{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-7.4","upperLimit":"37.0","value":"5.9"},{"groupId":"OG001","lowerLimit":"-11.1","upperLimit":"25.9","value":"9.1"}]}],"title":"Sensory Subscale"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-16.7","upperLimit":"12.5","value":"1.9"},{"groupId":"OG001","lowerLimit":"-4.2","upperLimit":"25.0","value":"5.7"}]}],"title":"Motor Subscale"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-33.3","upperLimit":"22.2","value":"0.6"},{"groupId":"OG001","lowerLimit":"-50.0","upperLimit":"44.4","value":"0.8"}]}],"title":"Autonomic Subscale"}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"27"}],"units":"Participants"}],"description":"Measured by the European Organization for Research and Treatment of Cancer (EORTC)-CIPN 20. Severity of CIPN will be summarized for each treatment arm, and treatment comparisons made via linear regression model with adjustment for baseline severity level. The EORTC QLQ-CIPN20 is a 20-item questionnaire that evaluates CIPN using 3 subscales that assess sensory (9 items), motor (8 items), and autonomic (3 items) symptoms and functioning. The CIPN-20 subscale raw scores are linearly converted to a 0-100 scale such that a high score corresponds to a worse condition or more symptoms. Change in severity was measured by the difference in the converted scores from baseline to three months and the range is -100 to 100.","dispersionType":"Full Range","groups":[{"description":"Patients undergo acupuncture during chemotherapy infusion on day 1 and fluorouracil pump disconnect on day 3 of each biweekly chemotherapy infusion over 12 weeks. Patients also undergo self-administered acupressure over 11 minutes daily for 12 weeks and undergo standard of care oral cryotherapy.\n\nAcupuncture Therapy: Undergo acupuncture\n\nAcupressure Therapy: Undergo acupressure\n\nOral Cryotherapy: Undergo oral cryotherapy\n\nQuestionnaire Administration: Ancillary studies\n\nQuality-of-Life Assessment: Ancillary studies","id":"OG000","title":"Arm I (Acupuncture, Acupressure, Cryotherapy)"},{"description":"Patients undergo standard of care oral cryotherapy.\n\nOral Cryotherapy: Undergo oral cryotherapy\n\nQuestionnaire Administration: Ancillary studies\n\nQuality-of-Life Assessment: Ancillary studies","id":"OG001","title":"Arm II (Cryotherapy)"}],"paramType":"MEAN","populationDescription":"Due to missing patient reported outcomes the overall number of participants analyzed differs from patients that completed the study.","reportingStatus":"POSTED","timeFrame":"At 3 months","title":"Change in Severity of Chemotherapy-induced Peripheral Neuropathy (CIPN) From Baseline to 3 Months","type":"PRIMARY","unitOfMeasure":"units on a scale"}