{
"info": {
"nct_id": "NCT00716872",
"official_title": "Evaluating Internet-Based Interventions for Insomnia in Cancer Patients",
"inclusion_criteria": "* Age = At least 21 years old\n* Regular access to the Internet, including e-mail\n* Cancer patient\n\n * Any type of cancer (EXCEPT non-melanoma skin cancer)\n * In remission from any stage of cancer (active treatment completed at least one month prior to enrollment)\n* Insomnia diagnosis (combined from DSM-IV and ICSD):\n\n * Subjective complaints of poor sleep for at least 6 months\n * Sleep difficulties ≥3 nights/week\n* Difficulty falling asleep (≥30 minutes to fall asleep) OR\n* Difficulty staying asleep (≥30 minutes awake in the middle of the night)\n\n * ≤6.5 hours sleep/night\n * Poor sleep causes marked distress or significant impairment in daytime functioning (e.g. fatigue, performance deficits, mood disturbance)\n* Participant feels that the insomnia was caused/aggravated by cancer or cancer treatment\nHealthy volunteers allowed\nMust have minimum age of 21 Years",
"exclusion_criteria": "* Having a sleep disorder other than insomnia (e.g. sleep apnea, RLS, narcolepsy, parasomnias)\n* Having a medical condition other than cancer that causes insomnia\n* Experiencing a psychiatric disturbance (major depression, psychosis)\n* Experiencing substance abuse\n* Currently undergoing psychotherapy or counseling\n* Changing sleep/anxiety/depression medication within the past month\n* Having an \"unusual\" sleep pattern\n\n * Normal bedtime is after 2am OR\n * Normal wake time is after 9am\n* Working as a shift worker (that is, having a schedule that requires working through the night)\n* Participants reports that she is pregnant or intending to get pregnant in the next 4 months",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Age = At least 21 years old",
"criterions": [
{
"exact_snippets": "Age = At least 21 years old",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 21,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age = At least 21 years old",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 21,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Regular access to the Internet, including e-mail",
"criterions": [
{
"exact_snippets": "Regular access to the Internet",
"criterion": "Internet access",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
},
{
"exact_snippets": "including e-mail",
"criterion": "e-mail access",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Regular access to the Internet",
"criterion": "Internet access",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
},
{
"exact_snippets": "including e-mail",
"criterion": "e-mail access",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Cancer patient",
"criterions": [
{
"exact_snippets": "Cancer patient",
"criterion": "cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Cancer patient",
"criterion": "cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Any type of cancer (EXCEPT non-melanoma skin cancer)",
"criterions": [
{
"exact_snippets": "Any type of cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "type",
"expected_value": "any"
}
},
{
"exact_snippets": "EXCEPT non-melanoma skin cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "exclusion",
"expected_value": "non-melanoma skin cancer"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Any type of cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "type",
"expected_value": "any"
}
},
{
"not_criteria": {
"exact_snippets": "EXCEPT non-melanoma skin cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "exclusion",
"expected_value": "non-melanoma skin cancer"
}
}
}
]
}
},
{
"identified_line": {
"line": "* In remission from any stage of cancer (active treatment completed at least one month prior to enrollment)",
"criterions": [
{
"exact_snippets": "In remission from any stage of cancer",
"criterion": "cancer remission",
"requirement": {
"requirement_type": "status",
"expected_value": "in remission"
}
},
{
"exact_snippets": "active treatment completed at least one month prior to enrollment",
"criterion": "cancer treatment",
"requirement": {
"requirement_type": "completion time",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "month"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "In remission from any stage of cancer",
"criterion": "cancer remission",
"requirement": {
"requirement_type": "status",
"expected_value": "in remission"
}
},
{
"exact_snippets": "active treatment completed at least one month prior to enrollment",
"criterion": "cancer treatment",
"requirement": {
"requirement_type": "completion time",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "month"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Insomnia diagnosis (combined from DSM-IV and ICSD):",
"criterions": [
{
"exact_snippets": "Insomnia diagnosis (combined from DSM-IV and ICSD)",
"criterion": "insomnia",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "Insomnia diagnosis (combined from DSM-IV and ICSD)",
"criterion": "insomnia",
"requirement": {
"requirement_type": "diagnostic_criteria",
"expected_value": [
"DSM-IV",
"ICSD"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Insomnia diagnosis (combined from DSM-IV and ICSD)",
"criterion": "insomnia",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "Insomnia diagnosis (combined from DSM-IV and ICSD)",
"criterion": "insomnia",
"requirement": {
"requirement_type": "diagnostic_criteria",
"expected_value": [
"DSM-IV",
"ICSD"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Subjective complaints of poor sleep for at least 6 months",
"criterions": [
{
"exact_snippets": "Subjective complaints of poor sleep for at least 6 months",
"criterion": "poor sleep",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Subjective complaints of poor sleep for at least 6 months",
"criterion": "poor sleep",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Sleep difficulties ≥3 nights/week",
"criterions": [
{
"exact_snippets": "Sleep difficulties ≥3 nights/week",
"criterion": "sleep difficulties",
"requirement": {
"requirement_type": "frequency",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "nights/week"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Sleep difficulties ≥3 nights/week",
"criterion": "sleep difficulties",
"requirement": {
"requirement_type": "frequency",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "nights/week"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Difficulty falling asleep (≥30 minutes to fall asleep) OR",
"criterions": [
{
"exact_snippets": "Difficulty falling asleep (≥30 minutes to fall asleep)",
"criterion": "difficulty falling asleep",
"requirement": {
"requirement_type": "time to fall asleep",
"expected_value": {
"operator": ">=",
"value": 30,
"unit": "minutes"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Difficulty falling asleep (≥30 minutes to fall asleep)",
"criterion": "difficulty falling asleep",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 30,
"unit": "minutes"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Difficulty staying asleep (≥30 minutes awake in the middle of the night)",
"criterions": [
{
"exact_snippets": "Difficulty staying asleep (≥30 minutes awake in the middle of the night)",
"criterion": "difficulty staying asleep",
"requirement": {
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"operator": ">=",
"value": 30,
"unit": "minutes"
}
}
}
]
},
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{
"exact_snippets": "Difficulty staying asleep (≥30 minutes awake in the middle of the night)",
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"unit": "minutes"
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{
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"criterions": [
{
"exact_snippets": "Poor sleep causes marked distress",
"criterion": "sleep quality",
"requirement": {
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}
},
{
"exact_snippets": "Poor sleep causes ... significant impairment in daytime functioning",
"criterion": "sleep quality",
"requirement": {
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}
},
{
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"criterion": "daytime functioning",
"requirement": {
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}
},
{
"exact_snippets": "performance deficits",
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"requirement": {
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}
},
{
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}
}
]
},
"logical_structure": {
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{
"and_criteria": [
{
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}
},
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{
"identified_line": {
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{
"exact_snippets": "Participant feels that the insomnia was caused/aggravated by cancer",
"criterion": "insomnia",
"requirement": {
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"expected_value": "cancer"
}
},
{
"exact_snippets": "Participant feels that the insomnia was ... aggravated by ... cancer treatment",
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"expected_value": "cancer treatment"
}
}
]
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}
},
{
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}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
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{
"exact_snippets": "Healthy volunteers allowed",
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}
}
]
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}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "minimum age of 21 Years",
"criterion": "age",
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"expected_value": {
"operator": ">=",
"value": 21,
"unit": "Years"
}
}
}
]
},
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"exact_snippets": "minimum age of 21 Years",
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"unit": "Years"
}
}
}
]
}
}
],
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{
"identified_line": {
"line": "* Having a sleep disorder other than insomnia (e.g. sleep apnea, RLS, narcolepsy, parasomnias)",
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{
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{
"exact_snippets": "Having a medical condition other than cancer that causes insomnia",
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}
}
]
},
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}
}
}
},
{
"identified_line": {
"line": "* Experiencing a psychiatric disturbance (major depression, psychosis)",
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{
"exact_snippets": "Experiencing a psychiatric disturbance (major depression, psychosis)",
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"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "major depression",
"criterion": "major depression",
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}
},
{
"exact_snippets": "psychosis",
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}
}
]
},
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"and_criteria": [
{
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}
},
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}
},
{
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}
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]
}
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]
}
},
{
"identified_line": {
"line": "* Experiencing substance abuse",
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{
"exact_snippets": "Experiencing substance abuse",
"criterion": "substance abuse",
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}
}
]
},
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}
}
}
},
{
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}
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}
}
}
},
{
"identified_line": {
"line": "* Changing sleep/anxiety/depression medication within the past month",
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{
"exact_snippets": "Changing sleep/anxiety/depression medication",
"criterion": "medication change",
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"anxiety",
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]
}
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"exact_snippets": "within the past month",
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"unit": "month"
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}
}
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"unit": "month"
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}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "Having an \"unusual\" sleep pattern",
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}
}
]
},
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}
}
}
},
{
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{
"exact_snippets": "Normal bedtime is after 2am",
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"operator": ">",
"value": 2,
"unit": "am"
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"exact_snippets": "Normal bedtime is after 2am",
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"operator": ">",
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"unit": "am"
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}
}
]
}
},
{
"identified_line": {
"line": "* Normal wake time is after 9am",
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{
"exact_snippets": "Normal wake time is after 9am",
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"operator": ">",
"value": 9,
"unit": "am"
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}
}
]
},
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"operator": ">",
"value": 9,
"unit": "am"
}
}
}
}
},
{
"identified_line": {
"line": "* Working as a shift worker (that is, having a schedule that requires working through the night)",
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{
"exact_snippets": "Working as a shift worker (that is, having a schedule that requires working through the night)",
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}
}
]
},
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}
}
}
},
{
"identified_line": {
"line": "* Participants reports that she is pregnant or intending to get pregnant in the next 4 months",
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{
"exact_snippets": "Participants reports that she is pregnant",
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}
},
{
"exact_snippets": "intending to get pregnant in the next 4 months",
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}
}
]
},
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"exact_snippets": "Participants reports that she is pregnant",
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}
},
{
"exact_snippets": "intending to get pregnant in the next 4 months",
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}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* ≤6.5 hours sleep/night",
"criterions": [
{
"exact_snippets": "≤6.5 hours sleep/night",
"criterion": "sleep duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "<=",
"value": 6.5,
"unit": "hours/night"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "\u001f\u001e6.5 hours sleep/night",
"criterion": "sleep duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "<=",
"value": 6.5,
"unit": "hours/night"
}
}
}
]
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}