{
"info": {
"nct_id": "NCT06595901",
"official_title": "Characterizing Mental and Cognitive Health and Physical Activity in the Perioperative Breast Cancer Setting",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "Eligibility Criteria Patients:\n\n* A physician-confirmed diagnosis of breast cancer (stage I-III)\n* Female over the age of 18\n* Scheduled to receive curative-intent breast surgery and chemotherapy (neoadjuvant or adjuvant)\n* Able to understand and willing to sign an Institutional Review Board (IRB)-approved informed consent document. Given documented mental and cognitive health declines after both neoadjuvant and adjuvant treatment regimens, the investigators are including both patient populations in this exploratory study. Patients of all baseline anxiety, depression, cognitive function, and physical activity levels are eligible to participate.\n\nEligibility Criteria Stakeholders:\n\n* Healthcare personnel with a staked interest in patient care during chemotherapy, including but not limited to surgical oncologists, medical oncologists, physical and occupational therapists, nurses, patient navigators, dietitians, and exercise physiologists\n* Able to understand and willing to sign an IRB-approved informed consent document"
},
"inclusion_lines": [
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"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": [],
"miscellaneous_lines": [
{
"line": "* A physician-confirmed diagnosis of breast cancer (stage I-III)",
"criterions": [
{
"exact_snippets": "physician-confirmed diagnosis of breast cancer",
"criterion": "breast cancer diagnosis",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": "physician-confirmed"
}
]
},
{
"exact_snippets": "stage I-III",
"criterion": "breast cancer stage",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "stage"
},
{
"operator": "<=",
"value": 3,
"unit": "stage"
}
]
}
}
]
}
]
},
{
"line": "* Female over the age of 18",
"criterions": [
{
"exact_snippets": "Female",
"criterion": "gender",
"requirements": [
{
"requirement_type": "value",
"expected_value": "female"
}
]
},
{
"exact_snippets": "over the age of 18",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Scheduled to receive curative-intent breast surgery and chemotherapy (neoadjuvant or adjuvant)",
"criterions": [
{
"exact_snippets": "Scheduled to receive curative-intent breast surgery",
"criterion": "curative-intent breast surgery",
"requirements": [
{
"requirement_type": "scheduled",
"expected_value": true
}
]
},
{
"exact_snippets": "Scheduled to receive ... chemotherapy (neoadjuvant or adjuvant)",
"criterion": "chemotherapy",
"requirements": [
{
"requirement_type": "scheduled",
"expected_value": true
},
{
"requirement_type": "type",
"expected_value": [
"neoadjuvant",
"adjuvant"
]
}
]
}
]
},
{
"line": "* Able to understand and willing to sign an Institutional Review Board (IRB)-approved informed consent document. Given documented mental and cognitive health declines after both neoadjuvant and adjuvant treatment regimens, the investigators are including both patient populations in this exploratory study. Patients of all baseline anxiety, depression, cognitive function, and physical activity levels are eligible to participate.",
"criterions": [
{
"exact_snippets": "Able to understand and willing to sign an Institutional Review Board (IRB)-approved informed consent document.",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "understanding",
"expected_value": true
},
{
"requirement_type": "willingness",
"expected_value": true
}
]
},
{
"exact_snippets": "Patients of all baseline anxiety ... levels are eligible to participate.",
"criterion": "baseline anxiety",
"requirements": [
{
"requirement_type": "level",
"expected_value": "all"
}
]
},
{
"exact_snippets": "Patients of all baseline ... depression ... levels are eligible to participate.",
"criterion": "baseline depression",
"requirements": [
{
"requirement_type": "level",
"expected_value": "all"
}
]
},
{
"exact_snippets": "Patients of all baseline ... cognitive function ... levels are eligible to participate.",
"criterion": "baseline cognitive function",
"requirements": [
{
"requirement_type": "level",
"expected_value": "all"
}
]
},
{
"exact_snippets": "Patients of all baseline ... physical activity levels are eligible to participate.",
"criterion": "baseline physical activity",
"requirements": [
{
"requirement_type": "level",
"expected_value": "all"
}
]
}
]
},
{
"line": "* Healthcare personnel with a staked interest in patient care during chemotherapy, including but not limited to surgical oncologists, medical oncologists, physical and occupational therapists, nurses, patient navigators, dietitians, and exercise physiologists",
"criterions": [
{
"exact_snippets": "Healthcare personnel with a staked interest in patient care during chemotherapy",
"criterion": "healthcare personnel",
"requirements": [
{
"requirement_type": "interest",
"expected_value": "staked interest in patient care during chemotherapy"
}
]
},
{
"exact_snippets": "surgical oncologists",
"criterion": "profession",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "medical oncologists",
"criterion": "profession",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "physical and occupational therapists",
"criterion": "profession",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "nurses",
"criterion": "profession",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "patient navigators",
"criterion": "profession",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "dietitians",
"criterion": "profession",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "exercise physiologists",
"criterion": "profession",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Able to understand and willing to sign an IRB-approved informed consent document",
"criterions": [
{
"exact_snippets": "Able to understand",
"criterion": "cognitive ability",
"requirements": [
{
"requirement_type": "understanding",
"expected_value": true
}
]
},
{
"exact_snippets": "willing to sign",
"criterion": "willingness to participate",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
}
]
},
{
"exact_snippets": "IRB-approved informed consent document",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "approval",
"expected_value": "IRB-approved"
}
]
}
]
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"line": "Eligibility Criteria Patients:",
"criterions": []
},
{
"line": "Eligibility Criteria Stakeholders:",
"criterions": []
}
]
}