{
"info": {
"nct_id": "NCT04789694",
"official_title": "Prehabilitation in Patients With Gynaecological Cancer Planned for Postponed Surgical Management: A Prospective Randomised Trial.",
"inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 85 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "Inclusion criteria\n\nTwo groups of patients will be eligible for the trial:\n\ni) Epithelial ovarian cancer patients referred for NACT: a) FIGO stage III or IV disease; b) Patient is not a candidate for primary debulking surgery; c) Patient is a suitable candidate for standard of care combined chemotherapy; d) Patient is a candidate for interval.debulking surgery\n\nii) Stage I or II endometrial cancer patients classifying as frail according to the validated modified Frailty Index: a) FIGO stage I or II; b) Patient is classified as frail; c) Patient is suitable candidate for hormonal therapy.\n\nExclusion criteria\n\n1. Second malignant tumour (under the treatment)\n2. Patient is not suitable for any surgery delay\n3. Patient is not physically able to meet the prehabilitation intervention plan or is unable to walk"
},
"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 be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirements": [
{
"requirement_type": "N/A",
"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 85 Years",
"criterions": [
{
"exact_snippets": "maximum age of 85 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 85,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"line": "i) Epithelial ovarian cancer patients referred for NACT: a) FIGO stage III or IV disease; b) Patient is not a candidate for primary debulking surgery; c) Patient is a suitable candidate for standard of care combined chemotherapy; d) Patient is a candidate for interval.debulking surgery",
"criterions": [
{
"exact_snippets": "Epithelial ovarian cancer patients",
"criterion": "epithelial ovarian cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "FIGO stage III or IV disease",
"criterion": "FIGO stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"III",
"IV"
]
}
]
},
{
"exact_snippets": "Patient is not a candidate for primary debulking surgery",
"criterion": "primary debulking surgery candidacy",
"requirements": [
{
"requirement_type": "candidacy",
"expected_value": false
}
]
},
{
"exact_snippets": "Patient is a suitable candidate for standard of care combined chemotherapy",
"criterion": "standard of care combined chemotherapy candidacy",
"requirements": [
{
"requirement_type": "candidacy",
"expected_value": true
}
]
},
{
"exact_snippets": "Patient is a candidate for interval.debulking surgery",
"criterion": "interval debulking surgery candidacy",
"requirements": [
{
"requirement_type": "candidacy",
"expected_value": true
}
]
}
]
},
{
"line": "ii) Stage I or II endometrial cancer patients classifying as frail according to the validated modified Frailty Index: a) FIGO stage I or II; b) Patient is classified as frail; c) Patient is suitable candidate for hormonal therapy.",
"criterions": [
{
"exact_snippets": "Stage I or II endometrial cancer",
"criterion": "endometrial cancer stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"I",
"II"
]
}
]
},
{
"exact_snippets": "Patient is classified as frail",
"criterion": "frailty",
"requirements": [
{
"requirement_type": "classification",
"expected_value": "frail"
}
]
},
{
"exact_snippets": "Patient is suitable candidate for hormonal therapy",
"criterion": "suitability for hormonal therapy",
"requirements": [
{
"requirement_type": "suitability",
"expected_value": true
}
]
}
]
},
{
"line": "1. Second malignant tumour (under the treatment)",
"criterions": [
{
"exact_snippets": "Second malignant tumour (under the treatment)",
"criterion": "second malignant tumour",
"requirements": [
{
"requirement_type": "treatment status",
"expected_value": "under the treatment"
}
]
}
]
},
{
"line": "2. Patient is not suitable for any surgery delay",
"criterions": [
{
"exact_snippets": "Patient is not suitable for any surgery delay",
"criterion": "suitability for surgery delay",
"requirements": [
{
"requirement_type": "suitability",
"expected_value": false
}
]
}
]
},
{
"line": "3. Patient is not physically able to meet the prehabilitation intervention plan or is unable to walk",
"criterions": [
{
"exact_snippets": "Patient is not physically able to meet the prehabilitation intervention plan",
"criterion": "physical ability to meet prehabilitation intervention plan",
"requirements": [
{
"requirement_type": "ability",
"expected_value": false
}
]
},
{
"exact_snippets": "is unable to walk",
"criterion": "ability to walk",
"requirements": [
{
"requirement_type": "ability",
"expected_value": false
}
]
}
]
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"line": "Inclusion criteria",
"criterions": []
},
{
"line": "Two groups of patients will be eligible for the trial:",
"criterions": []
},
{
"line": "Exclusion criteria",
"criterions": []
}
]
}