{
    "info": {
        "nct_id": "NCT04837820",
        "official_title": "Effect and Mechanism of Acupuncture for Cancer-related Cognitive Difficulties (ENHANCE)",
        "inclusion_criteria": "* English-proficient adult women with a history of stage 0, I, II, or III breast cancer\n* Free of oncologic disease by clinical examination or history\n* Moderate or greater CRCD as indicated by a score of \"quite a bit\" or \"very much\" on at least one of the two items that specifically assess concentration and memory on the EORTC QLQ-C30 (version 3.0)\n* Report that cognitive functions worsened since cancer diagnosis by replying \"Yes\" to all 3 questions\n\n  * Do you think or feel that your memory or mental ability has gotten worse since your cancer diagnosis?\n  * Do you think your mind isn't as sharp now as it was before your cancer diagnosis?\n  * Do you feel like these problems have made it harder to function on your job or take care of things around the home?\n* Presence of insomnia symptoms as indicated by a score ≥8 on the ISI134\n* Willing to adhere to all study-related procedures, including randomization to one of the 3 possible choices: acupuncture, sham acupuncture, or wait-list control\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Metastatic breast cancer (stage IV)\n* Less than 1 month since completion of surgery, chemotherapy or radiation therapy\n* Greater than 10 years since most recent breast cancer diagnosis\n* Use of acupuncture for sleep or cognitive symptom management within the past 3 months\n* Diagnosis of Alzheimer's disease, vascular dementia, Parkinson disease, or other organic brain disorder\n* Score of >10 indicative of overt dementia on the Blessed Orientation-Memory-Concentration (BOMC)135\n* Primary psychiatric disorder not in remission\n* As per medical record or self-report, history of stroke or head injury requiring visit to the emergency room or hospitalization, with confirmed structural lesion on neuroimaging, persistent cognitive difficulties impacting work or daily life, or required cognitive rehabilitation.\n* Pre-existing, uncorrectable visual or auditory impairment that would preclude ability to complete the assessments\n* Initiation or change in hormonal or targeted therapy within the past 4 weeks\n* Plans to initiate or change hormonal or targeted therapy in the coming 8 weeks\n* Altered dose of somnogenic medication (e.g. hypnotics, sedatives, antidepressants) in past 8 weeks\n* Enrolled or plans to enroll on another MSK neurocognitive study\n* Unable to provide informed consent for himself/herself",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* English-proficient adult women with a history of stage 0, I, II, or III breast cancer",
            "criterions": [
                {
                    "exact_snippets": "English-proficient",
                    "criterion": "language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "language",
                            "expected_value": "English"
                        }
                    ]
                },
                {
                    "exact_snippets": "adult women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "adult women",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age group",
                            "expected_value": "adult"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of stage 0, I, II, or III breast cancer",
                    "criterion": "breast cancer history",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "0",
                                "I",
                                "II",
                                "III"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Free of oncologic disease by clinical examination or history",
            "criterions": [
                {
                    "exact_snippets": "Free of oncologic disease by clinical examination or history",
                    "criterion": "oncologic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Moderate or greater CRCD as indicated by a score of \"quite a bit\" or \"very much\" on at least one of the two items that specifically assess concentration and memory on the EORTC QLQ-C30 (version 3.0)",
            "criterions": [
                {
                    "exact_snippets": "Moderate or greater CRCD as indicated by a score of \"quite a bit\" or \"very much\" on at least one of the two items that specifically assess concentration and memory on the EORTC QLQ-C30 (version 3.0)",
                    "criterion": "CRCD (Cognitive-Related Cognitive Dysfunction)",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "quite a bit",
                                "very much"
                            ]
                        },
                        {
                            "requirement_type": "assessment tool",
                            "expected_value": "EORTC QLQ-C30 (version 3.0)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Report that cognitive functions worsened since cancer diagnosis by replying \"Yes\" to all 3 questions",
            "criterions": [
                {
                    "exact_snippets": "cognitive functions worsened since cancer diagnosis",
                    "criterion": "cognitive function",
                    "requirements": [
                        {
                            "requirement_type": "change since cancer diagnosis",
                            "expected_value": "worsened"
                        }
                    ]
                },
                {
                    "exact_snippets": "replying \"Yes\" to all 3 questions",
                    "criterion": "response to questions",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "Yes to all 3 questions"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Do you think or feel that your memory or mental ability has gotten worse since your cancer diagnosis?",
            "criterions": [
                {
                    "exact_snippets": "memory or mental ability has gotten worse since your cancer diagnosis",
                    "criterion": "memory or mental ability",
                    "requirements": [
                        {
                            "requirement_type": "change",
                            "expected_value": "worse since cancer diagnosis"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Do you think your mind isn't as sharp now as it was before your cancer diagnosis?",
            "criterions": [
                {
                    "exact_snippets": "mind isn't as sharp now as it was before your cancer diagnosis",
                    "criterion": "cognitive sharpness",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": "decline since cancer diagnosis"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Do you feel like these problems have made it harder to function on your job or take care of things around the home?",
            "criterions": [
                {
                    "exact_snippets": "harder to function on your job",
                    "criterion": "functioning at job",
                    "requirements": [
                        {
                            "requirement_type": "difficulty",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "take care of things around the home",
                    "criterion": "functioning at home",
                    "requirements": [
                        {
                            "requirement_type": "difficulty",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of insomnia symptoms as indicated by a score ≥8 on the ISI134",
            "criterions": [
                {
                    "exact_snippets": "Presence of insomnia symptoms as indicated by a score ≥8 on the ISI134",
                    "criterion": "insomnia symptoms",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "ISI134 score"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing to adhere to all study-related procedures, including randomization to one of the 3 possible choices: acupuncture, sham acupuncture, or wait-list control",
            "criterions": [
                {
                    "exact_snippets": "Willing to adhere to all study-related procedures",
                    "criterion": "willingness to adhere to study procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "randomization to one of the 3 possible choices: acupuncture, sham acupuncture, or wait-list control",
                    "criterion": "randomization acceptance",
                    "requirements": [
                        {
                            "requirement_type": "acceptance",
                            "expected_value": [
                                "acupuncture",
                                "sham acupuncture",
                                "wait-list control"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Metastatic breast cancer (stage IV)",
            "criterions": [
                {
                    "exact_snippets": "Metastatic breast cancer (stage IV)",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        },
                        {
                            "requirement_type": "metastatic",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Less than 1 month since completion of surgery, chemotherapy or radiation therapy",
            "criterions": [
                {
                    "exact_snippets": "Less than 1 month since completion of surgery",
                    "criterion": "time since surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Less than 1 month since completion of ... chemotherapy",
                    "criterion": "time since chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Less than 1 month since completion of ... radiation therapy",
                    "criterion": "time since radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Greater than 10 years since most recent breast cancer diagnosis",
            "criterions": [
                {
                    "exact_snippets": "Greater than 10 years since most recent breast cancer diagnosis",
                    "criterion": "time since most recent breast cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "time",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of acupuncture for sleep or cognitive symptom management within the past 3 months",
            "criterions": [
                {
                    "exact_snippets": "Use of acupuncture for sleep ... within the past 3 months",
                    "criterion": "acupuncture for sleep management",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the past 3 months"
                        }
                    ]
                },
                {
                    "exact_snippets": "Use of acupuncture for ... cognitive symptom management within the past 3 months",
                    "criterion": "acupuncture for cognitive symptom management",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the past 3 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of Alzheimer's disease, vascular dementia, Parkinson disease, or other organic brain disorder",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of Alzheimer's disease",
                    "criterion": "Alzheimer's disease",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis of ... vascular dementia",
                    "criterion": "vascular dementia",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis of ... Parkinson disease",
                    "criterion": "Parkinson disease",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis of ... other organic brain disorder",
                    "criterion": "organic brain disorder",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Score of >10 indicative of overt dementia on the Blessed Orientation-Memory-Concentration (BOMC)135",
            "criterions": [
                {
                    "exact_snippets": "Score of >10 indicative of overt dementia on the Blessed Orientation-Memory-Concentration (BOMC)",
                    "criterion": "Blessed Orientation-Memory-Concentration (BOMC) score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Primary psychiatric disorder not in remission",
            "criterions": [
                {
                    "exact_snippets": "Primary psychiatric disorder not in remission",
                    "criterion": "primary psychiatric disorder",
                    "requirements": [
                        {
                            "requirement_type": "remission status",
                            "expected_value": "not in remission"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* As per medical record or self-report, history of stroke or head injury requiring visit to the emergency room or hospitalization, with confirmed structural lesion on neuroimaging, persistent cognitive difficulties impacting work or daily life, or required cognitive rehabilitation.",
            "criterions": [
                {
                    "exact_snippets": "history of stroke",
                    "criterion": "history of stroke",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... head injury requiring visit to the emergency room or hospitalization",
                    "criterion": "history of head injury",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "requiring visit to the emergency room or hospitalization"
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed structural lesion on neuroimaging",
                    "criterion": "structural lesion on neuroimaging",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "persistent cognitive difficulties impacting work or daily life",
                    "criterion": "persistent cognitive difficulties",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": [
                                "work",
                                "daily life"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "required cognitive rehabilitation",
                    "criterion": "cognitive rehabilitation",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pre-existing, uncorrectable visual or auditory impairment that would preclude ability to complete the assessments",
            "criterions": [
                {
                    "exact_snippets": "Pre-existing, uncorrectable visual ... impairment",
                    "criterion": "visual impairment",
                    "requirements": [
                        {
                            "requirement_type": "correctability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Pre-existing, uncorrectable ... auditory impairment",
                    "criterion": "auditory impairment",
                    "requirements": [
                        {
                            "requirement_type": "correctability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Initiation or change in hormonal or targeted therapy within the past 4 weeks",
            "criterions": [
                {
                    "exact_snippets": "Initiation or change in hormonal or targeted therapy within the past 4 weeks",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "initiation or change",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Initiation or change in hormonal or targeted therapy within the past 4 weeks",
                    "criterion": "targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "initiation or change",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Plans to initiate or change hormonal or targeted therapy in the coming 8 weeks",
            "criterions": [
                {
                    "exact_snippets": "Plans to initiate or change hormonal or targeted therapy",
                    "criterion": "hormonal or targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "initiation or change",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in the coming 8 weeks",
                    "criterion": "timeframe for therapy change",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Altered dose of somnogenic medication (e.g. hypnotics, sedatives, antidepressants) in past 8 weeks",
            "criterions": [
                {
                    "exact_snippets": "Altered dose of somnogenic medication (e.g. hypnotics, sedatives, antidepressants) in past 8 weeks",
                    "criterion": "dose of somnogenic medication",
                    "requirements": [
                        {
                            "requirement_type": "alteration",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "past 8 weeks"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Enrolled or plans to enroll on another MSK neurocognitive study",
            "criterions": [
                {
                    "exact_snippets": "Enrolled or plans to enroll on another MSK neurocognitive study",
                    "criterion": "enrollment in another MSK neurocognitive study",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "enrolled",
                                "plans to enroll"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable to provide informed consent for himself/herself",
            "criterions": [
                {
                    "exact_snippets": "Unable to provide informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}