Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-02-25 @ 10:21 PM
Study NCT ID:
NCT02976103
Status:
COMPLETED
Last Update Posted:
2020-03-12
First Post:
2016-11-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'donna_berry@dfci.harvard.edu', 'phone': '617-632-1909', 'title': 'Donna Berry, PhD, RN', 'organization': 'Dana-Farber Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected only when the participant was on study (usually 1-6 weeks).', 'description': 'Per protocol, adverse events that could reasonably be expected to relate to the NSR device (jacket) included:\n\n1. Dislodging post-surgical drains, possibly resulting in infection\n2. Becoming over warm or irritating skin\n\nData were collected by chart review and patient report either verbally to the study coordinator or on the study diary.', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 0, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 0, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Intensity (on the 0-10 Pain Intensity Numeric Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'OG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-2 weeks', 'description': 'Pain Intensity Numeric Scale (0-10)(higher scores = worse outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Standard Care arm (n=54): 52 of 54 participants who answered T3 with a PINS score, plus 2 participants who answered for the same day in their T2 diary Jacki+Standard Care arm (n=68): 64 of 64 participants who answered T3 with a PINS score, plus 4 participants who answered for the same day in their T2 diary'}, {'type': 'SECONDARY', 'title': 'Symptom Distress Scale - Pain Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'OG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-2 weeks', 'description': '1 item (score range 1-5); higher score = worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '13 participants in the standard care arm and 8 in the Jacki Jacket arm (total of 21) did not answer the T3 questionnaire or did not answer this item'}, {'type': 'SECONDARY', 'title': 'Symptom Distress Scale - Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'OG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-2 weeks', 'description': '1 item (score range 1-5); higher score = worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '14 participants in the standard care arm and 8 in the Jacki Jacket arm (total of 21) did not answer the T3 questionnaire or did not answer this item'}, {'type': 'SECONDARY', 'title': 'PROMIS Pain Intensity Scale (Short Form 3a)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'OG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}], 'classes': [{'categories': [{'measurements': [{'value': '46.8', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '46.1', 'spread': '5.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-2 weeks', 'description': '3 items (T score 0-100); higher score = worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '13 participants in the Standard Care arm and 9 in the Jacki Jacket arm (Total of 21) did not provide complete data to calculate this scale'}, {'type': 'SECONDARY', 'title': 'PROMIS Pain Interference Scale - Short Form 8a', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'OG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}], 'classes': [{'categories': [{'measurements': [{'value': '58.9', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '59.1', 'spread': '7.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-2 weeks', 'description': '8 items (T score 0-100); higher score = worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '13 participants in the Standard Care arm and 10 in the Jacki Jacket arm (total of 23) did not complete answer the T3 questionnaire or did not answer all items required to calculate a score'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-C30: Global QOL Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'OG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}], 'classes': [{'categories': [{'measurements': [{'value': '66.0', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '64.1', 'spread': '16.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-2 weeks', 'description': '2 items; score range 0-100 (higher score = better outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'T3 respondents'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-C30: Physical Functioning Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'OG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}], 'classes': [{'categories': [{'measurements': [{'value': '76.3', 'spread': '23.9', 'groupId': 'OG000'}, {'value': '71.7', 'spread': '20.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-2 weeks', 'description': '5 items; score range 0-100 (higher score = better outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'T3 respondents'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-C30: Role Functioning Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'OG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}], 'classes': [{'categories': [{'measurements': [{'value': '36.1', 'spread': '27.2', 'groupId': 'OG000'}, {'value': '40.3', 'spread': '24.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-2 weeks', 'description': '2 items; score range 0-100 (higher score = better outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'T3 respondents'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-C30: Emotional Functioning Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'OG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}], 'classes': [{'categories': [{'measurements': [{'value': '72.8', 'spread': '20.1', 'groupId': 'OG000'}, {'value': '73.3', 'spread': '21.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-2 weeks', 'description': '4 items; score range 0-100 (higher score = better outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'T3 respondents'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-C30: Cognitive Functioning Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'OG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}], 'classes': [{'categories': [{'measurements': [{'value': '84.0', 'spread': '22.9', 'groupId': 'OG000'}, {'value': '81.0', 'spread': '21.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-2 weeks', 'description': '2 items; score range 0-100 (higher score = better outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'T3 respondents'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-C30: Social Functioning Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'OG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}], 'classes': [{'categories': [{'measurements': [{'value': '59.0', 'spread': '28.7', 'groupId': 'OG000'}, {'value': '56.5', 'spread': '26.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-2 weeks', 'description': '2 items; score range 0-100 (higher score = better outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'T3 respondents'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-BR23: Body Image Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'OG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}], 'classes': [{'categories': [{'measurements': [{'value': '56.6', 'spread': '29.8', 'groupId': 'OG000'}, {'value': '64.8', 'spread': '25.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-2 weeks', 'description': '4 items (score 0-100); higher score = worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-BR23: Sexual Functioning Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'OG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}], 'classes': [{'categories': [{'measurements': [{'value': '18.0', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '15.8', 'spread': '19.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-2 weeks', 'description': '2 items (range 0-100); higher score = better outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-BR23: Sexual Enjoyment Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'OG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}], 'classes': [{'categories': [{'measurements': [{'value': '54.9', 'spread': '35.2', 'groupId': 'OG000'}, {'value': '57.6', 'spread': '29.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-2 weeks', 'description': '1 item (range 0-100); higher score = better outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The majority of respondents skipped this item because they were not sexually active in the time period immediately after surgery'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-BR23: Future Perspective Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'OG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}], 'classes': [{'categories': [{'measurements': [{'value': '49.4', 'spread': '30.2', 'groupId': 'OG000'}, {'value': '53.1', 'spread': '30.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-2 weeks', 'description': '1 item (range 0-100); higher score = worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-BR23: Systemic Therapy Side Effects Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'OG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}], 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '15.4', 'spread': '12.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-2 weeks', 'description': '7 items (range 0-100); higher score = worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-BR23: Breast Symptoms Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'OG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}], 'classes': [{'categories': [{'measurements': [{'value': '32.8', 'spread': '21.9', 'groupId': 'OG000'}, {'value': '31.4', 'spread': '21.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-2 weeks', 'description': '4 items (range 0-100); higher score = worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-BR23: Arm Symptoms Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'OG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}], 'classes': [{'categories': [{'measurements': [{'value': '30.9', 'spread': '20.2', 'groupId': 'OG000'}, {'value': '30.9', 'spread': '19.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-2 weeks', 'description': '3 items (range 0-100); higher score = worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-BR23: Upset by Hair Loss Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'OG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'spread': '38.8', 'groupId': 'OG000'}, {'value': '24.2', 'spread': '33.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-2 weeks', 'description': '1 item (range 0-100); higher score = worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Most participants did not answer this item as they had not experienced hair loss (did not receive chemotherapy prior to surgery)'}, {'type': 'SECONDARY', 'title': 'Pain Patterns At Home: Average Daily Pain Intensity (Daily Diary)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'OG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '5.0'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '5.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 week', 'description': 'Average 0-10 Pain Intensity Numeric Scale Rating, for 7 days post-discharge, if at least 5 days reported (T2 diary)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '16 in Jacki arm and 21 in Standard Care arm did not return T2 diary; 2 in Standard Care arm returned diary with missing data, for a total of 23 missing this measure in Standard Care arm'}, {'type': 'SECONDARY', 'title': 'Pain Management At Home: Use of Pain Medication (Daily Diary)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'OG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '16.1'}, {'value': '10.7', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '28.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1-2 weeks', 'description': 'Participant self-report of average daily morphine eqivalent dose taken in first 7 days post-discharge (if at least 5 days reported)', 'unitOfMeasure': 'morphine equivalent dose units', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who returned T2 diary with sufficient information on medication usage to calculate a 7-day average morphine equivalent dose'}, {'type': 'SECONDARY', 'title': 'Pain Management At Home: Use of Mastectomy Bra (Daily Diary)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'OG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1-2 weeks', 'description': 'Self-reported proportion of days in the first 7 days post discharge that participant wore a mastectomy bra (if at least 5 days reported)', 'unitOfMeasure': 'Proportion of days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who returned a T2 diary with sufficient data on wearing a mastectomy bra to calculate a proportion for the first 7 days post-discharge'}, {'type': 'SECONDARY', 'title': 'Pain Management At Home: Use of Mastectomy Camisole (Daily Diary)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'OG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.0'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1-2 weeks', 'description': 'Self-reported proportion of days in the first 7 days post discharge that participant wore a mastectomy camisole (if at least 5 days reported)', 'unitOfMeasure': 'Proportion of days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who returned a T2 diary with sufficient data on wearing a mastectomy camisole to calculate a proportion for the first 7 days post-discharge'}, {'type': 'SECONDARY', 'title': 'Patient-Reported Usage of Jacki Recovery Jacket (Daily Diary)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '1.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1-2 weeks', 'description': 'Self-reported proportion of days in the first 7 days post-discharge that participant wore the Jacki recovery jacket at all; no score is better or worse', 'unitOfMeasure': 'Proportion of days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Summary measure for participants in the Jacki Recovery Jacket + Standard Care arm only. A proportion score was calculated if the measure was reported for at least 5 of the first 7 days post-discharge. Of 73 participants assigned to this arm, 53 returned a T2 diary, and 49 had sufficient data to calculate a proportion score.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'FG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '54 participants answered final (T3) questionnaire', 'groupId': 'FG000', 'numSubjects': '54'}, {'comment': '64 participants answered final (T3 questionnaire)', 'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'Recruitment dates: 03/09/2017-12/21/2017'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'BG001', 'title': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given\n\nJacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws\n\nStandard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '75'}, {'value': '47', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '66'}, {'value': '48', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pain Intensity Numeric (0-10) Scale (PINS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '2.2', 'groupId': 'BG000'}, {'value': '4.7', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '4.7', 'spread': '2.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '1 item (score 0-10); higher score = worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Symptom Distress Scale - Pain Frequency', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '3.8', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '3.9', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '1 participant did not provide a response'}, {'title': 'Symptom Distress Scale - Pain Intensity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '2.8', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '3.0', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PROMIS Pain Intensity Short Form 3a', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54.4', 'spread': '6.7', 'groupId': 'BG000'}, {'value': '53.7', 'spread': '5.4', 'groupId': 'BG001'}, {'value': '54.0', 'spread': '6.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '3 items (T score 0-100); higher score = worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '2 participants did not complete the required items to calculate a total score'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-13', 'size': 568434, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-17T13:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-01-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-19', 'studyFirstSubmitDate': '2016-11-18', 'resultsFirstSubmitDate': '2020-02-19', 'studyFirstSubmitQcDate': '2016-11-28', 'lastUpdatePostDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-19', 'studyFirstPostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity (on the 0-10 Pain Intensity Numeric Scale)', 'timeFrame': '1-2 weeks', 'description': 'Pain Intensity Numeric Scale (0-10)(higher scores = worse outcome)'}], 'secondaryOutcomes': [{'measure': 'Symptom Distress Scale - Pain Frequency', 'timeFrame': '1-2 weeks', 'description': '1 item (score range 1-5); higher score = worse outcome'}, {'measure': 'Symptom Distress Scale - Pain Intensity', 'timeFrame': '1-2 weeks', 'description': '1 item (score range 1-5); higher score = worse outcome'}, {'measure': 'PROMIS Pain Intensity Scale (Short Form 3a)', 'timeFrame': '1-2 weeks', 'description': '3 items (T score 0-100); higher score = worse outcome'}, {'measure': 'PROMIS Pain Interference Scale - Short Form 8a', 'timeFrame': '1-2 weeks', 'description': '8 items (T score 0-100); higher score = worse outcome'}, {'measure': 'EORTC QLQ-C30: Global QOL Scale', 'timeFrame': '1-2 weeks', 'description': '2 items; score range 0-100 (higher score = better outcome)'}, {'measure': 'EORTC QLQ-C30: Physical Functioning Scale', 'timeFrame': '1-2 weeks', 'description': '5 items; score range 0-100 (higher score = better outcome)'}, {'measure': 'EORTC QLQ-C30: Role Functioning Scale', 'timeFrame': '1-2 weeks', 'description': '2 items; score range 0-100 (higher score = better outcome)'}, {'measure': 'EORTC QLQ-C30: Emotional Functioning Scale', 'timeFrame': '1-2 weeks', 'description': '4 items; score range 0-100 (higher score = better outcome)'}, {'measure': 'EORTC QLQ-C30: Cognitive Functioning Scale', 'timeFrame': '1-2 weeks', 'description': '2 items; score range 0-100 (higher score = better outcome)'}, {'measure': 'EORTC QLQ-C30: Social Functioning Scale', 'timeFrame': '1-2 weeks', 'description': '2 items; score range 0-100 (higher score = better outcome)'}, {'measure': 'EORTC QLQ-BR23: Body Image Subscale', 'timeFrame': '1-2 weeks', 'description': '4 items (score 0-100); higher score = worse outcome'}, {'measure': 'EORTC QLQ-BR23: Sexual Functioning Subscale', 'timeFrame': '1-2 weeks', 'description': '2 items (range 0-100); higher score = better outcome'}, {'measure': 'EORTC QLQ-BR23: Sexual Enjoyment Subscale', 'timeFrame': '1-2 weeks', 'description': '1 item (range 0-100); higher score = better outcome'}, {'measure': 'EORTC QLQ-BR23: Future Perspective Subscale', 'timeFrame': '1-2 weeks', 'description': '1 item (range 0-100); higher score = worse outcome'}, {'measure': 'EORTC QLQ-BR23: Systemic Therapy Side Effects Subscale', 'timeFrame': '1-2 weeks', 'description': '7 items (range 0-100); higher score = worse outcome'}, {'measure': 'EORTC QLQ-BR23: Breast Symptoms Subscale', 'timeFrame': '1-2 weeks', 'description': '4 items (range 0-100); higher score = worse outcome'}, {'measure': 'EORTC QLQ-BR23: Arm Symptoms Subscale', 'timeFrame': '1-2 weeks', 'description': '3 items (range 0-100); higher score = worse outcome'}, {'measure': 'EORTC QLQ-BR23: Upset by Hair Loss Subscale', 'timeFrame': '1-2 weeks', 'description': '1 item (range 0-100); higher score = worse outcome'}, {'measure': 'Pain Patterns At Home: Average Daily Pain Intensity (Daily Diary)', 'timeFrame': '1 week', 'description': 'Average 0-10 Pain Intensity Numeric Scale Rating, for 7 days post-discharge, if at least 5 days reported (T2 diary)'}, {'measure': 'Pain Management At Home: Use of Pain Medication (Daily Diary)', 'timeFrame': '1-2 weeks', 'description': 'Participant self-report of average daily morphine eqivalent dose taken in first 7 days post-discharge (if at least 5 days reported)'}, {'measure': 'Pain Management At Home: Use of Mastectomy Bra (Daily Diary)', 'timeFrame': '1-2 weeks', 'description': 'Self-reported proportion of days in the first 7 days post discharge that participant wore a mastectomy bra (if at least 5 days reported)'}, {'measure': 'Pain Management At Home: Use of Mastectomy Camisole (Daily Diary)', 'timeFrame': '1-2 weeks', 'description': 'Self-reported proportion of days in the first 7 days post discharge that participant wore a mastectomy camisole (if at least 5 days reported)'}, {'measure': 'Patient-Reported Usage of Jacki Recovery Jacket (Daily Diary)', 'timeFrame': '1-2 weeks', 'description': 'Self-reported proportion of days in the first 7 days post-discharge that participant wore the Jacki recovery jacket at all; no score is better or worse'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['recovery', 'pain', 'surgical drains'], 'conditions': ['Mastectomy']}, 'referencesModule': {'references': [{'pmid': '31612292', 'type': 'RESULT', 'citation': 'Berry DL, Blonquist TM, Halpenny B, Hong F, Morrison-Ma SC, McCullough MC, Carelli K, Dominici LS, King TA. The Jacki Jacket after mastectomy with reconstruction: a randomized pilot study. Breast Cancer Res Treat. 2020 Jan;179(2):377-385. doi: 10.1007/s10549-019-05465-9. Epub 2019 Oct 14.'}]}, 'descriptionModule': {'briefSummary': 'This research study is studying a garment called the Jacki® recovery jacket that can be worn after surgery as a possible way to manage pain from surgical drains.\n\nThe study intervention involved in this study is:\n\n-"Jacki" recovery jacket', 'detailedDescription': 'In this research study, the investigators are studying the Jacki, a garment that can be worn post-mastectomy with pockets that hold post-surgical drains. The Jacki was invented by a cancer survivor who leads A Little Easier Recovery®, a non-profit organization in Massachusetts, and may help participants manage the pain of post-surgical drains to increase comfort and ease of daily living. The jacket has not previously been tested in a research study. The investigators are hoping to learn whether the jacket is effective in reducing pain and discomfort from the time participants leave the hospital until they return to have their drains removed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are ≥ 18 years old.\n* Patients who speak and understand English.\n* Patients who have had mastectomy with reconstructive surgery in one or both breasts.\n\nExclusion Criteria:\n\n* Co-morbid delirium\n* Dementia\n* Mental illness, or neurocognitive deficit prohibiting informed consent and/or ability to complete study procedures.'}, 'identificationModule': {'nctId': 'NCT02976103', 'briefTitle': 'Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket: Randomized Trial', 'orgStudyIdInfo': {'id': '16-403'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard Care', 'description': '-Standard Care pain medicine/management will be given', 'interventionNames': ['Other: Standard Care Pain medicine/management']}, {'type': 'EXPERIMENTAL', 'label': 'JACKI® RECOVERY JACKET + Standard Care', 'description': '* Patient will be encouraged to use the Jacki Recovery Jacket at home\n* Patient will be taught how to tuck the drainage tubes in the jacket pocket\n* Patient will be taught how to un-tuck the drainage tubes from jacket pocket\n* Standard care pain medicine/management will be given', 'interventionNames': ['Device: Jacki Recovery jacket', 'Other: Standard Care Pain medicine/management']}], 'interventions': [{'name': 'Jacki Recovery jacket', 'type': 'DEVICE', 'description': 'An outer jacket that holds surgical drains and allows access for blood draws', 'armGroupLabels': ['JACKI® RECOVERY JACKET + Standard Care']}, {'name': 'Standard Care Pain medicine/management', 'type': 'OTHER', 'description': 'Standard care pain medicine and management in hospitals where the study enrolls', 'armGroupLabels': ['JACKI® RECOVERY JACKET + Standard Care', 'Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02130', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Faulkner Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Donna Berry, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Daisy Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Donna Berry, PhD, RN', 'investigatorFullName': 'Donna Berry, PhD, RN, FAAN, AOCN', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}