{
"info": {
"nct_id": "NCT02251782",
"official_title": "Adherence to Minimally Invasive CRC Screening In Non-Adherent Patients Who Have Not Completed Colorectal Cancer Screening",
"inclusion_criteria": "* 50 years of age or greater, but less than 76 years old\n* Has not completed recommended screening for colonoscopy or FIT\n\n * No colonoscopy in previous 10 years\n * No fecal occult blood test (FOBT) or FIT in previous year and/or > 13 months late FIT\n* No flexible sigmoidoscopy in previous 5 years\n* Verifiable offer of screening recommendation according to health system standard in at least two independent interactions and a verifiable lack of adherence for two most recent\n* Verifiable lack of adherence for >3 months following last screening recommendation\n* Primary Care Provider (PCP) has agreed to refer patients for consideration of enrollment in the study\n* Subject able to understand and sign written informed consent (IC)\nHealthy volunteers allowed\nMust have minimum age of 50 Years\nMust have maximum age of 76 Years",
"exclusion_criteria": "* Family history of CRC in a first-degree relative\n* Personal history of colonic adenomatous polyps, CRC or inflammatory bowel disease\n* Symptoms for which colonoscopy or sigmoidoscopy would otherwise be performed (hematochezia, new onset diarrhea or constipation, abdominal pain)\n* Comorbid illness precluding endoscopic evaluation (coronary artery disease with myocardial infarction within 6 months, unstable angina or congestive heart failure, chronic obstructive pulmonary disease requiring home oxygen, other diseases that limit life expectancy to less than 10 years)\n* Chronic gastritis, pregnancy, cancer(s) other than colorectal",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* 50 years of age or greater, but less than 76 years old",
"criterions": [
{
"exact_snippets": "50 years of age or greater, but less than 76 years old",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 50,
"unit": "years"
},
{
"operator": "<",
"value": 76,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* Has not completed recommended screening for colonoscopy or FIT",
"criterions": [
{
"exact_snippets": "Has not completed recommended screening for colonoscopy",
"criterion": "colonoscopy screening",
"requirements": [
{
"requirement_type": "completion",
"expected_value": false
}
]
},
{
"exact_snippets": "Has not completed recommended screening for ... FIT",
"criterion": "FIT screening",
"requirements": [
{
"requirement_type": "completion",
"expected_value": false
}
]
}
]
},
{
"line": "* No colonoscopy in previous 10 years",
"criterions": [
{
"exact_snippets": "No colonoscopy in previous 10 years",
"criterion": "colonoscopy",
"requirements": [
{
"requirement_type": "time since last procedure",
"expected_value": {
"operator": ">=",
"value": 10,
"unit": "years"
}
}
]
}
]
},
{
"line": "* No fecal occult blood test (FOBT) or FIT in previous year and/or > 13 months late FIT",
"criterions": [
{
"exact_snippets": "No fecal occult blood test (FOBT) or FIT in previous year",
"criterion": "fecal occult blood test (FOBT) or FIT",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "> 13 months late FIT",
"criterion": "FIT",
"requirements": [
{
"requirement_type": "timeliness",
"expected_value": {
"operator": ">",
"value": 13,
"unit": "months"
}
}
]
}
]
},
{
"line": "* No flexible sigmoidoscopy in previous 5 years",
"criterions": [
{
"exact_snippets": "No flexible sigmoidoscopy in previous 5 years",
"criterion": "flexible sigmoidoscopy",
"requirements": [
{
"requirement_type": "time since last procedure",
"expected_value": {
"operator": ">=",
"value": 5,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Verifiable offer of screening recommendation according to health system standard in at least two independent interactions and a verifiable lack of adherence for two most recent",
"criterions": [
{
"exact_snippets": "Verifiable offer of screening recommendation according to health system standard",
"criterion": "screening recommendation offer",
"requirements": [
{
"requirement_type": "verifiability",
"expected_value": true
},
{
"requirement_type": "standard",
"expected_value": "health system standard"
}
]
},
{
"exact_snippets": "at least two independent interactions",
"criterion": "independent interactions",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "interactions"
}
}
]
},
{
"exact_snippets": "verifiable lack of adherence for two most recent",
"criterion": "adherence",
"requirements": [
{
"requirement_type": "verifiability",
"expected_value": true
},
{
"requirement_type": "adherence",
"expected_value": "lack of adherence"
},
{
"requirement_type": "recency",
"expected_value": "two most recent"
}
]
}
]
},
{
"line": "* Verifiable lack of adherence for >3 months following last screening recommendation",
"criterions": [
{
"exact_snippets": "lack of adherence for >3 months following last screening recommendation",
"criterion": "adherence to screening recommendation",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "months"
}
},
{
"requirement_type": "verification",
"expected_value": true
}
]
}
]
},
{
"line": "* Primary Care Provider (PCP) has agreed to refer patients for consideration of enrollment in the study",
"criterions": [
{
"exact_snippets": "Primary Care Provider (PCP) has agreed to refer patients",
"criterion": "PCP referral agreement",
"requirements": [
{
"requirement_type": "agreement",
"expected_value": true
}
]
}
]
},
{
"line": "* Subject able to understand and sign written informed consent (IC)",
"criterions": [
{
"exact_snippets": "Subject able to understand and sign written informed consent (IC)",
"criterion": "ability to understand and sign informed consent",
"requirements": [
{
"requirement_type": "ability",
"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 50 Years",
"criterions": [
{
"exact_snippets": "minimum age of 50 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 76 Years",
"criterions": [
{
"exact_snippets": "maximum age of 76 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 76,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Family history of CRC in a first-degree relative",
"criterions": [
{
"exact_snippets": "Family history of CRC in a first-degree relative",
"criterion": "family history of CRC",
"requirements": [
{
"requirement_type": "relation",
"expected_value": "first-degree relative"
}
]
}
]
},
{
"line": "* Personal history of colonic adenomatous polyps, CRC or inflammatory bowel disease",
"criterions": [
{
"exact_snippets": "Personal history of colonic adenomatous polyps",
"criterion": "colonic adenomatous polyps",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "Personal history of ... CRC",
"criterion": "colorectal cancer (CRC)",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "Personal history of ... inflammatory bowel disease",
"criterion": "inflammatory bowel disease",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* Symptoms for which colonoscopy or sigmoidoscopy would otherwise be performed (hematochezia, new onset diarrhea or constipation, abdominal pain)",
"criterions": [
{
"exact_snippets": "hematochezia",
"criterion": "hematochezia",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "new onset diarrhea",
"criterion": "new onset diarrhea",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "constipation",
"criterion": "constipation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "abdominal pain",
"criterion": "abdominal pain",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Comorbid illness precluding endoscopic evaluation (coronary artery disease with myocardial infarction within 6 months, unstable angina or congestive heart failure, chronic obstructive pulmonary disease requiring home oxygen, other diseases that limit life expectancy to less than 10 years)",
"criterions": [
{
"exact_snippets": "Comorbid illness precluding endoscopic evaluation (coronary artery disease with myocardial infarction within 6 months",
"criterion": "coronary artery disease with myocardial infarction",
"requirements": [
{
"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
]
},
{
"exact_snippets": "Comorbid illness precluding endoscopic evaluation ... unstable angina",
"criterion": "unstable angina",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Comorbid illness precluding endoscopic evaluation ... congestive heart failure",
"criterion": "congestive heart failure",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Comorbid illness precluding endoscopic evaluation ... chronic obstructive pulmonary disease requiring home oxygen",
"criterion": "chronic obstructive pulmonary disease requiring home oxygen",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Comorbid illness precluding endoscopic evaluation ... other diseases that limit life expectancy to less than 10 years",
"criterion": "other diseases that limit life expectancy",
"requirements": [
{
"requirement_type": "life expectancy",
"expected_value": {
"operator": "<",
"value": 10,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Chronic gastritis, pregnancy, cancer(s) other than colorectal",
"criterions": [
{
"exact_snippets": "Chronic gastritis",
"criterion": "chronic gastritis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "pregnancy",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "cancer(s) other than colorectal",
"criterion": "cancer other than colorectal",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}