{
"info": {
"nct_id": "NCT02505165",
"official_title": "A Clinic-Based Interdisciplinary Intervention for Parents of Children With Cancer",
"inclusion_criteria": "* The child has been diagnosed with leukemia or lymphoma, malignant solid tumor, or malignant brain tumor\n* The child is being treated for cancer and returning to the medical center (CCHMC or OUHSC).\n* The child is 18 years of age or younger\n* Recruitment occurs within 2-12 weeks post diagnosis\n* The parent is responsible for care and is willing to give consent and participate\n* The child is willing to give assent or consent and participate (only for children 8 years old and older)\n* The parent gives patient permission to participate.\n* Parent is fluent in English\nHealthy volunteers allowed\nMust have minimum age of 0 Years\nMust have maximum age of 18 Years",
"exclusion_criteria": "* The child is experiencing an imminent medical crisis necessitating significant medical intervention\n* The child with cancer is determined to be in the terminal phase of illness and/or is receiving end of life care\n* The diagnosis is determined to be a relapse or a second malignancy\n* The parent is currently being treated for a serious psychiatric disorder, or, evidences mental retardation\n* The parent is younger than 18 years of age\n* The parent is not English speaking\n* The parent is unwilling to give written permission for child participation\n* If the patient's treatment visit schedule is too infrequent to meet the study visit timeline requirements",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* The child has been diagnosed with leukemia or lymphoma, malignant solid tumor, or malignant brain tumor",
"criterions": [
{
"exact_snippets": "The child has been diagnosed with leukemia",
"criterion": "leukemia",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "The child has been diagnosed with ... lymphoma",
"criterion": "lymphoma",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "The child has been diagnosed with ... malignant solid tumor",
"criterion": "malignant solid tumor",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "The child has been diagnosed with ... malignant brain tumor",
"criterion": "malignant brain tumor",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "The child has been diagnosed with leukemia",
"criterion": "leukemia",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "The child has been diagnosed with ... lymphoma",
"criterion": "lymphoma",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "The child has been diagnosed with ... malignant solid tumor",
"criterion": "malignant solid tumor",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "The child has been diagnosed with ... malignant brain tumor",
"criterion": "malignant brain tumor",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* The child is being treated for cancer and returning to the medical center (CCHMC or OUHSC).",
"criterions": [
{
"exact_snippets": "The child is being treated for cancer",
"criterion": "cancer treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "returning to the medical center (CCHMC or OUHSC)",
"criterion": "returning to medical center",
"requirement": {
"requirement_type": "location",
"expected_value": [
"CCHMC",
"OUHSC"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "The child is being treated for cancer",
"criterion": "cancer treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "returning to the medical center (CCHMC or OUHSC)",
"criterion": "returning to medical center",
"requirement": {
"requirement_type": "location",
"expected_value": [
"CCHMC",
"OUHSC"
]
}
}
]
}
},
{
"identified_line": {
"line": "* The child is 18 years of age or younger",
"criterions": [
{
"exact_snippets": "The child is 18 years of age or younger",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 18,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "The child is 18 years of age or younger",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 18,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Recruitment occurs within 2-12 weeks post diagnosis",
"criterions": [
{
"exact_snippets": "Recruitment occurs within 2-12 weeks post diagnosis",
"criterion": "time since diagnosis",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "weeks"
},
{
"operator": "<=",
"value": 12,
"unit": "weeks"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Recruitment occurs within 2-12 weeks post diagnosis",
"criterion": "time since diagnosis",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "weeks"
},
{
"operator": "<=",
"value": 12,
"unit": "weeks"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* The parent is responsible for care and is willing to give consent and participate",
"criterions": [
{
"exact_snippets": "The parent is responsible for care",
"criterion": "parental responsibility",
"requirement": {
"requirement_type": "responsibility",
"expected_value": true
}
},
{
"exact_snippets": "willing to give consent",
"criterion": "willingness to give consent",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "willing to ... participate",
"criterion": "willingness to participate",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "The parent is responsible for care",
"criterion": "parental responsibility",
"requirement": {
"requirement_type": "responsibility",
"expected_value": true
}
},
{
"exact_snippets": "willing to give consent",
"criterion": "willingness to give consent",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "willing to ... participate",
"criterion": "willingness to participate",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* The child is willing to give assent or consent and participate (only for children 8 years old and older)",
"criterions": [
{
"exact_snippets": "The child is willing to give assent or consent",
"criterion": "willingness to give assent or consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "only for children 8 years old and older",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 8,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "only for children 8 years old and older",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 8,
"unit": "years"
}
}
},
"then_criteria": {
"exact_snippets": "The child is willing to give assent or consent",
"criterion": "willingness to give assent or consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* The parent gives patient permission to participate.",
"criterions": [
{
"exact_snippets": "The parent gives patient permission to participate.",
"criterion": "parental permission",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "The parent gives patient permission to participate.",
"criterion": "parental permission",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Parent is fluent in English",
"criterions": [
{
"exact_snippets": "Parent is fluent in English",
"criterion": "parent's English fluency",
"requirement": {
"requirement_type": "fluency",
"expected_value": "fluent"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Parent is fluent in English",
"criterion": "parent's English fluency",
"requirement": {
"requirement_type": "fluency",
"expected_value": "fluent"
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 0 Years",
"criterions": [
{
"exact_snippets": "minimum age of 0 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 0,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 0 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 0,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 18 Years",
"criterions": [
{
"exact_snippets": "maximum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* The child is experiencing an imminent medical crisis necessitating significant medical intervention",
"criterions": [
{
"exact_snippets": "The child is experiencing an imminent medical crisis",
"criterion": "imminent medical crisis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "necessitating significant medical intervention",
"criterion": "significant medical intervention",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "The child is experiencing an imminent medical crisis",
"criterion": "imminent medical crisis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "necessitating significant medical intervention",
"criterion": "significant medical intervention",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* The child with cancer is determined to be in the terminal phase of illness and/or is receiving end of life care",
"criterions": [
{
"exact_snippets": "The child with cancer is determined to be in the terminal phase of illness",
"criterion": "terminal phase of illness",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "is receiving end of life care",
"criterion": "end of life care",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "The child with cancer is determined to be in the terminal phase of illness",
"criterion": "terminal phase of illness",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "is receiving end of life care",
"criterion": "end of life care",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* The diagnosis is determined to be a relapse or a second malignancy",
"criterions": [
{
"exact_snippets": "diagnosis is determined to be a relapse",
"criterion": "diagnosis",
"requirement": {
"requirement_type": "condition",
"expected_value": "relapse"
}
},
{
"exact_snippets": "diagnosis is determined to be ... a second malignancy",
"criterion": "diagnosis",
"requirement": {
"requirement_type": "condition",
"expected_value": "second malignancy"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "diagnosis is determined to be a relapse",
"criterion": "diagnosis",
"requirement": {
"requirement_type": "condition",
"expected_value": "relapse"
}
},
{
"exact_snippets": "diagnosis is determined to be ... a second malignancy",
"criterion": "diagnosis",
"requirement": {
"requirement_type": "condition",
"expected_value": "second malignancy"
}
}
]
}
},
{
"identified_line": {
"line": "* The parent is currently being treated for a serious psychiatric disorder, or, evidences mental retardation",
"criterions": [
{
"exact_snippets": "The parent is currently being treated for a serious psychiatric disorder",
"criterion": "psychiatric disorder treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "evidences mental retardation",
"criterion": "mental retardation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "The parent is currently being treated for a serious psychiatric disorder",
"criterion": "psychiatric disorder treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "evidences mental retardation",
"criterion": "mental retardation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* The parent is younger than 18 years of age",
"criterions": [
{
"exact_snippets": "parent is younger than 18 years of age",
"criterion": "parent age",
"requirement": {
"requirement_type": "age",
"expected_value": {
"operator": "<",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "parent is younger than 18 years of age",
"criterion": "parent age",
"requirement": {
"requirement_type": "age",
"expected_value": {
"operator": "<",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* The parent is not English speaking",
"criterions": [
{
"exact_snippets": "The parent is not English speaking",
"criterion": "parent language",
"requirement": {
"requirement_type": "language",
"expected_value": "not English"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "The parent is not English speaking",
"criterion": "parent language",
"requirement": {
"requirement_type": "language",
"expected_value": "not English"
}
}
}
},
{
"identified_line": {
"line": "* The parent is unwilling to give written permission for child participation",
"criterions": [
{
"exact_snippets": "The parent is unwilling to give written permission",
"criterion": "parental consent",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "The parent is unwilling to give written permission",
"criterion": "parental consent",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* If the patient's treatment visit schedule is too infrequent to meet the study visit timeline requirements",
"criterions": [
{
"exact_snippets": "patient's treatment visit schedule is too infrequent",
"criterion": "treatment visit schedule",
"requirement": {
"requirement_type": "frequency",
"expected_value": "sufficient to meet study visit timeline requirements"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "patient's treatment visit schedule is too infrequent",
"criterion": "treatment visit schedule",
"requirement": {
"requirement_type": "frequency",
"expected_value": "sufficient to meet study visit timeline requirements"
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}