{
    "info": {
        "nct_id": "NCT01564394",
        "official_title": "Effects of Qigong on Fatigue & Quality of Life in Elderly Prostate Cancer Survivors",
        "inclusion_criteria": "* Significant fatigue as assessed during screening with the NCI Common Terminology Criteria for Adverse Events (CTCAE) Safety Profiler of fatigue using a cut-off value of ≥ 1; and/or with a fatigue grading scale (general questions that assess level of fatigue currently and in the past week from a scale of 0-100) with a cut off value of >20\n* Are sedentary as defined by <150 minutes of mild, moderate, or intense intensity exercise/week per Centers for Disease Control and Prevention(CDC) guidelines\n* Able to speak and read English fluently, and understand informed consent\n* Reside within 60 miles of Huntsman Cancer Institute and have access to regular transportation to all assessments and intervention classes at HCI\n* Willing to: sign a medical record release form; be randomized and willing to participate in classes and all baseline and follow-up appointments\n* Significant others and domestic partners of elderly prostate cancer survivors will be eligible if they are at least 18 years of age, read and speak English, willing to sign an informed consent, and provide a physician's release for exercise\nHealthy volunteers allowed\nMust have minimum age of 55 Years\nMust have maximum age of 99 Years",
        "exclusion_criteria": "* Clinical evidence of metastatic disease other than elevated prostate-antigen specific (PSA) levels\n* Current practice of Qigong, Tai Chi or other similar types of Complementary and Alternative medicine that may share similar principles of Qigong\n* Inability to pass the Folstein Mini Mental Status Exam (score <23)\n* Unable to drive or secure transportation to complete all aspects of the study\n* Health conditions (e.g. severe hearing loss, respiratory, cardiovascular, or neurological problems) that might interfere with the required intervention\n* Unwilling to be randomized to study groups and/or commit to 12 weeks of Qigong or non-aerobic stretching classes",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Significant fatigue as assessed during screening with the NCI Common Terminology Criteria for Adverse Events (CTCAE) Safety Profiler of fatigue using a cut-off value of ≥ 1; and/or with a fatigue grading scale (general questions that assess level of fatigue currently and in the past week from a scale of 0-100) with a cut off value of >20",
            "criterions": [
                {
                    "exact_snippets": "Significant fatigue as assessed during screening with the NCI Common Terminology Criteria for Adverse Events (CTCAE) Safety Profiler of fatigue using a cut-off value of ≥ 1",
                    "criterion": "fatigue",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "NCI CTCAE Safety Profiler"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "fatigue grading scale (general questions that assess level of fatigue currently and in the past week from a scale of 0-100) with a cut off value of >20",
                    "criterion": "fatigue",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "0-100 scale"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Are sedentary as defined by <150 minutes of mild, moderate, or intense intensity exercise/week per Centers for Disease Control and Prevention(CDC) guidelines",
            "criterions": [
                {
                    "exact_snippets": "Are sedentary as defined by <150 minutes of mild, moderate, or intense intensity exercise/week",
                    "criterion": "exercise level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 150,
                                "unit": "minutes/week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to speak and read English fluently, and understand informed consent",
            "criterions": [
                {
                    "exact_snippets": "Able to speak and read English fluently",
                    "criterion": "English language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "fluency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "understand informed consent",
                    "criterion": "understanding of informed consent",
                    "requirements": [
                        {
                            "requirement_type": "understanding",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Reside within 60 miles of Huntsman Cancer Institute and have access to regular transportation to all assessments and intervention classes at HCI",
            "criterions": [
                {
                    "exact_snippets": "Reside within 60 miles of Huntsman Cancer Institute",
                    "criterion": "residence proximity",
                    "requirements": [
                        {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "miles"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "have access to regular transportation to all assessments and intervention classes at HCI",
                    "criterion": "transportation access",
                    "requirements": [
                        {
                            "requirement_type": "access",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing to: sign a medical record release form; be randomized and willing to participate in classes and all baseline and follow-up appointments",
            "criterions": [
                {
                    "exact_snippets": "Willing to: sign a medical record release form",
                    "criterion": "willingness to sign a medical record release form",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willing to: ... be randomized",
                    "criterion": "willingness to be randomized",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willing to: ... willing to participate in classes",
                    "criterion": "willingness to participate in classes",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willing to: ... willing to participate in ... all baseline and follow-up appointments",
                    "criterion": "willingness to participate in all baseline and follow-up appointments",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant others and domestic partners of elderly prostate cancer survivors will be eligible if they are at least 18 years of age, read and speak English, willing to sign an informed consent, and provide a physician's release for exercise",
            "criterions": [
                {
                    "exact_snippets": "Significant others and domestic partners of elderly prostate cancer survivors",
                    "criterion": "relationship to prostate cancer survivor",
                    "requirements": [
                        {
                            "requirement_type": "relationship",
                            "expected_value": [
                                "significant other",
                                "domestic partner"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "read and speak English",
                    "criterion": "language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "language",
                            "expected_value": [
                                "read English",
                                "speak English"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to sign an informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "provide a physician's release for exercise",
                    "criterion": "physician's release for exercise",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "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 55 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 55 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 55,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 99 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 99 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 99,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Clinical evidence of metastatic disease other than elevated prostate-antigen specific (PSA) levels",
            "criterions": [
                {
                    "exact_snippets": "Clinical evidence of metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "elevated prostate-antigen specific (PSA) levels",
                    "criterion": "elevated PSA levels",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current practice of Qigong, Tai Chi or other similar types of Complementary and Alternative medicine that may share similar principles of Qigong",
            "criterions": [
                {
                    "exact_snippets": "Current practice of Qigong",
                    "criterion": "Qigong practice",
                    "requirements": [
                        {
                            "requirement_type": "current practice",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Current practice of ... Tai Chi",
                    "criterion": "Tai Chi practice",
                    "requirements": [
                        {
                            "requirement_type": "current practice",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Current practice of ... other similar types of Complementary and Alternative medicine that may share similar principles of Qigong",
                    "criterion": "similar Complementary and Alternative medicine practice",
                    "requirements": [
                        {
                            "requirement_type": "current practice",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to pass the Folstein Mini Mental Status Exam (score <23)",
            "criterions": [
                {
                    "exact_snippets": "Inability to pass the Folstein Mini Mental Status Exam (score <23)",
                    "criterion": "Folstein Mini Mental Status Exam",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": "<",
                                "value": 23,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable to drive or secure transportation to complete all aspects of the study",
            "criterions": [
                {
                    "exact_snippets": "Unable to drive",
                    "criterion": "ability to drive",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Unable to ... secure transportation",
                    "criterion": "ability to secure transportation",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Health conditions (e.g. severe hearing loss, respiratory, cardiovascular, or neurological problems) that might interfere with the required intervention",
            "criterions": [
                {
                    "exact_snippets": "severe hearing loss",
                    "criterion": "hearing loss",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "respiratory ... problems",
                    "criterion": "respiratory problems",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiovascular ... problems",
                    "criterion": "cardiovascular problems",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "neurological problems",
                    "criterion": "neurological problems",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unwilling to be randomized to study groups and/or commit to 12 weeks of Qigong or non-aerobic stretching classes",
            "criterions": [
                {
                    "exact_snippets": "Unwilling to be randomized to study groups",
                    "criterion": "willingness to be randomized",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "commit to 12 weeks of Qigong or non-aerobic stretching classes",
                    "criterion": "commitment to classes",
                    "requirements": [
                        {
                            "requirement_type": "commitment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}