{
    "info": {
        "nct_id": "NCT03344757",
        "official_title": "Culturally Adapted Cognitive Behavioral Stress and Self-Management (C-CBSM) Intervention for Prostate Cancer",
        "inclusion_criteria": "1. ≥ 18 years of age;\n2. Hispanic/Latino self-identification;\n3. Spanish speakers (including bilinguals who express interest in a Spanish-based psychosocial intervention);\n4. Primary diagnosis of localized Prostate Cancer (T1-T3, N0, M0);\n5. Surgical or radiation treatment (e.g., external beam, brachytherapy, proton) within minimum of 4 months and maximum of 72-months;\n6. Some patients with prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis) may be enrolled, per P.I. discretion, based on a case-by-case review;\n7. Willingness to be randomized and followed for approximately12 months.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. History of non-skin cancer within the last 2 years.\n2. Prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis) within the past six months, as these conditions can interfere with adequate participation in our experimental conditions may be exclusionary, per P.I. discretion, based on a case-by-case review;\n3. Active alcohol dependence within the past six months may be exclusionary, per P.I. discretion, based on a case-by-case review;\n4. Active substance dependence within the past six months may be exclusionary, per P.I. discretion, based on a case-by-case review; and\n5. Acute or chronic immune system medical conditions, medications or conditions that impact immune and endocrine function (e.g., Chronic Fatigue Syndrome (CFS), Lupus, rheumatoid arthritis, Hepatitis C, or immunosuppressive treatment requiring conditions), per PI discretion based on a case by case review.\n6. Individuals scoring >3 on the SPMSQ will be excluded or per PI discretion based on a case by case review.\n\n   .",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. ≥ 18 years of age;",
            "criterions": [
                {
                    "exact_snippets": "≥ 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Hispanic/Latino self-identification;",
            "criterions": [
                {
                    "exact_snippets": "Hispanic/Latino self-identification",
                    "criterion": "Hispanic/Latino ethnicity",
                    "requirements": [
                        {
                            "requirement_type": "self-identification",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Spanish speakers (including bilinguals who express interest in a Spanish-based psychosocial intervention);",
            "criterions": [
                {
                    "exact_snippets": "Spanish speakers (including bilinguals who express interest in a Spanish-based psychosocial intervention)",
                    "criterion": "language",
                    "requirements": [
                        {
                            "requirement_type": "language",
                            "expected_value": "Spanish"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Primary diagnosis of localized Prostate Cancer (T1-T3, N0, M0);",
            "criterions": [
                {
                    "exact_snippets": "Primary diagnosis of localized Prostate Cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "primary"
                        },
                        {
                            "requirement_type": "localization",
                            "expected_value": "localized"
                        }
                    ]
                },
                {
                    "exact_snippets": "T1-T3",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "T"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "T"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "N0",
                    "criterion": "lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "N0"
                        }
                    ]
                },
                {
                    "exact_snippets": "M0",
                    "criterion": "metastasis",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "M0"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Surgical or radiation treatment (e.g., external beam, brachytherapy, proton) within minimum of 4 months and maximum of 72-months;",
            "criterions": [
                {
                    "exact_snippets": "Surgical or radiation treatment ... within minimum of 4 months and maximum of 72-months",
                    "criterion": "surgical or radiation treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "months"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 72,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Some patients with prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis) may be enrolled, per P.I. discretion, based on a case-by-case review;",
            "criterions": [
                {
                    "exact_snippets": "prior inpatient psychiatric treatment for severe mental illness",
                    "criterion": "prior inpatient psychiatric treatment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe mental illness"
                        }
                    ]
                },
                {
                    "exact_snippets": "overt signs of severe psychopathology (e.g., psychosis)",
                    "criterion": "severe psychopathology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Willingness to be randomized and followed for approximately12 months.",
            "criterions": [
                {
                    "exact_snippets": "Willingness to be randomized",
                    "criterion": "willingness to be randomized",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willingness to be ... followed for approximately12 months",
                    "criterion": "willingness to be followed",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "approximately 12 months"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. History of non-skin cancer within the last 2 years.",
            "criterions": [
                {
                    "exact_snippets": "History of non-skin cancer within the last 2 years.",
                    "criterion": "non-skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis) within the past six months, as these conditions can interfere with adequate participation in our experimental conditions may be exclusionary, per P.I. discretion, based on a case-by-case review;",
            "criterions": [
                {
                    "exact_snippets": "Prior inpatient psychiatric treatment for severe mental illness",
                    "criterion": "prior inpatient psychiatric treatment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe mental illness"
                        }
                    ]
                },
                {
                    "exact_snippets": "overt signs of severe psychopathology (e.g., psychosis)",
                    "criterion": "severe psychopathology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within the past six months",
                    "criterion": "time frame for psychiatric treatment or psychopathology",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Active alcohol dependence within the past six months may be exclusionary, per P.I. discretion, based on a case-by-case review;",
            "criterions": [
                {
                    "exact_snippets": "Active alcohol dependence within the past six months",
                    "criterion": "alcohol dependence",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the past six months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Active substance dependence within the past six months may be exclusionary, per P.I. discretion, based on a case-by-case review; and",
            "criterions": [
                {
                    "exact_snippets": "Active substance dependence within the past six months",
                    "criterion": "active substance dependence",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the past six months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Acute or chronic immune system medical conditions, medications or conditions that impact immune and endocrine function (e.g., Chronic Fatigue Syndrome (CFS), Lupus, rheumatoid arthritis, Hepatitis C, or immunosuppressive treatment requiring conditions), per PI discretion based on a case by case review.",
            "criterions": [
                {
                    "exact_snippets": "Acute or chronic immune system medical conditions",
                    "criterion": "immune system medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "medications or conditions that impact immune and endocrine function",
                    "criterion": "conditions that impact immune and endocrine function",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Chronic Fatigue Syndrome (CFS)",
                    "criterion": "Chronic Fatigue Syndrome (CFS)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Lupus",
                    "criterion": "Lupus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "rheumatoid arthritis",
                    "criterion": "rheumatoid arthritis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatitis C",
                    "criterion": "Hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "immunosuppressive treatment requiring conditions",
                    "criterion": "immunosuppressive treatment requiring conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Individuals scoring >3 on the SPMSQ will be excluded or per PI discretion based on a case by case review.",
            "criterions": [
                {
                    "exact_snippets": "Individuals scoring >3 on the SPMSQ",
                    "criterion": "SPMSQ score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "per PI discretion based on a case by case review",
                    "criterion": "PI discretion",
                    "requirements": [
                        {
                            "requirement_type": "discretion",
                            "expected_value": "case by case review"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": ".",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}