{
"info": {
"nct_id": "NCT04716920",
"official_title": "Tai Chi for Relieving Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Patients",
"inclusion_criteria": "* Be able to speak and read English\n* Been diagnosed with stage I-III breast cancer (BC)\n* Had completed all active treatments\n* Had been receiving an AI (anastrozole, letrozole, or exemestane) for at least 3 months\n* Had joint (knee, hand or hip) pain or stiffness that started or worsened after the initiation of AI\n* Report worst pain in the past week >= 4 on a 0-10 numeric rating scale\n* Be willing to adhere to all study procedures\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Has been diagnosed with another form of cancer in the past 5 years\n* Uncontrolled cardiac, pulmonary, or infectious disease\n* Body mass index (BMI) > 40 kg/m^2\n* Currently attending any mind-body therapy classes (e.g. yoga)\n* Joint pain due to inflammatory arthritic condition (such as rheumatoid arthritis, osteoarthritis or gout, which will be assessed during eligibility screening with patient self-reported data and will be screened through electronic medical record [EMR] data)\n* Had surgery or joint infection in the past 6 months\n* Currently taking corticosteroids or opioids, have discontinued or plan to discontinue AI in the next 6 months",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Be able to speak and read English",
"criterions": [
{
"exact_snippets": "speak and read English",
"criterion": "English language proficiency",
"requirement": {
"requirement_type": "ability",
"expected_value": [
"speak",
"read"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "speak and read English",
"criterion": "English language proficiency",
"requirement": {
"requirement_type": "ability",
"expected_value": [
"speak",
"read"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Been diagnosed with stage I-III breast cancer (BC)",
"criterions": [
{
"exact_snippets": "diagnosed with stage I-III breast cancer (BC)",
"criterion": "breast cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "N/A"
},
{
"operator": "<=",
"value": 3,
"unit": "N/A"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "diagnosed with stage I-III breast cancer (BC)",
"criterion": "breast cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "N/A"
},
{
"operator": "<=",
"value": 3,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Had completed all active treatments",
"criterions": [
{
"exact_snippets": "completed all active treatments",
"criterion": "active treatment completion",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "completed all active treatments",
"criterion": "active treatment completion",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Had been receiving an AI (anastrozole, letrozole, or exemestane) for at least 3 months",
"criterions": [
{
"exact_snippets": "receiving an AI (anastrozole, letrozole, or exemestane)",
"criterion": "aromatase inhibitor (AI) therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "at least 3 months",
"criterion": "duration of AI therapy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "receiving an AI (anastrozole, letrozole, or exemestane)",
"criterion": "aromatase inhibitor (AI) therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "at least 3 months",
"criterion": "duration of AI therapy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Had joint (knee, hand or hip) pain or stiffness that started or worsened after the initiation of AI",
"criterions": [
{
"exact_snippets": "joint (knee, hand or hip) pain or stiffness",
"criterion": "joint pain or stiffness",
"requirement": {
"requirement_type": "location",
"expected_value": [
"knee",
"hand",
"hip"
]
}
},
{
"exact_snippets": "started or worsened after the initiation of AI",
"criterion": "onset or worsening of joint pain or stiffness",
"requirement": {
"requirement_type": "timing",
"expected_value": "after the initiation of AI"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "joint (knee, hand or hip) pain or stiffness",
"criterion": "joint pain or stiffness",
"requirement": {
"requirement_type": "location",
"expected_value": [
"knee",
"hand",
"hip"
]
}
},
{
"exact_snippets": "started or worsened after the initiation of AI",
"criterion": "onset or worsening of joint pain or stiffness",
"requirement": {
"requirement_type": "timing",
"expected_value": "after the initiation of AI"
}
}
]
}
},
{
"identified_line": {
"line": "* Report worst pain in the past week >= 4 on a 0-10 numeric rating scale",
"criterions": [
{
"exact_snippets": "worst pain in the past week >= 4 on a 0-10 numeric rating scale",
"criterion": "worst pain",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "0-10 numeric rating scale"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "worst pain in the past week >= 4 on a 0-10 numeric rating scale",
"criterion": "worst pain",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "0-10 numeric rating scale"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Be willing to adhere to all study procedures",
"criterions": [
{
"exact_snippets": "willing to adhere to all study procedures",
"criterion": "adherence to study procedures",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "willing to adhere to all study procedures",
"criterion": "adherence to study procedures",
"requirement": {
"requirement_type": "willingness",
"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 FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"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"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Has been diagnosed with another form of cancer in the past 5 years",
"criterions": [
{
"exact_snippets": "diagnosed with another form of cancer in the past 5 years",
"criterion": "another form of cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "diagnosed with another form of cancer in the past 5 years",
"criterion": "another form of cancer",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "diagnosed with another form of cancer in the past 5 years",
"criterion": "another form of cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "diagnosed with another form of cancer in the past 5 years",
"criterion": "another form of cancer",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Uncontrolled cardiac, pulmonary, or infectious disease",
"criterions": [
{
"exact_snippets": "Uncontrolled cardiac ... disease",
"criterion": "cardiac disease",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "Uncontrolled ... pulmonary ... disease",
"criterion": "pulmonary disease",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "Uncontrolled ... infectious disease",
"criterion": "infectious disease",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Uncontrolled cardiac ... disease",
"criterion": "cardiac disease",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "Uncontrolled ... pulmonary ... disease",
"criterion": "pulmonary disease",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "Uncontrolled ... infectious disease",
"criterion": "infectious disease",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
}
]
}
},
{
"identified_line": {
"line": "* Body mass index (BMI) > 40 kg/m^2",
"criterions": [
{
"exact_snippets": "Body mass index (BMI) > 40 kg/m^2",
"criterion": "body mass index (BMI)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 40,
"unit": "kg/m^2"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Body mass index (BMI) > 40 kg/m^2",
"criterion": "body mass index (BMI)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 40,
"unit": "kg/m^2"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Currently attending any mind-body therapy classes (e.g. yoga)",
"criterions": [
{
"exact_snippets": "Currently attending any mind-body therapy classes (e.g. yoga)",
"criterion": "mind-body therapy classes attendance",
"requirement": {
"requirement_type": "attendance",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Currently attending any mind-body therapy classes (e.g. yoga)",
"criterion": "mind-body therapy classes attendance",
"requirement": {
"requirement_type": "attendance",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Joint pain due to inflammatory arthritic condition (such as rheumatoid arthritis, osteoarthritis or gout, which will be assessed during eligibility screening with patient self-reported data and will be screened through electronic medical record [EMR] data)",
"criterions": [
{
"exact_snippets": "Joint pain due to inflammatory arthritic condition (such as rheumatoid arthritis, osteoarthritis or gout",
"criterion": "inflammatory arthritic condition",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Joint pain",
"criterion": "joint pain",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Joint pain due to inflammatory arthritic condition (such as rheumatoid arthritis, osteoarthritis or gout",
"criterion": "inflammatory arthritic condition",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Joint pain",
"criterion": "joint pain",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Had surgery or joint infection in the past 6 months",
"criterions": [
{
"exact_snippets": "Had surgery ... in the past 6 months",
"criterion": "surgery",
"requirement": {
"requirement_type": "recency",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
},
{
"exact_snippets": "joint infection in the past 6 months",
"criterion": "joint infection",
"requirement": {
"requirement_type": "recency",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Had surgery ... in the past 6 months",
"criterion": "surgery",
"requirement": {
"requirement_type": "recency",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
},
{
"exact_snippets": "joint infection in the past 6 months",
"criterion": "joint infection",
"requirement": {
"requirement_type": "recency",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Currently taking corticosteroids or opioids, have discontinued or plan to discontinue AI in the next 6 months",
"criterions": [
{
"exact_snippets": "Currently taking corticosteroids",
"criterion": "corticosteroid use",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Currently taking ... opioids",
"criterion": "opioid use",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "have discontinued ... AI",
"criterion": "AI discontinuation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "plan to discontinue AI in the next 6 months",
"criterion": "AI discontinuation plan",
"requirement": {
"requirement_type": "timeframe",
"expected_value": "next 6 months"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Currently taking corticosteroids",
"criterion": "corticosteroid use",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Currently taking ... opioids",
"criterion": "opioid use",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "have discontinued ... AI",
"criterion": "AI discontinuation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "plan to discontinue AI in the next 6 months",
"criterion": "AI discontinuation plan",
"requirement": {
"requirement_type": "timeframe",
"expected_value": "next 6 months"
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}