{
"info": {
"nct_id": "NCT03375801",
"official_title": "Implementing a Decision Aid for Breast Cancer and DCIS Patients Deciding on Their Radiation Treatment: A Pre- and Post-intervention Study.",
"inclusion_criteria": "* 18 years or older\n* Female\n* Doubtful indication of:\n\n * Whole breast irradiation after lumpectomy for DCIS\n * Whole breast irradiation after lumpectomy for low risk invasive BC (TOP-1 study)\n * Boost dose in case of Breast Conserving Therapy\n * Thoracic wall irradiation post mastectomy\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Metastasis\n* Inability to speak and read Dutch. Inability to use internet access, either in the home or at a hospital facility.",
"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": "* Female",
"criterions": [
{
"exact_snippets": "Female",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "female"
}
]
}
]
},
{
"line": "* Doubtful indication of:",
"criterions": [
{
"exact_snippets": "Doubtful indication of",
"criterion": "indication",
"requirements": [
{
"requirement_type": "certainty",
"expected_value": "doubtful"
}
]
}
]
},
{
"line": "* Whole breast irradiation after lumpectomy for DCIS",
"criterions": [
{
"exact_snippets": "Whole breast irradiation",
"criterion": "breast irradiation",
"requirements": [
{
"requirement_type": "procedure",
"expected_value": "whole breast irradiation"
}
]
},
{
"exact_snippets": "lumpectomy",
"criterion": "lumpectomy",
"requirements": [
{
"requirement_type": "procedure",
"expected_value": true
}
]
},
{
"exact_snippets": "DCIS",
"criterion": "DCIS",
"requirements": [
{
"requirement_type": "condition",
"expected_value": true
}
]
}
]
},
{
"line": "* Whole breast irradiation after lumpectomy for low risk invasive BC (TOP-1 study)",
"criterions": [
{
"exact_snippets": "Whole breast irradiation after lumpectomy",
"criterion": "whole breast irradiation",
"requirements": [
{
"requirement_type": "procedure",
"expected_value": "after lumpectomy"
}
]
},
{
"exact_snippets": "low risk invasive BC",
"criterion": "invasive breast cancer",
"requirements": [
{
"requirement_type": "risk level",
"expected_value": "low"
}
]
}
]
},
{
"line": "* Boost dose in case of Breast Conserving Therapy",
"criterions": [
{
"exact_snippets": "Boost dose in case of Breast Conserving Therapy",
"criterion": "Breast Conserving Therapy",
"requirements": [
{
"requirement_type": "treatment",
"expected_value": "Boost dose"
}
]
}
]
},
{
"line": "* Thoracic wall irradiation post mastectomy",
"criterions": [
{
"exact_snippets": "Thoracic wall irradiation post mastectomy",
"criterion": "thoracic wall irradiation",
"requirements": [
{
"requirement_type": "timing",
"expected_value": "post mastectomy"
}
]
}
]
},
{
"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": "* Metastasis",
"criterions": [
{
"exact_snippets": "Metastasis",
"criterion": "metastasis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Inability to speak and read Dutch. Inability to use internet access, either in the home or at a hospital facility.",
"criterions": [
{
"exact_snippets": "Inability to speak and read Dutch",
"criterion": "language ability",
"requirements": [
{
"requirement_type": "ability",
"expected_value": "speak and read Dutch"
}
]
},
{
"exact_snippets": "Inability to use internet access",
"criterion": "internet access ability",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}