{
"info": {
"nct_id": "NCT04572282",
"official_title": "Single Arm Pilot Study on a Mobile App for Symptoms Monitoring in Cancer Patients on Active Treatments",
"inclusion_criteria": "* adults (18 years old or older)\n* with a cancer diagnosis at any stage of any primary tumor (solid or hematologic)\n* in systemic oncologic treatments of any type (including but not limited to immunotherapy, chemotherapy and targeted therapies) expected to continue for at least 4 weeks after enrolment, except when single treatment with hormone therapy for prostate cancer or breast cancer\n* fluent in written Portuguese\n* with a personal mobile smartphone (android or iphone)\n* willing to give informed consent for study participation\n\nExclusion criteria:\n\n* Cognitive impairment or disability that limits capacity to comply with study interventions and assessments as per attending physician's evaluation\n* Having a life expectancy < 3 months as determined by the attending oncologist ECOG performance status greater than 2\n* Unable to read and comprehend written portuguese language\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* adults (18 years old or older)",
"criterions": [
{
"exact_snippets": "adults (18 years old or older)",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* with a cancer diagnosis at any stage of any primary tumor (solid or hematologic)",
"criterions": [
{
"exact_snippets": "cancer diagnosis",
"criterion": "cancer diagnosis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "any stage",
"criterion": "cancer stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "any"
}
]
},
{
"exact_snippets": "any primary tumor (solid or hematologic)",
"criterion": "primary tumor type",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"solid",
"hematologic"
]
}
]
}
]
},
{
"line": "* in systemic oncologic treatments of any type (including but not limited to immunotherapy, chemotherapy and targeted therapies) expected to continue for at least 4 weeks after enrolment, except when single treatment with hormone therapy for prostate cancer or breast cancer",
"criterions": [
{
"exact_snippets": "systemic oncologic treatments of any type (including but not limited to immunotherapy, chemotherapy and targeted therapies)",
"criterion": "systemic oncologic treatments",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "expected to continue for at least 4 weeks after enrolment",
"criterion": "duration of treatment",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
]
},
{
"exact_snippets": "single treatment with hormone therapy for prostate cancer or breast cancer",
"criterion": "hormone therapy",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": true
}
]
}
]
},
{
"line": "* fluent in written Portuguese",
"criterions": [
{
"exact_snippets": "fluent in written Portuguese",
"criterion": "Portuguese language proficiency",
"requirements": [
{
"requirement_type": "fluency",
"expected_value": "written"
}
]
}
]
},
{
"line": "* with a personal mobile smartphone (android or iphone)",
"criterions": [
{
"exact_snippets": "personal mobile smartphone (android or iphone)",
"criterion": "personal mobile smartphone",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"android",
"iphone"
]
}
]
}
]
},
{
"line": "* willing to give informed consent for study participation",
"criterions": [
{
"exact_snippets": "willing to give informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
}
]
}
]
},
{
"line": "* Cognitive impairment or disability that limits capacity to comply with study interventions and assessments as per attending physician's evaluation",
"criterions": [
{
"exact_snippets": "Cognitive impairment or disability that limits capacity to comply with study interventions and assessments",
"criterion": "cognitive impairment or disability",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "limits capacity to comply with study interventions and assessments"
}
]
}
]
},
{
"line": "* Having a life expectancy < 3 months as determined by the attending oncologist ECOG performance status greater than 2",
"criterions": [
{
"exact_snippets": "life expectancy < 3 months",
"criterion": "life expectancy",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": "<",
"value": 3,
"unit": "months"
}
}
]
},
{
"exact_snippets": "ECOG performance status greater than 2",
"criterion": "ECOG performance status",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* Unable to read and comprehend written portuguese language",
"criterions": [
{
"exact_snippets": "Unable to read and comprehend written portuguese language",
"criterion": "comprehension of written Portuguese",
"requirements": [
{
"requirement_type": "ability",
"expected_value": false
}
]
}
]
},
{
"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": [],
"failed_inclusion": [
{
"line": "Exclusion criteria:",
"criterions": []
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}