{
"info": {
"nct_id": "NCT02644382",
"official_title": "Improving Surgical Decision-making in Young Women With Breast Cancer",
"inclusion_criteria": "Patients for key informant interviews-\n\n1. Newly diagnosed women with Stage 0-3 breast cancer\n2. Between the ages of 18 and 40 who are seen at DFCI and have not yet had their primary breast cancer surgery.\n\nPatients for focus groups:\n\n1. diagnosis of Stage 0-3 breast cancer at age 40 and younger\n2. currently between the ages of 18-43\n3. English-speaking\n4. 1-3 years from diagnosis\n5. Had breast cancer surgery\n6. no evidence of recurrent or metastatic disease.\n\nProviders:\n\nMust care for women who have breast cancer. Can be surgeons, surgical oncologists, medical and/or radiation oncologists\n\nPatients for Surgical Decision Making Pilot\n\n1. Women with newly-diagnosed, unilateral Stage 0-3 breast cancer\n2. Between the ages of 18 and 40\n3. Who are seen by a surgeon at DFCI/BWH or Faulkner Hospital\n4. English speaking\n5. Have not yet had their primary breast cancer surgery\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "Patients for key informant interviews-",
"criterions": [
{
"exact_snippets": "Patients for key informant interviews",
"criterion": "participation in key informant interviews",
"requirements": [
{
"requirement_type": "participation",
"expected_value": true
}
]
}
]
},
{
"line": "1. Newly diagnosed women with Stage 0-3 breast cancer",
"criterions": [
{
"exact_snippets": "Newly diagnosed women",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "female"
}
]
},
{
"exact_snippets": "Newly diagnosed women",
"criterion": "diagnosis status",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "newly diagnosed"
}
]
},
{
"exact_snippets": "Stage 0-3 breast cancer",
"criterion": "breast cancer stage",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "stage"
},
{
"operator": "<=",
"value": 3,
"unit": "stage"
}
]
}
}
]
}
]
},
{
"line": "2. Between the ages of 18 and 40 who are seen at DFCI and have not yet had their primary breast cancer surgery.",
"criterions": [
{
"exact_snippets": "ages of 18 and 40",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 40,
"unit": "years"
}
]
}
}
]
},
{
"exact_snippets": "seen at DFCI",
"criterion": "location of care",
"requirements": [
{
"requirement_type": "presence",
"expected_value": "DFCI"
}
]
},
{
"exact_snippets": "have not yet had their primary breast cancer surgery",
"criterion": "primary breast cancer surgery",
"requirements": [
{
"requirement_type": "completion",
"expected_value": false
}
]
}
]
},
{
"line": "Patients for focus groups:",
"criterions": [
{
"exact_snippets": "Patients for focus groups",
"criterion": "participation in focus groups",
"requirements": [
{
"requirement_type": "eligibility",
"expected_value": true
}
]
}
]
},
{
"line": "1. diagnosis of Stage 0-3 breast cancer at age 40 and younger",
"criterions": [
{
"exact_snippets": "diagnosis of Stage 0-3 breast cancer",
"criterion": "breast cancer stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 3,
"unit": "N/A"
}
]
}
}
]
},
{
"exact_snippets": "age 40 and younger",
"criterion": "age",
"requirements": [
{
"requirement_type": "age",
"expected_value": {
"operator": "<=",
"value": 40,
"unit": "years"
}
}
]
}
]
},
{
"line": "2. currently between the ages of 18-43",
"criterions": [
{
"exact_snippets": "currently between the ages of 18-43",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 43,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "3. English-speaking",
"criterions": [
{
"exact_snippets": "English-speaking",
"criterion": "language",
"requirements": [
{
"requirement_type": "proficiency",
"expected_value": "English"
}
]
}
]
},
{
"line": "4. 1-3 years from diagnosis",
"criterions": [
{
"exact_snippets": "1-3 years from diagnosis",
"criterion": "time since diagnosis",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "years"
},
{
"operator": "<=",
"value": 3,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "5. Had breast cancer surgery",
"criterions": [
{
"exact_snippets": "Had breast cancer surgery",
"criterion": "breast cancer surgery",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "6. no evidence of recurrent or metastatic disease.",
"criterions": [
{
"exact_snippets": "no evidence of recurrent ... disease",
"criterion": "recurrent disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "no evidence of ... metastatic disease",
"criterion": "metastatic disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "Must care for women who have breast cancer. Can be surgeons, surgical oncologists, medical and/or radiation oncologists",
"criterions": [
{
"exact_snippets": "women who have breast cancer",
"criterion": "breast cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Can be surgeons, surgical oncologists, medical and/or radiation oncologists",
"criterion": "care provider type",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"surgeons",
"surgical oncologists",
"medical oncologists",
"radiation oncologists"
]
}
]
}
]
},
{
"line": "Patients for Surgical Decision Making Pilot",
"criterions": [
{
"exact_snippets": "Surgical Decision Making Pilot",
"criterion": "participation in Surgical Decision Making Pilot",
"requirements": [
{
"requirement_type": "participation",
"expected_value": true
}
]
}
]
},
{
"line": "1. Women with newly-diagnosed, unilateral Stage 0-3 breast cancer",
"criterions": [
{
"exact_snippets": "Women",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "female"
}
]
},
{
"exact_snippets": "newly-diagnosed",
"criterion": "diagnosis status",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "newly-diagnosed"
}
]
},
{
"exact_snippets": "unilateral",
"criterion": "cancer laterality",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "unilateral"
}
]
},
{
"exact_snippets": "Stage 0-3 breast cancer",
"criterion": "breast cancer stage",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "Stage"
},
{
"operator": "<=",
"value": 3,
"unit": "Stage"
}
]
}
}
]
}
]
},
{
"line": "2. Between the ages of 18 and 40",
"criterions": [
{
"exact_snippets": "Between the ages of 18 and 40",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 40,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "3. Who are seen by a surgeon at DFCI/BWH or Faulkner Hospital",
"criterions": [
{
"exact_snippets": "seen by a surgeon at DFCI/BWH or Faulkner Hospital",
"criterion": "surgeon consultation",
"requirements": [
{
"requirement_type": "location",
"expected_value": [
"DFCI/BWH",
"Faulkner Hospital"
]
}
]
}
]
},
{
"line": "4. English speaking",
"criterions": [
{
"exact_snippets": "English speaking",
"criterion": "language",
"requirements": [
{
"requirement_type": "proficiency",
"expected_value": "English"
}
]
}
]
},
{
"line": "5. Have not yet had their primary breast cancer surgery",
"criterions": [
{
"exact_snippets": "Have not yet had their primary breast cancer surgery",
"criterion": "primary breast cancer surgery",
"requirements": [
{
"requirement_type": "completion",
"expected_value": false
}
]
}
]
},
{
"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"
}
}
]
}
]
},
{
"line": "Must have maximum age of 80 Years",
"criterions": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"line": "Providers:",
"criterions": []
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}