{
"info": {
"nct_id": "NCT06817694",
"official_title": "Cognitive Behavioral Therapy for Fear of Cancer Recurrence in Women With BRCA1/2 Gene",
"inclusion_criteria": "* 1) Have completed primary treatment for breast or ovarian cancer (with the exception of adjuvant hormone therapy) for at least 3 months but no more than 10 years.\n* 2) Be known to carry a BRCA1/2 genetic mutation.\n* 3) Have a clinical level of fear of cancer recurrence as defined by a score of 13 or more on the Fear of Cancer Recurrence Inventory severity subscale.\n* 4) Be at least 18 years of age.\n* 5) be able to read, understand and express herself in French.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* 1) Have distant metastases.\n* 2) Have a known cognitive disorder.\n* 3) Have a known severe psychological disorder (e.g., psychotic disorder, bipolar disorder, substance abuse or dependence disorder).\n* 4) Women taking psychotropic medication are eligible, but only if the dosage has been stable for at least one month.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* 1) Have completed primary treatment for breast or ovarian cancer (with the exception of adjuvant hormone therapy) for at least 3 months but no more than 10 years.",
"criterions": [
{
"exact_snippets": "completed primary treatment for breast or ovarian cancer",
"criterion": "primary treatment completion",
"requirements": [
{
"requirement_type": "cancer type",
"expected_value": [
"breast",
"ovarian"
]
}
]
},
{
"exact_snippets": "completed primary treatment ... for at least 3 months",
"criterion": "primary treatment completion duration",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3,
"unit": "months"
}
]
}
}
]
},
{
"exact_snippets": "completed primary treatment ... no more than 10 years",
"criterion": "primary treatment completion duration",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 10,
"unit": "years"
}
]
}
}
]
},
{
"exact_snippets": "with the exception of adjuvant hormone therapy",
"criterion": "adjuvant hormone therapy",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": true
}
]
}
]
},
{
"line": "* 2) Be known to carry a BRCA1/2 genetic mutation.",
"criterions": [
{
"exact_snippets": "carry a BRCA1/2 genetic mutation",
"criterion": "BRCA1/2 genetic mutation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* 3) Have a clinical level of fear of cancer recurrence as defined by a score of 13 or more on the Fear of Cancer Recurrence Inventory severity subscale.",
"criterions": [
{
"exact_snippets": "clinical level of fear of cancer recurrence ... score of 13 or more on the Fear of Cancer Recurrence Inventory severity subscale",
"criterion": "fear of cancer recurrence",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 13,
"unit": "score on the Fear of Cancer Recurrence Inventory severity subscale"
}
}
]
}
]
},
{
"line": "* 4) Be at least 18 years of age.",
"criterions": [
{
"exact_snippets": "at least 18 years of age",
"criterion": "age",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* 5) be able to read, understand and express herself in French.",
"criterions": [
{
"exact_snippets": "be able to read ... in French",
"criterion": "French reading ability",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
},
{
"exact_snippets": "be able to ... understand ... in French",
"criterion": "French comprehension ability",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
},
{
"exact_snippets": "be able to ... express herself in French",
"criterion": "French speaking ability",
"requirements": [
{
"requirement_type": "ability",
"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": "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"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* 1) Have distant metastases.",
"criterions": [
{
"exact_snippets": "Have distant metastases",
"criterion": "distant metastases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* 2) Have a known cognitive disorder.",
"criterions": [
{
"exact_snippets": "Have a known cognitive disorder.",
"criterion": "cognitive disorder",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* 3) Have a known severe psychological disorder (e.g., psychotic disorder, bipolar disorder, substance abuse or dependence disorder).",
"criterions": [
{
"exact_snippets": "known severe psychological disorder ... psychotic disorder",
"criterion": "psychotic disorder",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "known severe psychological disorder ... bipolar disorder",
"criterion": "bipolar disorder",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "known severe psychological disorder ... substance abuse or dependence disorder",
"criterion": "substance abuse or dependence disorder",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* 4) Women taking psychotropic medication are eligible, but only if the dosage has been stable for at least one month.",
"criterions": [
{
"exact_snippets": "Women taking psychotropic medication",
"criterion": "psychotropic medication",
"requirements": [
{
"requirement_type": "gender",
"expected_value": "female"
},
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "dosage has been stable for at least one month",
"criterion": "psychotropic medication dosage stability",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "month"
}
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}