{
"info": {
"nct_id": "NCT06106360",
"official_title": "A Pilot Prospective Clinical Trial Using Remote Patient Monitoring for Cancer Patients Undergoing Outpatient Chemotherapy",
"inclusion_criteria": "* Planned to be treated with a new cytotoxic chemotherapy or chemoimmunotherapy regimen for a solid tumor or malignant hematology condition for at least 4 months\n* ECOG performance status of 0-2\n* Age of 18 or older patient with any solid tumor or hematologic malignancy\n* English or Spanish speaker\n* Own an Apple iPhone\n* Capacity and willingness to provide informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Patients undergoing concurrent radiation since they will be seen on a daily basis by clinic care teams and are not likely to benefit from active remote patient monitoring\n* Patients unwilling or unable to comply with the protocol, including wearing the Apple Watch (including recharging daily) and answering queries on the Locus Health iPhone application per the protocol and study group cadence\n* Any condition for which in the Investigator's opinion would limit compliance with study requirements",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Planned to be treated with a new cytotoxic chemotherapy or chemoimmunotherapy regimen for a solid tumor or malignant hematology condition for at least 4 months",
"criterions": [
{
"exact_snippets": "Planned to be treated with a new cytotoxic chemotherapy or chemoimmunotherapy regimen",
"criterion": "treatment plan",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"cytotoxic chemotherapy",
"chemoimmunotherapy"
]
},
{
"requirement_type": "novelty",
"expected_value": "new"
}
]
},
{
"exact_snippets": "solid tumor or malignant hematology condition",
"criterion": "condition type",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"solid tumor",
"malignant hematology condition"
]
}
]
},
{
"exact_snippets": "for at least 4 months",
"criterion": "treatment duration",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "months"
}
}
]
}
]
},
{
"line": "* ECOG performance status of 0-2",
"criterions": [
{
"exact_snippets": "ECOG performance status of 0-2",
"criterion": "ECOG performance status",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
]
}
]
},
{
"line": "* Age of 18 or older patient with any solid tumor or hematologic malignancy",
"criterions": [
{
"exact_snippets": "Age of 18 or older",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
},
{
"exact_snippets": "any solid tumor",
"criterion": "solid tumor",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "hematologic malignancy",
"criterion": "hematologic malignancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* English or Spanish speaker",
"criterions": [
{
"exact_snippets": "English or Spanish speaker",
"criterion": "language",
"requirements": [
{
"requirement_type": "language",
"expected_value": [
"English",
"Spanish"
]
}
]
}
]
},
{
"line": "* Own an Apple iPhone",
"criterions": [
{
"exact_snippets": "Own an Apple iPhone",
"criterion": "Apple iPhone ownership",
"requirements": [
{
"requirement_type": "ownership",
"expected_value": true
}
]
}
]
},
{
"line": "* Capacity and willingness to provide informed consent",
"criterions": [
{
"exact_snippets": "Capacity ... to provide informed consent",
"criterion": "capacity to provide informed consent",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "willingness to provide informed consent",
"criterion": "willingness to provide informed consent",
"requirements": [
{
"requirement_type": "presence",
"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": "* Patients undergoing concurrent radiation since they will be seen on a daily basis by clinic care teams and are not likely to benefit from active remote patient monitoring",
"criterions": [
{
"exact_snippets": "Patients undergoing concurrent radiation",
"criterion": "concurrent radiation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Patients unwilling or unable to comply with the protocol, including wearing the Apple Watch (including recharging daily) and answering queries on the Locus Health iPhone application per the protocol and study group cadence",
"criterions": [
{
"exact_snippets": "Patients unwilling or unable to comply with the protocol",
"criterion": "compliance with protocol",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
},
{
"requirement_type": "ability",
"expected_value": true
}
]
},
{
"exact_snippets": "wearing the Apple Watch",
"criterion": "wearing the Apple Watch",
"requirements": [
{
"requirement_type": "compliance",
"expected_value": true
}
]
},
{
"exact_snippets": "recharging daily",
"criterion": "recharging Apple Watch",
"requirements": [
{
"requirement_type": "frequency",
"expected_value": "daily"
}
]
},
{
"exact_snippets": "answering queries on the Locus Health iPhone application",
"criterion": "answering queries on the Locus Health iPhone application",
"requirements": [
{
"requirement_type": "compliance",
"expected_value": true
}
]
}
]
},
{
"line": "* Any condition for which in the Investigator's opinion would limit compliance with study requirements",
"criterions": [
{
"exact_snippets": "Any condition for which in the Investigator's opinion would limit compliance with study requirements",
"criterion": "condition limiting compliance",
"requirements": [
{
"requirement_type": "opinion",
"expected_value": "Investigator's opinion"
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}