Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-26 @ 4:01 AM
Study NCT ID:
NCT01700959
Status:
COMPLETED
Last Update Posted:
2018-06-28
First Post:
2012-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tara.brinkman@stjude.org', 'phone': '(901) 595-5683', 'title': 'Tara M. Brinkman, PhD', 'organization': "St. Jude Children's Research Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.', 'eventGroups': [{'id': 'EG000', 'title': 'Melatonin: NI Without DSOL', 'description': 'Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.\n\nmelatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 37, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo: NI Without DSOL', 'description': 'Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.\n\nplacebo: Placebo tablets to match the melatonin will be comprised of inert substances.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 37, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Melatonin: NI With DSOL', 'description': 'Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.\n\nmelatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 52, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG003', 'title': 'Placebo: NI With DSOL', 'description': 'Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.\n\nplacebo: Placebo tablets to match the melatonin will be comprised of inert substances.', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 60, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG004', 'title': 'Melatonin: No NI With DSOL', 'description': 'Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.\n\nmelatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 57, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Placebo: No NI With DSOL', 'description': 'Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.\n\nplacebo: Placebo tablets to match the melatonin will be comprised of inert substances.', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 58, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Palpitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 25, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 20, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 26, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 37, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 27, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 32, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 32, 'numAffected': 27}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 37, 'numAffected': 26}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 35, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypersomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nightmares', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 34, 'numAffected': 25}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 36, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 17, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 21, 'numAffected': 20}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Delayed orgasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Incomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 16, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 38, 'numAffected': 26}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 35, 'numAffected': 24}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Libido decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urinary frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Irregular menstruation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cough', 'stats': 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'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bladder perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Flu-like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Maculo-papular rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Esophageal dilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin: NI Without DSOL', 'description': 'Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.\n\nmelatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.'}, {'id': 'OG001', 'title': 'Placebo: NI Without DSOL', 'description': 'Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.\n\nplacebo: Placebo tablets to match the melatonin will be comprised of inert substances.'}, {'id': 'OG002', 'title': 'Melatonin: NI With DSOL', 'description': 'Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.\n\nmelatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.'}, {'id': 'OG003', 'title': 'Placebo: NI With DSOL', 'description': 'Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.\n\nplacebo: Placebo tablets to match the melatonin will be comprised of inert substances.'}, {'id': 'OG004', 'title': 'Melatonin: No NI With DSOL', 'description': 'Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.\n\nmelatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.'}, {'id': 'OG005', 'title': 'Placebo: No NI With DSOL', 'description': 'Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.\n\nplacebo: Placebo tablets to match the melatonin will be comprised of inert substances.'}], 'classes': [{'title': 'Auditory Attention Difference', 'categories': [{'measurements': [{'value': '0.35', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.87', 'groupId': 'OG001'}, {'value': '0.06', 'spread': '1.11', 'groupId': 'OG002'}, {'value': '0.37', 'spread': '0.96', 'groupId': 'OG003'}]}]}, {'title': 'Sustained Attention Difference', 'categories': [{'measurements': [{'value': '0.06', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '1.30', 'groupId': 'OG001'}, {'value': '0.24', 'spread': '1.16', 'groupId': 'OG002'}, {'value': '0.08', 'spread': '1.39', 'groupId': 'OG003'}]}]}, {'title': 'Working Memory Difference', 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.82', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.75', 'groupId': 'OG002'}, {'value': '0.004', 'spread': '0.76', 'groupId': 'OG003'}]}]}, {'title': 'Long-term Verbal Memory Difference', 'categories': [{'measurements': [{'value': '0.02', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '1.04', 'groupId': 'OG001'}, {'value': '-0.13', 'spread': '0.98', 'groupId': 'OG002'}, {'value': '-0.15', 'spread': '1.29', 'groupId': 'OG003'}]}]}, {'title': 'Cognitive Flexibility', 'categories': [{'measurements': [{'value': '0.31', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '0.31', 'spread': '1.060', 'groupId': 'OG001'}, {'value': '0.31', 'spread': '1.37', 'groupId': 'OG002'}, {'value': '0.18', 'spread': '1.19', 'groupId': 'OG003'}]}]}, {'title': 'Cognitive Fluency Difference', 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '0.74', 'groupId': 'OG001'}, {'value': '0.16', 'spread': '0.64', 'groupId': 'OG002'}, {'value': '0.18', 'spread': '0.63', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months after start of therapy', 'description': 'Efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer (Cohorts 1 and 2 only). The measures were analyzed to compare change in neurocognitive performance from baseline to 6 months between active treatment and placebo groups. The unit of measure is a standardized z-score with a mean of 0 and standard deviation of 1. A higher z-score represents a better outcome.', 'unitOfMeasure': 'Z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on intent to treat. Include participants who were randomized and completed the 6-month assessment.'}, {'type': 'SECONDARY', 'title': 'Sleep Onset Latency as Measured by Actigraphy and Self-report.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '66', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin: NI Without DSOL', 'description': 'Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.\n\nmelatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.'}, {'id': 'OG001', 'title': 'Placebo: NI Without DSOL', 'description': 'Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.\n\nplacebo: Placebo tablets to match the melatonin will be comprised of inert substances.'}, {'id': 'OG002', 'title': 'Melatonin: NI With DSOL', 'description': 'Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.\n\nmelatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.'}, {'id': 'OG003', 'title': 'Placebo: NI With DSOL', 'description': 'Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.\n\nplacebo: Placebo tablets to match the melatonin will be comprised of inert substances.'}, {'id': 'OG004', 'title': 'Melatonin: No NI With DSOL', 'description': 'Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.\n\nmelatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.'}, {'id': 'OG005', 'title': 'Placebo: No NI With DSOL', 'description': 'Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.\n\nplacebo: Placebo tablets to match the melatonin will be comprised of inert substances.'}], 'classes': [{'title': 'Sleep onset latency - actigraphy', 'categories': [{'measurements': [{'value': '5.66', 'spread': '29.70', 'groupId': 'OG002'}, {'value': '-10.96', 'spread': '30.21', 'groupId': 'OG003'}, {'value': '-8.47', 'spread': '23.95', 'groupId': 'OG004'}, {'value': '1.95', 'spread': '39.71', 'groupId': 'OG005'}]}]}, {'title': 'Sleet onset latency - self-report', 'categories': [{'measurements': [{'value': '-20.59', 'spread': '23.73', 'groupId': 'OG002'}, {'value': '17.79', 'spread': '37.19', 'groupId': 'OG003'}, {'value': '-18.14', 'spread': '27.06', 'groupId': 'OG004'}, {'value': '-29.03', 'spread': '64.49', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and six months after start of therapy', 'description': 'Efficacy of melatonin on delayed sleep onset latency in long-term childhood cancer survivors (Cohorts 2 and 3 only). The measures were analyzed to compare change in sleep onset latency from baseline to 6 months between active treatment and placebo groups.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on intent to treat. Includes participants who were randomized and completed the 6-month assessment.'}, {'type': 'SECONDARY', 'title': 'Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin: NI With DSOL (Actigraphy)', 'description': 'Data by participant actigraphy. Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.\n\nmelatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.'}, {'id': 'OG001', 'title': 'Melatonin: NI With DSOL (Self-report)', 'description': 'Data by participant self-report. Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.\n\nmelatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.'}], 'classes': [{'title': 'Auditory Attention Difference', 'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000'}, {'value': '-0.09', 'groupId': 'OG001'}]}]}, {'title': 'Sustained Attention Difference', 'categories': [{'measurements': [{'value': '-0.10', 'groupId': 'OG000'}, {'value': '-0.16', 'groupId': 'OG001'}]}]}, {'title': 'Working Memory Difference', 'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000'}, {'value': '-0.001', 'groupId': 'OG001'}]}]}, {'title': 'Long-term Verbal Memory Difference', 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000'}, {'value': '-0.02', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive Flexibility', 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000'}, {'value': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive Fluency Difference', 'categories': [{'measurements': [{'value': '-0.22', 'groupId': 'OG000'}, {'value': '0.03', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and six months after start of therapy', 'description': "Investigate whether improvement in sleep onset latency due to melatonin treatment is associated with neurocognitive improvement in long-term childhood cancer survivors (Cohort 2). The change in neurocognitive performance from baseline to 6 months will be examined in relation to change in sleep onset latency. The unit of measure is a standardized z-score with a mean of 0 and standard deviation of 1. The unit of measurement is a correlation coefficient (Pearson's R2). The range is from -1.0 to 1.0. A zero indicates no correlation while values closer to -1.0 or 1.0 reflect a stronger association. A negative correlation suggests that as sleep latency decreased, neurocognitive functioning improved.", 'unitOfMeasure': 'Z-score', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on intent to treat includes Cohort 2 participants randomized to melatonin who completed the 6-month assessment. Cohorts 1 and 3 were not assessed. 2 assessments of the primary outcome collected in Cohort 2 included self-report and actigraphy. 50 is the total number with actigraphy data. Data were missing for 12 participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Melatonin: NI Without DSOL', 'description': 'Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.\n\nmelatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.'}, {'id': 'FG001', 'title': 'Placebo: NI Without DSOL', 'description': 'Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.\n\nplacebo: Placebo tablets to match the melatonin will be comprised of inert substances.'}, {'id': 'FG002', 'title': 'Melatonin: NI With DSOL', 'description': 'Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.\n\nmelatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.'}, {'id': 'FG003', 'title': 'Placebo: NI With DSOL', 'description': 'Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.\n\nplacebo: Placebo tablets to match the melatonin will be comprised of inert substances.'}, {'id': 'FG004', 'title': 'Melatonin: No NI With DSOL', 'description': 'Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.\n\nmelatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.'}, {'id': 'FG005', 'title': 'Placebo: No NI With DSOL', 'description': 'Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.\n\nplacebo: Placebo tablets to match the melatonin will be comprised of inert substances.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '88'}, {'groupId': 'FG002', 'numSubjects': '105'}, {'groupId': 'FG003', 'numSubjects': '105'}, {'groupId': 'FG004', 'numSubjects': '96'}, {'groupId': 'FG005', 'numSubjects': '97'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '65'}, {'groupId': 'FG003', 'numSubjects': '70'}, {'groupId': 'FG004', 'numSubjects': '69'}, {'groupId': 'FG005', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '35'}, {'groupId': 'FG004', 'numSubjects': '27'}, {'groupId': 'FG005', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '12'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Noncompliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'Side effects', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '911 participants were enrolled and screened between February 2013 and June 2017. Of the 911, 298 were ineligible and 33 withdrew prior to randomization. 580 were randomized.', 'preAssignmentDetails': 'The remaining 580 participants were categorized into three mutually exclusive groups: (1) neurocognitive impairment (NI) without delayed sleep onset latency (DSOL), (2) NI with DSOL, and (3) No NI with DSOL. Participants were then randomized to take melatonin or placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '66', 'groupId': 'BG004'}, {'value': '68', 'groupId': 'BG005'}, {'value': '380', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Melatonin: NI Without DSOL', 'description': 'Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.\n\nmelatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.'}, {'id': 'BG001', 'title': 'Placebo: NI Without DSOL', 'description': 'Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.\n\nplacebo: Placebo tablets to match the melatonin will be comprised of inert substances.'}, {'id': 'BG002', 'title': 'Melatonin: NI With DSOL', 'description': 'Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.\n\nmelatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.'}, {'id': 'BG003', 'title': 'Placebo: NI With DSOL', 'description': 'Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.\n\nplacebo: Placebo tablets to match the melatonin will be comprised of inert substances.'}, {'id': 'BG004', 'title': 'Melatonin: No NI With DSOL', 'description': 'Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.\n\nmelatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.'}, {'id': 'BG005', 'title': 'Placebo: No NI With DSOL', 'description': 'Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.\n\nplacebo: Placebo tablets to match the melatonin will be comprised of inert substances.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.8', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '36.4', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '32.8', 'spread': '7.8', 'groupId': 'BG002'}, {'value': '32.4', 'spread': '9.3', 'groupId': 'BG003'}, {'value': '35.8', 'spread': '9.0', 'groupId': 'BG004'}, {'value': '36.5', 'spread': '8.2', 'groupId': 'BG005'}, {'value': '34.46', 'spread': '8.7', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}, {'value': '46', 'groupId': 'BG005'}, {'value': '207', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '173', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}, {'value': '59', 'groupId': 'BG004'}, {'value': '61', 'groupId': 'BG005'}, {'value': '347', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '26', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '36', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}, {'value': '59', 'groupId': 'BG005'}, {'value': '338', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis based on intent to treat. Include participants who were randomized and completed the 6-month assessment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-11', 'size': 8489744, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-03-29T16:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 911}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-26', 'studyFirstSubmitDate': '2012-09-25', 'resultsFirstSubmitDate': '2018-03-29', 'studyFirstSubmitQcDate': '2012-10-02', 'lastUpdatePostDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-26', 'studyFirstPostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.', 'timeFrame': 'Baseline and 6 months after start of therapy', 'description': 'Efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer (Cohorts 1 and 2 only). The measures were analyzed to compare change in neurocognitive performance from baseline to 6 months between active treatment and placebo groups. The unit of measure is a standardized z-score with a mean of 0 and standard deviation of 1. A higher z-score represents a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Sleep Onset Latency as Measured by Actigraphy and Self-report.', 'timeFrame': 'Baseline and six months after start of therapy', 'description': 'Efficacy of melatonin on delayed sleep onset latency in long-term childhood cancer survivors (Cohorts 2 and 3 only). The measures were analyzed to compare change in sleep onset latency from baseline to 6 months between active treatment and placebo groups.'}, {'measure': 'Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report.', 'timeFrame': 'Baseline and six months after start of therapy', 'description': "Investigate whether improvement in sleep onset latency due to melatonin treatment is associated with neurocognitive improvement in long-term childhood cancer survivors (Cohort 2). The change in neurocognitive performance from baseline to 6 months will be examined in relation to change in sleep onset latency. The unit of measure is a standardized z-score with a mean of 0 and standard deviation of 1. The unit of measurement is a correlation coefficient (Pearson's R2). The range is from -1.0 to 1.0. A zero indicates no correlation while values closer to -1.0 or 1.0 reflect a stronger association. A negative correlation suggests that as sleep latency decreased, neurocognitive functioning improved."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Melatonin', 'Neurocognitive impairment', 'Sleep disturbance', 'Childhood cancer survivors'], 'conditions': ['Cancer Malignancies']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.stjude.org', 'label': "St. Jude Children's Research Hospital"}, {'url': 'http://www.stjude.org/protocols', 'label': 'Clinical Trials Open at St. Jude'}]}, 'descriptionModule': {'briefSummary': 'Primary objective:\n\n1. To examine the efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer.\n\nSecondary objectives:\n\n1. To evaluate the efficacy of melatonin treatment on delayed sleep onset latency in long-term childhood cancer survivors.\n2. To investigate whether improvement in sleep onset latency due to melatonin treatment is associated with neurocognitive improvement in long-term childhood cancer survivors.\n\nThis study is a randomized double-blind placebo controlled trial of time release melatonin for adult survivors of childhood cancer who demonstrate impaired neurocognitive functioning and/or difficulty falling asleep.', 'detailedDescription': 'All participants undergo a general neurocognitive evaluation at baseline and 6-month follow-up, focused on assessment of intelligence, academic skills, attention, processing speed, memory and executive functions.\n\nSleep parameters using self-report and actigraphy will be assessed at three time points during the study: Baseline, 3-months, and 6-months.\n\nParticipants will be divided into 3 mutually exclusive groups:\n\n* Cohort 1: Participant has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning at or below the 10th percentile, AND is absent of delayed sleep onset latency defined as an inability to fall asleep within 30 minutes less than once a week during the past month.\n* Cohort 2: Participant has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning at or below the 10th percentile, AND has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes at least once a week during the past month.\n* Cohort 3: Participant is absent of neurocognitive impairment defined as performance \\>10th percentile on all six measures of attention, memory, and executive functioning, AND has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes \\> once a week during the past month.\n\nWithin each group, participants will be randomly assigned to take either 3 mgs of time release melatonin or placebo 1-2 hours before bedtime each night for 6 months.\n\nPsychosocial measures of health-related quality of life and psychological distress will be completed at baseline and following 6 months of melatonin/placebo treatment.\n\nBiological samples for serum melatonin levels will be collected at baseline and at the 6 month follow-up evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A St. Jude Life participant who was previously treated at St. Jude Children's Research Hospital\n* 10 or more years from diagnosis\n* 18 years of age or older\n* Able to speak and understand the English language\n* Participant has a full scale intelligence quotient (FSIQ) score \\>79.\n* Cohort 1 participant:\n\n * Has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning ≤10th percentile.\n * Is absent of delayed sleep onset latency defined as an inability to fall asleep within 30 minutes \\< once a week during the past month.\n* Cohort 2 participant:\n\n * Has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning ≤10th percentile.\n * Has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes ≥ once a week during the past month.\n* Cohort 3 participant:\n\n * Is absent of neurocognitive impairment defined as performance \\>10th percentile on all six measures of attention, memory, and executive functioning.\n * Has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes ≥ once a week during the past month.\n* Female participant of childbearing age must not be pregnant or lactating\n* Female research participant of childbearing age and male research participant of child fathering potential agrees to use safe contraceptive methods\n\nExclusion Criteria:\n\n* Known allergy to melatonin or any ingredients of the study product or placebo\n* Participant currently is taking melatonin\n* Known sleep apnea or medically treated sleep disorder (e.g. restless leg syndrome)\n* Known diabetes mellitus - insulin treated\n* Participant has uncontrolled seizure disorder in past 12 months\n* Reported current illicit drug or alcohol abuse or dependence\n* Reported current major psychiatric illness (i.e. schizophrenia, bipolar disorder)\n* Current treatment with: (1) benzodiazepines or other central nervous system depressants, (2) fluvoxamine, (3) anticoagulants (e.g. coumadin), (4) immunosuppressant or corticosteroids, OR (5) nifedipine (Procardia XL(R))\n* Employed in a position that requires night work (i.e. 10pm to 6am)\n* Females who are pregnant or lactating/nursing\n* History of neurologic event (i.e. traumatic brain injury) unrelated to cancer or its treatment\n* Sensory impairment (vision, hearing) that prohibits completion of neurocognitive examination"}, 'identificationModule': {'nctId': 'NCT01700959', 'briefTitle': 'Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort', 'organization': {'class': 'OTHER', 'fullName': "St. Jude Children's Research Hospital"}, 'officialTitle': 'Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort', 'orgStudyIdInfo': {'id': 'MIND'}, 'secondaryIdInfos': [{'id': 'P30CA021765', 'link': 'https://reporter.nih.gov/quickSearch/P30CA021765', 'type': 'NIH'}, {'id': 'NCI-2012-02053', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trial Registration Program'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Melatonin', 'description': 'Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime.', 'interventionNames': ['Drug: melatonin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'melatonin', 'type': 'DRUG', 'otherNames': ['N-Acetyl-5-Methoxytryptamine'], 'description': 'Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.', 'armGroupLabels': ['Melatonin']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo tablets to match the melatonin will be comprised of inert substances.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Tara Brinkman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Jude Children's Research Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Jude Children's Research Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}