[96a5a0]: / output / allTrials / identified / NCT05257876_identified.json

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{
"info": {
"nct_id": "NCT05257876",
"official_title": "An Evidence-based Breathing Exercise Intervention Protocol for Chronic Pain Management in Breast Cancer Survivors: A Preliminary Randomized Controlled Trial",
"inclusion_criteria": "1. female breast cancer survivors ≥18 years age;\n2. has a confirmed diagnosis of breast cancer at stage I, II or IIIa;\n3. has been experiencing pain since cancer diagnosis constantly or intermittently for ≥3 months, with the average pain intensity in the last seven days on a numerical scale ≥4/10 (\"0\" indicates no pain and \"10\" indicates the worst pain);\n4. has completed active anticancer treatment (such as chemotherapy, radiotherapy, surgery) for at least three months;\n5. agrees to participate in the research and is willing to give informed consent;\n6. can read and understand Mandarin Chinese.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "1. extremely weak and unable to perform the breathing exercises;\n2. mentally incapable (i.e., unable to follow the study instructions);\n3. has scheduled pain management interventions, such as having a procedure or operation;\n4. receiving other pain relief treatments, such as acupuncture, yoga, qigong, exercise program, etc.;\n5. has any pre-existing chronic pain conditions before cancer diagnosis, such as arthritis, rheumatoid arthritis, chronic low back pain, migraines, trigeminal neuralgia, fibromyalgia, joint dysfunction, Complex Regional Pain Syndrome, endometriosis, etc.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. female breast cancer survivors ≥18 years age;",
"criterions": [
{
"exact_snippets": "female breast cancer survivors",
"criterion": "breast cancer survivor",
"requirements": [
{
"requirement_type": "gender",
"expected_value": "female"
}
]
},
{
"exact_snippets": "≥18 years age",
"criterion": "age",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "2. has a confirmed diagnosis of breast cancer at stage I, II or IIIa;",
"criterions": [
{
"exact_snippets": "confirmed diagnosis of breast cancer",
"criterion": "breast cancer diagnosis",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": true
}
]
},
{
"exact_snippets": "stage I, II or IIIa",
"criterion": "breast cancer stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"I",
"II",
"IIIa"
]
}
]
}
]
},
{
"line": "3. has been experiencing pain since cancer diagnosis constantly or intermittently for ≥3 months, with the average pain intensity in the last seven days on a numerical scale ≥4/10 (\"0\" indicates no pain and \"10\" indicates the worst pain);",
"criterions": [
{
"exact_snippets": "has been experiencing pain since cancer diagnosis",
"criterion": "pain since cancer diagnosis",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3,
"unit": "months"
}
]
}
}
]
},
{
"exact_snippets": "average pain intensity in the last seven days on a numerical scale ≥4/10",
"criterion": "average pain intensity",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "/10"
}
}
]
}
]
},
{
"line": "4. has completed active anticancer treatment (such as chemotherapy, radiotherapy, surgery) for at least three months;",
"criterions": [
{
"exact_snippets": "has completed active anticancer treatment (such as chemotherapy, radiotherapy, surgery)",
"criterion": "completion of active anticancer treatment",
"requirements": [
{
"requirement_type": "time since completion",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
]
}
]
},
{
"line": "5. agrees to participate in the research and is willing to give informed consent;",
"criterions": [
{
"exact_snippets": "agrees to participate in the research",
"criterion": "participation agreement",
"requirements": [
{
"requirement_type": "agreement",
"expected_value": true
}
]
},
{
"exact_snippets": "willing to give informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
}
]
}
]
},
{
"line": "6. can read and understand Mandarin Chinese.",
"criterions": [
{
"exact_snippets": "can read and understand Mandarin Chinese",
"criterion": "Mandarin Chinese language proficiency",
"requirements": [
{
"requirement_type": "ability",
"expected_value": [
"read",
"understand"
]
}
]
}
]
},
{
"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"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "1. extremely weak and unable to perform the breathing exercises;",
"criterions": [
{
"exact_snippets": "extremely weak",
"criterion": "physical strength",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "extremely weak"
}
]
},
{
"exact_snippets": "unable to perform the breathing exercises",
"criterion": "ability to perform breathing exercises",
"requirements": [
{
"requirement_type": "ability",
"expected_value": false
}
]
}
]
},
{
"line": "2. mentally incapable (i.e., unable to follow the study instructions);",
"criterions": [
{
"exact_snippets": "mentally incapable (i.e., unable to follow the study instructions)",
"criterion": "mental capability",
"requirements": [
{
"requirement_type": "capability",
"expected_value": false
}
]
}
]
},
{
"line": "3. has scheduled pain management interventions, such as having a procedure or operation;",
"criterions": [
{
"exact_snippets": "scheduled pain management interventions",
"criterion": "pain management interventions",
"requirements": [
{
"requirement_type": "scheduled",
"expected_value": true
}
]
},
{
"exact_snippets": "having a procedure or operation",
"criterion": "procedure or operation",
"requirements": [
{
"requirement_type": "scheduled",
"expected_value": true
}
]
}
]
},
{
"line": "4. receiving other pain relief treatments, such as acupuncture, yoga, qigong, exercise program, etc.;",
"criterions": [
{
"exact_snippets": "receiving other pain relief treatments, such as acupuncture, yoga, qigong, exercise program, etc.",
"criterion": "other pain relief treatments",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "5. has any pre-existing chronic pain conditions before cancer diagnosis, such as arthritis, rheumatoid arthritis, chronic low back pain, migraines, trigeminal neuralgia, fibromyalgia, joint dysfunction, Complex Regional Pain Syndrome, endometriosis, etc.",
"criterions": [
{
"exact_snippets": "pre-existing chronic pain conditions before cancer diagnosis",
"criterion": "pre-existing chronic pain conditions",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "arthritis",
"criterion": "arthritis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "rheumatoid arthritis",
"criterion": "rheumatoid arthritis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "chronic low back pain",
"criterion": "chronic low back pain",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "migraines",
"criterion": "migraines",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "trigeminal neuralgia",
"criterion": "trigeminal neuralgia",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "fibromyalgia",
"criterion": "fibromyalgia",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "joint dysfunction",
"criterion": "joint dysfunction",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Complex Regional Pain Syndrome",
"criterion": "Complex Regional Pain Syndrome",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "endometriosis",
"criterion": "endometriosis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}