{
    "info": {
        "nct_id": "NCT05390827",
        "official_title": "Remote Digital Physiological Data Collection in Cancer: An MSK Registry Protocol",
        "inclusion_criteria": "Project 1: HealthKit\n\n* Individuals who meet at least one of the following criteria:\n\n  * Diagnosis of new onset early-stage (I-III), low-grade (I-II), or locally advanced solid tumor within 24 months of initial recruitment approach\n  * Diagnosis of primary invasive solid tumor from 2015 onwards\n  * Diagnosis of metastatic (stage IV) or high-grade (III-IV) disease\n  * Enrolled onto an investigational trial in the EDD Service\n  * Seen in the MSK UCC from 2021 and onwards\n  * Completion of Baseline Medical History (BMH) Questionnaire\n  * Adult without a history of cancer <50 years of age\n  * Adult without a history of cancer ≥ 50 years of age\n* 18 to 90 years old\n* Own an Apple iPhone with valid iOS operating software\n* Have the MyMSK app downloaded on their iPhone or be willing to download the MyMSK app\n* Willing to provide informed consent\n* Self-reported \"very well\" comprehension of written and verbal English language\n\nProject 2: DigIT-Ex\n\nIndividuals who meet one of the following criteria:\n\n* Patients at MSK who are:\n* Scheduled to undergo any type of BMT (Cohort 1)\n* Diagnosed with new onset AML and scheduled to initiate antineoplastic therapy (Cohort 2)\n* Scheduled to undergo any surgery for prostate cancer (Cohort 3)\n* Scheduled to undergo any lung cancer surgery (Cohort 4)\n* Scheduled to undergo TNT for locally advanced rectal cancer (Cohort 5)\n* Scheduled to initiate androgen deprivation therapy for at least 12 months and has one of the following prostate cancer diagnoses (Cohort 6):\n* High risk/very high localized, locally advanced,\n* Biochemically recurrent prostate cancer\n* Treatment naïve, low-volume metastatic prostate cancer\n* Scheduled Scheduled to undergo chemotherapy for metastatic pancreatic cancer (Cohort 7)\n* Individuals without cancer <50 years of age (Cohort 8)\n* Individuals without cancer ≥50 years of age (Cohort 9)\n\n  * 18 to 90 years old at the time of consent\n  * Willing and able to download the Withings Health Mate app onto their personal mobile device\n  * Willing to provide mobile digital physiological data for a period of at least six months to a maximum of one year following consent\n  * Willing to provide informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 90 Years",
        "exclusion_criteria": "Project 1: HealthKit\n\n* Unable or unwilling to successfully export and share physiological data\n\nProject 2: DigIT-Ex\n\n* Unable or unwilling to appropriately use digital platforms or devices",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "Project 1: HealthKit",
            "criterions": [
                {
                    "exact_snippets": "Project 1: HealthKit",
                    "criterion": "project",
                    "requirements": [
                        {
                            "requirement_type": "name",
                            "expected_value": "HealthKit"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Individuals who meet at least one of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "Individuals who meet at least one of the following criteria",
                    "criterion": "eligibility criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of new onset early-stage (I-III), low-grade (I-II), or locally advanced solid tumor within 24 months of initial recruitment approach",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of new onset early-stage (I-III), low-grade (I-II), or locally advanced solid tumor",
                    "criterion": "solid tumor",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "I",
                                "II",
                                "III"
                            ]
                        },
                        {
                            "requirement_type": "grade",
                            "expected_value": [
                                "I",
                                "II"
                            ]
                        },
                        {
                            "requirement_type": "local advancement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 24 months of initial recruitment approach",
                    "criterion": "time since diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 24,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of primary invasive solid tumor from 2015 onwards",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of primary invasive solid tumor",
                    "criterion": "primary invasive solid tumor",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "from 2015 onwards",
                    "criterion": "diagnosis year",
                    "requirements": [
                        {
                            "requirement_type": "year",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2015,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of metastatic (stage IV) or high-grade (III-IV) disease",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of metastatic (stage IV)",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis of ... high-grade (III-IV) disease",
                    "criterion": "high-grade disease",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Enrolled onto an investigational trial in the EDD Service",
            "criterions": [
                {
                    "exact_snippets": "Enrolled onto an investigational trial",
                    "criterion": "enrollment in investigational trial",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in the EDD Service",
                    "criterion": "EDD Service",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Seen in the MSK UCC from 2021 and onwards",
            "criterions": [
                {
                    "exact_snippets": "Seen in the MSK UCC",
                    "criterion": "MSK UCC visit",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "from 2021 and onwards",
                    "criterion": "year of visit",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2021,
                                        "unit": "year"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Completion of Baseline Medical History (BMH) Questionnaire",
            "criterions": [
                {
                    "exact_snippets": "Completion of Baseline Medical History (BMH) Questionnaire",
                    "criterion": "Baseline Medical History (BMH) Questionnaire",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adult without a history of cancer <50 years of age",
            "criterions": [
                {
                    "exact_snippets": "Adult",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "category",
                            "expected_value": "adult"
                        }
                    ]
                },
                {
                    "exact_snippets": "without a history of cancer",
                    "criterion": "history of cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "<50 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 50,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adult without a history of cancer ≥ 50 years of age",
            "criterions": [
                {
                    "exact_snippets": "Adult",
                    "criterion": "age group",
                    "requirements": [
                        {
                            "requirement_type": "category",
                            "expected_value": "adult"
                        }
                    ]
                },
                {
                    "exact_snippets": "without a history of cancer",
                    "criterion": "cancer history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 50 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 18 to 90 years old",
            "criterions": [
                {
                    "exact_snippets": "18 to 90 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 90,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Own an Apple iPhone with valid iOS operating software",
            "criterions": [
                {
                    "exact_snippets": "Own an Apple iPhone",
                    "criterion": "Apple iPhone ownership",
                    "requirements": [
                        {
                            "requirement_type": "ownership",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "valid iOS operating software",
                    "criterion": "iOS operating software",
                    "requirements": [
                        {
                            "requirement_type": "validity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have the MyMSK app downloaded on their iPhone or be willing to download the MyMSK app",
            "criterions": [
                {
                    "exact_snippets": "Have the MyMSK app downloaded on their iPhone",
                    "criterion": "MyMSK app on iPhone",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "be willing to download the MyMSK app",
                    "criterion": "willingness to download MyMSK app",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing to provide informed consent",
            "criterions": [
                {
                    "exact_snippets": "Willing to provide informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Self-reported \"very well\" comprehension of written and verbal English language",
            "criterions": [
                {
                    "exact_snippets": "Self-reported \"very well\" comprehension of written and verbal English language",
                    "criterion": "comprehension of written and verbal English language",
                    "requirements": [
                        {
                            "requirement_type": "self-reported comprehension level",
                            "expected_value": "very well"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Project 2: DigIT-Ex",
            "criterions": [
                {
                    "exact_snippets": "Project 2: DigIT-Ex",
                    "criterion": "project name",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "DigIT-Ex"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Individuals who meet one of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "Individuals who meet one of the following criteria",
                    "criterion": "eligibility",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients at MSK who are:",
            "criterions": [
                {
                    "exact_snippets": "Patients at MSK",
                    "criterion": "location",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "MSK"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Scheduled to undergo any type of BMT (Cohort 1)",
            "criterions": [
                {
                    "exact_snippets": "Scheduled to undergo any type of BMT",
                    "criterion": "BMT (Bone Marrow Transplant)",
                    "requirements": [
                        {
                            "requirement_type": "scheduled",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosed with new onset AML and scheduled to initiate antineoplastic therapy (Cohort 2)",
            "criterions": [
                {
                    "exact_snippets": "Diagnosed with new onset AML",
                    "criterion": "acute myeloid leukemia (AML)",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "new onset"
                        }
                    ]
                },
                {
                    "exact_snippets": "scheduled to initiate antineoplastic therapy",
                    "criterion": "antineoplastic therapy",
                    "requirements": [
                        {
                            "requirement_type": "schedule",
                            "expected_value": "initiate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Scheduled to undergo any surgery for prostate cancer (Cohort 3)",
            "criterions": [
                {
                    "exact_snippets": "Scheduled to undergo any surgery for prostate cancer",
                    "criterion": "surgery for prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "scheduled",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Scheduled to undergo any lung cancer surgery (Cohort 4)",
            "criterions": [
                {
                    "exact_snippets": "Scheduled to undergo any lung cancer surgery",
                    "criterion": "lung cancer surgery",
                    "requirements": [
                        {
                            "requirement_type": "scheduled",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Scheduled to undergo TNT for locally advanced rectal cancer (Cohort 5)",
            "criterions": [
                {
                    "exact_snippets": "Scheduled to undergo TNT",
                    "criterion": "TNT treatment schedule",
                    "requirements": [
                        {
                            "requirement_type": "scheduled",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced rectal cancer",
                    "criterion": "rectal cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Scheduled to initiate androgen deprivation therapy for at least 12 months and has one of the following prostate cancer diagnoses (Cohort 6):",
            "criterions": [
                {
                    "exact_snippets": "Scheduled to initiate androgen deprivation therapy for at least 12 months",
                    "criterion": "androgen deprivation therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "one of the following prostate cancer diagnoses",
                    "criterion": "prostate cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* High risk/very high localized, locally advanced,",
            "criterions": [
                {
                    "exact_snippets": "High risk/very high localized, locally advanced",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "high risk",
                                "very high localized",
                                "locally advanced"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Biochemically recurrent prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "Biochemically recurrent prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "recurrence",
                            "expected_value": "biochemical"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment naïve, low-volume metastatic prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "Treatment naïve",
                    "criterion": "treatment history",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "naïve"
                        }
                    ]
                },
                {
                    "exact_snippets": "low-volume metastatic prostate cancer",
                    "criterion": "metastatic prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "volume",
                            "expected_value": "low"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Scheduled Scheduled to undergo chemotherapy for metastatic pancreatic cancer (Cohort 7)",
            "criterions": [
                {
                    "exact_snippets": "Scheduled to undergo chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "scheduled",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic pancreatic cancer",
                    "criterion": "pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "metastatic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Individuals without cancer <50 years of age (Cohort 8)",
            "criterions": [
                {
                    "exact_snippets": "without cancer",
                    "criterion": "cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "<50 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 50,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Individuals without cancer ≥50 years of age (Cohort 9)",
            "criterions": [
                {
                    "exact_snippets": "without cancer",
                    "criterion": "cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "≥50 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 18 to 90 years old at the time of consent",
            "criterions": [
                {
                    "exact_snippets": "18 to 90 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 90,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing and able to download the Withings Health Mate app onto their personal mobile device",
            "criterions": [
                {
                    "exact_snippets": "Willing and able to download the Withings Health Mate app",
                    "criterion": "Withings Health Mate app download",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "onto their personal mobile device",
                    "criterion": "personal mobile device",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing to provide mobile digital physiological data for a period of at least six months to a maximum of one year following consent",
            "criterions": [
                {
                    "exact_snippets": "Willing to provide mobile digital physiological data",
                    "criterion": "mobile digital physiological data",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for a period of at least six months to a maximum of one year",
                    "criterion": "duration of data provision",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 6,
                                        "unit": "months"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "year"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing to provide informed consent",
            "criterions": [
                {
                    "exact_snippets": "Willing to provide informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 90 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 90 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 90,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "Project 1: HealthKit",
            "criterions": [
                {
                    "exact_snippets": "HealthKit",
                    "criterion": "project name",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "HealthKit"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable or unwilling to successfully export and share physiological data",
            "criterions": [
                {
                    "exact_snippets": "Unable or unwilling to successfully export and share physiological data",
                    "criterion": "ability to export and share physiological data",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Project 2: DigIT-Ex",
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                {
                    "exact_snippets": "Project 2: DigIT-Ex",
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                            "requirement_type": "N/A",
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                {
                    "exact_snippets": "Unable or unwilling to appropriately use digital platforms or devices",
                    "criterion": "use of digital platforms or devices",
                    "requirements": [
                        {
                            "requirement_type": "ability",
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                        },
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                            "requirement_type": "willingness",
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    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}