{
"info": {
"nct_id": "NCT03217201",
"official_title": "Systematic Light Exposure to Treat Cancer-Related Fatigue in Breast Cancer Patients",
"inclusion_criteria": "* Newly diagnosed patients with stage 1 through 3a Breast Cancer scheduled to receive a 12-week, 16-week, 18-week, 20-week, or 24-week chemotherapy regimen, adjuvant, neoadjuvant, or already receiving chemotherapy.\n* MSH, COH and MSK can recruit participants schedule to go on aromatase inhibitors after treatment.\n* Currently over the age of 18.\n* English language proficient.\n* Able to provide informed consent.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Under age 18\n* Breast cancer patients scheduled to undergo chemo regimen other than the 12-week, 18-week, 20-week, or 24-week regimen\n* Stage 3B breast cancer inflammatory or Stage 4 breast cancer\n* Pregnancy\n* Currently employed in night shift work\n* Confounding underlying medical illnesses which may cause fatigue (e.g., severe Anemia not controlled by medication, per self-report corroborated by medical chart review (e.g., Hb<10gm/dl))\n* Eye Diseases which limit the ability of light to be processed (e.g., untreated cataracts, severe glaucoma, macular degeneration, blindness, pupil dilation problems or retina damage)\n* Secondary cancer diagnosis (prior or current) within the past 5 years\n* Severe sleep disorders (e.g., Narcolepsy)\n* Self- reported history of bipolar disorder or manic episodes (which is a contra-indication for light treatment)\n* Severe psychological impairment (e.g., hospitalization for depressive episode in the past 12 months\n* Previous use of light therapy to alleviate fatigue or depressive symptoms\n* Lives outside of the United States throughout the duration of study",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Newly diagnosed patients with stage 1 through 3a Breast Cancer scheduled to receive a 12-week, 16-week, 18-week, 20-week, or 24-week chemotherapy regimen, adjuvant, neoadjuvant, or already receiving chemotherapy.",
"criterions": [
{
"exact_snippets": "Newly diagnosed patients",
"criterion": "diagnosis status",
"requirement": {
"requirement_type": "status",
"expected_value": "newly diagnosed"
}
},
{
"exact_snippets": "stage 1 through 3a Breast Cancer",
"criterion": "breast cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "stage"
},
{
"operator": "<=",
"value": 3.1,
"unit": "stage"
}
]
}
}
},
{
"exact_snippets": "scheduled to receive a 12-week, 16-week, 18-week, 20-week, or 24-week chemotherapy regimen",
"criterion": "chemotherapy regimen duration",
"requirement": {
"requirement_type": "duration",
"expected_value": [
"12-week",
"16-week",
"18-week",
"20-week",
"24-week"
]
}
},
{
"exact_snippets": "adjuvant, neoadjuvant, or already receiving chemotherapy",
"criterion": "chemotherapy type/status",
"requirement": {
"requirement_type": "type/status",
"expected_value": [
"adjuvant",
"neoadjuvant",
"already receiving"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Newly diagnosed patients",
"criterion": "diagnosis status",
"requirement": {
"requirement_type": "status",
"expected_value": "newly diagnosed"
}
},
{
"exact_snippets": "stage 1 through 3a Breast Cancer",
"criterion": "breast cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "stage"
},
{
"operator": "<=",
"value": 3.1,
"unit": "stage"
}
]
}
}
},
{
"exact_snippets": "scheduled to receive a 12-week, 16-week, 18-week, 20-week, or 24-week chemotherapy regimen",
"criterion": "chemotherapy regimen duration",
"requirement": {
"requirement_type": "duration",
"expected_value": [
"12-week",
"16-week",
"18-week",
"20-week",
"24-week"
]
}
},
{
"exact_snippets": "adjuvant, neoadjuvant, or already receiving chemotherapy",
"criterion": "chemotherapy type/status",
"requirement": {
"requirement_type": "type/status",
"expected_value": [
"adjuvant",
"neoadjuvant",
"already receiving"
]
}
}
]
}
},
{
"identified_line": {
"line": "* MSH, COH and MSK can recruit participants schedule to go on aromatase inhibitors after treatment.",
"criterions": [
{
"exact_snippets": "schedule to go on aromatase inhibitors after treatment",
"criterion": "aromatase inhibitors",
"requirement": {
"requirement_type": "schedule",
"expected_value": "after treatment"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "schedule to go on aromatase inhibitors after treatment",
"criterion": "aromatase inhibitors",
"requirement": {
"requirement_type": "schedule",
"expected_value": "after treatment"
}
}
]
}
},
{
"identified_line": {
"line": "* Currently over the age of 18.",
"criterions": [
{
"exact_snippets": "over the age of 18",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "over the age of 18",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* English language proficient.",
"criterions": [
{
"exact_snippets": "English language proficient",
"criterion": "English language proficiency",
"requirement": {
"requirement_type": "proficiency",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "English language proficient",
"criterion": "English language proficiency",
"requirement": {
"requirement_type": "proficiency",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Able to provide informed consent.",
"criterions": [
{
"exact_snippets": "Able to provide informed consent.",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Able to provide informed consent.",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Under age 18",
"criterions": [
{
"exact_snippets": "Under age 18",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Under age 18",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Breast cancer patients scheduled to undergo chemo regimen other than the 12-week, 18-week, 20-week, or 24-week regimen",
"criterions": [
{
"exact_snippets": "Breast cancer patients",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "scheduled to undergo chemo regimen other than the 12-week, 18-week, 20-week, or 24-week regimen",
"criterion": "chemo regimen duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "!=",
"value": 12,
"unit": "week"
}
}
},
{
"exact_snippets": "scheduled to undergo chemo regimen other than the 12-week, 18-week, 20-week, or 24-week regimen",
"criterion": "chemo regimen duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "!=",
"value": 18,
"unit": "week"
}
}
},
{
"exact_snippets": "scheduled to undergo chemo regimen other than the 12-week, 18-week, 20-week, or 24-week regimen",
"criterion": "chemo regimen duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "!=",
"value": 20,
"unit": "week"
}
}
},
{
"exact_snippets": "scheduled to undergo chemo regimen other than the 12-week, 18-week, 20-week, or 24-week regimen",
"criterion": "chemo regimen duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "!=",
"value": 24,
"unit": "week"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
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"expected_value": true
}
},
{
"and_criteria": [
{
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}
}
},
{
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},
{
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},
{
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"requirement": {
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"expected_value": {
"operator": "!=",
"value": 24,
"unit": "week"
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}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Stage 3B breast cancer inflammatory or Stage 4 breast cancer",
"criterions": [
{
"exact_snippets": "Stage 3B breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "stage",
"expected_value": "3B"
}
},
{
"exact_snippets": "inflammatory",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "type",
"expected_value": "inflammatory"
}
},
{
"exact_snippets": "Stage 4 breast cancer",
"criterion": "breast cancer",
"requirement": {
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"expected_value": "4"
}
}
]
},
"logical_structure": {
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{
"and_criteria": [
{
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"expected_value": "3B"
}
},
{
"exact_snippets": "inflammatory",
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}
}
]
},
{
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"requirement": {
"requirement_type": "stage",
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}
}
]
}
},
{
"identified_line": {
"line": "* Pregnancy",
"criterions": [
{
"exact_snippets": "Pregnancy",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Pregnancy",
"criterion": "pregnancy",
"requirement": {
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"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* Currently employed in night shift work",
"criterions": [
{
"exact_snippets": "Currently employed in night shift work",
"criterion": "employment status",
"requirement": {
"requirement_type": "work schedule",
"expected_value": "night shift"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Currently employed in night shift work",
"criterion": "employment status",
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}
}
]
}
},
{
"identified_line": {
"line": "* Confounding underlying medical illnesses which may cause fatigue (e.g., severe Anemia not controlled by medication, per self-report corroborated by medical chart review (e.g., Hb<10gm/dl))",
"criterions": [
{
"exact_snippets": "Confounding underlying medical illnesses which may cause fatigue (e.g., severe Anemia",
"criterion": "confounding underlying medical illnesses",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "severe Anemia not controlled by medication",
"criterion": "severe Anemia",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
},
{
"exact_snippets": "Hb<10gm/dl",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 10,
"unit": "gm/dl"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Confounding underlying medical illnesses which may cause fatigue (e.g., severe Anemia",
"criterion": "confounding underlying medical illnesses",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "severe Anemia not controlled by medication",
"criterion": "severe Anemia",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
}
]
},
{
"exact_snippets": "Hb<10gm/dl",
"criterion": "hemoglobin level",
"requirement": {
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"expected_value": {
"operator": "<",
"value": 10,
"unit": "gm/dl"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Eye Diseases which limit the ability of light to be processed (e.g., untreated cataracts, severe glaucoma, macular degeneration, blindness, pupil dilation problems or retina damage)",
"criterions": [
{
"exact_snippets": "Eye Diseases which limit the ability of light to be processed",
"criterion": "eye diseases",
"requirement": {
"requirement_type": "severity",
"expected_value": "limit the ability of light to be processed"
}
},
{
"exact_snippets": "untreated cataracts",
"criterion": "cataracts",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "untreated"
}
},
{
"exact_snippets": "severe glaucoma",
"criterion": "glaucoma",
"requirement": {
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"expected_value": "severe"
}
},
{
"exact_snippets": "macular degeneration",
"criterion": "macular degeneration",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "blindness",
"criterion": "blindness",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "pupil dilation problems",
"criterion": "pupil dilation problems",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "retina damage",
"criterion": "retina damage",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
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{
"and_criteria": [
{
"exact_snippets": "Eye Diseases which limit the ability of light to be processed",
"criterion": "eye diseases",
"requirement": {
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"expected_value": "limit the ability of light to be processed"
}
},
{
"or_criteria": [
{
"exact_snippets": "untreated cataracts",
"criterion": "cataracts",
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"expected_value": "untreated"
}
},
{
"exact_snippets": "severe glaucoma",
"criterion": "glaucoma",
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}
},
{
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}
},
{
"exact_snippets": "blindness",
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}
},
{
"exact_snippets": "pupil dilation problems",
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"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "retina damage",
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"expected_value": true
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* Secondary cancer diagnosis (prior or current) within the past 5 years",
"criterions": [
{
"exact_snippets": "Secondary cancer diagnosis (prior or current) within the past 5 years",
"criterion": "secondary cancer diagnosis",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5,
"unit": "years"
}
]
}
}
}
]
},
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"criterion": "secondary cancer diagnosis",
"requirement": {
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"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5,
"unit": "years"
}
]
}
}
}
}
},
{
"identified_line": {
"line": "* Severe sleep disorders (e.g., Narcolepsy)",
"criterions": [
{
"exact_snippets": "Severe sleep disorders (e.g., Narcolepsy)",
"criterion": "sleep disorders",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
}
]
},
"logical_structure": {
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}
}
}
},
{
"identified_line": {
"line": "* Self- reported history of bipolar disorder or manic episodes (which is a contra-indication for light treatment)",
"criterions": [
{
"exact_snippets": "Self- reported history of bipolar disorder",
"criterion": "bipolar disorder",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "manic episodes",
"criterion": "manic episodes",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Self- reported history of bipolar disorder",
"criterion": "bipolar disorder",
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"expected_value": true
}
},
{
"exact_snippets": "manic episodes",
"criterion": "manic episodes",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Severe psychological impairment (e.g., hospitalization for depressive episode in the past 12 months",
"criterions": [
{
"exact_snippets": "Severe psychological impairment",
"criterion": "psychological impairment",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "hospitalization for depressive episode in the past 12 months",
"criterion": "hospitalization for depressive episode",
"requirement": {
"requirement_type": "time frame",
"expected_value": "past 12 months"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Severe psychological impairment",
"criterion": "psychological impairment",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "hospitalization for depressive episode in the past 12 months",
"criterion": "hospitalization for depressive episode",
"requirement": {
"requirement_type": "time frame",
"expected_value": "past 12 months"
}
}
]
}
},
{
"identified_line": {
"line": "* Previous use of light therapy to alleviate fatigue or depressive symptoms",
"criterions": [
{
"exact_snippets": "Previous use of light therapy",
"criterion": "light therapy",
"requirement": {
"requirement_type": "previous use",
"expected_value": true
}
},
{
"exact_snippets": "alleviate fatigue",
"criterion": "fatigue",
"requirement": {
"requirement_type": "alleviation",
"expected_value": true
}
},
{
"exact_snippets": "depressive symptoms",
"criterion": "depressive symptoms",
"requirement": {
"requirement_type": "alleviation",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Previous use of light therapy",
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"expected_value": true
}
},
{
"or_criteria": [
{
"exact_snippets": "alleviate fatigue",
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}
},
{
"exact_snippets": "depressive symptoms",
"criterion": "depressive symptoms",
"requirement": {
"requirement_type": "alleviation",
"expected_value": true
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* Lives outside of the United States throughout the duration of study",
"criterions": [
{
"exact_snippets": "Lives outside of the United States",
"criterion": "residency location",
"requirement": {
"requirement_type": "location",
"expected_value": "outside of the United States"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Lives outside of the United States",
"criterion": "residency location",
"requirement": {
"requirement_type": "location",
"expected_value": "outside of the United States"
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}