{
"info": {
"nct_id": "NCT02957357",
"official_title": "Optimizing the Effectiveness of Routine Post-treatment Surveillance in Prostate Cancer Survivors",
"inclusion_criteria": "* Newly-diagnosed, histologically-proven, localized prostate adenocarcinoma.\n* Completion of baseline interview prior to initiating therapy.\n* Patient ability to complete study interview: no cognitive impairment, language or hearing problems.\n* Not diagnosed with prostate cancer through transurethral resection of the prostate (TURP).\n* Age 35-80.\n* English speaking.\n* Has telephone.\nHealthy volunteers allowed\nMust be MALE",
"exclusion_criteria": "* Initiation of treatment for prostate cancer prior to completion of baseline interview.\n* Cognitive impairment.\n* Hearing problems.\n* Inability to speak or understand English.",
"miscellaneous_criteria": "Inclusion Criteria for the National Cancer Data Base cohort:\n\n* Patient data part of the NCDB\n* Diagnosed with prostate cancer in 2004-2005.\n* Treated for prostate cancer with surgery (prostatectomy) or radiation therapy\n\nInclusion/Exclusion Criteria for the NC ProCESS cohort:"
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Newly-diagnosed, histologically-proven, localized prostate adenocarcinoma.",
"criterions": [
{
"exact_snippets": "Newly-diagnosed",
"criterion": "diagnosis status",
"requirement": {
"requirement_type": "status",
"expected_value": "newly-diagnosed"
}
},
{
"exact_snippets": "histologically-proven",
"criterion": "diagnosis confirmation method",
"requirement": {
"requirement_type": "method",
"expected_value": "histologically-proven"
}
},
{
"exact_snippets": "localized",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "localized"
}
},
{
"exact_snippets": "prostate adenocarcinoma",
"criterion": "cancer type",
"requirement": {
"requirement_type": "type",
"expected_value": "prostate adenocarcinoma"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Newly-diagnosed",
"criterion": "diagnosis status",
"requirement": {
"requirement_type": "status",
"expected_value": "newly-diagnosed"
}
},
{
"exact_snippets": "histologically-proven",
"criterion": "diagnosis confirmation method",
"requirement": {
"requirement_type": "method",
"expected_value": "histologically-proven"
}
},
{
"exact_snippets": "localized",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "localized"
}
},
{
"exact_snippets": "prostate adenocarcinoma",
"criterion": "cancer type",
"requirement": {
"requirement_type": "type",
"expected_value": "prostate adenocarcinoma"
}
}
]
}
},
{
"identified_line": {
"line": "* Completion of baseline interview prior to initiating therapy.",
"criterions": [
{
"exact_snippets": "Completion of baseline interview",
"criterion": "baseline interview",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
"exact_snippets": "prior to initiating therapy",
"criterion": "therapy initiation",
"requirement": {
"requirement_type": "timing",
"expected_value": "after baseline interview completion"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Completion of baseline interview",
"criterion": "baseline interview",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
"exact_snippets": "prior to initiating therapy",
"criterion": "therapy initiation",
"requirement": {
"requirement_type": "timing",
"expected_value": "after baseline interview completion"
}
}
]
}
},
{
"identified_line": {
"line": "* Patient ability to complete study interview: no cognitive impairment, language or hearing problems.",
"criterions": [
{
"exact_snippets": "no cognitive impairment",
"criterion": "cognitive impairment",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "no ... language ... problems",
"criterion": "language problems",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "no ... hearing problems",
"criterion": "hearing problems",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "no cognitive impairment",
"criterion": "cognitive impairment",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "no ... language ... problems",
"criterion": "language problems",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "no ... hearing problems",
"criterion": "hearing problems",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Not diagnosed with prostate cancer through transurethral resection of the prostate (TURP).",
"criterions": [
{
"exact_snippets": "Not diagnosed with prostate cancer through transurethral resection of the prostate (TURP).",
"criterion": "prostate cancer diagnosis through TURP",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Not diagnosed with prostate cancer through transurethral resection of the prostate (TURP).",
"criterion": "prostate cancer diagnosis through TURP",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Age 35-80.",
"criterions": [
{
"exact_snippets": "Age 35-80",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 35,
"unit": "years"
},
{
"operator": "<=",
"value": 80,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age 35-80",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 35,
"unit": "years"
},
{
"operator": "<=",
"value": 80,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* English speaking.",
"criterions": [
{
"exact_snippets": "English speaking",
"criterion": "language",
"requirement": {
"requirement_type": "proficiency",
"expected_value": "English"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "English speaking",
"criterion": "language",
"requirement": {
"requirement_type": "proficiency",
"expected_value": "English"
}
}
]
}
},
{
"identified_line": {
"line": "* Has telephone.",
"criterions": [
{
"exact_snippets": "Has telephone.",
"criterion": "telephone",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Has telephone.",
"criterion": "telephone",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"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 be MALE",
"criterions": [
{
"exact_snippets": "MALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "male"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "MALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "male"
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Initiation of treatment for prostate cancer prior to completion of baseline interview.",
"criterions": [
{
"exact_snippets": "Initiation of treatment for prostate cancer",
"criterion": "treatment initiation for prostate cancer",
"requirement": {
"requirement_type": "timing",
"expected_value": "prior to completion of baseline interview"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Initiation of treatment for prostate cancer",
"criterion": "treatment initiation for prostate cancer",
"requirement": {
"requirement_type": "timing",
"expected_value": "prior to completion of baseline interview"
}
}
}
},
{
"identified_line": {
"line": "* Cognitive impairment.",
"criterions": [
{
"exact_snippets": "Cognitive impairment",
"criterion": "cognitive impairment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Cognitive impairment",
"criterion": "cognitive impairment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Hearing problems.",
"criterions": [
{
"exact_snippets": "Hearing problems",
"criterion": "hearing problems",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Hearing problems",
"criterion": "hearing problems",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
}
],
"miscellaneous_lines": [
{
"identified_line": {
"line": "* Diagnosed with prostate cancer in 2004-2005.",
"criterions": [
{
"exact_snippets": "Diagnosed with prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "Diagnosed ... in 2004-2005",
"criterion": "diagnosis year",
"requirement": {
"requirement_type": "year range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2004,
"unit": "year"
},
{
"operator": "<=",
"value": 2005,
"unit": "year"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Diagnosed with prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "Diagnosed ... in 2004-2005",
"criterion": "diagnosis year",
"requirement": {
"requirement_type": "year range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2004,
"unit": "year"
},
{
"operator": "<=",
"value": 2005,
"unit": "year"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Treated for prostate cancer with surgery (prostatectomy) or radiation therapy",
"criterions": [
{
"exact_snippets": "Treated for prostate cancer with surgery (prostatectomy)",
"criterion": "prostate cancer treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": [
"surgery",
"prostatectomy"
]
}
},
{
"exact_snippets": "Treated for prostate cancer with ... radiation therapy",
"criterion": "prostate cancer treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "radiation therapy"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Treated for prostate cancer with surgery (prostatectomy)",
"criterion": "prostate cancer treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": [
"surgery",
"prostatectomy"
]
}
},
{
"exact_snippets": "Treated for prostate cancer with ... radiation therapy",
"criterion": "prostate cancer treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "radiation therapy"
}
}
]
}
},
{
"identified_line": {
"line": "Inclusion Criteria for the National Cancer Data Base cohort:",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "Inclusion/Exclusion Criteria for the NC ProCESS cohort:",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
}
],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "* Inability to speak or understand English.",
"criterions": [
{
"exact_snippets": "Inability to speak ... English.",
"criterion": "ability to speak English",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "Inability to ... understand English.",
"criterion": "ability to understand English",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Inability to speak ... English.",
"criterion": "ability to speak English",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
},
{
"exact_snippets": "Inability to ... understand English.",
"criterion": "ability to understand English",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
}
]
}
}
],
"failed_miscellaneous": [
{
"identified_line": {
"line": "* Patient data part of the NCDB",
"criterions": [
{
"exact_snippets": "Patient data part of the NCDB",
"criterion": "NCDB data inclusion",
"requirement": {
"requirement_type": "inclusion",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
]
}