{
"info": {
"nct_id": "NCT05590273",
"official_title": "Forgotten Voices: Addressing Unmet Needs in Brain Tumor Caregivers (AIM 2)",
"inclusion_criteria": "* Caregiver participants must be the caregiver of a brain cancer patient who is currently enrolled in DoD CA200896 (IRBHM20022755)\n* Fluent in English\n* Willing and able to attend a minimum of 3 CALM sessions via telehealth\n* A caregiver is defined as the primary person who provides ongoing support to the brain cancer patient; it is not necessary that the caregiver lives with the patient or is related\n* Patient participants must have enrolled in the linked HM20022755 study\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Person does not consider themselves to be a caregiver of the patient\n* Caregiver does not have a loved one (patient diagnosed with brain cancer) enrolled in DoDCA200896 (IRB HM20022755)\n* Caregiver does not speak English\n* Caregiver is unable to provide consent\n* Caregiver does not have access to telehealth\n* Caregiver is under the age of 18\n* Professional caregivers who received financial compensation for their services are ineligible",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Caregiver participants must be the caregiver of a brain cancer patient who is currently enrolled in DoD CA200896 (IRBHM20022755)",
"criterions": [
{
"exact_snippets": "Caregiver participants must be the caregiver of a brain cancer patient",
"criterion": "caregiver status",
"requirements": [
{
"requirement_type": "relationship",
"expected_value": "caregiver of a brain cancer patient"
}
]
},
{
"exact_snippets": "currently enrolled in DoD CA200896 (IRBHM20022755)",
"criterion": "patient enrollment",
"requirements": [
{
"requirement_type": "enrollment status",
"expected_value": "enrolled in DoD CA200896 (IRBHM20022755)"
}
]
}
]
},
{
"line": "* Fluent in English",
"criterions": [
{
"exact_snippets": "Fluent in English",
"criterion": "English fluency",
"requirements": [
{
"requirement_type": "fluency",
"expected_value": true
}
]
}
]
},
{
"line": "* Willing and able to attend a minimum of 3 CALM sessions via telehealth",
"criterions": [
{
"exact_snippets": "Willing and able to attend a minimum of 3 CALM sessions via telehealth",
"criterion": "attendance of CALM sessions",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
},
{
"requirement_type": "ability",
"expected_value": true
},
{
"requirement_type": "minimum number",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "sessions"
}
},
{
"requirement_type": "method",
"expected_value": "telehealth"
}
]
}
]
},
{
"line": "* A caregiver is defined as the primary person who provides ongoing support to the brain cancer patient; it is not necessary that the caregiver lives with the patient or is related",
"criterions": [
{
"exact_snippets": "A caregiver is defined as the primary person who provides ongoing support to the brain cancer patient",
"criterion": "caregiver",
"requirements": [
{
"requirement_type": "role",
"expected_value": "primary person who provides ongoing support to the brain cancer patient"
}
]
},
{
"exact_snippets": "it is not necessary that the caregiver lives with the patient",
"criterion": "caregiver living arrangement",
"requirements": [
{
"requirement_type": "necessity",
"expected_value": false
}
]
},
{
"exact_snippets": "it is not necessary that the caregiver ... is related",
"criterion": "caregiver relationship",
"requirements": [
{
"requirement_type": "necessity",
"expected_value": false
}
]
}
]
},
{
"line": "* Patient participants must have enrolled in the linked HM20022755 study",
"criterions": [
{
"exact_snippets": "Patient participants must have enrolled in the linked HM20022755 study",
"criterion": "enrollment in HM20022755 study",
"requirements": [
{
"requirement_type": "enrollment",
"expected_value": true
}
]
}
]
},
{
"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": [
{
"line": "* Person does not consider themselves to be a caregiver of the patient",
"criterions": [
{
"exact_snippets": "Person does not consider themselves to be a caregiver of the patient",
"criterion": "caregiver status",
"requirements": [
{
"requirement_type": "self-perception",
"expected_value": false
}
]
}
]
},
{
"line": "* Caregiver does not have a loved one (patient diagnosed with brain cancer) enrolled in DoDCA200896 (IRB HM20022755)",
"criterions": [
{
"exact_snippets": "Caregiver does not have a loved one (patient diagnosed with brain cancer) enrolled in DoDCA200896 (IRB HM20022755)",
"criterion": "caregiver's loved one enrollment",
"requirements": [
{
"requirement_type": "enrollment",
"expected_value": false
}
]
}
]
},
{
"line": "* Caregiver does not speak English",
"criterions": [
{
"exact_snippets": "Caregiver does not speak English",
"criterion": "caregiver language",
"requirements": [
{
"requirement_type": "language",
"expected_value": "English"
}
]
}
]
},
{
"line": "* Caregiver is unable to provide consent",
"criterions": [
{
"exact_snippets": "Caregiver is unable to provide consent",
"criterion": "caregiver consent",
"requirements": [
{
"requirement_type": "ability",
"expected_value": false
}
]
}
]
},
{
"line": "* Caregiver does not have access to telehealth",
"criterions": [
{
"exact_snippets": "Caregiver does not have access to telehealth",
"criterion": "caregiver telehealth access",
"requirements": [
{
"requirement_type": "access",
"expected_value": false
}
]
}
]
},
{
"line": "* Caregiver is under the age of 18",
"criterions": [
{
"exact_snippets": "Caregiver is under the age of 18",
"criterion": "caregiver age",
"requirements": [
{
"requirement_type": "age",
"expected_value": {
"operator": "<",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Professional caregivers who received financial compensation for their services are ineligible",
"criterions": [
{
"exact_snippets": "Professional caregivers who received financial compensation for their services",
"criterion": "professional caregivers",
"requirements": [
{
"requirement_type": "financial compensation",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}