{
    "info": {
        "nct_id": "NCT05327465",
        "official_title": "Exercise to Enhance Cardiovascular Health Among Black Prostate Cancer Patients With Androgen Deprivation Therapy: POWER Trial",
        "inclusion_criteria": "* Patients must meet all criteria to be eligible, including travel to Dana-Farber Cancer Institute (DFCI) to collect research data to address the study question.\n* Over 18 years old; children under the age of 18 will be excluded due to the rarity of the disease\n* Histologically diagnosed of localized or metastatic prostate cancer\n* Have been receiving androgen deprivation therapy (ADT) (i.e., luteinizing hormone-releasing hormone [LHRH] agonist/antagonist and/or androgen receptor [AR] agonist/antagonist) for at least one month with a plan to continue ADT for at least 4 months at the time of recruitment\n* Self-identify as Black\n* Medically cleared to participate in exercise by their referred physician or a certified clinical exercise physiologist\n* Are without medical conditions that could exacerbate with exercise, such as bone disease (excluding bone metastases) at imminent risk of fracture or uncontrolled cardiopulmonary or metabolic diseases\n* Speak English and/or Spanish\n* Currently participate in less than or equal to 60 minutes of moderate or vigorous structured exercise/week\n* Willing to travel to DFCI for necessary data collection\n* Ability to communicate and complete written forms in English and/or Spanish\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Are not receiving ADT (i.e., LHRH agonist/antagonist and/or AR agonist/antagonist)\n* Pre-existing medical conditions such as uncontrolled cardiopulmonary disease, or metabolic diseases that could exacerbate with exercise\n* Are not English or Spanish speaking\n* Patients with secondary diagnosis (with the exception of basal cell carcinoma)\n* Participate in more than 60 minutes of moderate or vigorous structured exercise/week\n* Unable to travel to DFCI for necessary data collection\n* May not be able to comply with the safety monitoring requirements of the study in the opinion of the investigator.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients must meet all criteria to be eligible, including travel to Dana-Farber Cancer Institute (DFCI) to collect research data to address the study question.",
            "criterions": [
                {
                    "exact_snippets": "travel to Dana-Farber Cancer Institute (DFCI)",
                    "criterion": "ability to travel to DFCI",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Over 18 years old; children under the age of 18 will be excluded due to the rarity of the disease",
            "criterions": [
                {
                    "exact_snippets": "Over 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "children under the age of 18 will be excluded",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum age",
                            "expected_value": {
                                "operator": "<",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically diagnosed of localized or metastatic prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "Histologically diagnosed",
                    "criterion": "histological diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "localized or metastatic prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "localized",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have been receiving androgen deprivation therapy (ADT) (i.e., luteinizing hormone-releasing hormone [LHRH] agonist/antagonist and/or androgen receptor [AR] agonist/antagonist) for at least one month with a plan to continue ADT for at least 4 months at the time of recruitment",
            "criterions": [
                {
                    "exact_snippets": "Have been receiving androgen deprivation therapy (ADT)",
                    "criterion": "androgen deprivation therapy (ADT)",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "plan to continue ADT for at least 4 months",
                    "criterion": "androgen deprivation therapy (ADT)",
                    "requirements": [
                        {
                            "requirement_type": "planned duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Self-identify as Black",
            "criterions": [
                {
                    "exact_snippets": "Self-identify as Black",
                    "criterion": "race",
                    "requirements": [
                        {
                            "requirement_type": "self-identification",
                            "expected_value": "Black"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Medically cleared to participate in exercise by their referred physician or a certified clinical exercise physiologist",
            "criterions": [
                {
                    "exact_snippets": "Medically cleared to participate in exercise by their referred physician or a certified clinical exercise physiologist",
                    "criterion": "medical clearance for exercise",
                    "requirements": [
                        {
                            "requirement_type": "authority",
                            "expected_value": [
                                "referred physician",
                                "certified clinical exercise physiologist"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Are without medical conditions that could exacerbate with exercise, such as bone disease (excluding bone metastases) at imminent risk of fracture or uncontrolled cardiopulmonary or metabolic diseases",
            "criterions": [
                {
                    "exact_snippets": "medical conditions that could exacerbate with exercise",
                    "criterion": "medical conditions exacerbated by exercise",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "bone disease (excluding bone metastases) at imminent risk of fracture",
                    "criterion": "bone disease at imminent risk of fracture",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled cardiopulmonary ... diseases",
                    "criterion": "uncontrolled cardiopulmonary diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled ... metabolic diseases",
                    "criterion": "uncontrolled metabolic diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Speak English and/or Spanish",
            "criterions": [
                {
                    "exact_snippets": "Speak English and/or Spanish",
                    "criterion": "language",
                    "requirements": [
                        {
                            "requirement_type": "proficiency",
                            "expected_value": [
                                "English",
                                "Spanish"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently participate in less than or equal to 60 minutes of moderate or vigorous structured exercise/week",
            "criterions": [
                {
                    "exact_snippets": "Currently participate in less than or equal to 60 minutes of moderate or vigorous structured exercise/week",
                    "criterion": "structured exercise participation",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "minutes/week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing to travel to DFCI for necessary data collection",
            "criterions": [
                {
                    "exact_snippets": "Willing to travel to DFCI",
                    "criterion": "willingness to travel",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "DFCI"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to communicate and complete written forms in English and/or Spanish",
            "criterions": [
                {
                    "exact_snippets": "Ability to communicate ... in English and/or Spanish",
                    "criterion": "language communication ability",
                    "requirements": [
                        {
                            "requirement_type": "language",
                            "expected_value": [
                                "English",
                                "Spanish"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "complete written forms in English and/or Spanish",
                    "criterion": "written form completion ability",
                    "requirements": [
                        {
                            "requirement_type": "language",
                            "expected_value": [
                                "English",
                                "Spanish"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Are not receiving ADT (i.e., LHRH agonist/antagonist and/or AR agonist/antagonist)",
            "criterions": [
                {
                    "exact_snippets": "Are not receiving ADT",
                    "criterion": "ADT (androgen deprivation therapy)",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "LHRH agonist/antagonist",
                    "criterion": "LHRH agonist/antagonist",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "AR agonist/antagonist",
                    "criterion": "AR agonist/antagonist",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pre-existing medical conditions such as uncontrolled cardiopulmonary disease, or metabolic diseases that could exacerbate with exercise",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled cardiopulmonary disease",
                    "criterion": "cardiopulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "metabolic diseases that could exacerbate with exercise",
                    "criterion": "metabolic diseases",
                    "requirements": [
                        {
                            "requirement_type": "exacerbation with exercise",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Are not English or Spanish speaking",
            "criterions": [
                {
                    "exact_snippets": "Are not English or Spanish speaking",
                    "criterion": "language",
                    "requirements": [
                        {
                            "requirement_type": "language",
                            "expected_value": [
                                "English",
                                "Spanish"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with secondary diagnosis (with the exception of basal cell carcinoma)",
            "criterions": [
                {
                    "exact_snippets": "Patients with secondary diagnosis",
                    "criterion": "secondary diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "with the exception of basal cell carcinoma",
                    "criterion": "basal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participate in more than 60 minutes of moderate or vigorous structured exercise/week",
            "criterions": [
                {
                    "exact_snippets": "Participate in more than 60 minutes of moderate or vigorous structured exercise/week",
                    "criterion": "exercise participation",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "minutes/week"
                            }
                        },
                        {
                            "requirement_type": "intensity",
                            "expected_value": [
                                "moderate",
                                "vigorous"
                            ]
                        },
                        {
                            "requirement_type": "structure",
                            "expected_value": "structured"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable to travel to DFCI for necessary data collection",
            "criterions": [
                {
                    "exact_snippets": "Unable to travel to DFCI",
                    "criterion": "ability to travel to DFCI",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* May not be able to comply with the safety monitoring requirements of the study in the opinion of the investigator.",
            "criterions": [
                {
                    "exact_snippets": "comply with the safety monitoring requirements of the study",
                    "criterion": "compliance with safety monitoring requirements",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}