{
    "info": {
        "nct_id": "NCT02200731",
        "official_title": "FAMOS: The Effect of Psychosocial Intervention for Childhood Cancer Survivors and Their Families: A Randomized Controlled Trial",
        "inclusion_criteria": "* Families of children in the age range of 0-17 years diagnosed with any kind of cancer and treated at one of the four pediatric oncology departments in Denmark are invited to participate in the project after ending primary medical treatment.\nHealthy volunteers allowed\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* If the child has a severe co-morbidity\n* If the child has a mental disorder at diagnosis\n* If the child is declared terminal ill at the end of treatment (less than 6 months of survival).\n* If the parents and the children do not speak Danish. The participants have to be able to read and answer the questionnaires at the least, to be included in the project.\n* If the parents do not wish to hand in consent form\n* If the family participates in another randomized psychosocial intervention project",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Families of children in the age range of 0-17 years diagnosed with any kind of cancer and treated at one of the four pediatric oncology departments in Denmark are invited to participate in the project after ending primary medical treatment.",
            "criterions": [
                {
                    "exact_snippets": "age range of 0-17 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 17,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "diagnosed with any kind of cancer",
                    "criterion": "cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treated at one of the four pediatric oncology departments in Denmark",
                    "criterion": "treatment location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "one of the four pediatric oncology departments in Denmark"
                        }
                    ]
                },
                {
                    "exact_snippets": "after ending primary medical treatment",
                    "criterion": "primary medical treatment",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "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 maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* If the child has a severe co-morbidity",
            "criterions": [
                {
                    "exact_snippets": "severe co-morbidity",
                    "criterion": "co-morbidity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If the child has a mental disorder at diagnosis",
            "criterions": [
                {
                    "exact_snippets": "mental disorder at diagnosis",
                    "criterion": "mental disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If the child is declared terminal ill at the end of treatment (less than 6 months of survival).",
            "criterions": [
                {
                    "exact_snippets": "child is declared terminal ill",
                    "criterion": "terminal illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "less than 6 months of survival",
                    "criterion": "survival time",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If the parents and the children do not speak Danish. The participants have to be able to read and answer the questionnaires at the least, to be included in the project.",
            "criterions": [
                {
                    "exact_snippets": "parents and the children do not speak Danish",
                    "criterion": "language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "language",
                            "expected_value": "Danish"
                        },
                        {
                            "requirement_type": "proficiency",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "participants have to be able to read and answer the questionnaires",
                    "criterion": "ability to read and answer questionnaires",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If the parents do not wish to hand in consent form",
            "criterions": [
                {
                    "exact_snippets": "parents do not wish to hand in consent form",
                    "criterion": "parental consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If the family participates in another randomized psychosocial intervention project",
            "criterions": [
                {
                    "exact_snippets": "family participates in another randomized psychosocial intervention project",
                    "criterion": "participation in another randomized psychosocial intervention project",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}