{
    "info": {
        "nct_id": "NCT05519982",
        "official_title": "Sleep Treatment Education Program (STEP-1): An Online Educational Intervention for Insomnia in Cancer Survivors",
        "inclusion_criteria": "* Age 40-89\n* History of a cancer diagnosis (except non-melanoma skin cancer) ≥ 1 year prior\n* No active cancer therapy (excluding chemoprevention) in the past four months, and no further therapy planned\n* Significant insomnia as evidenced by an Insomnia Severity Index score ≥12\n* Regular access to the internet on a daily basis\n* Able to read and write in English\nHealthy volunteers allowed\nMust have minimum age of 40 Years\nMust have maximum age of 89 Years",
        "exclusion_criteria": "* Survivors who report ever being diagnosed with Bipolar Disorder.\n* Survivors who report ever being diagnosed with a Seizure Disorder or have experienced a seizure in the past 12 months.\n* Intention to adjust (decrease or increase) use of any prescribed or over-the-counter medications taken to decrease insomnia during the study period.\n* Survivors diagnosed with sleep apnea who have declined treatment or are not adherent with treatment (as assessed by screening questions, see Appendix A).\n* Survivors with suspected sleep apnea who have not completed an evaluation by a sleep specialist (as assessed by screening questions, see Appendix A).\n* Usual bedtime does not fall between 5:00 pm and 5:00 am.\n* Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel across time zones, or employment in a position that could impact public safety (such as air traffic-controller, operating heavy machinery)\n* Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently.\n* Prior participation in a research study which provided an educational or behavioral intervention for insomnia.\n* Prior participation in a behavioral treatment or patient education program for insomnia delivered at the Dana-Farber Cancer Institute, or at Boston Children's Hospital.\n* Participation in behavioral or educational interventions for insomnia in the 2 years prior to enrollment. This includes in-person as well as synchronous and asynchronous online insomnia programs, but not independent use of books, workbooks or other written self-help materials addressing insomnia.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age 40-89",
            "criterions": [
                {
                    "exact_snippets": "Age 40-89",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 40,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 89,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of a cancer diagnosis (except non-melanoma skin cancer) ≥ 1 year prior",
            "criterions": [
                {
                    "exact_snippets": "History of a cancer diagnosis (except non-melanoma skin cancer)",
                    "criterion": "cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "non-melanoma skin cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 1 year prior",
                    "criterion": "time since cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No active cancer therapy (excluding chemoprevention) in the past four months, and no further therapy planned",
            "criterions": [
                {
                    "exact_snippets": "No active cancer therapy ... in the past four months",
                    "criterion": "active cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no further therapy planned",
                    "criterion": "further therapy",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant insomnia as evidenced by an Insomnia Severity Index score ≥12",
            "criterions": [
                {
                    "exact_snippets": "Significant insomnia as evidenced by an Insomnia Severity Index score ≥12",
                    "criterion": "insomnia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "Insomnia Severity Index score"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Regular access to the internet on a daily basis",
            "criterions": [
                {
                    "exact_snippets": "Regular access to the internet on a daily basis",
                    "criterion": "internet access",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": "daily"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to read and write in English",
            "criterions": [
                {
                    "exact_snippets": "Able to read ... in English",
                    "criterion": "English reading ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Able to ... write in English",
                    "criterion": "English writing ability",
                    "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 40 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 40 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 89 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 89 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 89,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Survivors who report ever being diagnosed with Bipolar Disorder.",
            "criterions": [
                {
                    "exact_snippets": "ever being diagnosed with Bipolar Disorder",
                    "criterion": "Bipolar Disorder diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Survivors who report ever being diagnosed with a Seizure Disorder or have experienced a seizure in the past 12 months.",
            "criterions": [
                {
                    "exact_snippets": "ever being diagnosed with a Seizure Disorder",
                    "criterion": "Seizure Disorder diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "experienced a seizure in the past 12 months",
                    "criterion": "seizure experience",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "past 12 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Intention to adjust (decrease or increase) use of any prescribed or over-the-counter medications taken to decrease insomnia during the study period.",
            "criterions": [
                {
                    "exact_snippets": "Intention to adjust (decrease or increase) use of any prescribed or over-the-counter medications taken to decrease insomnia",
                    "criterion": "medication use for insomnia",
                    "requirements": [
                        {
                            "requirement_type": "intention to adjust",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Survivors diagnosed with sleep apnea who have declined treatment or are not adherent with treatment (as assessed by screening questions, see Appendix A).",
            "criterions": [
                {
                    "exact_snippets": "Survivors diagnosed with sleep apnea",
                    "criterion": "sleep apnea diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "declined treatment",
                    "criterion": "treatment for sleep apnea",
                    "requirements": [
                        {
                            "requirement_type": "adherence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not adherent with treatment",
                    "criterion": "treatment for sleep apnea",
                    "requirements": [
                        {
                            "requirement_type": "adherence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Survivors with suspected sleep apnea who have not completed an evaluation by a sleep specialist (as assessed by screening questions, see Appendix A).",
            "criterions": [
                {
                    "exact_snippets": "suspected sleep apnea",
                    "criterion": "sleep apnea",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "have not completed an evaluation by a sleep specialist",
                    "criterion": "evaluation by a sleep specialist",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Usual bedtime does not fall between 5:00 pm and 5:00 am.",
            "criterions": [
                {
                    "exact_snippets": "Usual bedtime does not fall between 5:00 pm and 5:00 am.",
                    "criterion": "usual bedtime",
                    "requirements": [
                        {
                            "requirement_type": "time range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "am"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "pm"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel across time zones, or employment in a position that could impact public safety (such as air traffic-controller, operating heavy machinery)",
            "criterions": [
                {
                    "exact_snippets": "Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel across time zones",
                    "criterion": "employment with irregular sleep patterns",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "employment in a position that could impact public safety (such as air traffic-controller, operating heavy machinery)",
                    "criterion": "employment impacting public safety",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently.",
            "criterions": [
                {
                    "exact_snippets": "impairment (e.g., hearing, visual, cognitive)",
                    "criterion": "impairment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "interferes with the ability to complete all study procedures independently",
                    "criterion": "ability to complete study procedures independently",
                    "requirements": [
                        {
                            "requirement_type": "interference",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior participation in a research study which provided an educational or behavioral intervention for insomnia.",
            "criterions": [
                {
                    "exact_snippets": "Prior participation in a research study",
                    "criterion": "prior research study participation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "provided an educational or behavioral intervention for insomnia",
                    "criterion": "intervention type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "educational",
                                "behavioral"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "intervention for insomnia",
                    "criterion": "condition targeted by intervention",
                    "requirements": [
                        {
                            "requirement_type": "target condition",
                            "expected_value": "insomnia"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior participation in a behavioral treatment or patient education program for insomnia delivered at the Dana-Farber Cancer Institute, or at Boston Children's Hospital.",
            "criterions": [
                {
                    "exact_snippets": "Prior participation in a behavioral treatment or patient education program for insomnia",
                    "criterion": "prior participation in a program for insomnia",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "Dana-Farber Cancer Institute",
                                "Boston Children's Hospital"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participation in behavioral or educational interventions for insomnia in the 2 years prior to enrollment. This includes in-person as well as synchronous and asynchronous online insomnia programs, but not independent use of books, workbooks or other written self-help materials addressing insomnia.",
            "criterions": [
                {
                    "exact_snippets": "Participation in behavioral or educational interventions for insomnia",
                    "criterion": "participation in insomnia interventions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in the 2 years prior to enrollment",
                    "criterion": "time since participation in insomnia interventions",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "This includes in-person as well as synchronous and asynchronous online insomnia programs",
                    "criterion": "type of insomnia interventions",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "in-person",
                                "synchronous online",
                                "asynchronous online"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "but not independent use of books, workbooks or other written self-help materials addressing insomnia",
                    "criterion": "type of insomnia interventions",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "independent use of books",
                                "workbooks",
                                "other written self-help materials"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}