{
"info": {
"nct_id": "NCT01450020",
"official_title": "Sister Survivor: Improving the Survivorship Care of African-American Women With Breast Cancer",
"inclusion_criteria": "* TRIAL SUBJECTS:\n* Patient age 18 years or older who self-identifies as African-American\n* In early survivorship phase, defined as being 1-12 months post completion of treatment for stage 0-3 breast cancer\n* Receiving health care primarily through an health maintenance organization (HMO)\n* Patients with metastatic cancer or a second primary cancer, because their medical characteristics (e.g. disease progression) are significantly different\n* Breast cancer survivors (BCS) with other major disabling medical, psychiatric, or substance abuse conditions (e.g., anxiety, depression, alcohol/tobacco problems) will be excluded\n* PEER NAVIGATORS:\n* At least 25 years of age who self-identifies as African-American\n* Previously participated in any type of research study\n* Has at least high school education\n* Has been diagnosed with breast cancer, currently in remission or eradicated\n* Belongs to a breast cancer support group\n* Has a valid driver's license\n* Owns an operational vehicle\n* Has access to a personal computer with internet access\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Patient age 18 years or older who self-identifies as African-American",
"criterions": [
{
"exact_snippets": "Patient age 18 years or older",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
},
{
"exact_snippets": "self-identifies as African-American",
"criterion": "ethnicity",
"requirement": {
"requirement_type": "self-identification",
"expected_value": "African-American"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patient age 18 years or older",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
},
{
"exact_snippets": "self-identifies as African-American",
"criterion": "ethnicity",
"requirement": {
"requirement_type": "self-identification",
"expected_value": "African-American"
}
}
]
}
},
{
"identified_line": {
"line": "* In early survivorship phase, defined as being 1-12 months post completion of treatment for stage 0-3 breast cancer",
"criterions": [
{
"exact_snippets": "early survivorship phase",
"criterion": "survivorship phase",
"requirement": {
"requirement_type": "phase",
"expected_value": "early"
}
},
{
"exact_snippets": "1-12 months post completion of treatment",
"criterion": "time since treatment completion",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "months"
},
{
"operator": "<=",
"value": 12,
"unit": "months"
}
]
}
}
},
{
"exact_snippets": "stage 0-3 breast cancer",
"criterion": "breast cancer stage",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "stage"
},
{
"operator": "<=",
"value": 3,
"unit": "stage"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "early survivorship phase",
"criterion": "survivorship phase",
"requirement": {
"requirement_type": "phase",
"expected_value": "early"
}
},
{
"exact_snippets": "1-12 months post completion of treatment",
"criterion": "time since treatment completion",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "months"
},
{
"operator": "<=",
"value": 12,
"unit": "months"
}
]
}
}
},
{
"exact_snippets": "stage 0-3 breast cancer",
"criterion": "breast cancer stage",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "stage"
},
{
"operator": "<=",
"value": 3,
"unit": "stage"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Receiving health care primarily through an health maintenance organization (HMO)",
"criterions": [
{
"exact_snippets": "Receiving health care primarily through an health maintenance organization (HMO)",
"criterion": "health care provider",
"requirement": {
"requirement_type": "type",
"expected_value": "health maintenance organization (HMO)"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Receiving health care primarily through an health maintenance organization (HMO)",
"criterion": "health care provider",
"requirement": {
"requirement_type": "type",
"expected_value": "health maintenance organization (HMO)"
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with metastatic cancer or a second primary cancer, because their medical characteristics (e.g. disease progression) are significantly different",
"criterions": [
{
"exact_snippets": "metastatic cancer",
"criterion": "metastatic cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "second primary cancer",
"criterion": "second primary cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "metastatic cancer",
"criterion": "metastatic cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "second primary cancer",
"criterion": "second primary cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Breast cancer survivors (BCS) with other major disabling medical, psychiatric, or substance abuse conditions (e.g., anxiety, depression, alcohol/tobacco problems) will be excluded",
"criterions": [
{
"exact_snippets": "Breast cancer survivors (BCS)",
"criterion": "breast cancer survivor status",
"requirement": {
"requirement_type": "status",
"expected_value": true
}
},
{
"exact_snippets": "other major disabling medical ... conditions",
"criterion": "major disabling medical conditions",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "other major disabling ... psychiatric ... conditions",
"criterion": "major disabling psychiatric conditions",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "other major disabling ... substance abuse conditions",
"criterion": "major disabling substance abuse conditions",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "anxiety",
"criterion": "anxiety",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "depression",
"criterion": "depression",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "alcohol ... problems",
"criterion": "alcohol problems",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "tobacco problems",
"criterion": "tobacco problems",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Breast cancer survivors (BCS)",
"criterion": "breast cancer survivor status",
"requirement": {
"requirement_type": "status",
"expected_value": true
}
},
{
"not_criteria": {
"exact_snippets": "other major disabling medical ... conditions",
"criterion": "major disabling medical conditions",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
},
{
"not_criteria": {
"exact_snippets": "other major disabling ... psychiatric ... conditions",
"criterion": "major disabling psychiatric conditions",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
]
},
{
"not_criteria": {
"exact_snippets": "other major disabling ... substance abuse conditions",
"criterion": "major disabling substance abuse conditions",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
]
},
{
"not_criteria": {
"exact_snippets": "anxiety",
"criterion": "anxiety",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
]
},
{
"not_criteria": {
"exact_snippets": "depression",
"criterion": "depression",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
]
},
{
"not_criteria": {
"exact_snippets": "alcohol ... problems",
"criterion": "alcohol problems",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
]
},
{
"not_criteria": {
"exact_snippets": "tobacco problems",
"criterion": "tobacco problems",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* PEER NAVIGATORS:",
"criterions": [
{
"exact_snippets": "PEER NAVIGATORS",
"criterion": "peer navigators",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "PEER NAVIGATORS",
"criterion": "peer navigators",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* At least 25 years of age who self-identifies as African-American",
"criterions": [
{
"exact_snippets": "At least 25 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 25,
"unit": "years"
}
}
},
{
"exact_snippets": "self-identifies as African-American",
"criterion": "ethnicity",
"requirement": {
"requirement_type": "self-identification",
"expected_value": "African-American"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "At least 25 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 25,
"unit": "years"
}
}
},
{
"exact_snippets": "self-identifies as African-American",
"criterion": "ethnicity",
"requirement": {
"requirement_type": "self-identification",
"expected_value": "African-American"
}
}
]
}
},
{
"identified_line": {
"line": "* Previously participated in any type of research study",
"criterions": [
{
"exact_snippets": "Previously participated in any type of research study",
"criterion": "participation in research study",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Previously participated in any type of research study",
"criterion": "participation in research study",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Has at least high school education",
"criterions": [
{
"exact_snippets": "at least high school education",
"criterion": "education level",
"requirement": {
"requirement_type": "minimum level",
"expected_value": "high school"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "at least high school education",
"criterion": "education level",
"requirement": {
"requirement_type": "minimum level",
"expected_value": "high school"
}
}
]
}
},
{
"identified_line": {
"line": "* Belongs to a breast cancer support group",
"criterions": [
{
"exact_snippets": "Belongs to a breast cancer support group",
"criterion": "breast cancer support group membership",
"requirement": {
"requirement_type": "membership",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Belongs to a breast cancer support group",
"criterion": "breast cancer support group membership",
"requirement": {
"requirement_type": "membership",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Has a valid driver's license",
"criterions": [
{
"exact_snippets": "Has a valid driver's license",
"criterion": "driver's license",
"requirement": {
"requirement_type": "validity",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Has a valid driver's license",
"criterion": "driver's license",
"requirement": {
"requirement_type": "validity",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Owns an operational vehicle",
"criterions": [
{
"exact_snippets": "Owns an operational vehicle",
"criterion": "vehicle ownership",
"requirement": {
"requirement_type": "ownership",
"expected_value": true
}
},
{
"exact_snippets": "Owns an operational vehicle",
"criterion": "vehicle ownership",
"requirement": {
"requirement_type": "operational status",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Owns an operational vehicle",
"criterion": "vehicle ownership",
"requirement": {
"requirement_type": "ownership",
"expected_value": true
}
},
{
"exact_snippets": "Owns an operational vehicle",
"criterion": "vehicle ownership",
"requirement": {
"requirement_type": "operational status",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Has access to a personal computer with internet access",
"criterions": [
{
"exact_snippets": "Has access to a personal computer",
"criterion": "personal computer",
"requirement": {
"requirement_type": "access",
"expected_value": true
}
},
{
"exact_snippets": "internet access",
"criterion": "internet",
"requirement": {
"requirement_type": "access",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Has access to a personal computer",
"criterion": "personal computer",
"requirement": {
"requirement_type": "access",
"expected_value": true
}
},
{
"exact_snippets": "internet access",
"criterion": "internet",
"requirement": {
"requirement_type": "access",
"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": {
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"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "N/A",
"expected_value": "FEMALE"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
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"expected_value": "FEMALE"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* TRIAL SUBJECTS:",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Has been diagnosed with breast cancer, currently in remission or eradicated",
"criterions": [
{
"exact_snippets": "Has been diagnosed with breast cancer",
"criterion": "breast cancer diagnosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "currently in remission or eradicated",
"criterion": "breast cancer status",
"requirement": {
"requirement_type": "status",
"expected_value": [
"remission",
"eradicated"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Has been diagnosed with breast cancer",
"criterion": "breast cancer diagnosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"or_criteria": [
{
"exact_snippets": "currently in remission or eradicated",
"criterion": "breast cancer status",
"requirement": {
"requirement_type": "status",
"expected_value": "remission"
}
},
{
"exact_snippets": "currently in remission or eradicated",
"criterion": "breast cancer status",
"requirement": {
"requirement_type": "status",
"expected_value": "eradicated"
}
}
]
}
]
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}