapy and radiotherapy.\n* If they meet other criteria which predisposes to higher toxicity.\n* Have signed informed consent.\n* Have medical clearance for participation.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
"exclusion_criteria": "* Patient underwent previous cancer treatments.\n* Patients were previously diagnosed with cancer.\n* Pregnant patients.\n* Patients performing other type of therapeutic exercise at diagnosis time with an intake >or = to 150 moderate-intensity or 75 min of vigorous-intensity a day.\n* Therapeutic exercise practice not recommended because psychiatric or cognitive disorders or cute or chronic condition that prevents exercise (advanced lung disease, oxygen requirement, stenosis >70%, metastasis etc.).",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* 18 years or older",
"criterions": [
{
"exact_snippets": "18 years or older",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Breast cancer diagnosis I-III stage",
"criterions": [
{
"exact_snippets": "Breast cancer diagnosis",
"criterion": "breast cancer",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": true
}
]
},
{
"exact_snippets": "I-III stage",
"criterion": "cancer stage",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "stage"
},
{
"operator": "<=",
"value": 3,
"unit": "stage"
}
]
}
}
]
}
]
},
{
"line": "* On the waiting list to anticancer medical treatment (at least surgery, chemotherapy and radiotherapy.",
"criterions": [
{
"exact_snippets": "On the waiting list to anticancer medical treatment",
"criterion": "anticancer medical treatment waiting list",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "at least surgery, chemotherapy and radiotherapy",
"criterion": "anticancer medical treatment types",
"requirements": [
{
"requirement_type": "types",
"expected_value": [
"surgery",
"chemotherapy",
"radiotherapy"
]
}
]
}
]
},
{
"line": "* If they meet other criteria which predisposes to higher toxicity.",
"criterions": [
{
"exact_snippets": "predisposes to higher toxicity",
"criterion": "predisposition to higher toxicity",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Have signed informed consent.",
"criterions": [
{
"exact_snippets": "signed informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "signed",
"expected_value": true
}
]
}
]
},
{
"line": "* Have medical clearance for participation.",
"criterions": [
{
"exact_snippets": "medical clearance",
"criterion": "medical clearance",
"requirements": [
{
"requirement_type": "presence",
"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"
}
}
]
}
]
},
{
"line": "Must have maximum age of 70 Years",
"criterions": [
{
"exact_snippets": "maximum age of 70 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 70,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Patient underwent previous cancer treatments.",
"criterions": [
{
"exact_snippets": "Patient underwent previous cancer treatments.",
"criterion": "previous cancer treatments",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Patients were previously diagnosed with cancer.",
"criterions": [
{
"exact_snippets": "previously diagnosed with cancer",
"criterion": "cancer diagnosis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Pregnant patients.",
"criterions": [
{
"exact_snippets": "Pregnant patients",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Patients performing other type of therapeutic exercise at diagnosis time with an intake >or = to 150 moderate-intensity or 75 min of vigorous-intensity a day.",
"criterions": [
{
"exact_snippets": "Patients performing other type of therapeutic exercise at diagnosis time",
"criterion": "therapeutic exercise",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "intake >or = to 150 moderate-intensity or 75 min of vigorous-intensity a day",
"criterion": "exercise intensity and duration",
"requirements": [
{
"requirement_type": "intensity and duration",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 150,
"unit": "min"
},
{
"operator": ">=",
"value": 75,
"unit": "min"
}
]
}
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"line": "* Therapeutic exercise practice not recommended because psychiatric or cognitive disorders or cute or chronic condition that prevents exercise (advanced lung disease, oxygen requirement, stenosis >70%, metastasis etc.).",
"criterions": [
{
"exact_snippets": "psychiatric or cognitive disorders",
"criterion": "psychiatric or cognitive disorders",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "acute or chronic condition that prevents exercise",
"criterion": "acute or chronic condition that prevents exercise",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "advanced lung disease",
"criterion": "advanced lung disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "oxygen requirement",
"criterion": "oxygen requirement",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "stenosis >70%",
"criterion": "stenosis",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 70,
"unit": "%"
}
}
]
},
{
"exact_snippets": "metastasis",
"criterion": "metastasis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
}
],
"failed_miscellaneous": []
}