{
"info": {
"nct_id": "NCT05200572",
"official_title": "Feasibility of a Dyadic Life Review Intervention for Older Patients with Advanced Cancer and Mild Cognitive Impairment (MCI) and Their Caregivers",
"inclusion_criteria": "* Age ≥ 65\n* Able to provide informed consent. All patients will be assessed using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) 56 - a score >14.5 will define ability to independently provide informed consent.\n* Eligible patients have Stage III or IV cancer of any type\n* Additionally, at least 20 patients will have a will have a high likelihood of MCI based on screening score of <26 on the Montreal Cognitive Assessment (MoCA) within their eRecord chart.\n* Able to read and understand English\n\nPatient\nHealthy volunteers allowed\nMust have minimum age of 50 Years",
"exclusion_criteria": "* Patients scoring <14.5 on the UBACC\n* Unable to identify caregiver to participate in study\n\nCaregiver Inclusion Criteria:\n\n* One caregiver for each patient will be eligible and must be chosen by the patient. For the purposes of this study, a caregiver is defined as a valued and trusted person in a patient's life who is supportive in health care matters by providing valuable social support and/or direct assistive care.\n* Caregivers will be selected by the patient when asked if there is a \"family member, partner, friend or caregiver with whom you discuss or who can be helpful in health-related matters;\" patients who cannot identify such a person (\"caregiver\") will remain eligible for the study.\n* Age 50 or older\n* Ability to provide consent\n* Proficient in English\n\nCaregiver Exclusion Criteria\n\n* Caregivers unable to understand the consent form due to cognitive, health or sensory impairment will be excluded",
"miscellaneous_criteria": "Patient"
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Age ≥ 65",
"criterions": [
{
"exact_snippets": "Age ≥ 65",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 65,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age ≥ 65",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 65,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Able to provide informed consent. All patients will be assessed using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) 56 - a score >14.5 will define ability to independently provide informed consent.",
"criterions": [
{
"exact_snippets": "Able to provide informed consent",
"criterion": "informed consent ability",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "a score >14.5 will define ability to independently provide informed consent",
"criterion": "UBACC score",
"requirement": {
"requirement_type": "score",
"expected_value": {
"operator": ">",
"value": 14.5,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "a score >14.5 will define ability to independently provide informed consent",
"criterion": "UBACC score",
"requirement": {
"requirement_type": "score",
"expected_value": {
"operator": ">",
"value": 14.5,
"unit": "N/A"
}
}
},
"then_criteria": {
"exact_snippets": "Able to provide informed consent",
"criterion": "informed consent ability",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Additionally, at least 20 patients will have a will have a high likelihood of MCI based on screening score of <26 on the Montreal Cognitive Assessment (MoCA) within their eRecord chart.",
"criterions": [
{
"exact_snippets": "screening score of <26 on the Montreal Cognitive Assessment (MoCA)",
"criterion": "Montreal Cognitive Assessment (MoCA) score",
"requirement": {
"requirement_type": "score",
"expected_value": {
"operator": "<",
"value": 26,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "screening score of <26 on the Montreal Cognitive Assessment (MoCA)",
"criterion": "Montreal Cognitive Assessment (MoCA) score",
"requirement": {
"requirement_type": "score",
"expected_value": {
"operator": "<",
"value": 26,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Able to read and understand English",
"criterions": [
{
"exact_snippets": "Able to read and understand English",
"criterion": "English language proficiency",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Able to read and understand English",
"criterion": "English language proficiency",
"requirement": {
"requirement_type": "ability",
"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 have minimum age of 50 Years",
"criterions": [
{
"exact_snippets": "minimum age of 50 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 50 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Patient",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Patients scoring <14.5 on the UBACC",
"criterions": [
{
"exact_snippets": "scoring <14.5 on the UBACC",
"criterion": "UBACC score",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 14.5,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "scoring <14.5 on the UBACC",
"criterion": "UBACC score",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 14.5,
"unit": "N/A"
}
}
}
}
},
{
"identified_line": {
"line": "* Unable to identify caregiver to participate in study",
"criterions": [
{
"exact_snippets": "Unable to identify caregiver to participate in study",
"criterion": "caregiver identification",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Unable to identify caregiver to participate in study",
"criterion": "caregiver identification",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* One caregiver for each patient will be eligible and must be chosen by the patient. For the purposes of this study, a caregiver is defined as a valued and trusted person in a patient's life who is supportive in health care matters by providing valuable social support and/or direct assistive care.",
"criterions": [
{
"exact_snippets": "One caregiver for each patient will be eligible",
"criterion": "caregiver eligibility",
"requirement": {
"requirement_type": "quantity",
"expected_value": true
}
},
{
"exact_snippets": "must be chosen by the patient",
"criterion": "caregiver selection",
"requirement": {
"requirement_type": "selection",
"expected_value": "chosen by the patient"
}
},
{
"exact_snippets": "a caregiver is defined as a valued and trusted person in a patient's life",
"criterion": "caregiver definition",
"requirement": {
"requirement_type": "attributes",
"expected_value": [
"valued",
"trusted"
]
}
},
{
"exact_snippets": "supportive in health care matters by providing valuable social support and/or direct assistive care",
"criterion": "caregiver role",
"requirement": {
"requirement_type": "role",
"expected_value": [
"social support",
"direct assistive care"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "One caregiver for each patient will be eligible",
"criterion": "caregiver eligibility",
"requirement": {
"requirement_type": "quantity",
"expected_value": true
}
},
{
"exact_snippets": "must be chosen by the patient",
"criterion": "caregiver selection",
"requirement": {
"requirement_type": "selection",
"expected_value": "chosen by the patient"
}
}
]
},
{
"exact_snippets": "a caregiver is defined as a valued and trusted person in a patient's life",
"criterion": "caregiver definition",
"requirement": {
"requirement_type": "attributes",
"expected_value": [
"valued",
"trusted"
]
}
},
{
"exact_snippets": "supportive in health care matters by providing valuable social support and/or direct assistive care",
"criterion": "caregiver role",
"requirement": {
"requirement_type": "role",
"expected_value": [
"social support",
"direct assistive care"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Caregivers will be selected by the patient when asked if there is a \"family member, partner, friend or caregiver with whom you discuss or who can be helpful in health-related matters;\" patients who cannot identify such a person (\"caregiver\") will remain eligible for the study.",
"criterions": [
{
"exact_snippets": "Caregivers will be selected by the patient ... patients who cannot identify such a person (\"caregiver\") will remain eligible",
"criterion": "caregiver identification",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Caregivers will be selected by the patient ... patients who cannot identify such a person (\"caregiver\") will remain eligible",
"criterion": "caregiver identification",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* Age 50 or older",
"criterions": [
{
"exact_snippets": "Age 50 or older",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age 50 or older",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Ability to provide consent",
"criterions": [
{
"exact_snippets": "Ability to provide consent",
"criterion": "consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Ability to provide consent",
"criterion": "consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Proficient in English",
"criterions": [
{
"exact_snippets": "Proficient in English",
"criterion": "English proficiency",
"requirement": {
"requirement_type": "proficiency",
"expected_value": "proficient"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Proficient in English",
"criterion": "English proficiency",
"requirement": {
"requirement_type": "proficiency",
"expected_value": "proficient"
}
}
}
},
{
"identified_line": {
"line": "Caregiver Exclusion Criteria",
"criterions": [
{
"exact_snippets": "Caregiver Exclusion Criteria",
"criterion": "caregiver",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Caregiver Exclusion Criteria",
"criterion": "caregiver",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Caregivers unable to understand the consent form due to cognitive, health or sensory impairment will be excluded",
"criterions": [
{
"exact_snippets": "Caregivers unable to understand the consent form due to cognitive ... impairment will be excluded",
"criterion": "cognitive impairment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Caregivers unable to understand the consent form due to ... health ... impairment will be excluded",
"criterion": "health impairment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Caregivers unable to understand the consent form due to ... sensory impairment will be excluded",
"criterion": "sensory impairment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Caregivers unable to understand the consent form due to cognitive ... impairment will be excluded",
"criterion": "cognitive impairment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Caregivers unable to understand the consent form due to ... health ... impairment will be excluded",
"criterion": "health impairment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Caregivers unable to understand the consent form due to ... sensory impairment will be excluded",
"criterion": "sensory impairment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "Caregiver Inclusion Criteria:",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
}
],
"miscellaneous_lines": [
{
"identified_line": {
"line": "Patient",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
}
],
"failed_inclusion": [
{
"identified_line": {
"line": "* Eligible patients have Stage III or IV cancer of any type",
"criterions": [
{
"exact_snippets": "Stage III or IV cancer",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"III",
"IV"
]
}
},
{
"exact_snippets": "cancer of any type",
"criterion": "cancer type",
"requirement": {
"requirement_type": "type",
"expected_value": "any"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "Stage III or IV cancer",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "III"
}
},
{
"exact_snippets": "Stage III or IV cancer",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "IV"
}
}
]
},
{
"exact_snippets": "cancer of any type",
"criterion": "cancer type",
"requirement": {
"requirement_type": "type",
"expected_value": "any"
}
}
]
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}