{
"info": {
"nct_id": "NCT05891431",
"official_title": "Acceptability and Preliminary Effectiveness of a Mobile Health Intervention (Untire App) for Adult Cancer Patients and Survivors With Cancer Related Fatigue: A Pilot Clinical Study",
"inclusion_criteria": "* Adults with cancer or cancer survivors (18 years and older).\n* Self-reported current diagnosis or previous history of treatment for cancer (cancer survivor).\n* A moderate or severe level of fatigue as measured by items 1-3 of the Brief Fatigue Inventory (BFI).\n* Access to a smart phone, tablet, or iPad (Apple or Android).\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Participants < 18 years of age\n* Non-English language speakers\n* Participants with a diagnosis of and receiving treatment for severe psychological distress (e.g. major depression, psychotic disorder, anxiety disorder, or addiction).\n* Participants with a diagnosis of chronic fatigue syndrome, myalgic encephalomyelitis, or fibromyalgia.\n* Previous or current us of the Untire app",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Adults with cancer or cancer survivors (18 years and older).",
"criterions": [
{
"exact_snippets": "Adults with cancer",
"criterion": "cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "cancer survivors",
"criterion": "cancer survivor",
"requirement": {
"requirement_type": "status",
"expected_value": true
}
},
{
"exact_snippets": "18 years and older",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Adults with cancer",
"criterion": "cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "18 years and older",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "cancer survivors",
"criterion": "cancer survivor",
"requirement": {
"requirement_type": "status",
"expected_value": true
}
},
{
"exact_snippets": "18 years and older",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Self-reported current diagnosis or previous history of treatment for cancer (cancer survivor).",
"criterions": [
{
"exact_snippets": "Self-reported current diagnosis ... cancer",
"criterion": "current cancer diagnosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "previous history of treatment for cancer",
"criterion": "previous cancer treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Self-reported current diagnosis ... cancer",
"criterion": "current cancer diagnosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "previous history of treatment for cancer",
"criterion": "previous cancer treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* A moderate or severe level of fatigue as measured by items 1-3 of the Brief Fatigue Inventory (BFI).",
"criterions": [
{
"exact_snippets": "moderate or severe level of fatigue",
"criterion": "fatigue level",
"requirement": {
"requirement_type": "severity",
"expected_value": [
"moderate",
"severe"
]
}
},
{
"exact_snippets": "items 1-3 of the Brief Fatigue Inventory (BFI)",
"criterion": "Brief Fatigue Inventory (BFI)",
"requirement": {
"requirement_type": "measurement",
"expected_value": "items 1-3"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "moderate or severe level of fatigue",
"criterion": "fatigue level",
"requirement": {
"requirement_type": "severity",
"expected_value": [
"moderate",
"severe"
]
}
},
{
"exact_snippets": "items 1-3 of the Brief Fatigue Inventory (BFI)",
"criterion": "Brief Fatigue Inventory (BFI)",
"requirement": {
"requirement_type": "measurement",
"expected_value": "items 1-3"
}
}
]
}
},
{
"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 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Participants < 18 years of age",
"criterions": [
{
"exact_snippets": "Participants < 18 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Participants < 18 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 18,
"unit": "years"
}
}
}
}
},
{
"identified_line": {
"line": "* Non-English language speakers",
"criterions": [
{
"exact_snippets": "Non-English language speakers",
"criterion": "language",
"requirement": {
"requirement_type": "proficiency",
"expected_value": "non-English"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Non-English language speakers",
"criterion": "language",
"requirement": {
"requirement_type": "proficiency",
"expected_value": "non-English"
}
}
}
},
{
"identified_line": {
"line": "* Participants with a diagnosis of and receiving treatment for severe psychological distress (e.g. major depression, psychotic disorder, anxiety disorder, or addiction).",
"criterions": [
{
"exact_snippets": "diagnosis of ... severe psychological distress",
"criterion": "psychological distress",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "receiving treatment for severe psychological distress",
"criterion": "treatment for psychological distress",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "diagnosis of ... major depression",
"criterion": "major depression",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "diagnosis of ... psychotic disorder",
"criterion": "psychotic disorder",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "diagnosis of ... anxiety disorder",
"criterion": "anxiety disorder",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "diagnosis of ... addiction",
"criterion": "addiction",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "diagnosis of ... severe psychological distress",
"criterion": "psychological distress",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "receiving treatment for severe psychological distress",
"criterion": "treatment for psychological distress",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "diagnosis of ... major depression",
"criterion": "major depression",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "diagnosis of ... psychotic disorder",
"criterion": "psychotic disorder",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "diagnosis of ... anxiety disorder",
"criterion": "anxiety disorder",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "diagnosis of ... addiction",
"criterion": "addiction",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Participants with a diagnosis of chronic fatigue syndrome, myalgic encephalomyelitis, or fibromyalgia.",
"criterions": [
{
"exact_snippets": "diagnosis of chronic fatigue syndrome",
"criterion": "chronic fatigue syndrome",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "diagnosis of ... myalgic encephalomyelitis",
"criterion": "myalgic encephalomyelitis",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "diagnosis of ... fibromyalgia",
"criterion": "fibromyalgia",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "diagnosis of chronic fatigue syndrome",
"criterion": "chronic fatigue syndrome",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "diagnosis of ... myalgic encephalomyelitis",
"criterion": "myalgic encephalomyelitis",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "diagnosis of ... fibromyalgia",
"criterion": "fibromyalgia",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Previous or current us of the Untire app",
"criterions": [
{
"exact_snippets": "Previous or current use of the Untire app",
"criterion": "use of the Untire app",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Previous or current use of the Untire app",
"criterion": "use of the Untire app",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Access to a smart phone, tablet, or iPad (Apple or Android).",
"criterions": [
{
"exact_snippets": "Access to a smart phone, tablet, or iPad (Apple or Android).",
"criterion": "access to a smart device",
"requirement": {
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"expected_value": [
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"tablet",
"iPad"
]
}
},
{
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"criterion": "access to a smart device",
"requirement": {
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"expected_value": [
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"Android"
]
}
}
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"and_criteria": [
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}
},
{
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{
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}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}