{
"info": {
"nct_id": "NCT03757182",
"official_title": "Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients: A Single Cohort, Prospective Trial",
"inclusion_criteria": "* Diagnosis of advanced (stage 3 or 4) cancer of any type\n* Ambulatory (use of walking aids, such as cane and rollator, is acceptable)\n* Access to a device that has the capability to sync to the Fitbit\n* Expected to have standard of care oncology appointments at least once every 8 weeks (+/-7 days).\n* Have an understanding, ability, and willingness to fully comply with study procedures and restrictions\n* English or Spanish speaking\n* Ability to consent\n* Informed consent obtained from subject and ability for subject to comply with the requirements of the study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Allergy to surgical steel or elastomer/rubber\n* Using a pacemaker, implantable cardiac defibrillator, neurostimulator, implantable hearing aids, cochlear implants, or other electronic medical equipment. However, removable hearing aids are permitted.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Diagnosis of advanced (stage 3 or 4) cancer of any type",
"criterions": [
{
"exact_snippets": "Diagnosis of advanced (stage 3 or 4) cancer",
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"requirement": {
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"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3,
"unit": "stage"
}
]
}
}
},
{
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"criterion": "cancer type",
"requirement": {
"requirement_type": "type",
"expected_value": "any"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
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}
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}
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},
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"requirement": {
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}
}
]
}
},
{
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{
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"requirement": {
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"expected_value": true
}
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"logical_structure": {
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"expected_value": true
}
}
]
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},
{
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{
"exact_snippets": "Access to a device that has the capability to sync to the Fitbit",
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"requirement": {
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}
}
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},
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{
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"value": 8,
"unit": "weeks"
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"requirement": {
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"expected_value": {
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"unit": "weeks"
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]
}
}
}
]
}
},
{
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"criterions": [
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"requirement": {
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{
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}
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}
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{
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}
}
]
}
},
{
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"criterions": [
{
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"criterion": "informed consent",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "ability for subject to comply with the requirements of the study",
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},
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}
]
}
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{
"identified_line": {
"line": "Healthy volunteers allowed",
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{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
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"expected_value": "healthy"
}
}
]
},
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}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
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"unit": "Years"
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}
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}
],
"exclusion_lines": [
{
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"line": "* Allergy to surgical steel or elastomer/rubber",
"criterions": [
{
"exact_snippets": "Allergy to surgical steel",
"criterion": "allergy",
"requirement": {
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}
},
{
"exact_snippets": "Allergy to ... elastomer/rubber",
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]
}
}
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"logical_structure": {
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},
{
"exact_snippets": "Allergy to ... elastomer/rubber",
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]
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}
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{
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{
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}
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{
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}
},
{
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"failed_inclusion": [
{
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"failed_exclusion": [],
"failed_miscellaneous": []
}