{
    "info": {
        "nct_id": "NCT03707548",
        "official_title": "A Clinical Trial of Group-based Body Psychotherapy (BPT) to Improve Bodily Disturbances in Post-treatment Cancer Patients in Combination With Randomized Controlled Smartphone-triggered Bodily Interventions",
        "inclusion_criteria": "* Having received curatively intended treatment for any malignant neoplasm; primary treatment (surgery, radiotherapy, chemotherapy) being completed >/= 3 months ago before study inclusion. Any other ongoing anti-tumor therapy is allowed (e.g., hormonal therapy, adjuvant immunotherapy)\n* existing bodily disturbances\n* No sign of progress or recurrence of malignancy at study inclusion according to treating physician\n* Score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) Performance Score\n* Having an anticipated life expectancy of >/= 12 months, according to treating physician\n* age 18 years or older\n* Capacity to participate in group BPT sessions in Basel or Winterthur, 3 study assessments, and the smartphone-triggered interventions\n* Ability to provide informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Suffering from a severe current mental disorder\n* Risk of current suicidality, as indicated by a suicide item score >/= 2 in the BDI-II (Beck Depression Inventory), as this group BPT intervention is not appropriate to support suicidal patients in acute crises\n* Participation in any other clinical trial with a psychosocial intervention\n* Receiving any other current psychotherapeutic treatment with the exception of already established therapies\n* Inability to understand and speak German",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Having received curatively intended treatment for any malignant neoplasm; primary treatment (surgery, radiotherapy, chemotherapy) being completed >/= 3 months ago before study inclusion. Any other ongoing anti-tumor therapy is allowed (e.g., hormonal therapy, adjuvant immunotherapy)",
            "criterions": [
                {
                    "exact_snippets": "Having received curatively intended treatment for any malignant neoplasm",
                    "criterion": "curatively intended treatment for malignant neoplasm",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "primary treatment (surgery, radiotherapy, chemotherapy) being completed >/= 3 months ago before study inclusion",
                    "criterion": "completion of primary treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Any other ongoing anti-tumor therapy is allowed (e.g., hormonal therapy, adjuvant immunotherapy)",
                    "criterion": "ongoing anti-tumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* existing bodily disturbances",
            "criterions": [
                {
                    "exact_snippets": "existing bodily disturbances",
                    "criterion": "bodily disturbances",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No sign of progress or recurrence of malignancy at study inclusion according to treating physician",
            "criterions": [
                {
                    "exact_snippets": "No sign of progress or recurrence of malignancy",
                    "criterion": "progress or recurrence of malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "according to treating physician",
                    "criterion": "treating physician's assessment",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) Performance Score",
            "criterions": [
                {
                    "exact_snippets": "Score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) Performance Score",
                    "criterion": "ECOG Performance Score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Having an anticipated life expectancy of >/= 12 months, according to treating physician",
            "criterions": [
                {
                    "exact_snippets": "anticipated life expectancy of >/= 12 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* age 18 years or older",
            "criterions": [
                {
                    "exact_snippets": "age 18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Capacity to participate in group BPT sessions in Basel or Winterthur, 3 study assessments, and the smartphone-triggered interventions",
            "criterions": [
                {
                    "exact_snippets": "Capacity to participate in group BPT sessions in Basel or Winterthur",
                    "criterion": "capacity to participate in group BPT sessions",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "Basel",
                                "Winterthur"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Capacity to participate in ... 3 study assessments",
                    "criterion": "capacity to participate in study assessments",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 3,
                                "unit": "assessments"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Capacity to participate in ... smartphone-triggered interventions",
                    "criterion": "capacity to participate in smartphone-triggered interventions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to provide informed consent",
            "criterions": [
                {
                    "exact_snippets": "Ability to provide informed consent",
                    "criterion": "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 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": "* Suffering from a severe current mental disorder",
            "criterions": [
                {
                    "exact_snippets": "Suffering from a severe current mental disorder",
                    "criterion": "mental disorder",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "temporal",
                            "expected_value": "current"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Risk of current suicidality, as indicated by a suicide item score >/= 2 in the BDI-II (Beck Depression Inventory), as this group BPT intervention is not appropriate to support suicidal patients in acute crises",
            "criterions": [
                {
                    "exact_snippets": "Risk of current suicidality, as indicated by a suicide item score >/= 2 in the BDI-II (Beck Depression Inventory)",
                    "criterion": "suicidality",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "suicide item score >/= 2 in the BDI-II (Beck Depression Inventory)",
                    "criterion": "suicide item score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participation in any other clinical trial with a psychosocial intervention",
            "criterions": [
                {
                    "exact_snippets": "Participation in any other clinical trial with a psychosocial intervention",
                    "criterion": "participation in other clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "intervention type",
                            "expected_value": "psychosocial"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Receiving any other current psychotherapeutic treatment with the exception of already established therapies",
            "criterions": [
                {
                    "exact_snippets": "Receiving any other current psychotherapeutic treatment",
                    "criterion": "current psychotherapeutic treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "with the exception of already established therapies",
                    "criterion": "already established therapies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to understand and speak German",
            "criterions": [
                {
                    "exact_snippets": "Inability to understand and speak German",
                    "criterion": "German language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "proficiency",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}