{
"info": {
"nct_id": "NCT04150848",
"official_title": "A Biobehavioral Intervention for Young Men With Testicular Cancer: A Pilot Study",
"inclusion_criteria": "* between the ages of 18 and 39 years at the time of consent\n* confirmed diagnosis of testis cancer (any stage)\n* completed chemotherapy for testis cancer within 2 years prior to consent\n* fluency in English (per self-report)\n* sub-optimal self-regulation as evidenced by a score of 1.8 or below on the Goal Navigation Scale or a score of 4 or greater on the Distress Thermometer (DT)\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 39 Years",
"exclusion_criteria": "* lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder (per self-report)\n* active suicide plan\n* disorder that compromises comprehension of assessments or informed consent information\n* self-reported medical condition or medication use known to confound measures of systemic inflammation\n* daily smoking",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* between the ages of 18 and 39 years at the time of consent",
"criterions": [
{
"exact_snippets": "between the ages of 18 and 39 years",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 39,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* confirmed diagnosis of testis cancer (any stage)",
"criterions": [
{
"exact_snippets": "confirmed diagnosis of testis cancer",
"criterion": "testis cancer",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": true
}
]
},
{
"exact_snippets": "any stage",
"criterion": "cancer stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "any"
}
]
}
]
},
{
"line": "* completed chemotherapy for testis cancer within 2 years prior to consent",
"criterions": [
{
"exact_snippets": "completed chemotherapy for testis cancer",
"criterion": "chemotherapy for testis cancer",
"requirements": [
{
"requirement_type": "completion",
"expected_value": true
}
]
},
{
"exact_snippets": "within 2 years prior to consent",
"criterion": "time since chemotherapy completion",
"requirements": [
{
"requirement_type": "time since completion",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "years"
}
}
]
}
]
},
{
"line": "* fluency in English (per self-report)",
"criterions": [
{
"exact_snippets": "fluency in English (per self-report)",
"criterion": "fluency in English",
"requirements": [
{
"requirement_type": "self-reported",
"expected_value": true
}
]
}
]
},
{
"line": "* sub-optimal self-regulation as evidenced by a score of 1.8 or below on the Goal Navigation Scale or a score of 4 or greater on the Distress Thermometer (DT)",
"criterions": [
{
"exact_snippets": "sub-optimal self-regulation as evidenced by a score of 1.8 or below on the Goal Navigation Scale",
"criterion": "self-regulation",
"requirements": [
{
"requirement_type": "score",
"expected_value": {
"operator": "<=",
"value": 1.8,
"unit": "on the Goal Navigation Scale"
}
}
]
},
{
"exact_snippets": "sub-optimal self-regulation as evidenced by ... a score of 4 or greater on the Distress Thermometer (DT)",
"criterion": "self-regulation",
"requirements": [
{
"requirement_type": "score",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "on the Distress Thermometer (DT)"
}
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must be MALE",
"criterions": [
{
"exact_snippets": "Must be MALE",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "male"
}
]
}
]
},
{
"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"
}
}
]
}
]
},
{
"line": "Must have maximum age of 39 Years",
"criterions": [
{
"exact_snippets": "maximum age of 39 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 39,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder (per self-report)",
"criterions": [
{
"exact_snippets": "lifetime history of bipolar disorder",
"criterion": "bipolar disorder",
"requirements": [
{
"requirement_type": "lifetime history",
"expected_value": true
}
]
},
{
"exact_snippets": "lifetime history of ... schizophrenia",
"criterion": "schizophrenia",
"requirements": [
{
"requirement_type": "lifetime history",
"expected_value": true
}
]
},
{
"exact_snippets": "lifetime history of ... schizoaffective disorder",
"criterion": "schizoaffective disorder",
"requirements": [
{
"requirement_type": "lifetime history",
"expected_value": true
}
]
}
]
},
{
"line": "* active suicide plan",
"criterions": [
{
"exact_snippets": "active suicide plan",
"criterion": "suicide plan",
"requirements": [
{
"requirement_type": "status",
"expected_value": "active"
}
]
}
]
},
{
"line": "* disorder that compromises comprehension of assessments or informed consent information",
"criterions": [
{
"exact_snippets": "disorder that compromises comprehension of assessments or informed consent information",
"criterion": "disorder",
"requirements": [
{
"requirement_type": "impact",
"expected_value": "compromises comprehension of assessments or informed consent information"
}
]
}
]
},
{
"line": "* self-reported medical condition or medication use known to confound measures of systemic inflammation",
"criterions": [
{
"exact_snippets": "self-reported medical condition",
"criterion": "medical condition",
"requirements": [
{
"requirement_type": "confounding potential",
"expected_value": "known to confound measures of systemic inflammation"
}
]
},
{
"exact_snippets": "medication use known to confound measures of systemic inflammation",
"criterion": "medication use",
"requirements": [
{
"requirement_type": "confounding potential",
"expected_value": "known to confound measures of systemic inflammation"
}
]
}
]
},
{
"line": "* daily smoking",
"criterions": [
{
"exact_snippets": "daily smoking",
"criterion": "smoking",
"requirements": [
{
"requirement_type": "frequency",
"expected_value": "daily"
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}